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Global regulations and guidance

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Continuing the Global regulations and guidance list, 1000 records per page.

  1. EMEA-001847-PIP01-15 - paediatric investigation plan
  2. FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for…
  3. ema-rezolstaRezolsta
  4. 21 CFR 868.1800: Rhinoanemometer.
  5. ema-gemesisGemesis
  6. 2020-16-03_GSR 180 (E) banning of Chenodeoxycholic acid&Ursodeoxycholic acid extracted and…
  7. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  8. EMEA-002747-PIP01-20-M01 - paediatric investigation plan
  9. ema-m-m-rvaxproM-M-RVaxPro
  10. Management Board meeting: 6-7 June 2018
  11. ema-scintimunScintimun
  12. 21 CFR 866.5090: Antimitochondrial antibody immunological test system.
  13. Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices…
  14. Quality: non-immunologicals
  15. 21 CFR 820.100: Corrective and preventive action.
  16. Sixteenth Meeting of the Management Board
  17. PSUSA/00010242/202108 - periodic safety update report single assessment
  18. Proton Therapy System Approved for Marketing
  19. Bilateral interactions with non-EU regulators
  20. EMEA-002698-PIP01-19 - paediatric investigation plan
  21. 21 CFR 26.14: Transmission of preapproval inspection reports.
  22. GN-21-R5 Guidance on Change Notification for Registered MD (2023 Mar) PUB [ARCHIVED on 02…
  23. EU/3/24/2952 - orphan designation for treatment of congenital alpha-1 antitrypsin…
  24. Lyumjev (previously Liumjev)
  25. Nintedanib Systemic Sclerosis
  26. EMEA-000709-PIP01-09-M05 - paediatric investigation plan
  27. ema-tybostTybost
  28. EU/3/14/1343 - orphan designation for treatment of pancreatic cancer
  29. EMEA-001171-PIP01-11-M02 - paediatric investigation plan
  30. ema-famvir-referralFamvir - referral
  31. EMA Management Board: highlights of March 2018 meeting
  32. A Windfall for Medical Device Standards Development, AAMI StMP Has Launched!
  33. Two additional countries to benefit from EU-US mutual recognition agreement for…
  34. 21 CFR 876.5015: Pancreatic drainage stent and delivery system.
  35. Method of preparation: Interpretation of minimal manipulation
  36. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate…
  37. Origani dictamni herba - herbal medicinal product
  38. EU/3/22/2598 - orphan designation for treatment of giant axonal neuropathy
  39. 21 CFR 862.1375: Histidine test system.
  40. ema-lamictal-referralLamictal - referral
  41. Drug Safety Update: monthly PDF newsletter: Drug Safety Update June 2022
  42. 21 CFR 864.9875: Transfer set.
  43. European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 May 2005
  44. Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal…
  45. EU/3/14/1368 - orphan designation for treatment of fibrodysplasia ossificans progressiva
  46. EMEA-001986-PIP01-16 - paediatric investigation plan
  47. 21 CFR 886.5420: Contact lens inserter/remover.
  48. Call for expression of interest for independent scientific experts to participate in the…
  49. Leuprolide acetate for injectable suspension
  50. 21 CFR 822.38: What reports must I submit to you?
  51. Committee for Orphan Medicinal Products (COMP): 19-21 January 2021
  52. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30…
  53. Paediatric Committee elects Koenraad Norga as its new chair
  54. AAMI Nominates Members for Board of Directors
  55. Working parties and other groups
  56. EU/3/08/596 - orphan designation for treatment of Hodgkin's lymphoma
  57. Paediatric Committee (PDCO): 23-26 June 2020
  58. Concept paper for the revision of scientific guidelines on limited market for veterinary…
  59. EMA facilitates early engagement with medicine developers to combat antimicrobial…
  60. Training session for patients and consumers involved in European Medicines Agency…
  61. ema-altargoAltargo
  62. EU/3/03/177 - orphan designation for treatment of multiple myeloma
  63. EU/3/01/019 - orphan designation for treatment of pulmonary arterial hypertension and…
  64. Best practice in the labelling and packaging of medicines: Best practice guidance on the…
  65. Quality: specific types of products
  66. Paediatric Committee (PDCO): 23-26 February 2021
  67. Renewing Marketing Authorisations for medicines
  68. ema-peyona-previously-nymusaPeyona (previously Nymusa)
  69. Permission for conducting a Phase rB/IlA 'clinical study entitled , "A Phase IS /IrA…
  70. Pfizer withdraws its marketing authorisation application for Exulett (dalbavancin)
  71. EMEA-003040-PIP01-21 - paediatric investigation plan
  72. 21 CFR 874.3320: Group hearing aid or group auditory trainer.
  73. ema-lacosamide-accordLacosamide Accord
  74. Dabigatran Etexilate Leon Farma
  75. Clinical investigation of medicinal products indicated for the treatment of psoriasis…
  76. 21 CFR 73.32: Antarctic krill meal.
  77. Committee for Herbal Medicinal Products (HMPC): 12-13 September 2011
  78. Recommendations from the independent Expert Advisory Group on the use of Paclitaxel…
  79. cdsco-luspatercept-ace-536Luspatercept (ACE-536)
  80. 21 CFR 862.1420: Isocitric dehydrogenase test system.
  81. ema-respiporc-flu3Respiporc Flu3
  82. European Medicines Agency invites comments on new overarching guidance for the development…
  83. Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan
  84. EMEA-000786-PIP01-09-M02 - paediatric investigation plan
  85. ema-icatibant-accordIcatibant Accord
  86. EMA regular press briefing on public health emergencies
  87. Gilenya - direct healthcare professional communication (DHPC)
  88. Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or…
  89. ema-tevimbraTevimbra
  90. Innovative Medicines Initiative WEB-RADR workshop: mobile technologies and social media as…
  91. EMEA-003134-PIP01-21 - paediatric investigation plan
  92. Notice regarding sale of medicines without prescription
  93. PSUSA/00001696/201411 - periodic safety update report single assessment
  94. Cinnamomi cortex - herbal medicinal product
  95. Drug Alert list for month of October 2016
  96. cdsco-ramucirumab-injectionRamucirumab Injection
  97. 21 CFR 882.1540: Galvanic skin response measurement device.
  98. Regulatory information - use of eSubmission Gateway and web client extended to new…
  99. Committee for Advanced Therapies (CAT): 14-16 March 2018
  100. 21 CFR 890.5370: Nonmeasuring exercise equipment.
  101. Human autologous mesenchymal adult stem cells extracted from adipose tissue - paediatric…
  102. NOTICE regarding not of Standard Quality of Mediclone D
  103. Paediatric Committee (PDCO): 13-16 December 2022
  104. Appointment of CPIO for the purpose of RTI Technical Matters 7 Aug 24
  105. Data requirements for the replacement of established master seeds (MS) already used in…
  106. Biphasic Insulin Aspart Injection IP 100 IU/mL
  107. Cephalexin extended release Clavulanate Potassium tablet
  108. Committee for Orphan Medicinal Products (COMP): 3-5 November 2026
  109. New medicine to protect honey bees against Varroa mites
  110. ema-ngenlaNgenla
  111. 21 CFR 1.663: How do I request an FDA waiver or waiver extension for the 13-month limit…
  112. Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric…
  113. NMPA Issued the Announcement on Effective Implementation of Unique Identification for the…
  114. 21 CFR 888.3600: Implantable post-surgical kinematic measurement knee device.
  115. FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and…
  116. EMEA-000548-PIP01-09-M08 - paediatric investigation plan
  117. ema-adynoviAdynovi
  118. Utreglutide (GL0034) Solution for injection1.0 mg/mL
  119. ema-stimufendStimufend
  120. EU/3/12/1043 - orphan designation for diagnosis of positive folate-receptor status in…
  121. Committee for Orphan Medicinal Products (COMP): 11-12 January 2011
  122. cdsco-liraglutide-3-0-mgLiraglutide 3.0 mg
  123. ema-cymbaltaCymbalta
  124. Message from EMA’s outgoing Executive Director, Guido Rasi
  125. Metformin Hydrochloride IP (SR) + Pioglitazone Hydrochloride IP + Sitagliptin Phosphate IP…
  126. Clinical Trials Information System (CTIS): Walk-in clinic - November 2024
  127. Gavreto - withdrawal of application for variation to marketing authorisation
  128. Women of AAMI's Leadership Talk About Work-Life Balance, Opportunity, and Confidence
  129. ema-efgratinEfgratin
  130. Strengthening global collaboration on COVID-19 real-world evidence and observational…
  131. Paediatric Committee (PDCO): 9-11 November 2011
  132. European Medicines Agency recommends restricted use for piroxicam
  133. Voice Recognition Systems
  134. 21 CFR 892.5740: Radionuclide teletherapy source.
  135. ema-meloxoralMeloxoral
  136. How to improve the availability of veterinary vaccines in Europe
  137. EMA reviewing data on sabizabulin for COVID-19
  138. cdsco-toujeo-300-units-mlToujeo 300 Units/ml
  139. PSUSA/00002001/201504 - periodic safety update report single assessment
  140. SAR440340/REGN3500/itepekimab
  141. EU/3/11/854 - orphan designation for treatment of multiple myeloma
  142. Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2026
  143. Similar biological medicinal products containing biotechnology-derived proteins as active…
  144. Note on the removal of the target animal batch safetytest (TABST) from European…
  145. PSUSA/00001333/202302 - periodic safety update report single assessment
  146. EMEA-001597-PIP01-13 - paediatric investigation plan
  147. 21 CFR 882.5250: Burr hole cover.
  148. Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
  149. EMEA-000196-PIP01-08-M04 - paediatric investigation plan
  150. PSUSA/00002602/201703 - periodic safety update report single assessment
  151. EMEA-000694-PIP03-17 - paediatric investigation plan
  152. DR_G.S.R. 558(E) dt_17.07.2015_Amendment Rule 105_amendment in proviso and proviso added…
  153. ema-versican-plus-pi-l4rVersican Plus Pi/L4R
  154. PSUSA/00000313/201511 - periodic safety update report single assessment
  155. 21 CFR 868.5820: Dental protector.
  156. 2019.06.24 Draft G.S.R. 447(E) Definition Responsibility labelling requirements for…
  157. EU/3/14/1241 - orphan designation for treatment of Duchenne muscular dystrophy
  158. Use of herbal medicinal products containing thujone - Scientific guideline
  159. Environmental Risk Assessments in medicines
  160. Committee for Herbal Medicinal Products (HMPC): 18-20 July 2022
  161. PSUSA/00001584/201702 - periodic safety update report single assessment
  162. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent)
  163. cdsco-dupilumabnDupilumabn
  164. Committee for Herbal Medicinal Products (HMPC): 16-18 May 2022
  165. ema-olansekOlansek
  166. EU/3/24/2936 - orphan designation for treatment of C3 glomerulopathy
  167. HMA/EMA statement on approval of vaccines
  168. Heading Off Medical Supply Chain Woes, FDA Explores Proactive Solutions: An ISC 2022…
  169. European Medicines Agency releases good pharmacovigilance practice modules for public…
  170. How HTM Can Leverage AI to Enhance Efficiency and Productivity
  171. cdsco-everolimusEverolimus
  172. 21 CFR 874.3620: Ear, nose, and throat synthetic polymer material.
  173. Update of EU recommendations for 2018/2019 seasonal flu vaccine composition
  174. European Union (EU) International Organisation for Standardization (ISO) for…
  175. 21 CFR 870.2360: Electrocardiograph electrode.
  176. Non-clinical Working Party
  177. Warning on transmissible agents in summary of product characteristics and package leaflets…
  178. EMEA-002934-PIP01-20 - paediatric investigation plan
  179. ema-camzyosCamzyos
  180. NMPA Announcement on the Issues Related to the Implementation of the Measures for the…
  181. 21 CFR 25.44: Lead and cooperating agencies.
  182. Ronaxan and its associated names - referral
  183. Updated information on 32 mg intravenous ondansetron (Zofran) dose and pre-mixed…
  184. ema-biograstimBiograstim
  185. EMEA-001912-PIP02-16-M03 - paediatric investigation plan
  186. ema-leafletsLeaflets
  187. Health Product Vigilance Framework
  188. Paediatric Committee (PDCO): 10-13 October 2017
  189. EU/3/03/171 - orphan designation for treatment of ovarian cancer
  190. EMEA-001111-PIP01-10 - paediatric investigation plan
  191. Committee for Advanced Therapies (CAT): 14-15 July 2011
  192. PSUSA/00001509/202004 - periodic safety update report single assessment
  193. DR_G.S.R. 734(E) dt_21.12.2005_Amendment Schedule K_Production of Oxygen 93 percent
  194. PSUSA/00003013/201605 - periodic safety update report single assessment
  195. 21 CFR 866.5260: Complement C3b inactivator immunological test system.
  196. PSUSA/00009182/202012 - periodic safety update report single assessment
  197. PSUSA/00001860/201901 - periodic safety update report single assessment
  198. Notice Regarding Online Portal Sugam
  199. Committee for Orphan Medicinal Products: February 2005 meeting
  200. 21 CFR 1.700: Who is subject to a user fee under this subpart?
  201. 21 CFR 12.140: Review by the courts.
  202. EU/3/22/2740 - orphan designation for treatment of pancreatic cancer
  203. Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and…
  204. Eliquis - opinion on variation to marketing authorisation
  205. EU/3/08/545 - orphan designation for treatment of congenital erythropoietic porphyria
  206. ema-aduhelmAduhelm
  207. EMEA-001322-PIP01-12 - paediatric investigation plan
  208. EU/3/16/1608 - orphan designation for treatment of C3 glomerulopathy
  209. EMEA-001418-PIP01-15-M01 - paediatric investigation plan
  210. 17th meeting of the committee for veterinary medicinal products
  211. PSUSA/00001392/202308 - periodic safety update report single assessment
  212. Lansopon 15 mg and 30 mg - referral
  213. ema-coxatabCoxatab
  214. EMEA-002768-PIP01-20 - paediatric investigation plan
  215. cdsco-lyka-labsLyka Labs
  216. Axel Wirth: Ransomware-Linked Death Hits Close to Home
  217. 21 CFR 870.1120: Blood pressure cuff.
  218. EU/3/14/1263 - orphan designation for the treatment of sickle cell disease
  219. Public statement on the increased risk of serious infection and neutropenia in patients…
  220. Meeting highlights from the Paediatric Committee :14 -16 October 2009
  221. PSUSA/00001278/201703 - periodic safety update report single assessment
  222. ema-fF
  223. Drug Alert list for month of November 2021
  224. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August…
  225. Regulations for Administration on Human Organ Bank, Regulations for Administration on…
  226. ema-vibativVibativ
  227. NMPA Issues Three Guidances including the Guidance for Nomenclature for Generic Names of…
  228. Innovation Challenges Explore Ethylene Oxide Alternatives, Emissions Control
  229. 2023.03.09_NDCTR_G.S.R. 175(E)_ Amendment in First Schedule regarding use of induced…
  230. With Healthcare 'Under Constant Cyberattack,' HHS Releases Guidance
  231. ema-tavanic-referralTavanic - referral
  232. 21 CFR 868.1910: Esophageal stethoscope.
  233. Notice regarding requirement of stability data of COPP
  234. European Medicines Agency updates product-information template to label medicines subject…
  235. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 November 2022
  236. Pam Neiderer: The Evolution of Sterile Processing in Ambulatory Centers
  237. 21 CFR 862.2570: Instrumentation for clinical multiplex test systems.
  238. EU/3/16/1774 - orphan designation for treatment in haematopoietic stem cell…
  239. Committee for veterinary medicinal products: 73rd meeting
  240. Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR)…
  241. 21 CFR 868.5420: Ether hook.
  242. PSUSA/0000389/201412 - periodic safety update report single assessment
  243. Clinical and non-clinical evaluation during the consultation procedure on medicinal…
  244. Trilipix - Review update of Trilipix (fenofibric acid) and the ACCORD Lipid Trial
  245. PSUSA/00010376/201604 - periodic safety update report single assessment
  246. 21 CFR 870.4500: Cardiovascular surgical instruments.
  247. 31st meeting of the Committee for Orphan Medicinal Products
  248. PSUSA/10510/202301 - periodic safety update report single assessment
  249. 21 CFR 874.4500: Ear, nose, and throat microsurgical carbon dioxide laser.
  250. New gene therapy for the treatment of children with ultra-rare immune disorder recommended…
  251. Committee for Advanced Therapies (CAT): 19-21 January 2022
  252. EU/3/16/1627 - orphan designation for treatment of post-transplantation…
  253. 21 CFR 12.92: Prehearing conference procedure.
  254. Industry stakeholder meeting on Brexit and operation of the centralised procedure for…
  255. Paediatric Formulation Operational Expert Group
  256. PSUSA/00002832/201909 - periodic safety update report single assessment
  257. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 April 2013
  258. EU/3/22/2634 - orphan designation for treatment of follicular lymphoma
  259. EU/3/09/670 - orphan designation for treatment of acromegaly
  260. EMEA-000637-PIP02-10-M07 - paediatric investigation plan
  261. EU/3/06/412 - orphan designation for treatment of retinitis pigmentosa
  262. EU/3/13/1168 - orphan designation for treatment of limbal stem cell deficiency
  263. 21 CFR 58.190: Storage and retrieval of records and data.
  264. EMEA-000332-PIP01-08-M15 - paediatric investigation plan
  265. Paediatric Committee (PDCO): 9-12 September 2025
  266. Team-NB-List-PositionPapers-20240710
  267. EU/3/07/433 - orphan designation for treatment of renal-cell carcinoma
  268. 21 CFR 872.3330: Preformed crown.
  269. 21 CFR 60.34: FDA action on petitions.
  270. Committee for Orphan Medicinal Products (COMP): 11-13 April 2022
  271. Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh
  272. Orphan medicinal products
  273. NMPA Released Announcement on the Application of 13 ICH Guidelines Including S1A…
  274. PSUSA/00002828/202204 - periodic safety update report single assessment
  275. Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of…
  276. 21 CFR 864.6160: Manual blood cell counting device.
  277. Notice inviting Expression of Interest for development of Digital Drugs Regulatory System
  278. AAMI Fellow Program Opens 2022 Nomination Process
  279. EU/3/18/1990 - orphan designation for treatment of Friedreich’s ataxia
  280. EU/3/15/1591 - orphan designation for treatment of pseudohypoaldosteronism 1B
  281. PSUSA/00009174/201702 - periodic safety update report single assessment
  282. 21 CFR 870.2880: Ultrasonic transducer.
  283. Application Form for New Investigational Testing Authorization (ITA)
  284. NDCTR_G.S.R. 835(E) dt_22.11.2022_Amendment in First Schedule for non clinical testing…
  285. Medical Devices Product Classification Guide
  286. Core summary of product characteristics for human tetanus immunoglobulin for intramuscular…
  287. 21 CFR 71.27: Listing and exemption from certification on the Commissioner's initiative.
  288. PSUSA/00000778/201712 - periodic safety update report single assessment
  289. Matt Baretich: Old Dog, New Tricks
  290. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 January 2013
  291. Risk Management During Reprocessing – The State of Play
  292. New Class III Medical Device Licence Application Form
  293. PSUSA/00002095/201701 - periodic safety update report single assessment
  294. Long-acting formulations for injection containing barium selenate for all food producing…
  295. Is Your SPD Prepared to Reprocess Robotic Instruments
  296. Regulatory information – Mandatory use of common repository for human centralised…
  297. ema-fatrovax-rhdFatrovax RHD
  298. Committee for veterinary medicinal products: Meeting of 16 to 18 March 2004
  299. EU/3/19/2193 - orphan designation for treatment of periodic paralysis
  300. PSUSA/00000078/201601 - periodic safety update report single assessment
  301. Puncture Surgical Navigation Positioning System Approved for Marketing
  302. EU/3/14/1357 - orphan designation for treatment of acute respiratory distress syndrome…
  303. EMA website briefly unavailable on 3 March
  304. Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed…
  305. Guidance documents related to data submission for authorised medicines
  306. Drug Alert list for month of December 2020
  307. 21 CFR 898.11: Applicability.
  308. Committee for Medicinal Products for Human Use (CHMP): 18-21 July 2022
  309. AAMI & HSPA Outline 2022 Standards Updates at HSPA Expo
  310. cdsco-notice-ande-feedbackNotice ande Feedback
  311. VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs…
  312. Public statement on the current shortage of radiopharmaceuticals in the European Union
  313. 2026.01.21 G.S.R. 53(E)_Draft Notification for amendment in Schedule V w.r.t. unit of…
  314. EMEA-002745-PIP01-19 - paediatric investigation plan
  315. EMEA-002016-PIP03-19-M02 - paediatric investigation plan
  316. Typhoid Conjugate vaccineTCV
  317. 21 CFR 880.6210: Sharps needle destruction device.
  318. EU/3/04/232 - orphan designation for treatment of glioma
  319. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: March 22, 2023: Meeting of the…
  320. ema-ich-efficacyICH: efficacy
  321. Committee for Advanced Therapies (CAT): 6-8 November 2024
  322. Drugs Alert for the month of November 2017
  323. European Union clinical trials portal and Union database: Meeting with stakeholders
  324. Conditional marketing authorisation
  325. PSUSA/00010425/201808 - periodic safety update report single assessment
  326. European Medicines Agency welcomes new Head of Information and Communications Technology
  327. Committee for Medicinal Products for Veterinary Use (CVMP): 03-05 December 2024
  328. PSUSA/00010463/202107 - periodic safety update report single assessment
  329. EU/3/19/2239 - orphan designation for treatment of cystinuria
  330. 21 CFR 20.111: Data and information submitted voluntarily to the Food and Drug…
  331. Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292)
  332. Committee for Orphan Medicinal Products: September 2006 meeting
  333. ema-livmarliLivmarli
  334. ema-venviaVenvia
  335. Notice regarding Notification to notify all the medical device under sub-section (b) of…
  336. UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants…
  337. European Medicines Agency gives first positive opinions on medicinal products for use…
  338. Antimicrobial Resistance AMR Mitigation
  339. ARTEMIDE-Biliary01GCT/CT04/FF/2023/39848 CT/23/0001222
  340. PSUSA/00001367/201802 - periodic safety update report single assessment
  341. FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa…
  342. Regulatory requirements for vaccines intended to provide protection against variant…
  343. European Medicines Agency tightens conflicts-of-interests policies with immediate effect
  344. QMF149 150-80 microgram
  345. EMEA-000869-PIP01-10 - paediatric investigation plan
  346. EMEA-000957-PIP01-10 - paediatric investigation plan
  347. FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations…
  348. EMEA-002844-PIP01-20 - paediatric investigation plan
  349. EU/3/09/698 - orphan designation for treatment of sickle cell disease
  350. Annex C Guidance for Quality By Design as an Alternative Approach to Process Validation
  351. Public consultation starts on PRIME - a new scheme to optimise development of priority…
  352. 21 CFR 862.1435: Ketones (nonquantitative) test system.
  353. EU/3/16/1822 - orphan designation for treatment of interstitial cystitis
  354. cdsco-iview-1201IVIEW-1201
  355. ema-ema-closed-9-10-mayEMA closed 9-10 May
  356. Consultation: Draft Documents for Drug Good Manufacturing Practices (GMP) Inspection…
  357. 21 CFR 862.1085: Angiotensin I and renin test system.
  358. 21 CFR 864.7825: Sickle cell test.
  359. Polmacoxib Capsules 2mg
  360. PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine…
  361. List of Drugs Medical Devices Vaccine and Cosmetics declared as Spurious Adulterated…
  362. 21 CFR 878.3590: Ear prosthesis.
  363. Hyperimmune Intravenous Immunoglobulin
  364. Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2022
  365. Efonidipine Hydrochloride Ethanolate + Telmisartan IP + Chlorthalidone IP Tablets (Phase…
  366. EU/3/03/136 - orphan designation for treatment of follicular lymphoma
  367. ema-vfendVfend
  368. 29th meeting of the Committee for Orphan Medicinal Products
  369. William Maisel, MD, MPH, FDA Device Oversight Leader, Retires
  370. Benidipine Hydrochloride JP + Chlorthalidone IP Film coated tablets (Phase III Clinical…
  371. PSUSA/00010067/201510 - periodic safety update report single assessment
  372. Budesonide + Glycopyrronium + Formoterol Fumarate inhalation Powder (Phase IV)
  373. PSUSA/00002673/201712 - periodic safety update report single assessment
  374. EU/3/19/2151 - orphan designation for treatment of haemophilia B
  375. ema-ciambraCiambra
  376. Notice to All stakeholders for Strengthening of Private Medical Device Testing Laboratory
  377. European Medicines Agency Human Scientific Committees' Working Parties with Patients' and…
  378. EMEA-003366-PIP01-22 - paediatric investigation plan
  379. ema-onduarpOnduarp
  380. EU/3/16/1717 - orphan designation for treatment of tracheal stenosis
  381. EU/3/04/218 - orphan designation for treatment of renal-cell carcinoma
  382. cdsco-noticeNotice
  383. EMEA-003376-PIP01-22 - paediatric investigation plan
  384. 21 CFR 20.49: Denial of a request for records.
  385. PSUSA/00000434/201907 - periodic safety update report single assessment
  386. 21 CFR 884.2740: Perinatal monitoring system and accessories.
  387. ICH M14 guideline on general principles on plan, design and analysis of…
  388. Pediatric Advisory Committee Meeting Announcement - 09/16/2026
  389. 21 CFR 888.3050: Spinal interlaminal fixation orthosis.
  390. 21 CFR 1.1153: What are the requirements for submitting abridged analytical reports?
  391. Aztreonam-Avibactam (ATM-AVI
  392. Requirements to the chemical and pharmaceutical quality documentation concerning…
  393. cdsco-jan21-2010-g-s-r-45-eJan21,2010(G.S.R_45(E)
  394. 21 CFR 886.1450: Corneal radius measuring device.
  395. EMEA-001713-PIP02-14 - paediatric investigation plan
  396. Inspection of Nonclinical Laboratories Conducting Animal Rule-Specific Studies
  397. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  398. EMEA-002964-PIP01-21-M02 - paediatric investigation plan
  399. ema-ibandronic-acid-sandozIbandronic Acid Sandoz
  400. P/93/2010 - paediatric investigation plan
  401. 21 CFR 886.1350: Keratoscope.
  402. European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor…
  403. EMEA-002759-PIP01-19 - paediatric investigation plan
  404. EMEA-002656-PIP01-19 - paediatric investigation plan
  405. 21 CFR 878.4760: Removable skin staple.
  406. Committee for medicinal products for veterinary use: Meeting of 18 to 20 July 2006
  407. 21 CFR 866.5340: Ferritin immunological test system.
  408. Product Lifecycle Management (PLM) Portal Access Management Training Session
  409. (In Japanese)Amendment of Ministerial Ordinance on Good Post-marketing Study Practice for…
  410. EMEA-001634-PIP01-14 - paediatric investigation plan
  411. cdsco-erenumabErenumab
  412. QMS P0001.005: Quality System Manual
  413. 21 CFR 890.5360: Measuring exercise equipment.
  414. EMEA-001940-PIP01-16-M05 - paediatric investigation plan
  415. ema-eptifibatide-accordEptifibatide Accord
  416. ema-viral-diseasesViral diseases
  417. cdsco-enbrel-etanerceptEnbrel®’ (Etanercept
  418. EMEA-003351-PIP01-22 - paediatric investigation plan
  419. EU/3/12/1073 - orphan designation for treatment of malignant mesothelioma
  420. April 25, 2016: Meeting of the Peripheral and Central Nervous System Drugs Advisory…
  421. ema-leukoscanLeukoScan
  422. Healthcare Professionals' Organisations Working Group (HCP WG)
  423. PSUSA/00002060/201705 - periodic safety update report single assessment
  424. cdsco-pasireotide-larPasireotide LAR
  425. EMEA-001627-PIP01-14-M03 - paediatric investigation plan
  426. Tecentriq - withdrawal of application for variation to marketing authorisation
  427. PSUSA/00000527/201704 - periodic safety update report single assessment
  428. Safety and residues: pharmaceuticals
  429. EU/3/13/1224 - orphan designation for treatment of aneurysmal subarachnoid haemorrhage
  430. EMEA-000802-PIP01-09 - paediatric investigation plan
  431. EMEA-000184-PIP02-14 - paediatric investigation plan
  432. EMEA-000700-PIP02-10 - paediatric investigation plan
  433. EU/3/16/1660 - orphan designation for treatment of beta thalassaemia intermedia and major
  434. AAMI ARRAY Platform Offers ‘One-Stop Shop’ for Research, Standards, News, and More
  435. Committee for Proprietary Medicinal Products (CPMP): 24-25 April 2001 meeting (summary)
  436. European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission…
  437. Leighton Hansel: Despite Criticism, U.S. Regulation of Medical Devices Is a Success
  438. EMEA-001391-PIP01-12 - paediatric investigation plan
  439. aami-william-hyman-beep-beepWilliam Hyman: Beep, Beep
  440. EMEA-002438-PIP02-19-M02 - paediatric investigation plan
  441. Guideline on the assessment of clinical safety and efficacy in the preparation of European…
  442. HTM Leadership Groups Welcome Members
  443. ema-brineuraBrineura
  444. Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
  445. Glycopyrrolate IP + Budesonide IP + Formoterol Fumarate Dihydrate IP eq. to Formoterol…
  446. EU/3/14/1370 - orphan designation for treatment of polymyositis
  447. EMA website briefly unavailable on 3 December 2020
  448. Regulatory information - Revision of procedural guidance to reflect update of variations…
  449. Ginseng radix - herbal medicinal product
  450. EU/3/22/2712 - orphan designation for diagnosis of AL amyloidosis
  451. Ken Hoyme: Developing a ‘Software Bill of Materials’ for the Future of Cybersecurity
  452. European Medicines Agency/European Federation of Pharmaceutical Industries and…
  453. ema-oxmaxOxmax
  454. EU/3/21/2486 - orphan designation for treatment of multiple myeloma
  455. EMA event supporting materials
  456. EMEA-000153-PIP01-07-M05 - paediatric investigation plan
  457. 21 CFR 21.10: Policy concerning records about individuals.
  458. EMEA-002383-PIP01-18-M02 - paediatric investigation plan
  459. EU/3/16/1818 - orphan designation for treatment of acute liver failure
  460. EMEA-001144-PIP01-11 - paediatric investigation plan
  461. European Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth…
  462. Training on electronic submission of information on medicines - new pharmacovigilance…
  463. European Medicines Agency publishes policy on communicating safety issues for human…
  464. EMEA-002708-PIP02-21 - paediatric investigation plan
  465. EMEA-000609-PIP01-09-M03 - paediatric investigation plan
  466. March 1, 2016: Science Board to the FDA Meeting Announcement - 02/29/2016
  467. EU/3/19/2177 - orphan designation for treatment of glioma
  468. EMEA-002894-PIP01-20 - paediatric investigation plan
  469. PSUSA/00001275/201703 - periodic safety update report single assessment
  470. FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA…
  471. EMEA-002340-PIP01-18 - paediatric investigation plan
  472. PSUSA/00010145/201608 - periodic safety update report single assessment
  473. Notice Creation of Sub-login id(s) after primary registration in SUGAM portal
  474. NMPA Issued the Guiding Principles for Capacity Building of Cosmetics Inspection and…
  475. Policy Interpretation of the National Medical Products Administration on Issuing the…
  476. Testing of all categories of new drugs for their approval
  477. ema-hmpc-documentsHMPC Documents
  478. Setting of Public Relations Office at all Zonal and Sub-Zonal Office of CDSCO
  479. General dossier requirements
  480. EMEA-000100-PIP01-07-M01 - paediatric investigation plan
  481. 21 CFR 884.3200: Cervical drain.
  482. ICH S9 Non-clinical evaluation for anticancer pharmaceuticals - Scientific guideline
  483. Resmetirom 60mg,80mg,100mg tablet
  484. EU/3/12/1064 - orphan designation for treatment of ovarian cancer
  485. Trastuzumab and Pertuzumab
  486. EMEA-002869-PIP01-21 - paediatric investigation plan
  487. Drug Alert list for month of June 2020
  488. cdsco-rivaroxabanRivaroxaban
  489. 2025.08.01_S.O. 3551(E)_Appointment of Compounding Authority under the Drugs and Cosmetics…
  490. EMEA-000124-PIP01-07-M02 - paediatric investigation plan
  491. 21 CFR 11.50: Signature manifestations.
  492. Renatus® Transcatheter Aortic Valve System Approved for Marketing
  493. Meeting highlights from the Committee for Medicinal Products for Human Use,27-30 May 2008
  494. 21 CFR 872.3500: Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and…
  495. FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for…
  496. ema-duloxetine-lillyDuloxetine Lilly
  497. EMEA-001098-PIP01-10-M01 - paediatric investigation plan
  498. Background to clinical data publication policy
  499. In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse…
  500. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April…
  501. PSUSA/00010161/201612 - periodic safety update report single assessment
  502. Committee for veterinary medicinal products: 67th meeting
  503. cdsco-bemnifosbuvir-ruzasvirBemnifosbuvir+Ruzasvir
  504. EU/3/03/158 - orphan designation for treatment of metachromatic leukodystrophy
  505. EU/3/23/2848 - orphan designation for treatment of patients with light chain (AL)…
  506. Production and quality control of animal immunoglobins and immunosera for human use…
  507. ema-pararegParareg
  508. EU/3/16/1799 - orphan designation for treatment of tenosynovial giant cell tumour…
  509. Reclassification of medical devices in direct contact with the heart, central circulatory…
  510. Refusal of orphan designation for treatment of carcinoma in situ of the urinary bladder
  511. Annual trends for the adverse reaction case reports of health products and medical device…
  512. G.S.R 778 (E) dated 14 Oct 2022 regarding the New Drugs and Clinical Trials (Third…
  513. EU/3/14/1369 - orphan designation for treatment of dermatomyositis
  514. 21 CFR 888.4540: Orthopedic manual surgical instrument.
  515. ema-kalydecoKalydeco
  516. EMEA-001700-PIP01-14 - paediatric investigation plan
  517. EMEA-000703-PIP01-09 - paediatric investigation plan
  518. EU/3/21/2399 - orphan designation for treatment of lymphoplasmacytic lymphoma
  519. European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 October…
  520. Pharmaceutical Affairs Act
  521. ema-joulferonJoulferon
  522. MHRA approach to medicines using non-animal methods
  523. Sodium Hyaluronate + Polyethylene Glycol 400 + Propylene Glycol lubricant eye drops (Phase…
  524. EMEA-002663-PIP01-19 - paediatric investigation plan
  525. ema-asimtufiiAsimtufii
  526. Clinical investigation of medicinal products for the treatment of obsessive compulsive…
  527. HRF -10071 Tablets 10mg, 20mg, 40 mg, 100mg
  528. ema-kinpeygoKinpeygo
  529. cdsco-sep-25-2014-gsr-690-eSep 25 2014 GSR 690(E)
  530. 21 CFR 99.303: Extension of time for completing planned studies.
  531. 21 CFR 20.44: Expedited processing.
  532. Medicine Shortages in Australia: Reporting obligations and the TGA's compliance framework
  533. Non-Technical Aspects of Inspection (PIC/S Seminar 1999 Booklet)
  534. In vitro diagnostic medical devices: procurement, safety, quality and performance
  535. cdsco-empagliflozinEmpagliflozin
  536. PSUSA/00010670/202009 - periodic safety update report single assessment
  537. 21 CFR 74.2331: D&C Red No. 31.
  538. Nisamox Lactating Cow - referral
  539. NMPA Issued the Announcement on the Requirements for Relevant Electronic Application…
  540. Refusal of orphan designation for treatment of painful HIV-associated neuropathy
  541. EU/3/06/362 - orphan designation for treatment of acute liver failure
  542. ema-academiaAcademia
  543. PSUSA/00010005/202002 - periodic safety update report single assessment
  544. cdsco-recombinant-hepatits-eRecombinant Hepatits E
  545. PSUSA/00002607/202308 - periodic safety update report single assessment
  546. ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial…
  547. ema-cabazitaxel-tevaCabazitaxel Teva
  548. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  549. PSUSA/00000294/202309 - periodic safety update report single assessment
  550. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF SEP-2017
  551. PSUSA/00001158/201501 - periodic safety update report single assessment
  552. Committee for Advanced Therapies (CAT): 15-16 April 2010
  553. ribociclib with endocrine
  554. COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
  555. Best expertise vs conflicts of interests: Striking the right balance
  556. PSUSA/00000304/201803 - periodic safety update report single assessment
  557. PSUSA/00002702/202009 - periodic safety update report single assessment
  558. EMEA-002146-PIP02-18 - paediatric investigation plan
  559. EU/3/07/519 - orphan designation for prevention of cytomegalovirus disease in patients…
  560. EMEA-001026-PIP01-10 - paediatric investigation plan
  561. 21 CFR 876.5960: Computerized behavioral therapy device for treating symptoms of…
  562. Adverse drug reaction reporting using Medical Director: Using the ADR reporting template
  563. Harpagophyti radix - herbal medicinal product
  564. Semaglutide Tablets 3mg, 7mg and 14mg
  565. Committee for Herbal Medicinal Products (HMPC): 30-31 March 2011
  566. PSUSA/00003147/202401 - periodic safety update report single assessment
  567. Artificial intelligence in medicine regulation
  568. EMEA-002925-PIP01-20-M01 - paediatric investigation plan
  569. ema-betavert-n-referralBetavert N - referral
  570. Submitting a post-authorisation application
  571. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  572. ema-tysabriTysabri
  573. EMEA-001312-PIP03-19 - paediatric investigation plan
  574. 21 CFR 860.210: De Novo request format.
  575. EMEA-003171-PIP01-21 - paediatric investigation plan
  576. PSUSA/00010299/201603 - periodic safety update report single assessment
  577. Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid…
  578. EU/3/14/1323 - orphan designation for treatment of pancreatic cancer
  579. Notice regarding Pocedure to be followed for subsequent application in respect of FDCs…
  580. New treatment for rare autoimmune disease of nerve cells
  581. Inactivated Therapeutic Tuberculosis Vaccine.RUTI Vaccine
  582. European Medicines Agency recommends first gene therapy for approval
  583. ema-norvirNorvir
  584. ema-fexinidazole-winthropFexinidazole Winthrop
  585. European Medicines Agency meets with avian flu vaccine manufacturers
  586. Committee for Advanced Therapies (CAT): 7-8 April 2011
  587. (Appendix 11) The Standards for Marketing Approval of Anthelmintics
  588. Doxycycline 50% WSP - referral
  589. DR_G.S.R. 433(E) dt_07.06.2012_Amendment to GSR 577E_Addition of prohibition of Import of…
  590. First European Medicines Agency - European Federation of Pharmaceutical Industries and…
  591. EMEA-000288-PIP01-08-M02 - paediatric investigation plan
  592. Hederae helicis folium - herbal medicinal product
  593. EMA regular press briefing on COVID-19
  594. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 July 2017
  595. European Agency for the evaluation of medicinal products: Committee for Proprietary…
  596. EU/3/22/2703 - orphan designation for treatment of pseudoxanthoma elasticum
  597. ema-febseltiqFebseltiq
  598. EMEA-001487-PIP01-13 - paediatric investigation plan
  599. Personalised medicines – focus on patients and healthcare professionals
  600. ICH M4 Common technical document (CTD) for the registration of pharmaceuticals for human…
  601. Thymi herba - herbal medicinal product
  602. ema-oncology-working-partyOncology Working Party
  603. Inviting comments on standard IVD evaluation protocol drafted by ICMR and CDSCO 3
  604. Addressing challenges of innovative cancer immunotherapy medicines
  605. tga-boxed-warning-guidanceBoxed Warning guidance
  606. Completing the bioequivalence study information form
  607. PET (polyethylene terephthalate), used broadly
  608. The Innovative Devices Access Pathway (IDAP)
  609. Policy on Individual(s) accompanying a health products inspector (POL-0141)
  610. cfr-21-cfr-3-1-purpose21 CFR 3.1: Purpose.
  611. Vilanterol Trifenatate eq. to Vilanterol 12.5mcg + Glycopyrrolate IP eq. to Glycopyrronium…
  612. Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing…
  613. PSUSA/00000108/201912 - periodic safety update report single assessment
  614. Committee for veterinary medicinal products: 52nd meeting
  615. Eleventh Nitrosamine Implementation Oversight Group (NIOG) meeting
  616. Clinical trials for medicines: expert advice
  617. Europe recognizes ISO 14971:2019, Application of risk management to medical devices
  618. EU/3/23/2836 - orphan designation for treatment of Guillain-Barré syndrome
  619. Zileuton Ointment 1.25% and 5.0%
  620. ema-efficacy-pharmaceuticalsEfficacy: pharmaceuticals
  621. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6…
  622. Committee for Advanced Therapies (CAT): 15-16 May 2014
  623. 21 CFR 14.172: Utilization of an advisory committee at the request of an interested…
  624. EMEA-001693-PIP03-21 - paediatric investigation plan
  625. 2025.05.28_G.S.R. 345(E)_Draft notification for amendment in certain Drugs Rules (Related…
  626. PSUSA/00002673/201612 - periodic safety update report single assessment
  627. Scott A. Colburn: Conference Focuses on International Standards, Regulations
  628. Institutional Review Board
  629. EMEA-001448-PIP01-13-M03 - paediatric investigation plan
  630. Marvel LifeSciences Ltd withdraws its marketing-authorisation applications for Solumarv…
  631. Guidance on Stability Studies of IVDs 2024
  632. Twelfth Nitrosamine Implementation Oversight Group (NIOG) meeting
  633. 21 CFR 74.1203: FD&C Green No. 3.
  634. 21 CFR 1.918: What must be included in the Statement of Grounds in a petition requesting a…
  635. ema-betaferonBetaferon
  636. EMEA-001043-PIP02-16 - paediatric investigation plan
  637. PRAC: meeting archive 2015-2017
  638. PSUSA/00001997/202103 - periodic safety update report single assessment
  639. PSUSA/00000979/202103 - periodic safety update report single assessment
  640. 21 CFR 878.4340: Contact cooling system for aesthetic use.
  641. 21 CFR 1.1330: What records must I keep when I am performing the initial packing of a raw…
  642. Synchron Research Service: suspension of medicines over flawed studies
  643. EU/3/11/874 - orphan designation for treatment of Stargardt's disease
  644. 21 CFR 7.49: Recall communications.
  645. EU/3/04/195 - orphan designation for treatment of anaplastic thyroid cancer
  646. cdsco-mirikizumabMirikizumab
  647. Guide to Fees for Human Products
  648. PSUSA/00001713/201712 - periodic safety update report single assessment
  649. 2018 Annual Report for Medical Device Registration Released
  650. EU/3/10/771 - orphan designation for treatment of low-flow priapism
  651. Michael Appel: The Risk of Unknown Risks
  652. ema-suvaxyn-ery-referralSuvaxyn Ery - referral
  653. Follow up information session on the TransCelerate initiative
  654. PSUSA/00010631/201812 - periodic safety update report single assessment
  655. Sitagliptin Phosphate IP eq. to Sitagliptin + Dapagliflozin tablets (Phase III)
  656. Jan 17.01.2014 G.S.R. 29 (E)
  657. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 December 2011
  658. DR_G.S.R. 322(E) dt_03.05.1984_26A_reg Oxytetracycline liquid oral prep and Demeclocycline…
  659. EMA public workshop on extrapolation of efficacy and safety in medicine development
  660. PE009, the PIC/S guide to GMP for medicinal products
  661. CPL-2009-0031 tablet 140 mg of Cadila Pharmaceutical Ltd
  662. Pre-Market Guidance on Bare Cardiovascular Stents
  663. International regulators stress value of safe and effective vaccines
  664. Preliminary Report Form (FRM-0237)
  665. Knee Prosthesis System Approved for Marketing
  666. ema-access-to-documentsAccess to documents
  667. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 2020
  668. ema-sampling-and-testingSampling and testing
  669. PSUSA/00010347/201710 - periodic safety update report single assessment
  670. PSUSA/00002203/202304 - periodic safety update report single assessment
  671. 21 CFR 880.5700: Neonatal phototherapy unit.
  672. EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
  673. cdsco-5-aminolevulinic-acid5-aminolevulinic Acid
  674. Start of review of ambroxol and bromhexine
  675. EU/3/17/1875 - orphan designation for treatment of idiopathic CD4 lymphocytopenia
  676. cfr-21-cfr-812-10-waivers21 CFR 812.10: Waivers.
  677. Drug Alert list for month of October 2019
  678. EMEA-001178-PIP01-11-M06 - paediatric investigation plan
  679. EMEA-003182-PIP01-22 - paediatric investigation plan
  680. EU/3/24/2908 - orphan designation for treatment of acute myeloid leukaemia
  681. List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month…
  682. EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of…
  683. Harnessing AI in medicines regulation: use of large language models (LLMs)
  684. EMEA-002780-PIP02-20 - paediatric investigation plan
  685. Live bacterium B. thetaiotaomicron - paediatric investigation plan
  686. PSUSA/00003002/202005 - periodic safety update report single assessment
  687. EU/3/06/357 - orphan designation for treatment of Duchenne muscular dystrophy
  688. 21 CFR 862.1113: Bilirubin (total and unbound) in the neonate test system.
  689. ema-ajovyAjovy
  690. 21 CFR 870.1251: Temporary catheter for embolic protection during transcatheter…
  691. PSUSA-00002152-201902 - periodic safety update report single assessment
  692. 21 CFR 880.6890: General purpose disinfectants.
  693. EU/3/03/167 - orphan designation for treatment of chronic idiopathic myelofibrosis
  694. Stalevo - withdrawal of application for variation to marketing authorisation
  695. Caryophylli flos - herbal medicinal product
  696. CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived…
  697. Atezolizumab compared with chemotherapy
  698. Symbols used on medical devices: poster
  699. Filgrastim injection IP 300 mcg/ 0.5 ml
  700. 21 CFR 878.4930: Suture retention device.
  701. Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication
  702. Multiple sclerosis workshop - Registries initiative
  703. PSUSA/00002972/201610 - periodic safety update report single assessment
  704. EMEA-001463-PIP01-13 - paediatric investigation plan
  705. PSUSA/00000613/201505 - periodic safety update report single assessment
  706. ema-cluster-activitiesCluster activities
  707. 21 CFR 866.3145: Coxsackievirus serological reagents.
  708. Revised Export NOC Guidance document for Manufacture of Unapproved / Approved New Drugs…
  709. Eluxadoline Tablets 100 mg
  710. EMEA-001760-PIP01-15-M03 - paediatric investigation plan
  711. Committee for Herbal Medicinal Products (HMPC): 10 May 2011
  712. Committee for veterinary medicinal products: Meeting of 10 to 12 February 2004
  713. ema-quality-by-designQuality by design
  714. EU/3/12/1044 - orphan designation for diagnosis of positive folate-receptor status in…
  715. PSUSA/00002204/201804 - periodic safety update report single assessment
  716. EMEA-002595-PIP01-19 - paediatric investigation plan
  717. PSUSA/00002411/202303 - periodic safety update report single assessment
  718. February 2, 2024: Anesthesiology and Respiratory Therapy Devices Panel of the Medical…
  719. PSUSA/00000438/201510 - periodic safety update report single assessment
  720. EMEA-000172-PIP01-07-M03 - paediatric investigation plan
  721. Meeting of the EMEA working party on herbal medicinal products 4 and 5 November 2002
  722. ema-vitraveneVitravene
  723. EMEA-001824-PIP01-15 - paediatric investigation plan
  724. Provisions for Medical Device Registration and Filing
  725. Office Memorandum Grant of NOC for procuring unapproved/Approved New Drug
  726. Hydroxyethyl starch - direct healthcare professional communication (DHPC)
  727. EU/3/09/678 - orphan designation for treatment of soft tissue sarcoma
  728. Questions and answers on the possibility to extrapolate pre-inactivation titres as part of…
  729. Committee for Proprietary Medicinal Products (CPMP) 50th plenary meeting
  730. Organisation Management Service (OMS)
  731. EU/3/14/1305 - orphan designation for treatment of glioma
  732. EU/3/24/2945 - orphan designation for treatment of primary large B-cell lymphoma of…
  733. EMA and European Organisation for Research and Treatment of Cancer (EORTC) workshop: How…
  734. A Clouded Future for European Medical Device Harmonization
  735. cdsco-velpanatVELPANAT
  736. Statement on British Biotech Pharmaceuticals Ltd.'s ZACUTEX Application of the 5th May…
  737. Microbiological quality of medicinal cannabis products
  738. Submmission of notarized/apostilled documents for import and Registration of drugs in view…
  739. 21 CFR 21.42: Responses to requests.
  740. PSUSA/00001826/202105 - periodic safety update report single assessment
  741. EPAR summaries for the public: A further step for the provision of better information…
  742. EMEA-001416-PIP01-12-M03 - paediatric investigation plan
  743. FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety-emphasizing…
  744. EU/3/18/1992 - orphan designation for treatment of myasthenia gravis
  745. Statements of non-compliance with GMP now publicly available in EudraGMDP
  746. EMEA-003167-PIP01-21 - paediatric investigation plan
  747. PSUSA/00002795/201705 - periodic safety update report single assessment
  748. 21 CFR 886.3300: Absorbable implant (scleral buckling method).
  749. PSUSA/00002320/201804 - periodic safety update report single assessment
  750. ema-heplisavHeplisav
  751. FDA Explains Medical Device Cybersecurity Requirements
  752. EU/3/15/1447 - orphan designation for treatment of soft tissue sarcoma
  753. European Medicines Agency Management Board elects Kent Woods as new chair
  754. EU/3/15/1549 - orphan designation for treatment of primary graft dysfunction following…
  755. NMPA Issues Announcement on Requirements for the Management of Drug Records and Data…
  756. ema-bravecto-plusBravecto Plus
  757. Committee for Advanced Therapies (CAT): 15-17 July 2026
  758. CagriSema 1.0 (1,0) mg/ml +0.5 (0,5) mg/ml (0.25 mg/0.25 mg) /placebo
  759. Ken Hoyme: Success in Medical Device Cybersecurity Demands Collaboration
  760. cdsco-lixisenatideLixisenatide
  761. How do we ensure faster and better clinical trials in the EU? – Peter Arlett and Marianne…
  762. A Leader in Standards Development: Elisabeth George
  763. EMEA half-year report for 2008 shows activities to be on target, with a marked increase in…
  764. Drug Safety Update: monthly PDF newsletter: Drug Safety Update May 2023
  765. Classification of Medical Device pertaining to Software under the provisions of Medical…
  766. Paediatric Committee (PDCO): 27-30 January 2026
  767. PSUSA/00003084/201611 - periodic safety update report single assessment
  768. PSUSA/00000795/202110 - periodic safety update report single assessment
  769. Clinical investigation of medicinal products for the treatment of systemic lupus…
  770. Piperis methystici rhizoma - herbal medicinal product
  771. 21 CFR 866.5460: Haptoglobin immunological test system.
  772. 21 CFR 882.1275: Electroconductive media.
  773. Estradiol - direct healthcare professional communication (DHPC)
  774. Medical device cyber security information for users
  775. PSUSA/00000685/202104 - periodic safety update report single assessment
  776. Moxifloxacin Hydrochloride IP eq. to Moxifloxacin 0.5%w/v + Nepafenac 0.1%w/v +…
  777. EU/3/15/1475 - orphan designation for treatment of cryptococcosis
  778. 21 CFR 1.930: When will a waiver that we grant become effective?
  779. EU/3/15/1437 - orphan designation for treatment of acute myeloid leukaemia
  780. cdsco-tenofovirTenofovir
  781. Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation…
  782. EMEA-003302-PIP01-22 - paediatric investigation plan
  783. Applications for Marketing Approval for Medical Devices
  784. 21 CFR 1.401: Who is entitled to appeal?
  785. PSUSA/00010298/201803 - periodic safety update report single assessment
  786. 21 CFR 890.3675: Denis Brown splint.
  787. EU/3/16/1798 - orphan designation for treatment of gastric cancer
  788. PSUSA/00010199/201805 - periodic safety update report single assessment
  789. Intravascular Ultrasound Diagnostic Equipment and Disposable Intravascular Ultrasound…
  790. PSUSA/00002329/201806 - periodic safety update report single assessment
  791. European Medicines Agency recommends changes in use of leukaemia medicine Iclusig…
  792. 21 CFR 882.4700: Neurosurgical paddie.
  793. Levothyroxine: a review of clinical and quality considerations
  794. NMPA Announcement on Issuing Three Guidelines for Technical Review of the Registration…
  795. PSUSA/00001694/202303 - periodic safety update report single assessment
  796. Notice regarding D-Penicillamine Capsule
  797. Chapter 7 - Annual Reporting Guidance - Great Britain: Chapter 7- Annual Reporting…
  798. cdsco-product-recallsProduct Recalls
  799. EMEA-000560-PIP02-15 - paediatric investigation plan
  800. Regulations Governing Commission of Medical Devices Management and Accreditation of…
  801. NMPA Issues Announcement on Revising Package Inserts of Chuanbei Pipa Preparations
  802. EMEA-000494-PIP01-08-M09 - paediatric investigation plan
  803. 21 CFR 10.10: Summaries of administrative practices and procedures.
  804. PSUSA/00010155/202209 - periodic safety update report single assessment
  805. EU/3/06/365 - orphan designation for treatment of renal-cell carcinoma
  806. cdsco-import-drugs60Import Drugs60
  807. EMEA-001744-PIP01-14-M02 - paediatric investigation plan
  808. Start of rolling review for adapted Comirnaty COVID-19 vaccine
  809. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  810. Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting
  811. EU/3/15/1450 - orphan designation for diagnosis of gastro-entero-pancreatic neuroendocrine…
  812. EU/3/12/1075 - orphan designation for treatment of acromegaly
  813. April 20, 2023: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices…
  814. ARCHIVED - Medical Device Problem Reporting by Health Care Facilities, Medical…
  815. Prohance® (Gadoteridol 279.3 mg/mllnjection
  816. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 March 2012
  817. EU/3/17/1958 - orphan designation for treatment in haematopoietic stem cell…
  818. Paediatric Committee (PDCO): 12-15 September 2017
  819. EU/3/21/2520 - orphan designation for treatment of adrenoleukodystrophy
  820. ema-procysbiProcysbi
  821. Cnici benedicti herba - herbal medicinal product
  822. Outcomes of imposed non-interventional post-authorisation safety studies
  823. AAMI Standards Monitor Digest: March 2020
  824. ICH M4S Common technical document for the registration of pharmaceuticals for human use…
  825. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - April 2019
  826. NOTICE - regarding meeting of the stakeholders for feedback on new modules in SUGAM
  827. 21 CFR 876.4300: Endoscopic electrosurgical unit and accessories.
  828. A guide to defective medicinal products
  829. PSUSA/00001662/202401 - periodic safety update report single assessment
  830. European Medicines Agency closed 31 October to 2 November 2011
  831. Anisi fructus - herbal medicinal product
  832. List of medicines under additional monitoring
  833. PSUSA/00010475/202203 - periodic safety update report single assessment
  834. EMEA-001916-PIP01-15 - paediatric investigation plan
  835. EMEA-001326-PIP01-12 - paediatric investigation plan
  836. P/0321/2014 - paediatric investigation plan
  837. ema-rybelsusRybelsus
  838. Antimicrobial resistance – European Medicines Agency releases draft advice on the impact…
  839. 21 CFR 866.2900: Microbiological specimen collection and transport device.
  840. Susan Gillespie: A 'Must-Read' on Reprocessing
  841. ema-arikayceArikayce
  842. May 17, 2017: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory…
  843. Good Practices for Computerised Systems in Regulated GXP Environments
  844. Multidisciplinary: Nasal products
  845. ICH E16 Genomic biomarkers related to drug response: context, structure and format of…
  846. ema-hizentraHizentra
  847. PSUSA/00000007/201712 - periodic safety update report single assessment
  848. 21 CFR 880.6070: Bed board.
  849. EMA finds no evidence linking viral vector in Zynteglo to blood cancer
  850. EMEA-002267-PIP03-19 - paediatric investigation plan
  851. Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence…
  852. Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device…
  853. Borderlines with medical devices and other products in Great Britain
  854. Combined tetanus toxoid, reduced diphtheria toxoid, reduced recombinant pertussis vaccine…
  855. Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines - Schedule D…
  856. European Medicines Agency reviews cardiovascular risk of Multaq
  857. European Medicines Agency closed on 1 November 2013
  858. EMEA-002293-PIP01-17 - paediatric investigation plan
  859. PSUSA/00002355/202008 - periodic safety update report single assessment
  860. EU/3/15/1574 - orphan designation for treatment of focal segmental glomerulosclerosis
  861. EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating…
  862. EMEA-001841-PIP01-15 - paediatric investigation plan
  863. PSUSA/00001812/201706 - periodic safety update report single assessment
  864. Control of Clinical Trials Act 1987 [Establishment of the HPRA]
  865. Chlorhexidine Gluconate solution + Metronidazole Benzoate BP eq to Metronidazole Gel…
  866. Pat Baird and Erin Sparnon: When It Comes to Cybersecurity, You Can’t Do It Alone
  867. PSUSA/00010378/202005 - periodic safety update report single assessment
  868. 21 CFR 801.1: Medical devices; name and place of business of manufacturer, packer or…
  869. 21 CFR 862.1690: Thyroid stimulating hormone test system.
  870. Meeting highlights from the Committee for Medicinal Products for Human Use,22-24 January…
  871. Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2017
  872. 21 CFR 870.2860: Heart sound transducer.
  873. 21 CFR 1.337: What information must nontransporters establish and maintain to identify the…
  874. PSUSA/00010190/201612 - periodic safety update report single assessment
  875. PSUSA/00000188/202203 - periodic safety update report single assessment
  876. DR_G.S.R. 329(E) dt_03.04.2017_Form44_Particulars of new drug entries omitted
  877. Committee for Herbal Medicinal Products (HMPC): 10-12 May 2023
  878. PSUSA/00001125/202203 - periodic safety update report single assessment
  879. Reinforcing patient safety in Europe
  880. Committee for Herbal Medicinal Products (HMPC): 30 May – 31 May 2016
  881. Actos (pioglitazone) - Updated drug labels for pioglitazone-containing medicines
  882. Exelon - withdrawal of application for variation to marketing authorisation
  883. Cinnamomi corticis aetheroleum - herbal medicinal product
  884. 21 CFR 880.5860: Piston syringe.
  885. ema-vepacelVepacel
  886. EU/3/17/1971 - orphan designation for treatment of RARS2 syndrome
  887. Pharmaceutical development of intravenous medicinal products containing active substances…
  888. 26th meeting of the committee for veterinary medicinal products
  889. Proposal for a new Approved Cell & Tissue Name (ACN) application form
  890. 21 CFR 1.612: What competency and capacity must an accreditation body have to qualify for…
  891. EU/3/12/951 - orphan designation for treatment of carbamoyl-phosphate synthase-1…
  892. EMEA-000769-PIP01-09-M08 - paediatric investigation plan
  893. Over 1,000 studies now recorded in EU register of post-authorisation studies
  894. EU/3/10/783 - orphan designation for treatment of haemophilia A
  895. PSUSA/00010768/202310 - periodic safety update report single assessment
  896. PSUSA/00001621/201810 - periodic safety update report single assessment
  897. Baytril injectable and generics - referral
  898. Paediatric Committee (PDCO): 19-22 May 2026
  899. Drug Alert list for month of January 2021
  900. cdsco-test-documentTest Document
  901. EU/3/12/1090 - orphan designation for treatment of pancreatic cancer
  902. Coliprotec F4/F18 - withdrawal of application for variation to marketing authorisation
  903. EU report provides basis for effective fight against development of resistant bacteria
  904. EU/3/03/180 - orphan designation for treatment of chronic iron overload requiring…
  905. EU/3/17/1890 - orphan designation for treatment of diffuse large B-cell lymphoma
  906. Committee for Orphan Medicinal Products (COMP): 21-23 March 2016
  907. EMA Management Board: highlights of December 2017 meeting
  908. PSUSA/00001809/201707 - periodic safety update report single assessment
  909. Problems with Quality of Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina…
  910. EU/3/07/460 - orphan designation for treatment of acute myeloid leukaemia
  911. Fourth European Medicines Agency (EMA) and Nuclear Medicines Europe bilateral meeting
  912. Workshop on veterinary regulatory support for micro, small and medium-sized enterprises…
  913. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
  914. EU/3/13/1167 - orphan designation for treatment of ornithine-translocase deficiency
  915. Procedure to be followed for subsequent applicant in respect of FDCs declared as rational…
  916. Plantaginis lanceolatae folium - herbal medicinal product
  917. PIC/S Guidelines for Accession
  918. 21 CFR 12.32: Request for alternative form of hearing.
  919. European Medicines Agency closed 1 May 2018
  920. ema-rukobiaRukobia
  921. Novartis Europharm Ltd withdraws its applications for an extension of the indication for…
  922. SPOR and xEVMPD Stakeholder Engagement Webinars : Service Desk for SPOR and XEVMPD
  923. EU/3/10/812 - orphan designation for treatment of Duchenne muscular dystrophy
  924. Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium +Cilnidipine IP Film coated…
  925. Human & Veterinary Medicinal Products' Regulation - Turkey's Road to EU Membership
  926. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23…
  927. EU/3/14/1387 - orphan designation for treatment of familial cerebral cavernous…
  928. Low Acid Canned Food Manufacturers Part 2 - Processes/Procedures
  929. EMEA-000311-PIP04-13-M04 - paediatric investigation plan
  930. Committee for Advanced Therapies (CAT): 14-16 April 2021
  931. EMEA-001045-PIP02-18 - paediatric investigation plan
  932. ema-orkambiOrkambi
  933. EU/3/14/1386 - orphan designation for treatment of ovarian cancer
  934. EU/3/02/108 - orphan designation for prevention of post transplantation graft dysfunction
  935. Committee for Proprietary Medicinal Products (CPMP) 16th plenary meeting
  936. Extended mandate: First meeting of Executive Steering Group on Shortages and Safety of…
  937. cdsco-dupilumabDupilumab
  938. cdsco-baricitinib-ly3009104Baricitinib LY3009104
  939. 21 CFR 60.10: FDA assistance on eligibility.
  940. Antimicrobial resistance in human medicine
  941. EMA closed on Whit Monday, 20 May
  942. EU/3/13/1132 - orphan designation for treatment of malignant mesothelioma
  943. EMEA-000658-PIP01-08 - paediatric investigation plan
  944. Breast implants: reporting adverse incidents:
  945. Serious liver injury being observed in patients without cirrhosis taking Ocaliva…
  946. EMEA-000527-PIP01-08 - paediatric investigation plan
  947. Reclassification of medical devices that are substances to be introduced into the body or…
  948. Common Standards and Specifications on Biological Safety of Medical Devices (Addendum)
  949. 21 CFR 872.3520: OTC denture cleanser.
  950. Legal framework: Advanced therapies
  951. TR-02 R1.2 Contents of a Product Registration Submission for In Vitro Diagnostic Medical…
  952. EMEA-002122-PIP02-17-M01 - paediatric investigation plan
  953. Notice concerning the Publication of Guidance Materials concerning Application for…
  954. 21 CFR 73.2180: Guaiazulene.
  955. EMEA-003127-PIP01-21 - paediatric investigation plan
  956. Veterinary medicines: highlights of 2022
  957. Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA…
  958. International Recognition Procedure
  959. Clarification on Sputnik V vaccine in the EU approval process
  960. ema-novimp-referralNovimp - referral
  961. cdsco-pembrolizumabPembrolizumab
  962. ema-kaftrioKaftrio
  963. EMEA-001177-PIP02-20 - paediatric investigation plan
  964. 21 CFR 870.3935: Prosthetic heart valve holder.
  965. PSUSA/00009159/202003 - periodic safety update report single assessment
  966. cdsco-fiasp-insulinFIAsP Insulin
  967. Team-NB-MD-Sector-Survey-PressRelease-20240515
  968. Job Description for PIC/S Secretary / Executive Director
  969. 21 CFR 870.2780: Hydraulic, pneumatic, or photoelectric plethysmographs.
  970. EMEA-000027-PIP01-07 - paediatric investigation plan
  971. Zastaprazan Citrate Tablets 20mg
  972. EU/3/06/425 - orphan designation for atypical haemolytic uraemic syndrome
  973. EMEA-002920-PIP01-20 - paediatric investigation plan
  974. cdsco-emicizumabEmicizumab
  975. 21 CFR 830.20: Requirements for a unique device identifier.
  976. EMEA-000315-PIP01-08 - paediatric investigation plan
  977. EU/3/23/2856 - orphan designation for treatment of hereditary angioedema
  978. EU/3/23/2762 - orphan designation for treatment of GM2 gangliosidosis
  979. EMEA-000945-PIP01-10 - paediatric investigation plan
  980. Clinical trials for medicines: apply for authorisation in the UK
  981. PSUSA/00001195/202211 - periodic safety update report single assessment
  982. EMEA-002043-PIP01-16 - paediatric investigation plan
  983. Implementation of the pharmacovigilance legislation
  984. IT systems intermittently unavailable from 16 to 18 April 2021
  985. Clinical Data Publication (Policy 0070) re-launch - EMA webinar
  986. cdsco-nomination-formNomination Form
  987. Committee for Orphan Medicinal Products (COMP): 14-15 March 2017
  988. 21 CFR 866.5330: Factor XIII, A, S, immunological test system.
  989. EMEA-000792-PIP01-09-M01 - paediatric investigation plan
  990. Paediatric addendum to the guideline on clinical investigation of medicinal products in…
  991. Daratumumab Concentrate for Solution for Infusion 100 mg/5 mL Vial and 400 mg/20 mL Vial…
  992. Drug/Medical Device Combination Products Policy
  993. Yellow Fever Vaccine (live) I.P.
  994. A Reference Architecture's Value for Enhancing Healthcare Delivery Organization…
  995. Paediatric Committee (PDCO): 26-29 March 2019
  996. PSUSA/00010813/202211 - periodic safety update report single assessment
  997. cdsco-20102010
  998. 21 CFR 56.102: Definitions.

About this dataset

Regulations, guidance and official notices from medical device and medicines regulators worldwide, collected by Orca1 from each issuer's website. Only the title, issuer, date and link are shown here; the full text is searchable in Orca1.

Source: Medical device and medicines regulators and agencies as named on each record (EMA, MHRA, TGA, CDSCO, PMDA, NMPA, Health Canada, HSA, the FDA and others), collected by Orca1 from each issuer's website