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Global regulations and guidance

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

  1. ema-enurace-50-referralEnurace 50 - referral
  2. 21 CFR 886.1870: Stereoscope.
  3. European Medicines Agency starts review of Pandemrix
  4. Guidance on GxP data integrity
  5. EMA's Business Continuity Plan for Brexit published
  6. Olympus and Amplifire Team Up for Endoscope Sterile Processing
  7. nbcg-survey-2019Survey-2019
  8. Effentora - withdrawal of application for variation to marketing authorisation
  9. Niraparib Tablets 100 mg
  10. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9…
  11. Guidance for viewing and responding to a notification on the Consent for Non-compliance…
  12. European Medicines Agency updates on safety of Pradaxa
  13. 21 CFR 884.2700: Intrauterine pressure monitor and accessories.
  14. Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5
  15. Development of new medicinal products for the treatment of ulcerative colitis - Scientific…
  16. Antimicrobial resistance - European Medicines Agency provides advice on use of colistin…
  17. 21 CFR 864.9320: Copper sulfate solution for specific gravity determinations.
  18. Workshop on site and histology - Independent indications in oncology
  19. ema-topamax-referralTopamax - referral
  20. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31…
  21. 21 CFR 73.2162: Bismuth oxychloride.
  22. PSUSA/0058/201807 - periodic safety update report single assessment
  23. Glimepiride IP + Linagliptin + Metformin HCL (As ER) IP (1mg + 2.5mg + 1000mg & 2mg +…
  24. cdsco-oxfendazoleOXFENDAZOLE
  25. PSUSA/00010021/201807 - periodic safety update report single assessment
  26. Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
  27. EU/3/16/1656 - orphan designation for treatment of malignant mesothelioma
  28. ema-ofevOfev
  29. EMA and EATRIS webinar on navigating the regulatory requirements for advanced therapy…
  30. 21 CFR 862.1230: Cyclic AMP test system.
  31. EU/3/19/2235 - orphan designation for treatment of congenital alpha-1 antitrypsin…
  32. Pharmacovigilance (veterinary medicines)
  33. EMEA-000575-PIP01-09-M03 - paediatric investigation plan
  34. Cynarae folium - herbal medicinal product
  35. Dydrogesterone Extended Release Tablet 20 mg/30mgCT/SND/01/2023
  36. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 September 2017
  37. Pelargonii radix - herbal medicinal product
  38. SME and academia Clinical Trials Information System (CTIS) two-part training webinar - Day…
  39. ema-afstylaAfstyla
  40. EMEA-000181-PIP02-13-M01 - paediatric investigation plan
  41. Webinar on requesting access to and using EMA's substance, product, organisation and…
  42. EMEA-000892-PIP01-10 - paediatric investigation plan
  43. William Hyman: Don’t Forget Secondary Human Factors Effects
  44. Committee for Medicinal Products for Veterinary Use (CVMP): 21-23 May 2024
  45. PSUSA/00010642/201807 - periodic safety update report single assessment
  46. ema-uptraviUptravi
  47. 21 CFR 830.120: Responsibilities of an FDA-accredited issuing agency.
  48. EMEA-000850-PIP01-10 - paediatric investigation plan
  49. ema-flynpoviFlynpovi
  50. 21 CFR 868.5110: Oropharyngeal airway.
  51. Mitigating risk aversion in medicines regulation in the interest of public health
  52. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  53. Paediatric Committee (PDCO): 3-5 October 2012
  54. Committee for Orphan Medicinal Products (COMP): 17-19 January 2017
  55. PSUSA/00003043/201508 - periodic safety update report single assessment
  56. Committee for veterinary medicinal products: 40th meeting
  57. Veterinary medicinal products for zootechnical purposes - Scientific guideline
  58. EU/3/23/2775 - orphan designation for treatment of mastocytosis
  59. EMEA-002778-PIP01-20-M01 - paediatric investigation plan
  60. European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2009 (SI…
  61. Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2016
  62. Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based…
  63. EU/3/10/748 - orphan designation for treatment of Hutchinson-Gilford progeria
  64. Superseded - Conduct of pharmacovigilance for medicines used by the paediatric population…
  65. EMA-hosted virtual meetings
  66. Evaluation of Certain Pre-1988 Permitted Fixed Dose Combinations (FDCs) De novo for…
  67. 21 CFR 884.2982: Liquid crystal thermographic system.
  68. European Medicines Agency holds first stakeholder forum on the implementation of the new…
  69. 21 CFR 886.3800: Scleral shell.
  70. Notice dated 23.03.2016 regarding Preparation for global switch from tOPV to bOPV 2016
  71. EMEA-003391-PIP01-23 - paediatric investigation plan
  72. ema-bovalto-ibraxionBovalto Ibraxion
  73. Sandostatin LAR and associated names - referral
  74. PSUSA/00010376/202104 - periodic safety update report single assessment
  75. EU/3/00/006 - orphan designation for treatment of Gaucher disease
  76. PSUSA/00010502/201907 - periodic safety update report single assessment
  77. 21 CFR 876.5020: External penile rigidity devices.
  78. Guidance on medical/surgical face masks and respirator standards - key performance aspects
  79. CDSCO updated list of Laboratories for conducting Performance Evaluation of In-Vitro…
  80. Patient Involvement Strategy: Patient Involvement Strategy 2021-25
  81. Notice dated 30.5.2016 regarding Launch of Registration of Cosmetics and Ethics Committee…
  82. 21 CFR 1.660: Where do I apply for accreditation or renewal of accreditation by a…
  83. 21 CFR 886.4270: Intraocular gas.
  84. EU/3/17/1907 - orphan designation for prevention of bronchopulmonary dysplasia
  85. EMEA-000128-PIP01-07-M08 - paediatric investigation plan
  86. Regulatory information – 1.7% increase of fees from 1 April 2019
  87. DEL and GMP temporary measures due to COVID-19
  88. Modification of seasonal flu vaccines
  89. PSUSA/00001746/201508 - periodic safety update report single assessment
  90. Basic principles for conducting phase 1 studies in Japanese prior to initiating…
  91. EMEA-000736-PIP01-09 - paediatric investigation plan
  92. ema-combimarvCombimarv
  93. Regulatory information – Updated SME user guide now available
  94. cdsco-anagliptinAnagliptin
  95. Stella Blackburn appointed president of the International Society for Pharmacoepidemiology
  96. Liraglutide versus sulphonylurea
  97. EU enlargement countries to join EMEA as observers from 1 April 2003
  98. EMEA-002425-PIP01-18 - paediatric investigation plan
  99. EMEA-000734-PIP01-09 - paediatric investigation plan
  100. EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
  101. Personalised medical devices (including 3D-printed devices)
  102. 21 CFR 886.4440: AC-powered magnet.
  103. PSUSA/00003112/201709 - periodic safety update report single assessment
  104. ema-trydonisTrydonis
  105. Compliance and enforcement policy for health products (POL-0001)
  106. 21 CFR 862.1685: Thyroxine-binding globulin test system.
  107. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 22-24 January 2019
  108. Management Board meeting: 21-22 March 2012
  109. EMEA-001495-PIP01-13-M01 - paediatric investigation plan
  110. ema-nobilis-influenza-h5n6Nobilis Influenza H5N6
  111. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations…
  112. EMA tightens rules on “revolving door” for committee members and experts
  113. EMEA-000661-PIP01-09-M07 - paediatric investigation plan
  114. cdsco-eyu688EYU688
  115. EMEA-002194-PIP01-17 - paediatric investigation plan
  116. 2025.05.22_S.O. 2298(E)_Notification to prohibit the import, manufacture, sale and…
  117. Paediatric Committee (PDCO): 27-29 January 2016
  118. 21 CFR 870.1415: Coronary vascular physiologic simulation software device.
  119. Paediatric Committee (PDCO): 9-11 December 2015
  120. EMEA-002380-PIP01-18 - paediatric investigation plan
  121. Pemetrexed ditromethamine Hospira
  122. Joint HMA/EMA multi-stakeholder workshop on pharmacogenomics
  123. PSUSA/00001694/201501 - periodic safety update report single assessment
  124. Healthcare professionals: Key documents
  125. EU/3/07/485 - orphan designation for treatment of chronic lymphocytic leukaemia
  126. European Commission, European Medicines Agency and World Health Organization step up…
  127. Committee for Medicinal Products for Human Use (CHMP): 27-30 January 2020
  128. Revefenacin inhalation solution. 175 mcg /3ml
  129. PSUSA/00003048/202203 - periodic safety update report single assessment
  130. Training on electronic reporting of individual case safety reports (ICSRs) to…
  131. EMEA-001145-PIP01-10 - paediatric investigation plan
  132. Adrenaline Auto-Injectors (AAIs) safety campaign: Y defnydd cywir o’ch Chwistrellydd…
  133. Therapeutic goods advertising compliance: 2022-23 Annual Report
  134. PSUSA/00003015/202203 - periodic safety update report single assessment
  135. "Package Unit" Italian Flour Mills
  136. UPDATE: Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova…
  137. European Medicines Agency website on suspected side effect reports now in all 23 EU…
  138. 21 CFR 872.3760: Denture relining, repairing, or rebasing resin.
  139. Working parties for healthcare professionals and for patients and consumers elect new…
  140. EU/3/22/2682 - orphan designation for treatment of Stargardt's disease
  141. Voices of HTM: Don Armstrong
  142. Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator…
  143. ema-cejemlyCejemly
  144. Regulatory information - EU recommendations for 2015/2016 seasonal flu vaccine composition
  145. cdsco-masitinib-lymphomaMasitinib Lymphoma
  146. PRAC concludes assessment of gadolinium agents used in body scans and recommends…
  147. recombinant human follicle stimulating hormone (r-h-FSH)
  148. 21 CFR 868.5935: External negative pressure ventilator.
  149. EMEA-000431-PIP01-08-M12 - paediatric investigation plan
  150. Determination of whether a clinical trial requires a Clinical Trial Authorisation…
  151. Introducing a New Alliance for Healthcare Technology Management in Mexico
  152. Committee for Advanced Therapies (CAT): 4-6 December 2019
  153. Pertuzumab Concentrate for Solution for Infusion 420 mg/14 mL Vial (30 mg/mL) (r-DNA…
  154. AAMI Seeks Volunteers to Join HTM Groups, 2022
  155. European Medicines Agency website unavailable 23-25 September 2011
  156. AAMI News, August 2021, Vol.56, No.8
  157. Committee for Advanced Therapies (CAT): 11-12 March 2010
  158. Suitability of the graduation of delivery devices for liquid dosage forms - Scientific…
  159. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April…
  160. 21 CFR 16.80: Administrative record of a regulatory hearing.
  161. PSUSA/00000048/202306 - periodic safety update report single assessment
  162. 21 CFR 1.21: Failure to reveal material facts.
  163. Team-NB Press Release Applications Survey 20181218
  164. First COVID-19 treatment recommended for EU authorisation
  165. Committee for Medicinal Products for Veterinary Use (CVMP): 21-22 May 2019
  166. A Smooth Flight Toward Success: Redefining Sterile Processing for Surgical Centers
  167. Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication
  168. Speical operation to prevent and detect illegal manufacturing of API formulations and…
  169. In-house manufacture of medical devices in Great Britain
  170. EMEA-000176-PIP01-07-M05 - paediatric investigation plan
  171. EMEA-002067-PIP02-17 - paediatric investigation plan
  172. ema-reblozylReblozyl
  173. Committee for Medicinal Products for Human Use (CHMP): 16-19 November 2015
  174. VICH GL11 Impurities in new veterinary medicinal products - Scientific guideline
  175. Committee for Advanced Therapies (CAT): 6-8 October 2021
  176. MK-7684A (Vibostolimab with Pembrolizumab)
  177. PSUSA/00000427/201812 - periodic safety update report single assessment
  178. Bisphosphonates - Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and…
  179. cdsco-ustekinumabUstekinumab
  180. PSUSA/00002026/201411 - periodic safety update report single assessment
  181. ema-trelegy-elliptaTrelegy Ellipta
  182. Bringing It Home: A Supply Chain Resilience Tactic
  183. PSUSA/00010070/201611 - periodic safety update report single assessment
  184. Guidance Document for Source Establishment - Reporting Adverse Reactions to Human Cells…
  185. EMA Management Board: highlights of October 2022 meeting
  186. 21 CFR 880.5300: Medical absorbent fiber.
  187. 21 CFR 17.48: Harmless error.
  188. Virtual manufacturing of medical devices
  189. EU/3/22/2729 - orphan designation for treatment of Canavan disease
  190. EMA business hours over Easter holiday period
  191. General Court confirms EMA approach to transparency
  192. ema-talam-referralTalam - referral
  193. European Medicines Agency updates on development of its policy on publication and access…
  194. EU/3/11/919 - orphan designation for prevention of oral mucositis in head and neck cancer…
  195. HTM Professionals Need IT Skills Now More than Ever, Here’s Why
  196. EMEA-001407-PIP01-12-M03 - paediatric investigation plan
  197. Committee for Advanced Therapies (CAT): 13-15 March 2013
  198. Public access to suspected side effect reports of veterinary medicines
  199. Release of Annual Report for National Medical Device Adverse Event Monitoring (2018)
  200. Post market responsibilities for manufacturers and sponsors of medical devices
  201. March 23rd 2018 GSR 277(E)
  202. EMEA-003002-PIP01-21 - paediatric investigation plan
  203. European Medicines Agency launches EudraPharm – the European medicines database
  204. Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal…
  205. cdsco-brolucizumab-120-mg-mlBrolucizumab, 120 mg/mL
  206. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5…
  207. Incorporating Security Risk Management into Your Quality Management System Using AAMI SW96
  208. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (13- valent)
  209. Details of Importers whose permissions have been suspended / cancelled 2023
  210. ema-resources-for-academiaResources for academia
  211. ema-aerinazeAerinaze
  212. EMEA-000463-PIP02-10 - paediatric investigation plan
  213. 21 CFR 870.2620: Line isolation monitor.
  214. Clinical Trials Information System (CTIS) sponsor end user training programme - February…
  215. Drug Alert list for month of December 2016
  216. Call for expression of interest for health professional and patient organisations…
  217. EMA Management Board: highlights of December 2021 meeting
  218. Committee for Orphan Medicinal Products (COMP) December highlights
  219. EMEA-000035-PIP01-07-M05 - paediatric investigation plan
  220. cdsco-68ga-evg32168Ga-EVG321
  221. EMEA-001397-PIP06-17 - paediatric investigation plan
  222. European Medicines Agency statement following withdrawal of Vioxx (rofecoxib)
  223. Description of composition of pegylated (conjugated) proteins in the summary of product…
  224. Checklist for Grant of Non Conviction Certificate for Medical Devices
  225. NMPA Issued the Announcement on Issues Concerning the Further Improvement of Drug-related…
  226. ema-toviazToviaz
  227. Submitting documents to be attached in the application for approval of new ethical drugs
  228. 21 CFR 890.1850: Diagnostic muscle stimulator.
  229. First nasal adrenaline spray for emergency treatment against allergic reactions
  230. NMPA Announcement on Issuing of Two Registration Technical Review Guidelines Including the…
  231. Prescription medicine clinical units
  232. ema-diflucan-referralDiflucan - referral
  233. Key deliverable of Falsified Medicines Directive achieved
  234. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - September 2015
  235. IFI44L Gene Methylation Detection Kit (PCR-Melting Curve Method) Approved for Marketing
  236. For Hurricane Season, FDA Offers Safety Tips for Medical Devices
  237. ema-constellaConstella
  238. European Union (EU) International Organisation for Standardization (ISO) for…
  239. Committee for Orphan Medicinal Products (COMP): 16-18 February 2021
  240. Clinical investigation of new medicinal products for the treatment of acute coronary…
  241. EMEA-001317-PIP01-12 - paediatric investigation plan
  242. European Medicines Agency updates guidance for annual strain change of seasonal influenza…
  243. Reclassification of spinal implantable medical devices
  244. Voices of Cybersecurity: Ali Youssef
  245. Committee for Orphan Medicinal Products (COMP): 4-6 December 2018
  246. Refusal of orphan designation for treatment of B-cell non-Hodgkin`s lymphoma
  247. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 3-4…
  248. EMEA-002110-PIP01-17 - paediatric investigation plan
  249. Temporary advice for management of oral retinoid medicines during the COVID-19 pandemic
  250. PSUSA/00001728/202007 - periodic safety update report single assessment
  251. EU/3/24/2957 - orphan designation for treatment of Friedreich's ataxia
  252. 21 CFR 16.62: Right to counsel.
  253. Committee for Advanced Therapies (CAT): 3-4 November 2016
  254. First regulatory workshop on COVID-19 facilitates global collaboration on vaccine…
  255. 21 CFR 862.3800: Reagents for molecular diagnostic instrument test systems.
  256. 21 CFR 814.9: Confidentiality of data and information in a premarket approval application…
  257. PSUSA/00001813/202310 - periodic safety update report single assessment
  258. Tenth stakeholder forum on the pharmacovigilance legislation
  259. Committee for Orphan Medicinal Products (COMP): 11-13 July 2017
  260. EMEA-000308-PIP01-08-M04 - paediatric investigation plan
  261. Trigonellae foenugraeci semen - herbal medicinal product
  262. cdsco-pasireotidepasireotide
  263. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January…
  264. Adjusted fees for applications to European Medicines Agency from 1 April 2012
  265. EudraVigilance training on electronic reporting of individual case safety reports in the…
  266. Acetaminophen - Addition of another concentration of liquid acetaminophen marketed for…
  267. EU/3/10/842 - orphan designation for treatment of squamous-cell carcinoma of the head and…
  268. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2014 (SI…
  269. ema-zydaxZydax
  270. EMEA-002358-PIP02-18-M03 - paediatric investigation plan
  271. COVID-19 vaccines: key facts
  272. Biologicals (priority applicant) determination, application form
  273. Regulatory changes to importing nicotine vaping products
  274. Tofacitinib Lotion 2%w/vCT/SND/26/2023
  275. Changing the (invented) name of a veterinary medicine
  276. March 11.03.2014 G.S.R 176 (E)
  277. ema-ovaleapOvaleap
  278. 21 CFR 872.1840: Dental x-ray position indicating device.
  279. EMEA-000342-PIP01-08-M07 - paediatric investigation plan
  280. cdsco-ipv-vaccineIPV vaccine
  281. EU/3/01/063 - orphan designation for treatment of chronic lymphocytic leukaemia
  282. Clarification for grant of permission for combipack product of lyophilised dry powder for…
  283. ema-oxybeeOxybee
  284. Typhoid Vi Conjugate Vaccine I.P.
  285. European Medicines Agency: Committee for Medicinal Products for Human Use25-28 July 2005
  286. EU/3/23/2842 - orphan designation for treatment of STXBP1 developmental and epileptic…
  287. 21 CFR 868.5905: Noncontinuous ventilator (IPPB).
  288. Bayer Schering Pharma withdraws its marketing authorisation application for Recothrom…
  289. New treatment for sickle cell disease
  290. Post opinion: Regulatory and procedural guidance
  291. EU/3/22/2636 - orphan designation for treatment of Angelman syndrome
  292. Quality of biological active substances produced by stable transgene expression in higher…
  293. Adenosine IP + Minoxidil IP Topical solution (Phase II Clinical Trial)
  294. cdsco-jnj-77242113JNJ-77242113
  295. PSUSA/00010333/202211 - periodic safety update report single assessment
  296. Safety: veterinary limited markets
  297. 21 CFR 876.5900: Ostomy pouch and accessories.
  298. cdsco-concizumabConcizumab
  299. EU/3/09/706 - orphan designation for treatment of Huntington’s disease
  300. PSUSA/00010492/201704 - periodic safety update report single assessment
  301. EU/3/24/2940 - orphan designation for treatment of GM1 gangliosidosis
  302. Sixth meeting of the Management Board of the European Agency for the Evaluation of…
  303. Committee for Medicinal Products for Human Use (CHMP): 18-21 March 2024
  304. Tedizolid Phosphate 200mg Tablet
  305. COVID-19 guidance: post-authorisation
  306. EMA website briefly unavailable on 29 November
  307. Training session on the review of product information (for patient and consumer…
  308. Human dietary exposure assessments
  309. Sirolimus product-specific bioequivalence guidance
  310. Blue Guide: advertising and promoting medicines
  311. Committee for Medicinal Products for Human Use (CHMP): 18-21 May 2015
  312. Glycopyrronium (As Glycopyrrolate IP) + Budesonide IP + Formoterol Fumarate (As Formoterol…
  313. EMEA-003245-PIP01-22 - paediatric investigation plan
  314. About Handling of Drug Master Files of Raw Materials for Medical Devices / ELD…
  315. HIMSS23: Challenges Adopting AI into Your Healthcare System
  316. EU/3/15/1445 - orphan designation for treatment of acute myeloid leukaemia
  317. cfr-21-cfr-886-4370-keratome21 CFR 886.4370: Keratome.
  318. EMEA-001203-PIP02-14-M02 - paediatric investigation plan
  319. Guideline for Development of Prototype Vaccines for Preparation for Pandemic Influenza
  320. PSUSA/00001909/202201 - periodic safety update report single assessment
  321. EU/3/10/804 - orphan designation for treatment of progressive supranuclear palsy
  322. PSUSA/00000559/201601 - periodic safety update report single assessment
  323. Chapter 1 - Submitting Notifications EUCEG Guidance - Northern Ireland
  324. Inspection tracker: Drug manufacturing establishments
  325. Catheter Entrapment with the ev3 Onyx Liquid Embolic System: FDA Safety Communication…
  326. Naming human medicines: MHRA guideline for the naming of medicinal products and braille…
  327. Pediatric Advisory Committee Meeting Announcement - 09/18/2024
  328. Webinar presentation: GMP clearance - Common deficiencies
  329. NitazoxanideTabet 500 mg and Hydroxychloroquine Tablet 200 mg
  330. ema-vectra-3dVectra 3D
  331. Biotechnology Inspection Guide (11/91)
  332. PSUSA/00010252/202106 - periodic safety update report single assessment
  333. PSUSA/00002870/201705 - periodic safety update report single assessment
  334. ema-who-we-areWho we are
  335. Scientific advice and protocol assistance
  336. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11…
  337. EMEA-002712-PIP01-19-M01 - paediatric investigation plan
  338. cfr-21-cfr-73-2190-henna21 CFR 73.2190: Henna.
  339. EU/3/22/2673 - orphan designation for treatment of peripheral T-cell lymphoma
  340. Advertising therapeutic goods that are only sold to health professionals
  341. EMEA-001925-PIP02-19 - paediatric investigation plan
  342. Voices of HTM: Renee Gordon
  343. EU/3/16/1718 - orphan designation for treatment of graft-versus-host disease
  344. Herbal medicinal products working group: Executive summary of adhoc meetings
  345. EU/3/20/2366 - orphan designation for treatment of multiple myeloma
  346. Committee for Medicinal Products for Human Use (CHMP): 18-21 July 2016
  347. ema-quadrisolQuadrisol
  348. EMEA-000370-PIP02-18-M01 - paediatric investigation plan
  349. Loratadine Sandoz 10 - referral
  350. EMEA-002832-PIP01-20 - paediatric investigation plan
  351. EMEA-001065-PIP01-10 - paediatric investigation plan
  352. EU/3/13/1164 - orphan designation for treatment of hyperargininaemia
  353. PSUSA/00011039/202307 - periodic safety update report single assessment
  354. Notice regarding Meeting for the registration of notified body through online portal
  355. EU/3/07/464 - orphan designation for treatment of cutaneous T-cell lymphoma
  356. Cost Recovery Implementation Statement, 2022-2023
  357. 21 CFR 862.3590: Meprobamate test system.
  358. EU/3/22/2735 - orphan designation for treatment of idiopathic pulmonary fibrosis
  359. 21 CFR 862.3550: Lead test system.
  360. 2019.01.10_Final GSR 20(E)__Notification of Mundra port and Kamarajar port under Rule 43A
  361. Non-clinical investigation of the dependence potential of medicinal products - Scientific…
  362. 21 CFR 876.5980: Gastrointestinal tube and accessories.
  363. Healthcare Organizations Warn of ‘Telehealth Cliff’
  364. ACT EU multi-stakeholder platform annual meeting
  365. EMEA-001413-PIP01-13 - paediatric investigation plan
  366. PSUSA/00000415/201608 - periodic safety update report single assessment
  367. EMEA-002694-PIP02-21 - paediatric investigation plan
  368. Gadolinium-containing contrast agents - referral
  369. Impact of brain immaturity when investigating medicinal products intended for neonatal use…
  370. cdsco-pregabalinPregabalin
  371. Boosting the development of medicines for children
  372. EMEA-001299-PIP03-17-M02 - paediatric investigation plan
  373. 21 CFR 866.3010: Acinetobacter calcoaceticus serological reagents.
  374. 21 CFR 74.1206: D&C Green No. 6.
  375. First oral treatment against residual haemolytic anaemia in patients with paroxysmal…
  376. EU/3/12/996 - orphan designation for treatment of meningioma
  377. Epidemiological data on blood transmissible infections - Scientific guideline
  378. Improving safety of medicines across Europe
  379. Notification - Extension of Import registration - Gazette notification G.S.R. 263(E), Mar…
  380. EU/3/11/938 - orphan designation for treatment of haemophilia B
  381. European Medicines Agency/CHMP Working Group with Healthcare Professionals' Organisations…
  382. Clinical aspects related to tissue engineered products - Scientific guideline
  383. ema-motilium-referralMotilium - referral
  384. Stephen Berger: Hospitals Must Address Interference Issue Raised by FCC Ruling
  385. Breast implants - patient perception of risk research
  386. ema-prozincProZinc
  387. Documents to be submitted for the application for GMP compliance inspection (Aug.2 ,2023)
  388. PSUSA/00003159/202012 - periodic safety update report single assessment
  389. ema-aprovelAprovel
  390. PSUSA/00010291/201506 - periodic safety update report single assessment
  391. Paediatric development and juvenile animal studies assessors meeting
  392. Caspofungin acetate - paediatric investigation plan
  393. cdsco-july-5-2008-g-s-r-364July 5,2008 (G.S.R 364)
  394. PSUSA/00010336/201907 - periodic safety update report single assessment
  395. VICH GL61 Pharmaceutical Development - Scientific guideline
  396. PSUSA/00000966/201607 - periodic safety update report single assessment
  397. GN-07-R3 Guidance on Complaint Handling (2023 Sep) PUB
  398. Committee for Medicinal Products for Human Use (CHMP): 21-24 July 2014
  399. EMA annual report 2022 published
  400. Navigating ANSI/AAMI ST108:2023: Guidance for Water Quality
  401. Committee for veterinary medicinal products: 47th meeting
  402. Human medicines: highlights of 2018
  403. FDA Commissioner Seeks Resources to Address Medical Device Shortages
  404. PSUSA/00001502/201504 - periodic safety update report single assessment
  405. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) sees…
  406. 21 CFR 862.1285: Etiocholanolone test system.
  407. Diacerein-containing medicines for oral administration - referral
  408. ema-thiotepa-riemserThiotepa Riemser
  409. EU/3/19/2240 - orphan designation for treatment of non-traumatic subarachnoid haemorrhage
  410. Workshop on FP7 and off-patent medicines developed for children
  411. 21 CFR 892.1840: Radiographic film.
  412. Microbiological Contamination of Equipment Gaskets with Product Contact
  413. Committee for Medicinal Products for Human Use (CHMP): 26-29 January 2026
  414. 21 CFR 870.5200: External cardiac compressor.
  415. Apixaban product-specific bioequivalence guidance
  416. 21 CFR 1.76: Medical devices.
  417. DR_G.S.R.186(E) dt_06.03.2019_Hydroquinone included in Note to Schedule H of D&C Rules…
  418. 2018.09.07_S.O. 4379(E) to S.O.4712 (E)_Prohibition & Restriction of FDC drugs_Section 26A
  419. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November…
  420. Privigen - direct healthcare professional communication (DHPC)
  421. PSUSA/00010298/202303 - periodic safety update report single assessment
  422. EMEA-001731-PIP01-14-M03 - paediatric investigation plan
  423. Management of Applications and Performance for Drug Establishment Licences (GUI-0127)
  424. Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 April 2020
  425. European Medicines Agency and EuropaBio annual bilateral meeting 2022
  426. 21 CFR 58.83: Reagents and solutions.
  427. Vaxneuvance - direct healthcare professional communication (DHPC)
  428. EMEA-002805-PIP01-20 - paediatric investigation plan
  429. PSUSA/00001404/201703 - periodic safety update report single assessment
  430. Registration for Import of cosmetics-GSR 426(E)
  431. Certican / Zortress(everolimus EVR)
  432. Innovative Product TRUPULSE™ Generator and Varipulse™ Bi-directional Catheter Approved for…
  433. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 April 2012
  434. PSUSA/00010236/201801 - periodic safety update report single assessment
  435. World Health Day: 7 April 2012
  436. Joint EMEA(NRG)/Interested Parties Meeting
  437. RESOLUTION RDC NO. 56, 06 APRIL 2001
  438. Measles and Rubella Vaccine (Live) LP. (Freeze Dried) in Multi dose vial (2.5 ml - 5 dose)
  439. Towards a robust global framework for conduct and oversight of clinical trials
  440. 21 CFR 862.3040: Alcohol test system.
  441. Guidance for completing SFDA On-line MDMA Application Form: JAPANESE Jurisdiction
  442. EMEA-001398-PIP02-13 - paediatric investigation plan
  443. European Medicines Agency recommends Acomplia must not be used in patients on…
  444. May 11, 2018: Joint Meeting of the Pediatric Advisory Committee and the Endocrinologic and…
  445. EMEA-001806-PIP03-18 - paediatric investigation plan
  446. Training session for patients, consumers and healthcare professionals interested in EMA…
  447. EU/3/06/356 - orphan designation for treatment of renal-cell carcinoma
  448. FAQ in Vitro Diagnostic IVD Devices 2024
  449. DIPEROXOCHLORIC ACID TOPOCAL SOLUTION 1.16MGCT/SND/25/2023
  450. F.No. Z-28015-2-2012-TB Dt.16.03.2018 Reg. Tuberculosis diagnosis and its management in…
  451. Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations…
  452. EMEA-001304-PIP02-13-M06 - paediatric investigation plan
  453. Scenesse recommended for rare disease that causes intolerance to sunlight
  454. 21 CFR 870.5210: Cardiopulmonary resuscitation (CPR) aid.
  455. Committee for Orphan Medicinal Products (COMP): 14-16 April 2013
  456. PSUSA/00010333/201611 - periodic safety update report single assessment
  457. PSUSA/00010145/201502 - periodic safety update report single assessment
  458. Pegylated Interferon @-2a
  459. Meeting highlights from the Paediatric Committee: 1 - 2 August 2007
  460. Committee for Medicinal Products for Human Use (CHMP): 13-16 December 2010
  461. September 14, 2016: Pediatric Advisory Committee Meeting Announcement - 09/14/2016
  462. ACCE Awards Recognize HTM Advocates, 2022
  463. ICH M9 on biopharmaceutics classification system based biowaivers - Scientific guideline
  464. ema-meprobamate-referralMeprobamate - referral
  465. ema-aldurazymeAldurazyme
  466. Handling competing interests
  467. Committee for Medicinal Products for Human Use (CHMP): 12-15 October 2020
  468. PSUSA/00010584/202303 - periodic safety update report single assessment
  469. cdsco-lee011LEE011
  470. Guidelines for taking action on samples of drugs declared spurious or not of standard
  471. EU/3/21/2550 - orphan designation for treatment of soft tissue sarcoma
  472. cdsco-nintedanibNintedanib
  473. PSUSA/00000391/202101 - periodic safety update report single assessment
  474. Vildagliptin + Dapagliflozin + Metformin hydrochloride IP tablets (Phase III)
  475. PSUSA/00001971/201810 - periodic safety update report single assessment
  476. Member News: September 2020
  477. ema-sonataSonata
  478. 21 CFR 26.48: Harmonization.
  479. EU/3/12/1054 - orphan designation for treatment of chronic lymphocytic leukaemia
  480. ema-clopidogrel-sandozClopidogrel Sandoz
  481. EU/3/17/1859 - orphan designation for treatment of cystic fibrosis
  482. Workshop on paediatric formulations for assessors in national regulatory agencies
  483. 21 CFR 814.44: Procedures for review of a PMA.
  484. ema-relenzaRelenza
  485. ema-neospectNeoSpect
  486. Paediatric investigation plans: Templates and forms
  487. EMA Management Board: highlights of October 2017 meeting
  488. PSUSA/00000294/201609 - periodic safety update report single assessment
  489. EMEA-001169-PIP02-13 - paediatric investigation plan
  490. ema-potactasolPotactasol
  491. cdsco-ataciceptAtacicept
  492. PSUSA/00001629/201605 - periodic safety update report single assessment
  493. Committee for Medicinal Products for Human Use (CHMP): 13-16 December 2021
  494. cfr-21-cfr-821-3-definitions21 CFR 821.3: Definitions.
  495. PSUSA/00000082/201509 - periodic safety update report single assessment
  496. cdsco-de-117DE-117
  497. Drug Alert list for month of August 2017
  498. ema-prevomaxPrevomax
  499. EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision
  500. EU/3/01/018 - orphan designation for treatment of glycogen storage disease type II…
  501. cdsco-etavopivat-200mgEtavopivat 200mg
  502. Registration of reusable or upclassified Class I devices and/or expiring CE certificates
  503. Review of field safety data by the European Medicines Agency finds a goodsafety record for…
  504. cfr-21-cfr-807-3-definitions21 CFR 807.3: Definitions.
  505. ema-nobivac-l4Nobivac L4
  506. PSUSA/00010440/202108 - periodic safety update report single assessment
  507. Committee for Orphan Medicinal Products (COMP): 11-12 June 2013
  508. Rituximab Biosimilar (DRL_RI) with MabThera®
  509. ema-fortekor-referralFortekor - referral
  510. E-Submission Guide R1.2 for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF…
  511. European Medicines Agency reviews treatment recommendations for Fabrazyme
  512. EU/3/12/1089 - orphan designation for treatment of Wilson's disease
  513. cdsco-pimodivirPimodivir
  514. ema-bridionBridion
  515. HMPC: meeting archive 2004-2011
  516. EMEA-000694-PIP04-18 - paediatric investigation plan
  517. Typhoid Conjugate Vaccine (Monovalent) [Typhoid Vi ConjugateVaccine]
  518. ema-truqapTruqap
  519. No change to product information for breast cancer medicine Tyverb following re-assessment…
  520. ema-spravatoSpravato
  521. cfr-21-cfr-73-1550-talc21 CFR 73.1550: Talc.
  522. cdsco-vtx002VTX002
  523. European Medicines Agency launches database of clinical studies in children completed…
  524. Decision tree for navigating nanotechnology-based products for medical application
  525. Boosting care for newborn babies in low-income countries
  526. Christopher Colvin: Clarifying Human Factors
  527. EMEA-003340-PIP01-22 - paediatric investigation plan
  528. 21 CFR 872.3080: Mercury and alloy dispenser.
  529. 21 CFR 20.55: Indexing trade secrets and confidential commercial or financial information.
  530. Spring 2013 Horizons: A Call for Papers on Home Healthcare
  531. 2015 European Union Good Clinical Practice Inspectors Working Group workshop
  532. Registration opens for workshop of the European Network of Paediatric Research at the…
  533. EMA and ECDC recommendations on heterologous vaccination courses against COVID-19…
  534. FDC of Daclatasvir Dihydrochloride Eq. to Daclatasvir 60mg Sofosbuvir 400mg film coated…
  535. European Medicines Agency finalises update to guideline on renewals
  536. Proforma for Drugs Controller Reporting activities
  537. Paediatric Committee (PDCO): 6-9 September 2022
  538. EMEA-000817-PIP02-11-M01 - paediatric investigation plan
  539. 21 CFR 814.37: PMA amendments and resubmitted PMAs.
  540. 2020.11.26_S.O. 4244(E)_Extension of Import license amid COVID-19 Pandemic for 6 months
  541. PSUSA/00000197/201802 - periodic safety update report single assessment
  542. ema-lumiracoxib-referralLumiracoxib - referral
  543. EU/3/10/847 - orphan designation for treatment of haemophilia A
  544. 2022 AAMI Business Meeting to Take Place on June 5
  545. Committee for Orphan Medicinal Products: March 2004 meeting
  546. First information day on periodic safety update reports (PSURs) – International Conference…
  547. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - February 2018
  548. Calling for New FDA Regulatory Framework for AI Healthcare Algorithms, Policy Experts Seek…
  549. Article 5 procedure: Regulatory and procedural guidance
  550. ema-protaphaneProtaphane
  551. European Medicines Agency veterinary medicines info day
  552. European Medicines Agency Management Board adopt new policies on handling of conflicts of…
  553. 21 CFR 806.30: FDA access to records.
  554. 21 CFR 73.1100: Cochineal extract; carmine.
  555. 2022.03.29_Draft GSR 228(E)_To amend Fourth Schedule wrt TSE or BSE certificate under MDR
  556. PSUSA/00002256/202307 - periodic safety update report single assessment
  557. EU/3/23/2790 - orphan designation for treatment of pancreatic cancer
  558. Diphtheria and Tetanus Vaccine (Adsorbed) for Adults and Adolescents I.P.
  559. EMEA-002693-PIP01-19 - paediatric investigation plan
  560. PSUSA/00001834/201504 - periodic safety update report single assessment
  561. Targanta Netherlands B.V. withdraws its marketing authorisation application for Ramvocid…
  562. Infusion pumps: T34 syringe drivers
  563. 21 CFR 20.20: Policy on disclosure of Food and Drug Administration records.
  564. Committee for Herbal Medicinal Products (HMPC): 17-19 November 2025
  565. PSUSA/00001334/202203 - periodic safety update report single assessment
  566. European Medicines Agency's 2010 annual report shows increase in activities
  567. EMEA-000883-PIP01-10-M05 - paediatric investigation plan
  568. Medical Devices Act
  569. EU/3/16/1690 - orphan designation for treatment of soft tissue sarcoma
  570. ema-rimmyrahRimmyrah
  571. Core summary of product characteristics (SmPC) and package leaflet for nanocolloidal…
  572. 21 CFR 74.1306: D&C Red No. 6.
  573. EU/3/21/2437 - orphan designation for treatment of beta thalassaemia intermedia and major
  574. Medical devices regulations: compliance and enforcement: Medical devices: the regulations…
  575. FDA Issues New Guidance on 'Refuse to Accept' Decisions Concerning Cybersecurity for…
  576. 21 CFR 822.18: How will I be notified of your decision?
  577. EMEA-002622-PIP01-19 - paediatric investigation plan
  578. Management Board meeting: 21 March 2019
  579. European Antibiotic Awareness Day 2022: Preventing antimicrobial resistance together
  580. 21 CFR 888.3043: Screw sleeve bone fixation device.
  581. cdsco-dec-22-2014-gsr-908-eDec 22 2014 GSR 908(E)
  582. 21 CFR 26.44: Transmission of product evaluation reports.
  583. EU/3/10/747 - orphan designation for treatment of renal-cell carcinoma
  584. Committee for Advanced Therapies (CAT): 9-11 September 2020
  585. PSUSA/00010209/201802 - periodic safety update report single assessment
  586. 21 CFR 886.5800: Ophthalmic bar reader.
  587. Drug Information Association / European Medicines Agency / Co-ordination Group for Mutual…
  588. EMEA-001511-PIP02-13 - paediatric investigation plan
  589. hsa-ngs-ivds-pdf-589-kbNGS (IVDs) [PDF, 589 KB]
  590. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11…
  591. PSUSA/00010353/202105 - periodic safety update report single assessment
  592. ema-certifectCertifect
  593. ema-management-board-membersManagement Board members
  594. Medical Device Machine Learning Principles Published Jointly by FDA, MHRA, and Health…
  595. ACT EU consolidated advice pilots: information and training webinar for Applicants
  596. UK withdrawal from the EU on 31 January 2020
  597. ema-mycapssaMycapssa
  598. POSTPONED: February 20, 2025 General and Plastic Surgery Devices Panel of the Medical…
  599. Data protection and privacy
  600. 21 CFR 20.27: Submission of records marked as confidential.
  601. Update of EU recommendations for 2019/2020 seasonal flu vaccine composition
  602. Concept Paper on the Revision of Annex 11 of the Guidelines on Good Manufacturing Practice…
  603. 21 CFR 70.19: Fees for listing.
  604. 2026.06.18 G.S.R. 496(E)_Notification of Chaudhary Charan Singh National Institute of…
  605. EU/3/21/2453 - orphan designation for prevention of retinopathy of prematurity
  606. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  607. Office Memorandum regarding Drugs Inspector's transfers in CDSCO
  608. NMPA Issued the Announcement on Enabling the New Version of Management System for Import…
  609. Yellow Fever Vaccine, Live, Attenuated (Freeze-dried)
  610. Drospirenone - Safety review update on the possible increased risk of blood clots with…
  611. EU/3/06/406 - orphan designation for treatment of amyotrophic lateral sclerosis
  612. EU/3/21/2506 - orphan designation for treatment of cone-rod dystrophy
  613. PSUSA/00010665/201805 - periodic safety update report single assessment
  614. Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported by ACT EU
  615. 21 CFR 866.3125: Citrobacter spp. serological reagents.
  616. EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for…
  617. 21 CFR 882.4125: Neurosurgical chair.
  618. Investigation of bioequivalence - Scientific guideline
  619. PSUSA/00001362/202007 - periodic safety update report single assessment
  620. EMEA-000827-PIP03-11 - paediatric investigation plan
  621. cdsco-trc160334TRC160334
  622. PSUSA/00000777/201507 - periodic safety update report single assessment
  623. First oral add-on treatment to insulin for treatment of certain patients with type 1…
  624. 21 CFR 886.4100: Radiofrequency electrosurgical cautery apparatus.
  625. EU/3/16/1720 - orphan designation for treatment of cholangiocarcinoma
  626. Committee for Orphan Medicinal Products (COMP): 13-15 July 2021
  627. Asked & Answered: Routine Equipment Cleaning and Maintenance Processes
  628. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 6-8…
  629. EMEA-002852-PIP01-20 - paediatric investigation plan
  630. Meeting highlights from the Paediatric Committee: 09 -11 December 2009
  631. EU/3/11/917 - orphan designation for treatment of mucopolysaccharidosis type IIIB…
  632. FDC of Metoprolol Tartrate IP + Ivabradine HCL eq to Ivabradine (25mg+5mg & 50mg+5mg) Film…
  633. EMEA-002685-PIP02-19-M01 - paediatric investigation plan
  634. ASR XL Acetabular System & DePuy ASR Hip Resurfacing System
  635. EMEA-002377-PIP01-18 - paediatric investigation plan
  636. ema-linhaliqLinhaliq
  637. Keys to Succession Planning in HTM
  638. Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2023
  639. ema-hepcludexHepcludex
  640. 21 CFR 20.85: Disclosure to other Federal Government departments and agencies.
  641. Webinar on reporting suspected side effects following administration of veterinary…
  642. (+)-Alpha- Dihydrotetrabenazine ({+})-α-DHTBZ) Powder
  643. 21 CFR 884.1185: Endometrial washer.
  644. EU/3/11/912 - orphan designation for prevention of graft loss in pancreatic islet…
  645. CellSeed Europe Ltd. withdraws its marketing-authorisation application for OraNera…
  646. NMPA, Ministry of Public Security, National Health Commission issued the Announcement on…
  647. Paediatric Committee (PDCO): 16-18 July 2014
  648. 21 CFR 866.3985: Device to detect and identify microorganisms and associated resistance…
  649. PSUSA/00000928/202312 - periodic safety update report single assessment
  650. ema-refixiaRefixia
  651. European Medicines Agency completes review of polymyxin-based medicines
  652. Cybersecurity Pressures Mount. What Can You Do About It?
  653. Head of Veterinary Medicines Unit to leave European Medicines Agency
  654. Pharmacogenomics in oncology - Scientific guideline
  655. Major European research project on monitoring and evaluation of medicines concludes
  656. Announcement of the National Medical Products Administration on the Release of the Good…
  657. 21 CFR 21.70: Disclosure and intra-agency use of records in Privacy Act Record Systems; no…
  658. Principles for Obtaining Indications based on Comparative Evaluation, etc. of the Quality…
  659. EU/3/22/2595 - orphan designation for treatment of mantle cell lymphoma
  660. Vaccines and Related Biological Products Advisory Committee May 28, 2026 Meeting…
  661. EMEA-002720-PIP01-19 - paediatric investigation plan
  662. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 October 2013
  663. Cardiovascular Diseases European Specialised Expert Community
  664. EU/3/08/573 - orphan designation for treatment of alpha-sarcoglycanopathy
  665. cdsco-dutasteride-topicalDutasteride topical
  666. EMEA-001418-PIP01-13-M02 - paediatric investigation plan
  667. cdsco-insulin-aspartInsulin Aspart
  668. Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance
  669. Template for notified body confirmation letter of the status of a formal application…
  670. SARS-CoV-2 (Covid-19) Vaccine (Variant XBB.1.5)
  671. EU/3/14/1277 - orphan designation for treatment of cystic fibrosis
  672. Acotiamide Hydrochloride hydrate SR Tablet 300mg
  673. Drug Safety Update: monthly PDF newsletter: Drug Safety Update May 2022
  674. EMEA-000527-PIP02-10 - paediatric investigation plan
  675. Asked & Answered: Medical Device Sterilization Validation
  676. Trastuzumab Deruxtecan48530
  677. Second industry stakeholder platform on the operation of European Union pharmacovigilance…
  678. PSUSA/00000438/201810 - periodic safety update report single assessment
  679. PSUSA/00002834/201708 - periodic safety update report single assessment
  680. PSUSA/00010030/202005 - periodic safety update report single assessment
  681. EU/3/23/2753 - orphan designation for treatment of limb girdle muscular dystrophy
  682. EU/3/04/190 - orphan designation for treatment of congenital lymphatic malformations
  683. European Medicines Agency advises doctors treating patients with nosocomial pneumonia with…
  684. EMEA-002594-PIP02-20 - paediatric investigation plan
  685. Tartaric acid - paediatric investigation plan
  686. ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
  687. EU/3/12/1038 - orphan designation for treatment of peripheral T-cell lymphoma (nodal…
  688. EU/3/19/2221 - orphan designation for treatment of soft tissue sarcoma
  689. Carglumic acid product-specific bioequivalence guidance
  690. EU/3/22/2663 - orphan designation for treatment of maple syrup urine disease
  691. EU/3/11/870 - orphan designation for treatment of pre-eclampsia
  692. European Medicines Agency Management Board re-elects Pat O'Mahony as chair
  693. Nivolumab 40mg/4ml & 100mg/10ml (10mg/ml) (r-DNA origin)
  694. PSUSA/00000559/202201 - periodic safety update report single assessment
  695. Datopotamab Deruxtecan (Dato-DXd)
  696. Decentralised Manufacture: Marketing Authorisation application
  697. 21 CFR 870.5100: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
  698. Committee for Orphan Medicinal Products: October 2004 meeting
  699. AAMI, CTA to Collaborate on AI Standards
  700. Committee for Orphan Medicinal Products (COMP): 10-12 June 2014
  701. Pregabalin Viatris (previously Pregabalin Mylan)
  702. 21 CFR 864.7490: Sulfhemoglobin assay.
  703. 21 CFR 880.5475: Jet lavage.
  704. European Medicines Agency recommendations on extension of shelf life for Tamiflu
  705. 21 CFR 884.6130: Assisted reproduction microtools.
  706. European Medicines Agency's Management Board officially appoints Guido Rasi as new…
  707. Terlipressin - direct healthcare professional communication (DHPC)
  708. Additional trade names application form for prescription medicine sponsors
  709. 21 CFR 888.4300: Depth gauge for clinical use.
  710. European Medicines Agency recommends withdrawal of marketing authorisations for cough…
  711. Abrocitinib or PF-04965842
  712. New Telemedicine Device Checks for Glaucoma at Home
  713. 21 CFR 870.4320: Cardiopulmonary bypass pulsatile flow generator.
  714. PSUSA/00000749/202102 - periodic safety update report single assessment
  715. 21 CFR 892.1850: Radiographic film cassette.
  716. World Mental Health Day: 10 October 2013
  717. cdsco-feb-17-2015-gsr-107-eFeb 17 2015 GSR 107(E)
  718. Porcimectin Injection and its associated names - referral
  719. Durvalumab in combination
  720. PSUSA/00001265/201612 - periodic safety update report single assessment
  721. New measures to minimise risk of meningioma with medicines containing nomegestrol or…
  722. EMEA-000316-PIP03-20 - paediatric investigation plan
  723. PSUSA/00001789/201911 - periodic safety update report single assessment
  724. Cancellation of products under RC/COS-003211, for import of Cosmetics under Cosmetics…
  725. Focus group on promotion of pharmacovigilance for food producing animals
  726. Clavudale 50mg tablet for cats and dogs - referral
  727. Committee for Medicinal Products for Human Use (CHMP): 12-15 March 2012
  728. Online application in Form 44 for issuance of New Drug permission of Bulk API drugs…
  729. Committee for Medicinal Products for Veterinary Use (CVMP) meeting 6-8 December 2016
  730. cdsco-brazikumab2Brazikumab2
  731. PSUSA/00000171/202002 - periodic safety update report single assessment
  732. Procurement activities 2018
  733. EMEA-001793-PIP01-15-M03 - paediatric investigation plan
  734. HTM Leader Harmonizes with 13485 in Recertification, Acquisition
  735. Durvalumab as Consolidation therapy
  736. ema-arzerraArzerra
  737. FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma…
  738. Powerful Ideas to Guide Ultraviolet Disinfection, Publish SPD Training Research
  739. ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on…
  740. Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as…
  741. Appendix 5 Target Processing Timelines
  742. Application for Certificate of Free Sale or Export Certificate for a medical device
  743. 21 CFR 820.130: Device packaging.
  744. Sixth meeting of the industry stakeholder platform on the operation of the centralised…
  745. EU/3/24/2933 - orphan designation for treatment of hepatitis D virus infection
  746. ema-lifmiorLifmior
  747. EU/3/01/056 - orphan designation for treatment of Niemann-Pick disease
  748. Update of EU recommendations for 2021–2022 seasonal flu vaccine composition
  749. 21 CFR 1.510: How must I maintain records of my FSVP?
  750. CTD modules 2, 3, 4 and 5 for registered complementary medicine applications- Guidance for…
  751. 21 CFR 20.90: Disclosure to contractors.
  752. EMEA-003138-PIP01-21 - paediatric investigation plan
  753. MDR_G.S.R. 356(E) dt_18.05.2022_Insert rule 43A for Suspension and cancellation of license…
  754. Cefepime-Tazobactam WCK 4282 vs. Meropenem
  755. EMEA-002516-PIP01-18 - paediatric investigation plan
  756. Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for…
  757. European medicines regulatory network
  758. Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled
  759. OTC medicine monograph: Bromhexine hydrochloride
  760. cdsco-filgotinibFilgotinib
  761. ema-zoelyZoely
  762. Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (Amendment)…
  763. Barrett Franklin: A Milestone for the TMC
  764. Sales of veterinary antibiotics continue to decline in most European countries
  765. cdsco-molnupiravir-mildb1Molnupiravir MildB1
  766. Handling of the Conditional Approval of Medical Devices and In Vitro Diagnostic…
  767. EMEA-001886-PIP01-15-M01 - paediatric investigation plan
  768. New membership list published for the European Network of Paediatric Research at the…
  769. Quality of medicines questions and answers: Part 1
  770. Magnetic resonance imaging equipment in clinical use: safety guidelines
  771. First vaccine for prevention of dengue
  772. cdsco-certolizumab-pegolCertolizumab Pegol
  773. Ethical considerations for paediatric trials - how can ethics committees in the European…
  774. Tucatinib Tablets 150 mg
  775. Paediatric Committee (PDCO): 7-9 November 2012
  776. EMEA-002163-PIP01-17 - paediatric investigation plan
  777. EU/3/01/035 - orphan designation for treatment of advanced idiopathic Parkinson's disease…
  778. PSUSA/00001997/202003 - periodic safety update report single assessment
  779. EMEA-000863-PIP01-10 - paediatric investigation plan
  780. Chapter 5 - Presentation Guidance - Great Britain: Chapter 5 - Presentation Guidance - GB
  781. 2026.01.22 G.S.R. 52(E)_Draft Notification for Revision of testing fees under Schedule B…
  782. cdsco-nivolumab-10mg-mlNivolumab 10mg/mL
  783. Increasing the availability of veterinary vaccines in the EU
  784. Biosimilar medicines can be interchanged
  785. Timelines for acceptance of CE marked medical devices in Great Britain (GB)
  786. ema-quality-manufacturingQuality: manufacturing
  787. EU/3/22/2600 - orphan designation for treatment of epilepsy with myoclonic-atonic seizures
  788. Cancellation of a product "Elementre - MD Peel-Tri AHA" under Registration Certificate No…
  789. Hae Choe: After 25+ Years in Standards, the Work Is Still Exciting
  790. EU/3/12/1076 - orphan designation for treatment of perinatal asphyxia
  791. Action plan for herbal medicines 2010-2011
  792. European Medicines Agency/International Federation for Animal Health Europe info day 2014
  793. PSUSA/00010430/202011 - periodic safety update report single assessment
  794. Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae…
  795. Getting to the Bottom of Issues with Bedside and Portable Vital Signs Monitors
  796. PSUSA/00001888/201704 - periodic safety update report single assessment
  797. Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2026
  798. EU/3/04/256 - orphan designation for treatment of chronic myeloid leukaemia
  799. GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.)
  800. ema-submission-datesSubmission dates
  801. Update on review of valsartan medicines: risk from NDMA remains low, a related substance…
  802. The role of regulators in establishing added benefit of novel therapies
  803. Olanzapine/Samidorphan Tablets 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg
  804. Drug Listing
  805. Questionnaire for Assessment
  806. ema-sS
  807. On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents
  808. European Medicines Agency closed 27 August 2018
  809. Notice-dated 29.10.12: Interactive meeting with stakeholders.
  810. Rolufta Ellipta (previously Rolufta)
  811. European Medicines Agency recommends revaccination for some travellers in need of…
  812. 21 CFR 82.1322: D&C Red No. 22.
  813. ema-oxervateOxervate
  814. cdsco-concizumab-prophylaxisconcizumab prophylaxis
  815. 2022 annual meeting of the members and Coordinating Group of the European network of…
  816. EU/3/19/2204 - orphan designation for treatment of multiple myeloma
  817. June 2-3, 2016: Circulatory System Devices Panel of the Medical Devices Advisory…
  818. 21 CFR 14.160: Establishment of standing technical advisory committees for human…
  819. 21 CFR 866.3350: Leptospira spp. serological reagents.
  820. Live Attenuated Tetravalent Recombinant Dengue Vaccine
  821. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 February 2015
  822. 21 CFR 870.3630: Pacemaker generator function analyzer.
  823. Product-information requirements
  824. EU/3/08/580 - orphan designation for treatment of spinal cord injury
  825. Pharmacovigilance Working Party
  826. European Surveillance of Veterinary Antimicrobial Consumption annual network meeting 2012
  827. Core summary of product characteristics for human prothrombin complex products…
  828. EU/3/15/1552 - orphan designation for treatment of mantle cell lymphoma
  829. ema-obgemsaObgemsa
  830. Metformin Hydrochloride IP (As extended release) + Glimepiride IP + Dapagliflozin…
  831. EU/3/13/1220 - orphan designation for treatment of dengue
  832. EU/3/21/2434 - orphan designation for treatment of glioma
  833. European Medicines Agency meeting with interested parties and research centres on the…
  834. Expiration Dating and Stability Testing for Human Drug Products
  835. EU/3/14/1280 - orphan designation for treatment of mucopolysaccharidosis, type IIIA…
  836. New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin
  837. PSUSA/00002217/201502 - periodic safety update report single assessment
  838. PSUSA/00010565/202106 - periodic safety update report single assessment
  839. cdsco-pik3caPIK3CA
  840. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for sponsors
  841. EMA website briefly unavailable on 23 May
  842. Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics
  843. EMEA-001114-PIP01-10-M03 - paediatric investigation plan
  844. DR_G.S.R. 828(E) dt_06.11.2019_Condition of licence for undertaking on brand or trade…
  845. cdsco-ly3484356LY3484356
  846. EU/3/04/189 - orphan designation for treatment of Friedreich's ataxia
  847. 21 CFR 803.42: If I am an importer, what information must I submit in my individual…
  848. Guidance document: How to complete the application for a new medical device…
  849. ema-viraferonpegViraferonPeg
  850. NSQ of Typhoid Polysaccharide Vaccine (TYPBAR) manufactured by M/s Bharat Biotech…
  851. AS P0005.002: Assessment Program Procedure
  852. Guideline on good pharmacovigilance practices (GVP): product or population-specific…
  853. 21 CFR 888.3410: Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing…
  854. PSUSA/00001054/201510 - periodic safety update report single assessment
  855. Committee for Orphan Medicinal Products (COMP): 7-9 January 2015
  856. Healthcare Professionals' Organisations Working Group (HCP WG)
  857. Guideline on clinical investigation of medicinal products in the treatment of chronic…
  858. 21 CFR 864.5200: Automated cell counter.
  859. cfr-21-cfr-870-1390-trocar21 CFR 870.1390: Trocar.
  860. Ifirmasta (previously Irbesartan Krka)
  861. Authorised Prescriber (AP) Applications - Quick Reference Guide
  862. Name Of Approved Clinical Centres
  863. NMPA Issued the Rules for Unique Identification System for Medical Devices
  864. How HTM Paperwork Speaks Louder Than Words
  865. EU/3/02/130 - orphan designation for treatment of gastric cancer
  866. Guideline on clinical investigation of recombinant and human plasma-derived factor IX…
  867. Testimonials and endorsements in advertising
  868. EU/3/20/2309 - orphan designation for treatment of idiopathic pulmonary fibrosis
  869. ema-procurementProcurement
  870. EU/3/05/294 - orphan designation for prevention of oral mucositis in head and neck cancer…
  871. PSUSA/00001798/202203 - periodic safety update report single assessment
  872. European Medicines Agency consulting on a draft guideline on pharmacovigilance for…
  873. EMEA-000328-PIP02-09 - paediatric investigation plan
  874. EMEA-002906-PIP01-20 - paediatric investigation plan
  875. EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine…
  876. Clinical Trials Information System (CTIS): Walk-in clinic
  877. PSUSA/00010298/201703 - periodic safety update report single assessment
  878. Guidance for Health Care Professionals on Special Access and Custom-Made Medical Devices
  879. Guidance for licensing electronic cigarettes and other inhaled nicotine-containing…
  880. Disposal/Rejection of Long Pending Applications on SUGAM Portal Awaiting Query Response
  881. eSubmission gateway webinar
  882. Valerianae radix - herbal medicinal product
  883. EU/3/08/598 - orphan designation for treatment of Duchenne muscular dystrophy
  884. EU/3/14/1348 - orphan designation for treatment of glioma
  885. 21 CFR 862.1100: Aspartate amino transferase (AST/SGOT) test system.
  886. 21 CFR 73.2299: Ferric ferrocyanide.
  887. 21 CFR 878.3300: Surgical mesh.
  888. 2018.07.03_Draft GSR 608E)_Perpetual Licensing
  889. ema-kengrexalKengrexal
  890. Idea AG withdraws its marketing authorisation application for Diractin (ketoprofen)
  891. Computer-to-Brain Interface for Paralyzed Patients to Launch Third Clinical Trial
  892. EU/3/20/2299 - orphan designation for treatment of achondroplasia
  893. 21 CFR 876.5450: Rectal dilator.
  894. cdsco-masitinibMasitinib
  895. Public consultation starts on first guideline on medicines for the treatment of lupus…
  896. 21 CFR 870.1405: Interventional cardiovascular implant simulation software device.
  897. Committee for Herbal Medicinal Products (HMPC): 18-20 March 2024
  898. 21 CFR 882.5275: Nerve cuff.
  899. EMA recommends approval of Spikevax for children aged 6 to 11
  900. Pilot Signal Management Expert Group
  901. Strengthened guidance on follow-up and risk management for ATMP developers
  902. cdsco-dalfampridineDalfampridine
  903. AAMI Releases Updated Guidance on EO Sterilization
  904. Improving AI-Enabled Medical Devices with Data Consortiums and Encryption Technology
  905. 21 CFR 868.2610: Gas pressure gauge.
  906. EU/3/15/1583 - orphan designation for prevention of graft-versus-host disease
  907. Guide to Traceback of Fresh Fruit and Vegetables Implicated in Epidemiological…
  908. PSUSA/00010432/201610 - periodic safety update report single assessment
  909. Safe use of emollient skin creams to treat dry skin conditions
  910. 21 CFR 888.3010: Bone fixation cerclage.
  911. Committee on Herbal Medicinal Products publishes its meeting agenda for the first time
  912. Access Consortium Generic Medicines Working Group Mandate
  913. ema-quality-working-partyQuality Working Party
  914. Regulatory awareness session on medical devices (Webinar)
  915. Pharmaceutical Affairs Act, Pharmaceutical Affairs Act(2018-1-31)
  916. Recommendation-NB-MED-2_1-1_rev4 Representative Sample
  917. 21 CFR 821.2: Exemptions and variances.
  918. CEN/CENELEC Accept European Commission Request for Medical Device Standardization
  919. November 3rd 2017 GSR 1367(E)
  920. EU/3/20/2335 - orphan designation for treatment of sickle cell disease
  921. Committee for Medicinal Products for Human Use (CHMP): 12-15 September 2022
  922. Dalbavancin Hydrochloride for injection 500mg
  923. ema-emea-efpia-info-dayEMEA-EFPIA Info day
  924. 21 CFR 1.720: Are user fees under this subpart refundable?
  925. EMEA-001397-PIP02-13 - paediatric investigation plan
  926. ‘We Know What We’re Doing!’ an International Comparison of Device Maintenance Incidents
  927. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23…
  928. 21 CFR 882.4440: Neurosurgical headrests.
  929. EU/3/15/1460 - orphan designation for treatment of hepatocellular carcinoma
  930. 21 CFR 874.4450: Powered insertion system for a cochlear implant electrode array.
  931. GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
  932. 21 CFR 868.1150: Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
  933. cdsco-ianalumabdecianalumabdec
  934. EU/3/13/1163 - orphan designation for treatment of argininosuccinic aciduria
  935. ema-healthcare-professionalsHealthcare professionals
  936. Quercus cortex - herbal medicinal product
  937. ema-vascace-referralVascace - referral
  938. PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS)…
  939. Joint TOPRA/EMA meeting: The annual European Medicines Agency review of the year and…
  940. Focus on Human Factors: New Six-Part Virtual Human Factors Training Series Kicks Off in…
  941. NOTICE regarding Strict regulatory control over manufacture, sale and distribution of…
  942. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
  943. EMEA-001133-PIP01-11 - paediatric investigation plan
  944. ema-tulatrixxTulatrixx
  945. PSUSA/00010242/202308 - periodic safety update report single assessment
  946. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  947. 21 CFR 878.5360: Tweezer-type epilator.
  948. PSUSA/00003016/202208 - periodic safety update report single assessment
  949. EU/3/14/1422 - orphan designation for treatment of mucopolysaccharidosis type IIIB
  950. Notice regarding consideration of the directions of Hon'ble SC India in the Case of 344…
  951. EU/3/23/2881 - orphan designation for treatment of acute myeloid leukaemia
  952. DR_G.S.R. 242(E) dt_18.03.1998_Substitution Rule 3A_Functions of laboratories in respect…
  953. Voriconazole product-specific bioequivalence guidance
  954. EMA systems disruption expected from 11 to 17 April
  955. 21 CFR 870.5300: DC-defibrillator (including paddles).
  956. Herniariae herba - herbal medicinal product
  957. 21 CFR 70.55: Request for scientific studies.
  958. ema-semler-referralSemler - referral
  959. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16…
  960. European Medicines Agency publishes format for submission of information on medicines
  961. Sunitinib product-specific bioequivalence guidance
  962. EMEA-003214-PIP01-22 - paediatric investigation plan
  963. EMEA-000488-PIP02-11 - paediatric investigation plan
  964. Drug Alert list for month of July 2022
  965. EMEA-001878-PIP01-15 - paediatric investigation plan
  966. EMA concludes defective device in ROCKET study does not impact Xarelto's safety
  967. EMA finalises opinion on presence of nitrosamines in medicines
  968. Focus group meeting on bacteriophages as veterinary medicines
  969. cdsco-ustekinumab-45mg-0-5mlUstekinumab 45mg/0.5mL
  970. cdsco-acalabrutinibAcalabrutinib
  971. Paediatric Committee re-elects chair
  972. Diltiazem Hydrochloride 2% Gel
  973. Metamizole - direct healthcare professional communication (DHPC)
  974. 21 CFR 73.3125: Iron oxides.
  975. Azelnidipine IP + Chlorthalidone IP Uncoated Tablet (Phase III Clinical Trial)
  976. EMEA-000923-PIP01-10 - paediatric investigation plan
  977. ema-multihance-referralMultiHance - referral
  978. SME Regulation and reports
  979. PSUSA/00000309/201701 - periodic safety update report single assessment
  980. Low Acid Canned Food Manufacturers Part 3 - Container/Closures (11/98)
  981. EMEA-001461-PIP02-14 - paediatric investigation plan
  982. 21 CFR 807.28: Updating device listing information.
  983. EU/3/23/2801 - orphan designation for treatment of congenital diaphragmatic hernia
  984. cdsco-adjuvant-durvalumabAdjuvant Durvalumab
  985. Similar biological medicinal products containing recombinant erythropoietins - Scientific…
  986. EMEA-000302-PIP01-08-M03 - paediatric investigation plan
  987. EMEA-003007-PIP01-21 - paediatric investigation plan
  988. ema-lucentisLucentis
  989. EMEA-001644-PIP02-14-M03 - paediatric investigation plan
  990. 21 CFR 880.6200: Ring cutter.
  991. 21 CFR 1.226: Who does not have to register under this subpart?
  992. 21 CFR 886.1850: AC-powered slitlamp biomicroscope.
  993. PSUSA/00010670/202109 - periodic safety update report single assessment
  994. 21 CFR 876.4890: Urological table and accessories.
  995. EU/3/17/1968 - orphan designation for treatment of congenital adrenal hyperplasia
  996. Capivasertib plus CDK4/6

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