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Global regulations and guidance

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

  1. Pioglitazone Hydrochloride IP eq. to Pioglitazone + Teneligliptin Hydrochloride Hydrate IP…
  2. Mometasone Furoate Sandoz - referral
  3. Dexdor - direct healthcare professional communication (DHPC)
  4. English version of the Standards for Marketing Approval of Cold Remedies, etc.
  5. New antiretrovirals improve quality of life of HIV/AIDS patients
  6. EU/3/16/1827 - orphan designation for treatment of spinocerebellar ataxia
  7. Drospirenone and Estetrol tablets (3 mg + 14.2 mg)
  8. EU/3/17/1905 - orphan designation for treatment of tuberculosis
  9. Committee for Herbal Medicinal Products (HMPC): 21-23 November 2022
  10. Mike Powers: Where Have the Instructions Gone?
  11. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course…
  12. Notice regarding classification of non notified medical devices
  13. EU/3/16/1613 - orphan designation for treatment of progressive supranuclear palsy
  14. 21 CFR 864.9195: Blood mixing devices and blood weighing devices.
  15. Tapping in to a New HTM Talent Pipeline Beyond U.S. Borders
  16. EMEA-000983-PIP01-10 - paediatric investigation plan
  17. EU/3/13/1138 - orphan designation for treatment of squamous-cell carcinoma of the head and…
  18. EU/3/05/262 - orphan designation for treatment of ultraviolet-A- and visible-light-induced…
  19. EMEA-003342-PIP01-22 - paediatric investigation plan
  20. Borderlines with medical devices and other products in Great Britain: Borderlines with…
  21. 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
  22. 21 CFR 12.139: Reconsideration and stay of action.
  23. 2021.10.18_S.O. 4326(E)_Reconstitution of DTAB 2021
  24. 21 CFR 882.5830: Implanted diaphragmatic/phrenic nerve stimulator.
  25. ema-nexavarNexavar
  26. EudraVigilance training on the electronic reporting of individual case safety reports…
  27. Review of hydroxyzine-containing medicines started
  28. What’s in Store for the AAMI Board? A Conversation with Gerry McDonnell
  29. ema-xenicalXenical
  30. 21 CFR 807.65: Exemptions for device establishments.
  31. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 March 2015
  32. EU/3/22/2609 - orphan designation for treatment of epidermolysis bullosa
  33. 21 CFR 860.240: Procedures for review of a De Novo request.
  34. Fosravuconazole capsules
  35. 21 CFR 862.1825: Vitamin D test system.
  36. Drug Safety Update: monthly PDF newsletter: Drug Safety Update October 2022
  37. Brexpiprazole 1mg/2mg/3mg/4mg Tablets
  38. EMEA-001156-PIP01-11-M07 - paediatric investigation plan
  39. Generating high-quality evidence from registry-based studies
  40. PSUSA/00010381/202004 - periodic safety update report single assessment
  41. ema-gripovac-3Gripovac 3
  42. EU/3/18/2131 - orphan designation for treatment of immune thrombocytopenia
  43. 21 CFR 1.245: Waiver request.
  44. Paediatric Committee (PDCO): 19-21 May 2010
  45. cdsco-aclidiniumAclidinium
  46. FDA cautions about dosing errors when switching between different oral formulations of…
  47. ema-norsed-combi-d-referralNorsed Combi D - referral
  48. EU/3/22/2701 - orphan designation for treatment of autosomal recessive congenital…
  49. EMEA-002125-PIP01-17 - paediatric investigation plan
  50. EU/3/12/1045 - orphan designation for treatment of cystic fibrosis
  51. SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Service (RMS)
  52. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 July 2015
  53. Committee for Proprietary Medicinal Products (CPMP) 12th plenary meeting
  54. Checklist for Common Inquiry Cases to Be Noted When Submitting Approval Applications for…
  55. ema-governance-proceduresGovernance procedures
  56. 21 CFR 868.1850: Monitoring spirometer.
  57. Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2021 (SI…
  58. Clinical Trials Information System (CTIS): Walk-in clinic - February 2023
  59. European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 January…
  60. 21 CFR 58.43: Animal care facilities.
  61. cdsco-gsk3196165GSK3196165
  62. ema-lartruvo-referralLartruvo - referral
  63. Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 March 2023
  64. EMEA-000468-PIP02-12-M08 - paediatric investigation plan
  65. EMEA-002721-PIP01-19 - paediatric investigation plan
  66. European Medicines Agency recommends restricting the use of oral moxifloxacin-containing…
  67. ema-divence-ibr-marker-liveDivence IBR Marker Live
  68. Thirty-third meeting of the Management Board
  69. BioPartners GmbH withdraws its application for Biferonex (interferon beta-1a)
  70. Agency releases new guidance on medicines based on stem cells
  71. PSUSA/00000422/202203 - periodic safety update report single assessment
  72. EMEA-002917-PIP01-20 - paediatric investigation plan
  73. 2026.07.02 G.S.R. 561(E)_Notification for consideration of Navi Mumbai International…
  74. GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB
  75. Safety clinical trial shows possible increased risk of cancer with weight-loss medicine…
  76. 21 CFR 73.1015: Chromium-cobalt-aluminum oxide.
  77. Manufacturing and marketing of certain FDCs as per directions of Hon'ble High Court…
  78. EU/3/09/660 - orphan designation for treatment of pancreatic cancer
  79. Committee for Orphan Medicinal Products (COMP): 15-17 March 2022
  80. PSUSA/00000111/202207 - periodic safety update report single assessment
  81. Committee for Advanced Therapies (CAT): 14-15 January 2010
  82. ema-chondrocelectChondroCelect
  83. Clinical Trials Information System (CTIS): Walk-in clinic - March 2023
  84. Zometa - withdrawal of application for variation to marketing authorisation
  85. NMPA Announcement on Issuing the Pharmaceutical Excipients Annex and Pharmaceutical…
  86. News in Brief - August 2020
  87. Inter-Committee Scientific Advisory Group on Oncology
  88. Enpr-EMA meeting documents archive
  89. Monitoring to ensure availability of Remdesivir and prevent its hoarding and black…
  90. 21 CFR 14.75: Examination of administrative record and other advisory committee records.
  91. Committee for Medicinal Products for Human Use (CHMP): 27-30 May 2024
  92. 21 CFR 861.24: Existing standard as a proposed standard.
  93. EMEA-001632-PIP01-14 - paediatric investigation plan
  94. Notification of commencement of supply
  95. Committee for Medicinal Products for Human Use (CHMP): 28-31 January 2019
  96. EMEA-000408-PIP01-08-M05 - paediatric investigation plan
  97. FARAWAVE Pulsed Field Ablation Catheter and FARASTAR Pulsed Field Ablation Generator…
  98. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - December 2018
  99. 21 CFR 862.3630: Methaqualone test system.
  100. Ulipristal acetate for uterine fibroids: EMA recommends restricting use
  101. ema-baqsimiBaqsimi
  102. 21 CFR 74.2327: D&C Red No. 27.
  103. 21 CFR 895.22: Submission of data and information by the manufacturer, distributor, or…
  104. Minoxidil IP 5%w/v + Finasteride IP 0.10%w/v + Latanoprost IP 0.03%w/v per ml topical…
  105. Aflibercept Injection 40 mg/ml, (2mg/0.05ml PFS/Vial)
  106. cdsco-jan-16-2015-gsr-38-eJan 16 2015 GSR 38(E)
  107. COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
  108. EU/3/08/569 - orphan designation for treatment of acute lymphoblastic leukaemia
  109. EU/3/13/1110 - orphan designation for treatment of Niemann-Pick's disease, type C
  110. ema-seretide-diskus-referralSeretide Diskus - referral
  111. Regulatory update - EMA encourages companies to submit type I variations for 2015 by end…
  112. EU/3/02/099 - orphan designation for treatment of oesophageal cancer
  113. Use of electronic health record data in clinical investigations - guidance for industry
  114. 21 CFR 882.5892: External vagal nerve stimulator for headache.
  115. Robot-Assisted Fracture Reduction System for Pelvic Fracture Approved for Marketing
  116. Good Clinical Practice (GCP) inspection program
  117. EMEA-003289-PIP01-22 - paediatric investigation plan
  118. European Medicines Agency completes review of protamine-containing medicines
  119. ema-pioglitazone-ratioPioglitazone ratio
  120. EU/3/14/1338 - orphan designation for treatment of Crigler-Najjar syndrome
  121. Potency declaration/labelling for biological medicinal products which contain modified…
  122. PSUSA/00010145/201508 - periodic safety update report single assessment
  123. ema-procomvaxProcomvax
  124. EMEA-003083-PIP01-21 - paediatric investigation plan
  125. AS F0010.2.001 AO Application for Recognition Flowchart
  126. Guidance 8: Product information
  127. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Linagliptin film coated…
  128. EU/3/17/1885 - orphan designation for treatment of congenital diaphragmatic hernia
  129. 21 CFR 14.15: Committees working under a contract with FDA.
  130. ema-suvaxyn-aujeszky-783-o-wSuvaxyn Aujeszky 783 + O/W
  131. Information session on the pilot for expert panels’ scientific advice to manufacturers of…
  132. 21 CFR 20.22: Partial disclosure of records.
  133. Press briefing on EU recommendation on first COVID-19 vaccine
  134. 21 CFR 890.1925: Isokinetic testing and evaluation system.
  135. European Medicines Agency recommends approval of two new treatment options for rare…
  136. Policy Interpretation of the Announcement on Optimizing of the Review and Approval Process…
  137. EMEA-001533-PIP01-13-M02 - paediatric investigation plan
  138. ema-levetiracetam-accordLevetiracetam Accord
  139. EMEA-003116-PIP01-21 - paediatric investigation plan
  140. SAMR Issued the Measures for the Administration of Imported Medicinal Materials
  141. cdsco-feb-3-2015-gsr-68-eFeb 3 2015 GSR 68(E)
  142. AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
  143. Drug Alert list for November 2018
  144. Rabies Vaccine, Human I.P. [Purified Inactivated Vero Cell Rabies vaccine – Lyophilized
  145. 2025.01.30_ S.O. 558(E)_Notification of IVRI Veterinary Government Analyst
  146. EMEA-002261-PIP01-17 - paediatric investigation plan
  147. cdsco-myl-14020MYL-14020
  148. Total Diet Study
  149. ema-panexcell-referralPanexcell - referral
  150. ICH S4 Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity…
  151. Harmonisation of requirements for influenza vaccines
  152. Considerations given to designation of a single stereo isomeric form (enantiomer), a…
  153. Committee for Medicinal Products for Human Use (CHMP): 20-23 April 2015
  154. ema-signiforSignifor
  155. EMEA-002977-PIP01-21 - paediatric investigation plan
  156. European Medicines Agency begins to publish recommendations based on safety signals
  157. 21 CFR 862.2: Regulation of calibrators.
  158. Typhoid Bivalent Conjugate Vaccine
  159. 21 CFR 866.3310: Hepatitis A virus (HAV) serological assays.
  160. EU/3/09/680 - orphan designation for treatment of pancreatic cancer
  161. Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting…
  162. ema-kogenate-bayerKogenate Bayer
  163. Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with…
  164. 21 CFR 892.1560: Ultrasonic pulsed echo imaging system.
  165. Metal-on-Metal Hip Implants: FDA Safety Communication [ARCHIVED]
  166. European Medicines Agency closed 9 May 2019
  167. EMEA-002902-PIP01-20 - paediatric investigation plan
  168. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 January 2016
  169. European Medicines Agency welcomes publication of pharmacovigilance fee Regulation in…
  170. cdsco-may-2nd-2017-gsr-429-eMay 2nd 2017 GSR 429(E)
  171. European Commission, EMA and FDA agree new priorities to strengthen their collaboration on…
  172. EMEA-002178-PIP01-17-M01 - paediatric investigation plan
  173. Second Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical…
  174. Committee for Orphan Medicinal Products (COMP): 2-4 September 2014
  175. Software and AI as a Medical Device Change Programme
  176. 21 CFR 866.3200: Echinococcus spp. serological reagents.
  177. Levothyroxine: a review of clinical and quality considerations: Levothyroxine tablet…
  178. Influenza vaccines prepared from viruses with the potential to cause a pandemic and…
  179. AstraZeneca: Withdraws its marketing authorisation application for Zactima (vandetanib)
  180. Committee for veterinary medicinal products: 54th meeting
  181. EU/3/19/2208 - orphan designation for treatment of Stargardt's disease
  182. EU/3/18/2044 - orphan designation for treatment of graft-versus-host disease
  183. Get more help to apply for medicines Integrated Scientific Advice (ISA)
  184. ema-krazatiKrazati
  185. EMEA-002791-PIP01-20 - paediatric investigation plan
  186. Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 March 2025
  187. EU/3/10/732 - orphan designation for treatment of Hodgkin's lymphoma
  188. cdsco-oral-etrasimodoral Etrasimod
  189. Pain-Measuring AI Granted De Novo Clearance to Help Doctors Make Post-Surgery Treatment…
  190. PSUSA/00000171/201702 - periodic safety update report single assessment
  191. Methadone medicinal products for oral use containing povidone - referral
  192. 21 CFR 866.3165: Cryptococcus neoformans serological reagents.
  193. Committee for Orphan Medicinal Products (COMP): 7-8 July 2010
  194. EU/3/05/314 - orphan designation for treatment of tuberculosis
  195. Post-authorisation safety studies (PASS)
  196. Excipients in the dossier for application for marketing authorisation for veterinary…
  197. ema-gemzar-referralGemzar - referral
  198. A Technical Guide for Communicating with Non-Technical Stakeholders
  199. EU/3/13/1104 - orphan designation for treatment of systemic sclerosis
  200. PSUSA/00001507/201504 - periodic safety update report single assessment
  201. cdsco-volrustomig-medi5752Volrustomig (MEDI5752)
  202. Q&A for “Planning of the Pediatric Drug Development Program during Development of Drugs…
  203. ema-skilarenceSkilarence
  204. EU/3/18/2025 - orphan designation for treatment of methylmalonic acidaemia
  205. EMEA-002398-PIP01-18 - paediatric investigation plan
  206. 21 CFR 809.11: Exceptions or alternatives to labeling requirements for in vitro diagnostic…
  207. 21 CFR 864.7500: Whole blood hemoglobin assays.
  208. 21 CFR 14.20: Notice of hearing before an advisory committee.
  209. Mentoring Halfway Across the World, the Benefit of an International Community
  210. EMEA-002842-PIP01-20 - paediatric investigation plan
  211. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 July 2023
  212. World Alzheimer's Month: September 2012
  213. PSUSA/00002993/201609 - periodic safety update report single assessment
  214. CHMP re-elects its Chair and Vice-Chair
  215. Provisions for Supervision and Administration of Medical Device Distribution
  216. Quarterly system demo - Q4 2023
  217. 21 CFR 876.5885: Tissue culture media for human ex vivo tissue and cell culture processing…
  218. Signal detection and management information day
  219. ema-posaconazole-ahclPosaconazole AHCL
  220. 5th meeting of the Committee for Orphan Medicinal Products
  221. EMEA-003175-PIP01-21 - paediatric investigation plan
  222. RESOLUTION RDC NO. 16, 28 MARCH 2013
  223. EMA recommends withdrawal of marketing authorisation for amfepramone medicines
  224. Medical devices: post-market surveillance requirements
  225. ema-nouryantNouryant
  226. 21 CFR 1.1300: Who is subject to this subpart?
  227. Regulatory information – Companies now required to update, complete and improve quality of…
  228. 21 CFR 888.5: Resurfacing technique.
  229. Use of antibiotics in animals is decreasing
  230. ema-aservo-equihalerAservo EquiHaler
  231. Committee for Proprietary Medicinal Products (CPMP) 40th plenary meeting
  232. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 13-15 April 2010
  233. 12th meeting of the Committee for Orphan Medicinal Products
  234. Union Product Database: release notes
  235. EU/3/09/697 - orphan designation for treatment of naevoid basal-cell carcinoma syndrome…
  236. How to facilitate development of cancer treatment based on genetically modified T-cells
  237. ema-lydaxxLydaxx
  238. End-of-year message from EMA’s Executive Director
  239. PSUSA/00000027/202107 - periodic safety update report single assessment
  240. EMEA-002432-PIP02-20 - paediatric investigation plan
  241. EMEA-003087-PIP01-21 - paediatric investigation plan
  242. Quarterly system demo - Q3 2023
  243. Filipendulae ulmariae flos - herbal medicinal product
  244. PSUSA/00010582/202109 - periodic safety update report single assessment
  245. ema-risperdal-referralRisperdal - referral
  246. P/116/2010 - paediatric investigation plan
  247. Single, central platform now mandatory for all periodic safety update reports
  248. EU/3/13/1213 - orphan designation for prevention of necrotising enterocolitis
  249. ema-bortezomib-hospiraBortezomib Hospira
  250. Committee for Veterinary Medicinal Products (CVMP)
  251. 21 CFR 20.67: Records exempted by other statutes.
  252. 21 CFR 886.5842: Spectacle frame.
  253. Tysabri - Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated…
  254. cdsco-nizubaglustatNizubaglustat
  255. Gelisia and associated names - referral
  256. PSUSA/00002781/201501 - periodic safety update report single assessment
  257. Committee for medicinal products for veterinary use: Meeting of 9-11 October 2007
  258. Inaugural Golf Tournament Tees Off at 2023 AAMI eXchange
  259. Best use of medicines legislation to bring new antibiotics to patients and combat the…
  260. Leonuri cardiacae herba - herbal medicinal product
  261. Investigation of subgroups in confirmatory clinical trials - Scientific guideline
  262. 21 CFR 822.34: What must I do with the records if the sponsor of the plan or an…
  263. ema-tukysaTukysa
  264. Workshop on the reflection paper on statistical methodology for the comparative assessment…
  265. 21 CFR 73.585: Tomato lycopene extract; tomato lycopene concentrate.
  266. MEDICAL DEVICE ALERT FOR " Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1…
  267. EU/3/24/2925 - orphan designation for treatment of acute radiation syndrome
  268. FDA is requiring opioid pain medicine manufacturers to update prescribing information…
  269. EMEA-002587-PIP01-19 - paediatric investigation plan
  270. EU/3/12/1086 - orphan designation for treatment of familial adenomatous polyposis (FAP)
  271. Exploring Virtual Reality for Clinical Education, Patient Therapy
  272. EU/3/17/1883 - orphan designation for treatment of Creutzfeldt-Jakob disease
  273. Committee for Medicinal Products for Human Use (CHMP): 16-19 September 2013
  274. Quality of transdermal patches - Scientific guideline
  275. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Information session…
  276. 21 CFR 888.3800: Wrist joint metal/polymer semi-constrained cemented prosthesis.
  277. 21 CFR 860.123: Reclassification petition: Content and form.
  278. 21 CFR 16.22: Initiation of regulatory hearing.
  279. Ezetimibe tablet 10 mg product-specific bioequivalence guidance
  280. Posaconazole product-specific bioequivalence guidance
  281. Spinal Cord Stimulation Instead of Pain Medication?
  282. European Medicines Agency welcomes new Head of Communication Department and new Head of…
  283. Third meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
  284. cfr-21-cfr-890-3520-plinth21 CFR 890.3520: Plinth.
  285. Sodium Zirconium Cyclosilicate powder for oral Suspension 5g/ 10g
  286. 21 CFR 812.145: Inspections.
  287. Adcetris - withdrawal of application for variation to marketing authorisation
  288. P/4/2010 - paediatric investigation plan
  289. hsa-part-ii-qualityPart II: Quality
  290. AAMI News, June 2020, Vol. 55, No. 6
  291. Letter regarding MSC,NCC & performance certificate
  292. European Medicines Agency workshop on medicines for older people
  293. FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine…
  294. EMEA-000810-PIP01-09 - paediatric investigation plan
  295. Patient-Centered Action for Rare Diseases Encouragement - "CARE Plan"
  296. 21 CFR 864.6150: Capillary blood collection tube.
  297. Guidance on the conduct of clinical trials in relation to the COVID-19 situation
  298. 21 CFR 866.2600: Wood's fluorescent lamp.
  299. ema-proteqflu-teProteqFlu-Te
  300. Committee for Proprietary Medicinal Products (CPMP) 44th plenary meeting
  301. Questions and answers: Article 31 non-pharmacovigilance referrals
  302. Pandemic influenza pharmacovigilance updates
  303. Examples of Points to Consider and Approaches for Utilization of Study Results Obtained…
  304. EMEA Management Board adopts work programme for a busy year ahead and agrees to move…
  305. ST98: New Standard in Medical Device Cleaning Spotlights ‘Clean’ for Manufacturers
  306. Sterile Drug Process Inspections (PDF - 292KB)
  307. PSUSA/00002947/201612 - periodic safety update report single assessment
  308. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017
  309. cdsco-bemnifosbuvirBemnifosbuvir
  310. EMEA-000645-PIP03-18 - paediatric investigation plan
  311. Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945
  312. PSUSA/00000375/202110 - periodic safety update report single assessment
  313. cdsco-enbrelEnbrel
  314. EMEA-002222-PIP01-17 - paediatric investigation plan
  315. PSUSA/00010402/202001 - periodic safety update report single assessment
  316. EMEA-002231-PIP01-17-M01 - paediatric investigation plan
  317. PSUSA/00001926/202110 - periodic safety update report single assessment
  318. The new EudraVigilance System and the electronic reporting of the individual case safety…
  319. 21 CFR 1.926: Under what circumstances may we deny a petition requesting a waiver?
  320. Nurse Call Systems Top List of Hospital Devices with Cybersecurity Risks
  321. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 January 2018
  322. 21 CFR 868.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  323. Health Institution Exemption for general medical devices
  324. EU/3/13/1105 - orphan designation for treatment of Duchenne muscular dystrophy
  325. Texas Children's HTM Takes a Team Approach to CMMS Review
  326. EU/3/18/2024 - orphan designation for prevention of invasive aspergillosis
  327. FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems with Blood Obtained…
  328. Recommendation-NB-MED-2_5_5-4_rev2 Assessment of the sensitivity of In Vitro Diagnostic…
  329. EMEA-002705-PIP02-19 - paediatric investigation plan
  330. Public Notice regarding pharmacovigilance reporting for veterinary products in India
  331. Guideline on clinical investigation of medicinal products in the treatment of patients…
  332. EMEA-001875-PIP02-18-M03 - paediatric investigation plan
  333. Semaglutide on functional capacity
  334. Concept Paper on the Revision of Annex 5 of the Guidelines on Good Manufacturing Practice…
  335. Solidaginis virgaureae herba - herbal medicinal product
  336. Plasma master file (PMF) certification
  337. ema-gliolanGliolan
  338. CMS Issues Proposed Rule for Coverage of Breakthrough Devices
  339. Drug Alert list for month of December 2019
  340. QMS F0008.4: Internal Assessment Schedule Instruction Form
  341. EMEA-002140-PIP01-17 - paediatric investigation plan
  342. Clopidogrel/Acetylsalicylic acid Teva
  343. Clopidogrel Krka d.d. (previously Zopya)
  344. cdsco-norditropinNorditropin®
  345. ema-bindrenBindRen
  346. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  347. Drug Alert list for month of May 2022 (Revised)
  348. Notice Order regarding SUGAM ONLINE Dated 01.12.2016
  349. Vaccines and Related Biological Products Advisory Committee May 22, 2025 Meeting…
  350. 21 CFR 892.1110: Positron camera.
  351. PRAC recommends updating advice on use of high-dose ibuprofen
  352. 22nd meeting of the committee for veterinary medicinal products
  353. EMA recommends first COVID-19 vaccine for authorisation in the EU
  354. Cholic acid - paediatric investigation plan
  355. ACB meeting statement, Meeting 4, 24 July 2014
  356. Committee for Proprietary Medicinal Products (CPMP) 24th plenary meeting
  357. EMEA-002882-PIP01-20 - paediatric investigation plan
  358. EMEA-003039-PIP01-21 - paediatric investigation plan
  359. Brivudine - direct healthcare professional communication (DHPC)
  360. EMEA-001984-PIP03-20 - paediatric investigation plan
  361. EMEA forecasts modest increase in applications in its 2004 budget and Management Board…
  362. Obtaining and maintaining a scientific opinion on a medicine for use outside the European…
  363. Lymphoseek - direct healthcare professional communication (DHPC)
  364. ema-fenflor-referralFenflor - referral
  365. 21 CFR 864.4010: General purpose reagent.
  366. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - June 2022
  367. ema-pharmaceutical-industryPharmaceutical industry
  368. David W. Braeutigam: To the 'Geeks' Go the Spoils
  369. High Value of Human Factors Engineer Embedded in the Clinical Setting
  370. European Medicines Agency recommendation on use of angiotensin-II-receptor antagonists…
  371. Kentera (previously Oxybutynin Nicobrand)
  372. EMEA-002333-PIP02-19 - paediatric investigation plan
  373. ema-zelnormZelnorm
  374. 21 CFR 866.3510: Rubella virus serological reagents.
  375. Reflection paper on resistance in ectoparasites - Scientific guideline
  376. Metalyse - direct healthcare professional communication (DHPC)
  377. Infectious Diseases Working Party
  378. Removing an orphan designation
  379. NMPA and General Administration of Customs issued the Announcement on the Setting up of…
  380. EMEA-003229-PIP01-22 - paediatric investigation plan
  381. cdsco-ranibizumab-0-5-mgRanibizumab 0.5 mg
  382. Avandia (rosiglitazone) - Reminder to healthcare providers and patients to enroll in the…
  383. ema-forxigaForxiga
  384. EMEA-000525-PIP01-08-M08 - paediatric investigation plan
  385. Infections associated with heater cooler units used in cardiopulmonary bypass and ECMO…
  386. EMEA-002597-PIP04-21-M01 - paediatric investigation plan
  387. cdsco-niclosamideNiclosamide
  388. 21 CFR 870.5050: Patient care suction apparatus.
  389. Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil product-specific…
  390. EU/3/23/2864 - orphan designation for treatment of follicular lymphoma
  391. ema-sanohex-referralSanohex - referral
  392. Risk assessment of medicinal products on human reproduction and lactation: from data to…
  393. cdsco-atezolizumabAtezolizumab
  394. EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
  395. NMPA Issued the Announcement on Issues Concerning the Import of Reference Drugs for…
  396. FDA warns that symptoms of a serious condition affecting the blood cells are not being…
  397. Is an orphan medicine still an orphan once it gets on the market?
  398. Insulin Glargine 100 IU/ml (r-DNA origin) Injection
  399. ema-cymevene-referralCymevene - referral
  400. Extrapolation of results from clinical studies conducted outside Europe to the…
  401. EMEA-001816-PIP02-15 - paediatric investigation plan
  402. Dapagliflozin + Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin film coated…
  403. EU/3/15/1468 - orphan designation for treatment of Gaucher disease
  404. Public Notice regarding Price Control dated 06.04.2017
  405. Liraglutide sc Injection
  406. 21 CFR 26.74: Preservation of regulatory authority.
  407. ema-aripiprazole-mylanAripiprazole Mylan
  408. EU/3/14/1335 - orphan designation for treatment of pemphigus
  409. UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain…
  410. 21 CFR 882.5860: Implanted neuromuscular stimulator.
  411. EU/3/16/1652 - orphan designation for treatment of amyotrophic lateral sclerosis
  412. Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication
  413. To update package insertPromotional Literature of FDC of Chlorpheniramine Maleate IP 2mg…
  414. Committee for Advanced Therapies (CAT): 10-12 May 2021
  415. Call for expressions of interest to appoint patient and healthcare-professional…
  416. European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and…
  417. cdsco-pegylated-factorPEGylated factor
  418. ema-cancerCancer
  419. 21 CFR 892.1410: Nuclear electrocardiograph synchronizer.
  420. 21 CFR 820.198: Complaint files.
  421. 21 CFR 58.49: Laboratory operation areas.
  422. Guidance document: Recognition and use of standards under the Medical Devices Regulations
  423. Veterinary focus group meeting - Committee for Medicinal Products for Veterinary Use…
  424. 21 CFR 866.3085: Brucella spp. serological reagents.
  425. Paediatric Committee (PDCO): 17-20 May 2022
  426. EU/3/09/619 - orphan designation for treatment of acute myeloid leukaemia
  427. ICH Q5D Derivation and characterisation of cell substrates used for production of…
  428. Clinical trials that include an in vitro diagnostic device
  429. EMEA-001071-PIP02-12-M02 - paediatric investigation plan
  430. Appendix 10 Product Interchangeability and Biowaiver Request for Chemical Generic Drug…
  431. Survey: Healthcare Organizations Struggle with Security Preparedness
  432. ema-trocoxilTrocoxil
  433. Clinical decision support software
  434. EU/3/22/2744 - orphan designation for treatment of sarcoidosis
  435. Radiopharmaceuticals - Scientific guideline
  436. EMA and the EUnetHTA 21 consortium set priorities for their collaboration
  437. Medicinal Products (Control of Placing on the Market) Regulations 2007 (Amendment) (No. 2)…
  438. Drug Alert January 2019 Revised
  439. COVID-19 Vaccine (inactivated, adjuvanted) Valneva
  440. 21 CFR 73.1530: Spirulina extract.
  441. PSUSA/00001635/202302 - periodic safety update report single assessment
  442. EMEA-002395-PIP01-18 - paediatric investigation plan
  443. ema-bleomycin-referralBleomycin - referral
  444. EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
  445. cdsco-fitusiranFitusiran
  446. Fu, Halamka, Kufahl, and Logan: Hospitals Need Better Cybersecurity, Not More Fear
  447. Notify the MHRA about a clinical investigation for a medical device
  448. Voxzogo - direct healthcare professional communication (DHPC)
  449. cdsco-empagliflozinEMPAgliflozin
  450. Sandimmun and associated names - referral
  451. 21 CFR 868.2480: Cutaneous carbon dioxide (PcCO2) monitor.
  452. 21 CFR 82.1331: D&C Red No. 31.
  453. cdsco-zyil-1ZYIL 1
  454. EMEA-002952-PIP01-21 - paediatric investigation plan
  455. Committee for Orphan Medicinal Products (COMP): 13-15 June 2017
  456. Committee for Advanced Therapies (CAT): 3-4 November 2022
  457. EU/3/23/2757 - orphan designation for treatment of perinatal asphyxia
  458. Salviae officinalis aetheroleum - herbal medicinal product
  459. ema-ranivisioRanivisio
  460. PSUSA/00000777/202007 - periodic safety update report single assessment
  461. Ezetimibe and simvastatin (fixed combination) - paediatric investigation plan
  462. PSUSA/00010161/201512 - periodic safety update report single assessment
  463. NovoNorm - withdrawal of application for variation to marketing authorisation
  464. cfr-21-cfr-890-3150-crutch21 CFR 890.3150: Crutch.
  465. ema-glossariesGlossaries
  466. Provisions for Crude Drugs Importation
  467. 21 CFR 886.3100: Ophthalmic tantalum clip.
  468. Glimepiride IP + Metformin Hydrochloride IP + Sitagliptin Phosphate Monohydrate IP film…
  469. European Medicines Agency update on stolen vials of Herceptin
  470. ema-duaklir-genuairDuaklir Genuair
  471. EU/3/10/734 - orphan designation for treatment of ornithine carbamoyltransferase…
  472. ema-cevenfactaCevenfacta
  473. EMEA-003109-PIP01-21 - paediatric investigation plan
  474. EMEA annual report shows 24 positive reviews for new human medicines in 2003. Agency…
  475. Medical Device Alert date 21 July 2022
  476. EMA confirms recommendation for non-renewal of authorisation of multiple myeloma medicine…
  477. EMA Management Board: highlights of December 2014 meeting
  478. EU/3/11/935 - orphan designation for treatment of Friedreich's ataxia
  479. Webinar presentation: GMP inspection trends for non-sterile registered medicines
  480. Committee for Medicinal Products for Human Use (CHMP): 11-14 December 2017
  481. PSUSA/00010474/201607 - periodic safety update report single assessment
  482. EMEA-001426-PIP01-13-M02 - paediatric investigation plan
  483. EMEA-002423-PIP01-18 - paediatric investigation plan
  484. Details of Manufacturers whose permissions have been suspended / cancelled 2023
  485. EU/3/19/2134 - orphan designation for treatment of infantile neuroaxonal dystrophy
  486. EMEA-001949-PIP02-18-M03 - paediatric investigation plan
  487. ACB meeting statement, Meeting 16, 12 November 2020
  488. 21 CFR 822.20: What are the consequences if I fail to submit a postmarket surveillance…
  489. 21 CFR 874.1600: Olfactory test device.
  490. cdsco-evenamide-or-placeboevenamide or placebo
  491. ema-ryeqoRyeqo
  492. ema-name-review-group-formName Review Group form
  493. ema-wezenlaWezenla
  494. 21 CFR 14.147: Membership of a color additive advisory committee.
  495. EU/3/05/263 - orphan designation for treatment of severe closed traumatic brain injury
  496. EMEA-000866-PIP01-10 - paediatric investigation plan
  497. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  498. EU/3/08/556 - orphan designation for treatment of cystic fibrosis
  499. EU/3/08/534 - orphan designation for treatment of retinitis pigmentosa
  500. FDA, European Commission and EMA reinforce collaboration to advance medicine development…
  501. ema-scintimunScintimun
  502. Committee for Orphan Medicinal Products (COMP): 14-16 April 2026
  503. EU/3/21/2433 - orphan designation for treatment of cystic fibrosis
  504. EMEA-003231-PIP01-22 - paediatric investigation plan
  505. NMPA Announcement on the Issuance of 21 Medical Device Industry Standards such as YY / T…
  506. Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 March 2024
  507. 21 CFR 861.34: Amendment or revocation of a standard.
  508. ema-voseviVosevi
  509. 21 CFR 99.105: Recipients of information.
  510. Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing (When…
  511. PSUSA/00001909/201801 - periodic safety update report single assessment
  512. 21 CFR 20.25: Retroactive application of regulations.
  513. EMEA-000994-PIP01-10-M01 - paediatric investigation plan
  514. Assessment of the genotoxic potential of antisense oligodeoxynucleotides - Scientific…
  515. Office memorandum regarding approval of the safety and efficacy of FDCs
  516. Orphan designation: Overview
  517. ema-esignature-webinareSignature webinar
  518. Access to Electronic Health Records by Sponsor representatives in clinical trials
  519. CardioGen-82 - Planned return of CardioGen-82 to market with new Boxed Warning
  520. FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to…
  521. Improved electronic reporting of suspected adverse reactions for better health protection
  522. EU/3/02/103 - orphan designation for treatment of acute intermittent porphyria
  523. ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug…
  524. 21 CFR 866.2350: Microbiological assay culture medium.
  525. EU/3/04/219 - orphan designation for treatment of autoimmune uveitis
  526. Rabitec - opinion on variation to marketing authorisation
  527. Plasma master file epidemiology
  528. Novo Nordisk withdraws its application to extend the marketing authorisations for NovoNorm…
  529. Quality of modified release dosage forms for veterinary use - Scientific guideline
  530. 21 CFR 807.41: Identification of importers and persons who import or offer for import.
  531. PSUSA/00010462/202010 - periodic safety update report single assessment
  532. EMEA-001669-PIP01-14 - paediatric investigation plan
  533. ema-renagelRenagel
  534. Recommendation-NB-MED-2_5_5-2_rev9 Combination of CE-marked and non-CE-marked medical
  535. EudraVigilance and Signal Management information day
  536. ema-toriselTorisel
  537. Clinical Trials Information System (CTIS) Bitesize Talk: How to submit a transitional…
  538. cfr-21-cfr-820-150-storage21 CFR 820.150: Storage.
  539. ema-duaviveDuavive
  540. cdsco-dexamethasone-sodiumDexamethasone sodium
  541. Auditing of medical device, including IVD medical device, applications
  542. Committee for Herbal Medicinal Products (HMPC): 26-27 January 2011
  543. Refusal of orphan designation for treatment of hepatocellular carcinoma
  544. EMEA-002110-PIP02-17 - paediatric investigation plan
  545. cdsco-trastuzumab-deruxtecanTrastuzumab Deruxtecan
  546. GN-12-1-R2.1 Guidance on Grouping of Medical Devices for Product Registration - General…
  547. EMEA-001024-PIP01-10-M02 - paediatric investigation plan
  548. DR_G.S.R. 604(E) dt_24.08.2001_Amendment to Part IV(rules)_Import and Registration
  549. EU/3/13/1230 - orphan designation for treatment of acute myeloid leukaemia
  550. Second industry stakeholder platform on research and development support
  551. EMEA-001792-PIP01-15 - paediatric investigation plan
  552. EMA recommends approval of treatment for attention deficit hyperactivity disorder
  553. EU/3/07/506 - orphan designation for treatment of Crigler-Najjar syndrome
  554. ema-somavertSomavert
  555. NDLS portal Public notice-31-03-2021
  556. EMEA-003174-PIP01-21 - paediatric investigation plan
  557. ema-evistaEvista
  558. EMEA-003339-PIP02-23 - paediatric investigation plan
  559. Provisional determination eligibility criteria
  560. October 30 2015 GSR 826(E)
  561. Ken Fuchs: Tell the FCC How You Feel About Spectrum Plan
  562. EMEA-003177-PIP01-21 - paediatric investigation plan
  563. April 19, 2023: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee…
  564. cdsco-anifrolumabAnifrolumab
  565. Notice regarding Regulatory pathway for R&D of Drug or vaccine for COVID-19
  566. CAT: Working parties and other groups
  567. Clinical Trials Information System (CTIS): Walk-in clinic - May 2024
  568. Trospium Chloride+Xanomeline
  569. Training session for patients, consumers and healthcare professionals involved in medicine…
  570. European Medicines Agency closed 23 December 2015 to 3 January 2016
  571. Committee for Advanced Therapies (CAT): 18-19 September 2014
  572. ema-topotecan-tevaTopotecan Teva
  573. ETF warns that monoclonal antibodies may not be effective against emerging strains of…
  574. Cellular, Tissue, and Gene Therapies Advisory Committee May 12, 2023 Meeting Announcement…
  575. PSUSA/00001457/202208 - periodic safety update report single assessment
  576. EMEA-001220-PIP05-19 - paediatric investigation plan
  577. European Medicines Agency gives new advice to better manage risk of adverse effects on the…
  578. PSUSA/00001509/202108 - periodic safety update report single assessment
  579. Montelukast Sodium IP eq. to Montelukast + Bilastine Orodispersible tablet (Phase IV)
  580. EMEA/H/N/PSR/J/0006 - periodic safety update report single assessment
  581. Information on convalescent plasma in Covid 19
  582. 21 CFR 868.1620: Halothane gas analyzer.
  583. Management Board meeting: 5 October 2023
  584. ema-spexotrasSpexotras
  585. cdsco-alglucosidaseAlglucosidase
  586. 21 CFR 801.6: Medical devices; misleading statements.
  587. EU/3/00/002 - orphan designation for treatment of Fabry disease
  588. Testing Laboratories approved by Statas&UT in Form 37 of Drugs Rule 1945 and Cos 23 of…
  589. EMEA-002350-PIP02-20 - paediatric investigation plan
  590. PSUSA/00002695/202301 - periodic safety update report single assessment
  591. Assessing dietary exposure to residues of veterinary medicines, feed additives and…
  592. PSUSA/00010491/201704 - periodic safety update report single assessment
  593. Mirabegron (ER) + Solifenacin Succinate IP tablets (Phase III
  594. Medical Devices Storage Guideline
  595. 21 CFR 866.5960: Human leukocyte antigen typing companion diagnostic test.
  596. PSUSA/00010441/201704 - periodic safety update report single assessment
  597. EU/3/13/1118 - orphan designation for treatment of neuronal ceroid lipofuscinosis type 2
  598. Pandemic Influenza Vaccine H5N1 Baxter AG
  599. EU/3/23/2810 - orphan designation for treatment in haematopoietic stem cell…
  600. EU/3/11/871 - orphan designation for treatment of pancreatic cancer
  601. Notice regarding Stability data for BA/BE study in Human for export
  602. ema-avastinAvastin
  603. cfr-21-cfr-50-3-definitions21 CFR 50.3: Definitions.
  604. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-29…
  605. Paediatric Committee (PDCO): 17-20 September 2019
  606. Chapter 1 - Submission Type Guidance - Great Britain
  607. cdsco-june-2-2011-gsr-425-eJune 2, 2011, (GSR 425 (E)
  608. Spikevax: EMA recommendation on booster
  609. Workshop on vaccine development against the Schmallenberg virus
  610. Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects
  611. 21 CFR 886.1770: Manual refractor.
  612. EMEA-001776-PIP04-17 - paediatric investigation plan
  613. European Medicines Agency website unavailable 19.00 to 23.00 Friday 14 September
  614. Countdown to launch of new EudraVigilance System
  615. EMEA-000457-PIP02-10-M02 - paediatric investigation plan
  616. EMEA-000643-PIP02-20 - paediatric investigation plan
  617. EMEA-001198-PIP03-17-M04 - paediatric investigation plan
  618. Understanding AAMI Standards Participation, Both Nationally and Internationally
  619. Archiving and retention of clinical trial records
  620. Cryoablation Apparatus Approved for Marketing
  621. 21 CFR 886.5100: Ophthalmic beta radiation source.
  622. 21 CFR 814.116: Procedures for review of an HDE.
  623. Committee for Orphan Medicinal Products: December 2005 meeting
  624. Committee for Advanced Therapies (CAT): 19-21 June 2019
  625. cfr-21-cfr-895-1-scope21 CFR 895.1: Scope.
  626. 21 CFR 874.3760: Sacculotomy tack (Cody tack)
  627. Medical device initial recall reporting form (FRM-0360)
  628. CIS bio international withdraw their application for Scintimun
  629. EMEA-001695-PIP01-14-M05 - paediatric investigation plan
  630. European Medicines Agency to publish information on ongoing medicine evaluations
  631. 2018.12.30_S.O. 3909 Aurvedic, Siddha and Unani Drugs Consultative Committee
  632. 21 CFR 880.5820: Therapeutic scrotal support.
  633. Clinical trials: how NHS trusts and health boards can maintain compliant electronic health…
  634. EMEA-000961-PIP01-10 - paediatric investigation plan
  635. 21 CFR 866.3957: Human immunodeficiency virus (HIV) nucleic acid (NAT) diagnostic and/or…
  636. 21 CFR 73.3122: 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one…
  637. Veterinary medicinal products containing gentamicin presented as solutions for injection…
  638. PSUSA/00000091/202101 - periodic safety update report single assessment
  639. Sterilisation of the medicinal product, active substance, excipient and primary container…
  640. 21 CFR 886.3130: Ophthalmic conformer.
  641. New platform for collection of sales and use data of antimicrobials in animals
  642. EU/3/23/2791 - orphan designation for treatment of Alport syndrome
  643. PSUSA/00001026/202012 - periodic safety update report single assessment
  644. EU/3/18/2011 - orphan designation for treatment of phosphaturic mesenchymal tumour
  645. International workshop on the ethical and good-clinical-practice aspects of clinical…
  646. Order of Annual Increments of CDSCO (HQ) Officials dated 06.01.2017
  647. EU/3/10/750 - orphan designation for treatment of tuberculosis
  648. European Medicines Agency agrees policy on publication of clinical trial data with more…
  649. ema-destaraDestara
  650. 21 CFR 886.1415: Ophthalmic trial lens frame.
  651. cdsco-solidarity-trialSolidarity trial
  652. GN 13-R1.1 Guidance on the Risk Classification of General Medical Devices [ARCHIVED on 31…
  653. ema-patrexPatrex
  654. EU/3/13/1204 - orphan designation for prevention of arteriovenous access dysfunction in…
  655. ema-apealeaApealea
  656. PSUSA/00001926/201610 - periodic safety update report single assessment
  657. Pharmaceutical Quality Control Labs (7/93)
  658. European Medicines Agency receives interim decisions of the General Court of the EU on…
  659. UPDATED PUBLIC PARTICIPATION INFORMATION: August 3, 2017: Meeting of the Arthritis…
  660. EMEA-002519-PIP03-21 - paediatric investigation plan
  661. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 February 2012
  662. Good pharmacovigilance practice (GPvP)
  663. Hank Balch: Where’s the Respect?
  664. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 6-7…
  665. March 31 2017 GSR 319(E)
  666. PSUSA/00010288/201505 - periodic safety update report single assessment
  667. EU/3/16/1825 - orphan designation for treatment of mucopolysaccharidosis type IIIB…
  668. EMEA-000185-PIP01-08-M05 - paediatric investigation plan
  669. GN-14-R3 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices…
  670. AAMI Standards Monitor Digest: May 2020
  671. Exceptions and modifications to the EU guidance on good pharmacovigilance practices that…
  672. 21 CFR 14.86: Rights and responsibilities of nonvoting members of advisory committees.
  673. EMEA-001567-PIP01-13-M03 - paediatric investigation plan
  674. EMEA-001174-PIP02-12-M02 - paediatric investigation plan
  675. cfr-21-cfr-58-41-general21 CFR 58.41: General.
  676. cdsco-ranibizumab-crvoRanibizumab CRVO
  677. Two additional countries to benefit from EU-US mutual recognition agreement for…
  678. FDA Advancing Regulatory Science to Accelerate Medical Extended Reality (MXR)
  679. List of approved countries for authorised human medicines: List of approved countries
  680. Envafolimab injection 200mg/1ml.
  681. Type-IA variations: questions and answers
  682. EMEA-001214-PIP04-19 - paediatric investigation plan
  683. Guidance and Insight from the Healthcare and Public Health Sector Coordinating Council
  684. Committee for Orphan Medicinal Products (COMP): 8-10 November 2022
  685. Interpretation of the NMPA Announcement on Further Adjustment and Optimization of Matters…
  686. July 17, 2025: Meeting of the Oncologic Drugs Advisory Committee - 07/17/2025
  687. ema-sugammadex-amomedSugammadex Amomed
  688. EMEA-001501-PIP11-21 - paediatric investigation plan
  689. EMEA-000312-PIP01-08-M07 - paediatric investigation plan
  690. Grouping Guidelines for Medical Devices Applications
  691. ema-begedinaBegedina
  692. EMEA-001214-PIP06-20 - paediatric investigation plan
  693. ema-capecitabine-tevaCapecitabine Teva
  694. EMEA-002102-PIP01-16 - paediatric investigation plan
  695. Just Published! AAMI HTM Succession Planning Guide
  696. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 April 2014
  697. PSUSA/00009159/202303 - periodic safety update report single assessment
  698. ema-agency-in-numbersAgency in numbers
  699. 21 CFR 862.2310: Clinical sample concentrator.
  700. Transatlantic Taskforce continues international fight against antimicrobial resistance
  701. 21 CFR 870.5800: Compressible limb sleeve.
  702. Risk management information day 2021
  703. cdsco-cc-92480-bms-986348CC-92480 (BMS-986348)
  704. cfr-21-cfr-7-3-definitions21 CFR 7.3: Definitions.
  705. EMEA-001549-PIP02-14 - paediatric investigation plan
  706. Drug Safety Update: monthly PDF newsletter: Drug Safety Update March 2023
  707. Steam Pressure for Retorts and Autoclaves
  708. MedTech Cybersecurity and Why Banking is an Industry to Follow – an AAMI Faculty Spotlight
  709. Progress on science, medicines and health
  710. Team-NB-PositionPaper 20181124
  711. 21 CFR 1.404: Who serves as the presiding officer for an appeal and for an informal…
  712. ema-ertapenem-sunErtapenem SUN
  713. ema-sylvantSylvant
  714. How tests and testing kits for coronavirus (COVID-19) work: Target Product Profile…
  715. Regulatory requirements for in-house IVDs
  716. Joint European Medicines Agency / Food and Drug Administration workshop for paediatric…
  717. Safety of COVID-19 vaccines
  718. EMEA-001719-PIP01-14 - paediatric investigation plan
  719. cdsco-semaglutide-2-4-mgSemaglutide 2.4 mg
  720. European Medicines Agency closed 5-9 May 2016
  721. Global regulators discuss observational studies of real world data for COVID-19 medicines
  722. SAR442168 to teriflunomide (Aubagio®)
  723. Acebrophylline 100mg + Erdosteine 300mg film coated bilayered tablets
  724. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 October 2014
  725. Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety…
  726. Signal management (veterinary medicines)
  727. GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB
  728. ema-alimtaAlimta
  729. EMEA-001457-PIP01-13 - paediatric investigation plan
  730. PSUSA/00010808/202203 - periodic safety update report single assessment
  731. EMEA-001982-PIP01-16 - paediatric investigation plan
  732. PSUSA/00000059/202009 - periodic safety update report single assessment
  733. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 March…
  734. EMEA-001892-PIP01-15 - paediatric investigation plan
  735. Committee for Orphan Medicinal Products (COMP): 9-10 November 2010
  736. ema-camceviCamcevi
  737. DR_G.S.R. 889(E) dt_12.12.2014_Amendment Rule 122DAB, Schedule Y & Appendix XII
  738. ema-mometamax-ultraMometamax Ultra
  739. Glycopyrrolate IP eq. to Glycopyrronium 25mcg + Formoterol Fumarate Dihydrate IP eq. to…
  740. SPC Charts — Are You Deploying this World-Class Tool?
  741. Ethinylestradiol-Drospirenone 24+4 - referral
  742. ema-orlaamOrlaam
  743. cdsco-etifoxine-hcl-50-mgEtifoxine HCl 50 mg
  744. 27th meeting of the Committee for Orphan Medicinal Products
  745. Tildrakizumab Injection 100 mg/ ml
  746. Linagliptin + Metformin Hydrochloride IP (as extended release) (2.5mg + 1000mg & 5mg +…
  747. Insulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)…
  748. Policy Interpretation of the Implementation Opinions of the NMPA on "Artificial…
  749. EMEA-003104-PIP02-22 - paediatric investigation plan
  750. Committee for Orphan Medicinal Products (COMP): 13-15 May 2025
  751. ema-liprologLiprolog
  752. EU/3/24/2941 - orphan designation for treatment of poliovirus infection
  753. European Medicines Agency update on safety of insulin glargine - Update
  754. Fees in Respect of Drugs and Medical Devices Order (justice.gc.ca)
  755. Two new medicines recommended for the treatment of chronic hepatitis C
  756. Notice dated July 11 2022
  757. EMEA-002895-PIP02-21 - paediatric investigation plan
  758. European Medicines Agency publishes list of human medicines under evaluation
  759. EMEA-002007-PIP02-17-M03 - paediatric investigation plan
  760. NMPA Announcement on Issuing 5 Technical Review Guidances for Registration
  761. cfr-21-cfr-73-2500-silver21 CFR 73.2500: Silver.
  762. ema-synjardySynjardy
  763. AI System ChatGPT Passes Medical Licensing Exam
  764. 21 CFR 13.25: Disclosure of data and information by the participants.
  765. Interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety…
  766. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 June 2026
  767. Veterinary e-submission workshop
  768. EU/3/17/1893 - orphan designation for treatment of anti-MAG neuropathy
  769. Guidance on Evaluation of Orthopedic Custom-made Artificial Knee Joint Prosthesis [143.62…
  770. Pazopanib product-specific bioequivalence guidance
  771. EMEA-002374-PIP01-18 - paediatric investigation plan
  772. ema-startvacStartvac
  773. ema-atectura-breezhalerAtectura Breezhaler
  774. EMA regrets to learn of the passing of Dr Eric Abadie, former CHMP Chair
  775. EU/3/15/1573 - orphan designation for treatment of Wilson's disease
  776. Clotrimazole Vaginal Film 50 mg
  777. ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human…
  778. PSUSA/00010239/201608 - periodic safety update report single assessment
  779. 21 CFR 60.40: Request for hearing.
  780. 21 CFR 866.3490: Rhinovirus serological reagents.
  781. EMEA-002727-PIP01-19-M01 - paediatric investigation plan
  782. EMEA-001350-PIP02-13-M04 - paediatric investigation plan
  783. Astellas withdraws its marketing authorisation application for Vibativ (telavancin)
  784. cdsco-july-17-2015-gsr-559-eJuly 17 2015 GSR 559(E)
  785. Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19
  786. Assurances to accompany a L(A)1 application
  787. Recommendation-NB-MED-2_1-4_rev7 Medical devices with a measuring function
  788. cdsco-favipiravir-umifenovirFavipiravir & Umifenovir
  789. ema-rigevidon-referralRigevidon - referral
  790. Stakeholder focus group meeting on availability of lumpy skin disease (LSD) vaccines…
  791. EU/3/21/2488 - orphan designation for treatment of Diamond-Blackfan anaemia
  792. EMEA-001407-PIP02-15-M05 - paediatric investigation plan
  793. Advertising guidance for Intravenous (IV) products
  794. EMEA-000828-PIP06-18 - paediatric investigation plan
  795. Guidance Document on Free sale certificate of Notified medical Devices in India
  796. PSUSA/00002569/202010 - periodic safety update report single assessment
  797. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 7-9 June 2011
  798. Second joint meeting of the EMA Scientific Committees' Working Party with Patients' and…
  799. Drug Alert list for month of December 2022
  800. 21 CFR 830.300: Devices subject to device identification data submission requirements.
  801. EU/3/08/583 - orphan designation for treatment of glioma
  802. Academia developing medicines for rare diseases to receive free EMA scientific advice
  803. PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections
  804. 21 CFR 99.405: Applicability of labeling, adulteration, and misbranding authority.
  805. EU/3/08/555 - orphan designation for treatment of acute lymphoblastic leukaemia
  806. Monitoring of the quality standards of hand sanitizer as per Drugs and Cosmetics Act, 1940…
  807. 7th meeting of the Committee for Orphan Medicinal Products
  808. 2025.10.16_G.S.R. 759(E) _ Notification of liquid anticeptic for household use or hospital…
  809. EU/3/13/1195 - orphan designation for treatment of cystic fibrosis
  810. 21 CFR 1.670: How do I apply to FDA for direct accreditation or renewal of direct…
  811. Mary Logan: A Tribute to Those Impacted by Unintended Consequences
  812. European Medicines Agency/CHMP Working Group with Healthcare Professionals' Organisations…
  813. FDA Indefinitely Extends Permission to Device Manufacturers to Modify Products Affected by…
  814. PSUSA/00002254/201804 - periodic safety update report single assessment
  815. 21 CFR 880.5440: Intravascular administration set.
  816. Industry stakeholder platform on research and development support
  817. Demonstration of palatability of veterinary medicinal products - Scientific guideline
  818. Table Talk: Compatibility of Materials Subjected to Sterilization
  819. E-Submission Guide R2 for General Medical Devices for ASEAN CSDT and IMDRF ToC based…
  820. EudraVigilance training on electronic reporting of ICSRs in the EEA
  821. Medical Device Cybersecurity Hygiene for Frontline Professionals
  822. PSUSA/00010846/202010 - periodic safety update report single assessment
  823. EU/3/16/1757 - orphan designation for treatment of myelofibrosis
  824. PSUSA/00001455/201910 - periodic safety update report single assessment
  825. cdsco-msp008-22cMSP008-22c
  826. Workshop: working towards new therapies for spinal muscular atrophy
  827. European Medicines Agency Implementation Working Group: Meeting with European Union…
  828. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May…
  829. ema-humalogHumalog
  830. Clinical trial notification (CTN) form - user guide
  831. EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
  832. EMEA-000944-PIP01-10 - paediatric investigation plan
  833. 21 CFR 866.5820: Systemic lupus erythematosus immunological test system.
  834. EU Innovation Network (EU-IN)
  835. Withdrawal of pain medicine flupirtine endorsed
  836. Exceptional good distribution practice (GDP) flexibilities for medicines during the…
  837. Soluble yeast beta-1,3/1,6-glucan - paediatric investigation plan
  838. PSUSA/00000187/201703 - periodic safety update report single assessment
  839. PSUSA/00010324/202312 - periodic safety update report single assessment
  840. Electronic Common Technical Document (eCTD) vendor workshop
  841. 21 CFR 12.60: Presiding officer.
  842. European Medicines Agency releases guideline on medicinal products for the treatment of…
  843. 21 CFR 870.2330: Echocardiograph.
  844. Delegation of powers to the officers in the DCG(I) Office to sign certain licences under…
  845. Scientific Advisory Group on Cardiovascular Issues
  846. Device specific vigilance guidance: Coronary Stents and associated delivery systems
  847. EU/3/19/2226 - orphan designation for treatment of osteosarcoma
  848. 2024.07.10_DR_G.S.R.374(E)_Notification reg rules for Compounding of offences under D & C…
  849. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 January 2013
  850. EU/3/22/2638 - orphan designation for treatment of methylmalonic acidaemia
  851. EU/3/04/233 - orphan designation for treatment of gamma sarcoglycanopathy
  852. Dengue Tetravalent Vaccine (Live, Attenuated)
  853. UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh…
  854. 21 CFR 878.4815: Magnetic surgical instrument system.
  855. Partial Revision of the “Points to Consider for Approval Applications for Home Medical…
  856. ema-oncophageOncophage
  857. EU/3/05/297 - orphan designation for treatment of Duchenne muscular dystrophy
  858. ema-fluad-paediatricFluad Paediatric
  859. HTM Soft Skills during the Pandemic
  860. Docetaxel - paediatric investigation plan
  861. Manufacture of the finished dosage form (human) - Scientific guideline
  862. Committee for Proprietary Medicinal Products (CPMP) 46th plenary meeting
  863. 21 CFR 808.5: Advisory opinions.
  864. ema-riprazoRiprazo
  865. ema-exzoltExzolt
  866. European Medicines Agency confirms positive benefit-risk balance of topical formulations…
  867. ema-chmp-chair-re-electedCHMP Chair re-elected
  868. Drug Alert for the Month of September 2023
  869. 21 CFR 874.3850: Endolymphatic shunt tube with valve.
  870. EU/3/01/067 - orphan designation for treatment of multiple myeloma
  871. 21 CFR 880.6600: Ultraviolet (UV) radiation chamber disinfection device.
  872. Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities…
  873. Moving Ahead of the Pack: Understanding Health System Priorities on AI-Enabled Clinical…
  874. BREAST-Q Reconstruction Module
  875. EMEA-001734-PIP01-14-M06 - paediatric investigation plan
  876. EU/3/21/2450 - orphan designation for treatment of mantle cell lymphoma
  877. 21 CFR 862.1080: Androsterone test system.
  878. 21 CFR 878.4805: Manual percutaneous surgical set assembled in the abdomen.
  879. AAMI Exceeds 10,000 Members, a Milestone for Health Technology
  880. Olanzapine Cipla (previously Olanzapine Neopharma)
  881. ema-tacforiusTacforius
  882. Gerry Castro: Understanding Human Nature Is Key to the Success of Health IT
  883. EMA-EFPIA Information Day 2011
  884. Section 14/14A application form relating to subsection 9(2) of TGO 92
  885. ICH Q4B Annex 1 Residue on ignition/sulphated ash - Scientific guideline
  886. Frontpro (previously known as Afoxolaner Merial) - opinion on variation to marketing…
  887. 21 CFR 876.5981: Oral removable palatal space occupying device for weight management…
  888. European Medicines Agency to review third- and fourth-generation combined oral…
  889. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
  890. Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan)
  891. Modified-release paracetamol-containing products to be suspended from EU market
  892. cdsco-lxe408LXE408
  893. EU/3/16/1791 - orphan designation for treatment of ovarian cancer
  894. Dimethyl fumarate Polpharma
  895. ICH Q5B Analysis of the expression construct in cell lines used for production of…
  896. European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP)
  897. Committee for Advanced Therapies (CAT): 15 June 2023
  898. European Medicines Agency: Committee for Medicinal Products for Human Use 14-17 November…
  899. EMEA-002577-PIP01-19 - paediatric investigation plan
  900. ema-trepulmixTrepulmix
  901. Caustinerf arsenical and Yranicid arsenical - referral
  902. Equine Klebsiella Immunoglobulin Injection 500 mg/5ml (100mg/ml)
  903. European Communities (Active Implantable Medical Devices) (Amendment) Regulations 2020 (SI…
  904. Stem cell-based products for veterinary use: specific questions on target animal safety to…
  905. Committee for Medicinal Products for Human Use (CHMP): 7-10 December 2020
  906. EMEA-001912-PIP01-15 - paediatric investigation plan
  907. ema-pioglitazone-teva-pharmaPioglitazone Teva Pharma
  908. EMEA-000456-PIP01-08-M02 - paediatric investigation plan
  909. Digital application dataset integration (DADI) and Product Management Service (PMS)…
  910. PSUSA/00010854/202104 - periodic safety update report single assessment
  911. ema-newslettersNewsletters
  912. PSUSA/00000407/202302 - periodic safety update report single assessment
  913. EU/3/20/2268 - orphan designation for diagnosis of AL amyloidosis
  914. Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 (SI…
  915. PSUSA/00003163/201603 - periodic safety update report single assessment
  916. Xagrid - direct healthcare professional communication (DHPC)
  917. (DOC Version - 134 K)
  918. ema-invokanaInvokana
  919. Guidance on the submission and content of notifications for Northern Ireland
  920. Cellular, Tissue, and Gene Therapies Advisory Committee June 9-10, 2022 Meeting…
  921. Record number of medicines for rare diseases recommended for approval in 2014
  922. EU/3/20/2376 - orphan designation for treatment of congenital hyperinsulinism
  923. November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices…
  924. European Medicines Agency explores ways to further involve patients in the benefit-risk…
  925. Remibrutinib 25 mg b.i.d.
  926. European Medicines Agency recommends first-in-class medicine for treatment of Duchenne…
  927. ema-lacosamide-ucbLacosamide UCB
  928. Public statement: Vasovist and nephrogenic systemic fibrosis (NSF)
  929. Risk management information day 2022
  930. EU/3/16/1674 - orphan designation for treatment in haematopoietic stem cell…
  931. Visit of GIRP - European Association of Pharmaceutical Full-line Wholesalers
  932. 21 CFR 872.3240: Dental bur.
  933. 21 CFR 866.3332: Reagents for detection of specific novel influenza A viruses.
  934. EudraVigilance Expert Working Group
  935. EMEA-001362-PIP01-12-M03 - paediatric investigation plan
  936. cdsco-oral-baricitinibOral Baricitinib
  937. Global Clinical Engineering and Health Technology Management Congress Bound for India…
  938. Access to MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin for therapeutic…
  939. cdsco-oral-ozanimodOral Ozanimod
  940. 30th meeting of the Committee for Orphan Medicinal Products
  941. Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
  942. CDRH Director Shuren Opens AAMI/FDA neXus
  943. 21 CFR 888.3560: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained…
  944. EMEA-000815-PIP01-09-M01 - paediatric investigation plan
  945. 21 CFR 864.7280: Factor V Leiden DNA mutation detection systems.
  946. Plasma Master File (PMF) background documents
  947. EU/3/09/665 - orphan designation for treatment of chronic myeloid leukaemia
  948. Committee for Orphan Medicinal Products (COMP): 1-3 September 2015
  949. Extraordinary Management Board meeting: 25 June 2020
  950. ema-doxagamma-4mg-referralDoxagamma 4mg - referral
  951. Paediatric Committee (PDCO): 21-24 August 2018
  952. Focus group meeting on dose optimisation of established veterinary antibiotics in the…
  953. ema-arxxantArxxant
  954. PSUSA/00000165/202210 - periodic safety update report single assessment
  955. Submission of notarized/apostilled documents for Import and Registration of cosmetics in…
  956. Researchers Develop Mixed Reality Headset for Remote Rural Patient Wound Care
  957. Chapter 9 - General advice on due diligence Northern Ireland: Chapter 9 - General Advice…
  958. Micotil 300 Injectie - referral
  959. ema-pergoverisPergoveris
  960. Opsumit - opinion on variation to marketing authorisation
  961. P/86/2010 - paediatric investigation plan
  962. EU/3/14/1290 - orphan designation for treatment of choroideraemia
  963. Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2015
  964. ema-circadinCircadin
  965. 21 CFR 862.1055: Newborn screening test system for amino acids, free carnitine, and…
  966. Augmented Reality Surgical Navigation: New Dimensions in Diagnostic Imaging
  967. 21 CFR 803.10: Generally, what are the reporting requirements that apply to me?
  968. Start of shelf-life of the finished dosage form (Annex to the note for guidance on the…
  969. PSUSA/00001907/201702 - periodic safety update report single assessment
  970. Notice for Import of Radiopharmaceutical Products
  971. PSUSA-00002641-202304 - periodic safety update report single assessment
  972. Lynparza recommended for approval in ovarian cancer
  973. ema-ecokinaseEcokinase
  974. EMEA-002988-PIP01-21 - paediatric investigation plan
  975. Narcolepsy treatment recommended for approval
  976. 21 CFR 58.31: Testing facility management.
  977. EMEA-000524-PIP01-08 - paediatric investigation plan
  978. cdsco-tin816TIN816
  979. 21 CFR 886.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  980. EU/3/15/1481 - orphan designation for treatment of Huntington’s disease
  981. ema-xgevaXgeva
  982. PSUSA/00001416/201505 - periodic safety update report single assessment
  983. PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
  984. INTP24 against Avastin® in
  985. ema-cortavanceCortavance
  986. 2025.10.16_ G.S.R. 760(E)_Notification regarding restriction of sale of drug products…
  987. Bamlanivimab and etesevimab for COVID-19
  988. EU/3/17/1846 - orphan designation for treatment of Erdheim-Chester disease
  989. Azelnidipine IP + Olmesartan Medomoxil IP film coated tablet (Phase III)
  990. BCD-201 (JSC BIOCAD) and Keytruda®
  991. 21 CFR 880.6880: Steam sterilizer.
  992. Join the AAMI Awards Committee by Our August Deadline!
  993. Troubleshooting HTM’s Supply Chain Issues
  994. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
  995. EMEA-001508-PIP01-13 - paediatric investigation plan
  996. EMEA-001066-PIP01-10 - paediatric investigation plan
  997. Design modifications of gene therapy medicinal products during development - Scientific…

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