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Global regulations and guidance

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

  1. Multilateral coalitions and initiatives
  2. Twenty-eighth meeting of the Management Board
  3. EMEA-001484-PIP01-13-M01 - paediatric investigation plan
  4. PSUSA/00010748/202007 - periodic safety update report single assessment
  5. Capivasertib + Paclitaxel versus placebo
  6. Restrictions in the use of flupirtine-containing medicines - CMDh endorses PRAC…
  7. Regulatory information - EMA introduces weekly start dates for the assessment of type II…
  8. 21 CFR 12.83: Advisory opinions.
  9. ICH: M 4 Q: Common technical document for the registration of pharmaceuticals for human…
  10. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  11. Union Pharmacovigilance Database: webinar on signal detection and analysis
  12. LIB003 (Low density lipoprotein)
  13. Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft…
  14. cdsco-sarizotanSarizotan
  15. 21 CFR 20.53: Use of private contractor for copying.
  16. PSUSA/00002952/201505 - periodic safety update report single assessment
  17. EMEA/H/N/PSR/S/0028 - periodic safety update report single assessment
  18. ema-gavretoGavreto
  19. PSUSA/00010300/201703 - periodic safety update report single assessment
  20. Adaptive pathways: key learnings and next steps
  21. Guideline on clinical investigation of medicinal products for the treatment of gout
  22. EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
  23. Transforming Healthcare Technology Management with XR Innovations
  24. FAQ on Phytopharmaceutical Drugs
  25. Committee for Advanced Therapies (CAT): 10-11 February 2011
  26. ACB meeting statement, Meeting 6, 28 May 2015
  27. 21 CFR 866.3958: Human immunodeficiency virus (HIV) viral load monitoring test.
  28. Dexpramipexole dihydrochloride monohydrate
  29. European Medicines Agency (EMA) Patients' and Consumers'(PCWP) and Healthcare…
  30. 21 CFR 822.25: What are my responsibilities after my postmarket surveillance plan has been…
  31. A “Colonial Pipeline” Moment – Axel Wirth on the Change Healthcare Breach
  32. Eleventh industry stakeholder platform on research and development support
  33. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  34. European Medicines Agency updates guideline on evaluation of anticancer medicines
  35. Submission Documents for Application of Drug Compliance Inspection
  36. European Medicines Agency / health-technology-assessment-body workshop on parallel…
  37. PDCO: Working parties and other groups
  38. EU/3/11/904 - orphan designation for treatment of ornithine transcarbamylase deficiency
  39. EMEA-000777-PIP01-09-M05 - paediatric investigation plan
  40. cdsco-lib003LIB003
  41. Medical literature monitoring
  42. cdsco-macitentan-75-mgMacitentan 75 mg
  43. FDA Issues Final Guidance on Cybersecurity in Medical Devices
  44. ema-verasealVeraseal
  45. Azithromycin-containing medicinal products for systemic use - referral
  46. ENCePP guide on methodological standards in pharmacoepidemiology revised
  47. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - January 2016
  48. European Network for Paediatric Research at the European Medicines Agency (Enpr-EMA)…
  49. Eighteenth Meeting of the Management Board
  50. Semaglutide with alcoholic steatohepatitis
  51. Notice Regarding Classification of Medical devices and in Vitro diagnostic Medical devices…
  52. Oncoscience AG withdraws its application for Theraloc (nimotuzumab)
  53. FDA has reviewed possible risks of pain medicine use during pregnancy
  54. Cyproterone - direct healthcare professional communication (DHPC)
  55. ema-focliviaFoclivia
  56. EMEA - EGA Info Day on Generic and Biosimilar Medicinal Products and the Centralised…
  57. Refusal of orphan designation for treatment of fibromyalgia
  58. Exporting active substances manufactured in Great Britain for use in EEA and Northern…
  59. EMEA-002272-PIP01-17 - paediatric investigation plan
  60. EU/3/09/723 - orphan designation for treatment of haemophilia B
  61. Launch of European project for monitoring benefits and risks of vaccines throughout their…
  62. GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (18Sep-pub)…
  63. AAMI News, March 2020, Vol. 55, Issue 3
  64. cdsco-ctd-guidance-finalCTD Guidance Final
  65. EU/3/14/1381 - orphan designation for treatment of Duchenne muscular dystrophy
  66. Ch. 1 - Regulatory Organization
  67. EU/3/16/1817 - orphan designation for treatment in haematopoietic stem cell…
  68. Management Board: Meetings 2012
  69. DR_G.S.R._63 dt_01.02.2013_Insertion of Rule 122DAC
  70. EU/3/14/1394 - orphan designation for treatment of pancreatic cancer
  71. Orphan medicines development - ask the European regulator
  72. Court of Justice upholds EMA’s approach to transparency
  73. 21 CFR 866.3235: Epstein-Barr virus serological reagents.
  74. 21 CFR 882.5200: Aneurysm clip.
  75. ema-sugammadex-adroiqSugammadex Adroiq
  76. Drugs Prohibited vide Gazette notification, Feb 10, 2011 (G.S.R.82(E))
  77. Cimicifugae rhizoma - herbal medicinal product
  78. ema-priligy-referralPriligy - referral
  79. 21 CFR 10.50: Promulgation of regulations and orders after an opportunity for a formal…
  80. 21 CFR 58.105: Test and control article characterization.
  81. ema-ecaltaEcalta
  82. European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and…
  83. PSUSA/00010226/202205 - periodic safety update report single assessment
  84. Management Board re-elects Christa Wirthumer-Hoche as chair
  85. AAMI Member and Author Challenges HTM Readers to "Dare To Be Great” with New Book
  86. Safety and efficacy data requirements for applications for immunological VMPs intended for…
  87. EMEA-000500-PIP01-08-M03 - paediatric investigation plan
  88. Exceptional release of a biological
  89. EU/3/24/2914 - orphan designation for treatment of neuroblastoma
  90. EU/3/18/1998 - orphan designation for treatment of naevoid basal-cell carcinoma syndrome…
  91. ema-evantEvant
  92. Yervoy - withdrawal of application for variation to marketing authorisation
  93. ema-ivermectin-referralIvermectin - referral
  94. EMEA-002758-PIP01-19-M02 - paediatric investigation plan
  95. Basic Principles on Electronic Submission of Study Data for New Drug Applications
  96. PSUSA/00010572/202206 - periodic safety update report single assessment
  97. ema-neoatriconNeoatricon
  98. EU/3/21/2477 - orphan designation for treatment of otoferlin gene-mediated hearing loss
  99. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  100. PSUSA/00001453/202310 - periodic safety update report single assessment
  101. CVMP Interested Parties’ meeting
  102. EU/3/09/643 - orphan designation for treatment of Rett syndrome
  103. Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets - referral
  104. PSUSA/00001124/201411 - periodic safety update report single assessment
  105. Voices of Cybersecurity: Kevin Fu
  106. Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19
  107. PSUSA/00002026/202011 - periodic safety update report single assessment
  108. International regulators work towards alignment on development and authorisation of…
  109. f GSK S. aureus candidate vaccine
  110. Deidentifying Wearable information May Not Fully Protect Users’ Privacy
  111. PSUSA/00000989/201506 - periodic safety update report single assessment
  112. Omacetaxine mepesuccinate - paediatric investigation plan
  113. ema-new-zealandNew Zealand
  114. National registers of authorised medicines
  115. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30…
  116. EMEA-001501-PIP02-13-M07 - paediatric investigation plan
  117. 21 CFR 20.32: Disclosure of Food and Drug Administration employee names.
  118. 21 CFR 1.235: How and when do you cancel your facility's registration information?
  119. Management Board completes framework for conflicts of interests
  120. Elvitegravir product-specific bioequivalence guidance
  121. POSTPONED: October 5, 2016 Microbiology Devices Panel of the Medical Devices Advisory…
  122. 21 CFR 1.1162: What are the consequences if FDA puts a LAAF-accredited laboratory on…
  123. ema-simponiSimponi
  124. 21 CFR 892.1870: Radiographic film/cassette changer programmer.
  125. European Medicines Agency recommends suspension of marketing authorisation of…
  126. One on One: Luis E. Araiza Colunga
  127. Audio -Video Recording of Informed Consent Process of All New Subjects in Clinical Trials…
  128. Core summary for product characteristics for human rabies immunoglobulin for intramuscular…
  129. 21 CFR 860.7: Determination of safety and effectiveness.
  130. Article 5(3) opinions on any scientific matter: human medicines
  131. cfr-21-cfr-73-2085-caramel21 CFR 73.2085: Caramel.
  132. EU/3/20/2328 - orphan designation for treatment of Friedreich’s ataxia
  133. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 March 2011
  134. Good Manufacturing Practice annual report 2019-20
  135. Generic and biosimilar medicines in the centralised procedure: 3rd EMA-EGA information day
  136. ema-dia-innovation-forumDIA Innovation Forum
  137. ema-sunosiSunosi
  138. How tests and testing kits for coronavirus (COVID-19) work: For patients, the public and…
  139. 21 CFR 866.5510: Immunoglobulins A, G, M, D, and E immunological test system.
  140. Mirabegron (as prolonged release) + Tamsulosin HCl IP (as Prolonged release) (25mg + 0.4mg…
  141. EU/3/06/399 - orphan designation for prevention of retinopathy of prematurity in neonates…
  142. 25 Years of EMA: building, learning and adapting to new challenges
  143. Expert meeting on gastroenterology and rheumatology
  144. EMA Human Scientific Committees' Working Parties with Patients' and Consumers'…
  145. EU/3/07/526 - orphan designation for treatment of acute myeloid leukaemia
  146. Pharmacovigilance Risk Assessment Committee (PRAC): 25-28 November 2019
  147. 21 CFR 884.5470: Unscented menstrual tampon.
  148. Novartis Vaccines and Diagnostics S.r.l. withdraws its application for paediatric use…
  149. VICH GL15 Efficacy of anthelmintics: specific recommendations for equines - Scientific…
  150. ema-mM
  151. AAMI News, December 2020, Vol.55, No.12
  152. Sitagliptin / Metformin hydrochloride Sun
  153. November 7, 2024: General and Plastic Surgery Devices Panel of the Medical Devices…
  154. EU/3/11/909 - orphan designation for treatment of pulmonary arterial hypertension
  155. Resmetirom Tablets 60mg,80mg and 100mg (Research centre)
  156. ema-xofluzaXofluza
  157. EMEA-002351-PIP01-18 - paediatric investigation plan
  158. Xgeva - withdrawal of application for variation to marketing authorisation
  159. Testing for toxins in medicinal cannabis products being supplied via SAS B in Australia
  160. ema-kesimptaKesimpta
  161. 21 CFR 880.6300: Implantable radiofrequency transponder system for patient identification…
  162. Questions and answers for biological medicinal products
  163. cdsco-cls-taCLS-TA
  164. ema-impulsorImpulsor
  165. Multidisciplinary: cell therapy and tissue engineering
  166. JNJ-61186372 (amivantamab)
  167. EMEA-000056-PIP03-10-M02 - paediatric investigation plan
  168. William Hyman: Reauthorization Bill Calls for FDA Report on Medical Device Service
  169. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 September 2014
  170. EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
  171. EMEA-002645-PIP01-19 - paediatric investigation plan
  172. February 17, 2016: Risk Communication Advisory Committee Meeting Announcement - 02/17/2016
  173. ema-ristabenRistaben
  174. ema-nasymNasym
  175. PSUSA/00001955/202002 - periodic safety update report single assessment
  176. Withdrawal of Covid-19 indication of Baricitinib Tablets 2mg & 4mg
  177. Committee for Herbal Medicinal Products (HMPC): 20-22 November 2023
  178. ICH Q6B Specifications: test procedures and acceptance criteria for…
  179. ema-ibuprofen-nvt-referralIbuprofen NVT - referral
  180. Gliclazide IP (As sustained release) + Dapagliflozin film coated bilayered tablets (Phase…
  181. April 23, 2018: Science Board to the FDA Meeting Announcement - 04/22/2018
  182. PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products
  183. PSUSA/00010364/201903 - periodic safety update report single assessment
  184. Call for expressions of interest for patients’ organisations representatives to join…
  185. Mike Capuano: A Medical Equipment Serviceability Standard
  186. EU/3/10/739 - orphan designation for treatment of citrullinaemia type 2
  187. ema-procurement-archiveProcurement archive
  188. 21 CFR 812.25: Investigational plan.
  189. ENCePP publishes the 'guide on methodological standards in pharmacoepidemiology'
  190. PSUSA/00001213/201801 - periodic safety update report single assessment
  191. Monoclonal antibodies for veterinary use: specific questions to be addressed by the Ad Hoc…
  192. Maximum residue limit assessment reports
  193. Janssen-Cilag International N.V. withdraws its application for an extension of indication…
  194. ema-evraEvra
  195. Glidipion (previously Pioglitazone Actavis Group)
  196. 21 CFR 822.11: What should I consider when designing my plan to conduct postmarket…
  197. cdsco-use-of-cosmeticsUse of Cosmetics
  198. EMA Management Board: highlights of December 2018 meeting
  199. Re-establishment of working seeds and working cell banks using TSE compliant materials…
  200. Committee for Advanced Therapies (CAT): 11-13 July 2012
  201. 21 CFR 11.300: Controls for identification codes/passwords.
  202. Oversight and monitoring of investigational medical product trials
  203. 21 CFR 1.509: How must the importer be identified at entry?
  204. Gender differences in cardiovascular diseases - Scientific guideline
  205. Demonstration of a possible impact of maternally derived antibodies on vaccine efficacy in…
  206. How to Find and Manage Artificial Intelligence in Your Facility
  207. Annex1 Guideline on drug interaction for drug development and appropriate provision of…
  208. ACMD meeting statement, Meeting 28, 26 August 2016
  209. Schering-Plough Europe withdraws its marketing authorisation application for Cylatron…
  210. EU/3/23/2872 - orphan designation for treatment of ricin poisoning
  211. 21 CFR 888.3670: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained…
  212. GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the…
  213. EMEA-000921-PIP01-10 - paediatric investigation plan
  214. First comprehensive overview of global initiatives on medicine regulation published
  215. New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E)
  216. Committee for Medicinal Products for Human Use (CHMP): 21-24 February 2022
  217. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  218. Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
  219. Call for Healthcare Technology’s ‘Bright Ideas,’ 2022
  220. Assessment and procurement of coronavirus (COVID-19) tests: Products in the pipeline…
  221. cdsco-durvalumabgctDurvalumabgct
  222. ema-casgevyCasgevy
  223. EMEA-001904-PIP03-18-M02 - paediatric investigation plan
  224. Skye Pharma PLC withdraws its application to extend the marketing authorisation for…
  225. 21 CFR 880.3: Effective dates of requirement for premarket approval.
  226. Regulatory science strategy
  227. NMPA Announcement on the Issuance of 21 Medical Device Industry Standards such as YY / T…
  228. ema-oncept-melanomaOncept Melanoma
  229. EudraVigilance training on the electronic reporting of individual case safety reports…
  230. PSUSA/00000584/202207 - periodic safety update report single assessment
  231. EMEA-002905-PIP01-20 - paediatric investigation plan
  232. Participating Authorities
  233. Q & A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign…
  234. Ecallantide - paediatric investigation plan
  235. ema-revinty-elliptaRevinty Ellipta
  236. HTM's WIL Power! Leadership Group to Host Free Webinar
  237. Myalepta - direct healthcare professional communication (DHPC)
  238. European Medicines Agency recommends approval of pomalidomide for the treatment of…
  239. cdsco-trastuzumab-aurTrastuzumab aur
  240. ema-insulin-aspart-sanofiInsulin aspart Sanofi
  241. Borderline products: how to tell if your product is a medicine
  242. cdsco-101-pgc-005101-PGC-005
  243. EMEA-003228-PIP01-22 - paediatric investigation plan
  244. ema-angioxAngiox
  245. Quality aspects included in the product information for vaccines for human use…
  246. European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment…
  247. Coordination group for mutual recognition and decentralised procedures for veterinary…
  248. EU/3/10/775 - orphan designation for treatment of thromboangiitis obliterans (Buerger's…
  249. Implementation of medical devices future regime
  250. DR_G.S.R. 72(E) dt_08.02.2013_Addition of Rule 122DD_Registration of Ethics Committee
  251. EU/3/08/541 - orphan designation for treatment of erythropoietic protoporphyria
  252. Workshop on haemophilia registries
  253. Recombinant Humanized Type III Collagen Solution Approved
  254. EMEA-000332-PIP02-17-M04 - paediatric investigation plan
  255. Introducing the AAMI Fellows Class of 2023
  256. FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial…
  257. EMA to support development of vaccines and treatments for novel coronavirus disease…
  258. Training session for patients and consumers interested in EMA activities
  259. NMPA issued the Announcement on the Annual Report for National ADR Monitoring (2018)
  260. ICH M4Q Location issues for common technical document for the registration of…
  261. First anniversary of PRIME: experience so far
  262. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12…
  263. Vilanterol Trifenatate eq. to Vilanterol 25mcg + Glycopyrrolate IP eq. to Glycopyrronium…
  264. EU/3/18/2072 - orphan designation for treatment of cystic fibrosis
  265. PSUSA/00000108/201912 - periodic safety update report single assessment
  266. EMEA-000778-PIP02-12-M01 - paediatric investigation plan
  267. 21 CFR 870.1220: Electrode recording catheter or electrode recording probe.
  268. Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal…
  269. PSUSA/00010287/201811 - periodic safety update report single assessment
  270. EMEA-000982-PIP01-10 - paediatric investigation plan
  271. ema-cabometyxCabometyx
  272. PSUSA/00002944/202107 - periodic safety update report single assessment
  273. 21 CFR 872.3070: Dental amalgam, mercury, and amalgam alloy.
  274. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 11-13 January 2011
  275. PSUSA/00001418/201601 - periodic safety update report single assessment
  276. European Medicines Agency gives first opinion for a vaccine for use outside the EU
  277. Separate and distinct biologicals
  278. Paediatric Committee (PDCO): 23-26 April 2024
  279. ema-nexgard-comboNexGard Combo
  280. COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
  281. Public Statement on Trovan/Trovan IV/Turvel/Turvel IV (Trovafloxacin/Alatrofloxacin)…
  282. Data requirements for adjuvants in vaccines for veterinary use - Scientific guideline
  283. Clinical efficacy and safety: respiratory system
  284. EU/3/17/1914 - orphan designation for treatment of primary sclerosing cholangitis
  285. 21 CFR 892.5780: Light beam patient position indicator.
  286. Global animal health conference: Global availability of veterinary medicines - providing a…
  287. The new EudraVigilance system and the electronic reporting of individual case safety…
  288. cfr-21-cfr-73-85-caramel21 CFR 73.85: Caramel.
  289. Management Board meeting: 13 December 2012
  290. Limitations to the use of ethylene oxide in the manufacture of medicinal products (human)…
  291. cdsco-iiim-290IIIM-290
  292. Feb 08.02.2013 (GSR 72(E)
  293. Esaxerenone Tablets 5.0mg
  294. Committee for Orphan Medicinal Products (COMP): 19-21 January 2016
  295. Action Plan for Medical Devices - Progress Report Card: December 2022
  296. cdsco-palbociclibPalbociclib
  297. Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP…
  298. ACT EU Clinical Trials Analytics Workshop - January 2024
  299. EU/3/18/2079 - orphan designation for treatment of haemophilia A
  300. Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials
  301. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 October 2021
  302. AAMI Awards 2025: Honoring Standards Developers, Technical Committees, and Sterilization…
  303. PSUSA/00001760/201601 - periodic safety update report single assessment
  304. 2026.08.06 G.S.R. 713(E)_Notification for amendment under Rule 89 of Drugs Rules 1945, for…
  305. PSUSA/00001330/201709 - periodic safety update report single assessment
  306. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for sponsors
  307. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  308. 21 CFR 73.69: Butterfly pea flower extract.
  309. EMEA-001943-PIP01-16-M07 - paediatric investigation plan
  310. PSUSA/00001534/201706 - periodic safety update report single assessment
  311. 21 CFR 7.84: Opportunity for presentation of views before report of criminal violation.
  312. EU/3/05/319 - orphan designation for treatment of Staphylococcus aureus bacteraemia
  313. Eight industry stakeholder platform on research and development support
  314. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - November 2017
  315. Points to Consider for Preparation of Attached Data to Application Form for Marketing…
  316. European Medicines Agency proposes new, faster scientific advice procedure
  317. PSUSA/00000402/202006 - periodic safety update report single assessment
  318. ema-fibrates-referralFibrates - referral
  319. Post-authorisation (veterinary medicines)
  320. EU/3/16/1802 - orphan designation for treatment of acute myeloid leukaemia
  321. The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized…
  322. ema-litfuloLitfulo
  323. Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2024
  324. JPB898 (Nivolumab) 10mg/ml (240mg/24ml) Concentrate for solution for infusion
  325. CT Angiography Image-aided Detection Software for Intracranial Aneurysms Approved for…
  326. European network of paediatric research at the European Medicines Agency (Enpr-EMA)…
  327. Teysuno - withdrawal of application for variation to marketing authorisation
  328. Just Published: A Five-Year Health Industry Cybersecurity Strategic Plan for Everyone
  329. Introducing the AAMI eXchange REWIRED App
  330. EMEA-002748-PIP01-20 - paediatric investigation plan
  331. 2023.05.11_Draft_NDCTR_G.S.R. 364(E)_Notification for registration of Clinical Research…
  332. AU G0019.3.007 Medical Device Regulatory Audit Report Form Guidelines
  333. EU/3/17/1855 - orphan designation for treatment of Lennox-Gastaut syndrome
  334. P/149/2011 - paediatric investigation plan
  335. cdsco-mirikizumabMirikizumab
  336. 21 CFR 862.3750: Quinine test system.
  337. Coronavirus disease (COVID-19)
  338. DR_G.S.R. 170(E) dt_12.03.2001_26A_reg certain FDCs
  339. 21 CFR 882.5899: Trunk and limb electrical stimulator to treat headache.
  340. Twelfth Paediatric Oncology Strategy Forum for Medicinal Product Development of CDK4/6…
  341. EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic…
  342. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.15) Regulations…
  343. EMEA-002618-PIP03-21 - paediatric investigation plan
  344. PSUSA/00003168/201602 - periodic safety update report single assessment
  345. EU/3/21/2556 - orphan designation for treatment of Merkel cell carcinoma
  346. Paracetamol product-specific bioequivalence guidance
  347. Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 March 2024
  348. cdsco-jan-24-2011-g-s-r-45-eJan 24, 2011 (G.S.R 45 (E))
  349. EMEA-001477-PIP01-13 - paediatric investigation plan
  350. ema-australiaAustralia
  351. EMEA-001965-PIP01-16 - paediatric investigation plan
  352. EMEA-002777-PIP01-20 - paediatric investigation plan
  353. Guideline on clinical investigation of medicinal products in the treatment of depression
  354. EMEA-001977-PIP02-16 - paediatric investigation plan
  355. 21 CFR 878.5900: Nonpneumatic tourniquet.
  356. October 27, 2020: Circulatory System Devices Panel of the Medical Devices Advisory…
  357. (DOC Version - 142 K)
  358. FDA reporting permanent skin color changes associated with use of Daytrana patch…
  359. EU/3/18/2003 - orphan designation for treatment of Lassa fever
  360. NMPA Issues 5 Technical Review Guidances for the Registration of Tendon and Ligament…
  361. Australian Dental Sector Working Group, Meeting statement, Meeting 1, 19 April 2021
  362. Mandatory requirements for an effective application
  363. AAMI TIR100: A Much-Needed Tool for Driving End-to-End Microbiological Quality and…
  364. ema-nevanacNevanac
  365. Provisions for In-vitro Diagnostic Reagent Registration and Filing
  366. PSUSA/00010390/202007 - periodic safety update report single assessment
  367. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23…
  368. 21 CFR 866.5830: Brain trauma assessment test.
  369. April 14, 2023: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the…
  370. Neoadjuvant Osimertinib
  371. Sale of Drugs over Internet contravening the provisions of Drugs and Cosmetics Rules, 1945
  372. Committee for Advanced Therapies (CAT): 10-12 August 2022
  373. Committee for medicinal products for veterinary use: Meeting of 20 to 22 June 2006
  374. ema-pazenirPazenir
  375. EMEA-003115-PIP01-21 - paediatric investigation plan
  376. 21 CFR 862.1460: Leucine aminopeptidase test system.
  377. 21 CFR 868.5270: Breathing system heater.
  378. Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2018
  379. EU/3/01/026 - orphan designation for treatment of cystic fibrosis
  380. Order Dated 06.02.2013: "Expert Committees to formulate Policy Guidelines and SOPs for…
  381. Capaivasertib+Abiraterone
  382. Allergen products: production and quality issues - Scientific guideline
  383. OTC medicine monograph: Laxatives: Docusate sodium and/or sennosides
  384. Meeting with Alliance for Regenerative Medicine
  385. EMEA-002475-PIP02-19-M02 - paediatric investigation plan
  386. European Medicines Agency roundtable with stakeholders on the 10-year anniversary of the…
  387. EMEA-000095-PIP02-21 - paediatric investigation plan
  388. eXtended EudraVigilance medicinal product dictionary face-to-face training course, Madrid
  389. EMEA-001392-PIP01-12 - paediatric investigation plan
  390. ema-medicinesMedicines
  391. 21 CFR 862.1350: Continuous glucose monitor secondary alarm system.
  392. Q&A on the Master File (MF) System, Part I
  393. ema-zyprexaZyprexa
  394. EU/3/06/359 - orphan designation for treatment of calpainopathy
  395. White Paper-One Year of Application
  396. cfr-21-cfr-21-60-policy21 CFR 21.60: Policy.
  397. EU/3/15/1517 - orphan designation for treatment of acute myeloid leukaemia
  398. Post-authorisation efficacy studies: questions and answers
  399. Committee for veterinary medicinal products: Meeting of 1 to 3 October 2002
  400. Committee for Herbal Medicinal Products (HMPC): 23-24 July 2018
  401. European Medicines Agency issues recommendations for 2012/2013 seasonal flu vaccine…
  402. Committee for Herbal Medicinal Products (HMPC): 28-30 March 2022
  403. Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted)…
  404. European Medicines Agency recommends suspension of Octagam in all EU Member States
  405. Second EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs), 'Focus on…
  406. EU/3/09/695 - orphan designation for treatment of ovarian cancer
  407. MMRV Vaccine Factsheet - Information for Parents and Caregivers
  408. Checklist for Form MD-22MD
  409. East African Community looks to EMA as model for future regional agency
  410. Committee for Medicinal Products for Human Use (CHMP): 24-27 February 2020
  411. ICH Considerations: general principles to address virus and vector shedding - Scientific…
  412. Drug Safety Update: monthly PDF newsletter: Drug Safety Update February 2022
  413. European Medicines Agency reveals new structure
  414. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2021
  415. European Medicines Agency roundtable on the small and medium-sized enterprise (SME)…
  416. cdsco-durvalumabDurvalumab
  417. 21 CFR 1.502: What foreign supplier verification program (FSVP) must I have?
  418. cdsco-serpinpcSerpinPC
  419. Millefolii flos - herbal medicinal product
  420. TGA-NATA MoU relating to the regulation of in-house IVDs
  421. EU/3/14/1310 - orphan designation for treatment of Fabry disease
  422. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (24 Valent)
  423. 21 CFR 862.1330: Globulin test system.
  424. Industry stakeholder meeting on Brexit and operation of the centralised procedure for…
  425. ISO Surveys Users of IMDRF Essential Principles
  426. ema-newsNews
  427. EMEA-003210-PIP01-22 - paediatric investigation plan
  428. Committee for Orphan Medicinal Products (COMP): 7-8 December 2010
  429. Product defect reporting and recall procedures for therapeutic products and cell, tissue…
  430. EMEA-001654-PIP02-17-M01 - paediatric investigation plan
  431. Principles for the Evaluation of Vaccines Against the Novel Coronavirus…
  432. FDA Drug Safety Communication: FDA warns of serious immune system reaction with seizure…
  433. Committee for Proprietary Medicinal Products (CPMP) 37th plenary meeting
  434. ema-dropcysDropcys
  435. Transfer of marketing authorisation: questions and answers
  436. PSUSA/00002030/201502 - periodic safety update report single assessment
  437. Strict regulatory actions to prevent illegal manufacturing, sale, distribution and import…
  438. March 25 2015 GSR 224(E)
  439. Paediatric Committee (PDCO): 22-25 April 2025
  440. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
  441. Committee for Herbal Medicinal Products (HMPC): 22-24 November 2021
  442. Environmental Risk Assessment Working Party
  443. Juniperi aetheroleum - herbal medicinal product
  444. Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership…
  445. Bilastine + Montelukast sodium IP eq. to Montelukast Oral Suspension (Phase III
  446. Chapter 9 - General Advice on Due Diligence - Great Britain
  447. Isophane Human Insulin suspension, (100 IU/mL)
  448. EMA cancer symposium: New approaches in patient-focused cancer medicine development
  449. EU/3/06/366 - orphan designation for treatment of Pseudomonas aeruginosa lung infection in…
  450. Referentials Management Service (RMS)
  451. Paediatric Committee (PDCO): 17-19 March 2010
  452. PSUSA/00001711/202307 - periodic safety update report single assessment
  453. NMPA Issues the Announcement on Implementing the 2020 Edition of the Pharmacopoeia of the…
  454. March 21-22, 2018: Joint Meeting of the Blood Products Advisory Committee and the…
  455. NIH to Fund Academic Center Research on Telehealth and Cancer Care
  456. Haemophilia registries workshop
  457. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October…
  458. Mycobacterium Tuberculosis (Live, Attenuated) Vaccine
  459. Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with…
  460. Marisa Delbò elected as new chair of herbal medicines committee
  461. European Antibiotic Awareness Day: 18 November 2012
  462. EU/3/14/1421 - orphan designation for treatment of gastrointestinal stromal tumours
  463. 21 CFR 882.1450: Brain injury adjunctive interpretive electroencephalograph assessment…
  464. GD211 Training, Module 1 - Introduction
  465. cdsco-ca-170CA-170
  466. EMEA-000715-PIP02-11-M06 - paediatric investigation plan
  467. Melaleucae aetheroleum - herbal medicinal product
  468. EU/3/00/010 - orphan designation for treatment of essential thrombocythaemia
  469. GN-10-R3.6 Guidance on Medical Device Field Safety Corrective Action (Updated on January…
  470. PSUSA/00000277/202012 - periodic safety update report single assessment
  471. 2021.08.02_Draft GSR 524(E)_Amendment in Eighth Schedule, Form CT-03
  472. Vildagliptin IP (as sustained release)Pioglitazone Hydrochloride IP eq. to Pioglitazone…
  473. Leadless cardiac pacemaker therapy: guidance from an MHRA Expert Advisory Group: Leadless…
  474. Possession and supply of vaping goods in Australia
  475. ema-eu-member-statesEU Member States
  476. Produce Safety Inspections
  477. ema-ferriproxFerriprox
  478. European Medicines Agency closed 13 June 2011
  479. 21 CFR 99.301: Agency action on a submission.
  480. Polyurethanes
  481. EMEA-000867-PIP01-10 - paediatric investigation plan
  482. EMEA-001150-PIP02-13-M05 - paediatric investigation plan
  483. AAMI Celebrates First-Ever BMET Apprenticeship Graduate
  484. cdsco-traconazoletraconazole
  485. 21 CFR 1.642: What competency and capacity must a third-party certification body have to…
  486. 21 CFR 830.330: Times for submission of unique device identification information.
  487. Determinations for Australian conformity assessment bodies
  488. Clinical trials: Phase 1, 14-Day Pilot Programme
  489. PSUSA/00001594/202006 - periodic safety update report single assessment
  490. ema-opsumitOpsumit
  491. cdsco-bepirovirsenBepirovirsen
  492. ema-stayveerStayveer
  493. 21 CFR 862.3645: Neuroleptic drugs radioreceptor assay test system.
  494. EMEA-002799-PIP01-20 - paediatric investigation plan
  495. EMEA-003219-PIP01-22 - paediatric investigation plan
  496. Bucillamine tablets 100mg
  497. PSUSA/00001834/201610 - periodic safety update report single assessment
  498. ema-vaccines-working-partyVaccines Working Party
  499. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 3-5 May 2011
  500. Handling of Prescription Drugs Having Different Crystalline Forms, etc.
  501. NMPA Notice on Issuing the Guidelines for On-Site Inspection of the Quality Management…
  502. PSUSA/00003159/201712 - periodic safety update report single assessment
  503. ema-neptraNeptra
  504. EU/3/13/1196 - orphan designation for treatment of Wiskott-Aldrich syndrome
  505. Trastuzumab Solution for Injection 600 mg/5 mL vial (120 mg/mL)[Trastuzumab with…
  506. Molnupiravir Moderate2s
  507. European Medicines Agency and EuropaBio annual bilateral meeting 2020
  508. ema-cupriorCuprior
  509. New medicine for rare neurodegenerative disorder in children
  510. ema-ifirmacombiIfirmacombi
  511. 2019 annual meeting of the members and Coordinating Group of the European network of…
  512. EMEA-002160-PIP01-17 - paediatric investigation plan
  513. EMEA-001304-PIP03-17 - paediatric investigation plan
  514. Simplified auto-registration of beneficiaries (IEC holders) on ICEGATE for e-SANCHIT and…
  515. EMEA-002766-PIP02-21 - paediatric investigation plan
  516. EU/3/14/1318 - orphan designation for treatment of acute pancreatitis
  517. Management Board meeting: 7-8 June 2023
  518. E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based…
  519. Handling of Japanese Data for Confirmation of Comparability of Biosimilars to the Original…
  520. EMEA-000901-PIP03-16-M02 - paediatric investigation plan
  521. PSUSA/00000277/201712 - periodic safety update report single assessment
  522. EU/3/18/2103 - orphan designation for treatment of biliary atresia
  523. What’s Happening at AAMI eXchange REWIRED
  524. ema-remsimaRemsima
  525. ema-deltanil-referralDeltanil - referral
  526. EMEA-002342-PIP03-18 - paediatric investigation plan
  527. Dairy Product Manufacturers (4/95)
  528. Insulin Human Rapid Marvel
  529. ema-raptivaRaptiva
  530. 21 CFR 888.3310: Hip joint metal/polymer constrained cemented or uncemented prosthesis.
  531. Cetrotide - direct healthcare professional communication (DHPC)
  532. Fluticasone Furoate Ph. Eur 200mcg + Umeclidinium Bromide eq. to Umeclidinium 62.5mcg +…
  533. ema-pemetrexed-krkaPemetrexed Krka
  534. Guidance Document: Requirements in the Recognition Process for Medical Device Single Audit…
  535. MDAC of Reporductive and Urology
  536. EMEA-002702-PIP01-19 - paediatric investigation plan
  537. ema-azacitidine-accordAzacitidine Accord
  538. EU/3/14/1406 - orphan designation for treatment of inborn errors in primary bile acid…
  539. cdsco-kaf156KAF156
  540. Bempedoic Acid (ETC-1002)
  541. Meeting highlights from the Committee for Medicinal Products for Human Use,17-20 November…
  542. EU/3/14/1307 - orphan designation for prevention of bronchopulmonary dysplasia
  543. EU/3/12/1042 - orphan designation for prevention of cytomegalovirus disease in patients…
  544. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27…
  545. European Medicines Agency advises on compassionate use of daclatasvir
  546. ema-tavneosTavneos
  547. Committee for medicinal products for veterinary use: Meeting of 12 to 13 July 2005
  548. Meeting highlights from the Paediatric Committee:27 - 29 May 2009
  549. Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline
  550. Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety…
  551. EU/3/14/1322 - orphan designation for treatment of cutaneous T-cell lymphoma
  552. AdTab (previously Lotilaner Elanco)
  553. PRAC starts safety review of pseudoephedrine-containing medicines
  554. Get Mobile for AAMI eXchange 2024!
  555. EU/3/12/992 - orphan designation for treatment of Duchenne muscular dystrophy
  556. 21 CFR 801.20: Label to bear a unique device identifier.
  557. PSUSA/00010570/201802 - periodic safety update report single assessment
  558. EU/3/15/1514 - orphan designation for treatment of autosomal dominant polycystic kidney…
  559. EMEA-002722-PIP01-19-M02 - paediatric investigation plan
  560. Cervarix - withdrawal of application for variation to marketing authorisation
  561. 21 CFR 862.1140: Calcitonin test system.
  562. Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 May 2015
  563. 21 CFR 868.1870: Gas volume calibrator.
  564. COVID-19 Rapid Antigen Tests - Guidance and checklist for businesses
  565. EU/3/18/2112 - orphan designation for treatment of biliary tract cancer
  566. 21 CFR 812.38: Confidentiality of data and information.
  567. cdsco-steroids-in-igaSteroids in Iga
  568. EU/3/20/2349 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  569. 21 CFR 862.1820: Xylose test system.
  570. Dovprela (previously Pretomanid FGK)
  571. Silodosin + Solifenacin Succinate Ph. Eur. Capsule (Phase III)
  572. Regulatory update - Changes to scientific advice procedures as of 17 November 2014
  573. EU/3/06/411 - orphan designation for prevention of graft-versus-host disease
  574. Feedback requested on the draft list of EU reference dates for periodic safety update…
  575. Human normal immunoglobulin - paediatric investigation plan
  576. EMA website briefly unavailable on 9 December
  577. PSUSA/00001924/202205 - periodic safety update report single assessment
  578. ema-encyzixEnCyzix
  579. Coordination of GCP inspections
  580. Highlights of Management Board meeting: June 2019
  581. PSUSA/00000421/202009 - periodic safety update report single assessment
  582. cdsco-acalabrutinibAcalabrutinib
  583. 21 CFR 866.4800: Radial immunodiffusion plate.
  584. Proposals to revise guidance on first-in-human clinical trials
  585. EMEA-003052-PIP01-21 - paediatric investigation plan
  586. Benidipine HCl IPTelmisartan IP Film coated tablets
  587. EMEA-001492-PIP01-13-M01 - paediatric investigation plan
  588. ICH Q3A (R2) Impurities in new drug substances - Scientific guideline
  589. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2023 (SI…
  590. 21 CFR 878.3510: Carbon dioxide gas controlled tissue expander.
  591. 21 CFR 862.3670: Phenothiazine test system.
  592. EMEA-000268-PIP01-08 - paediatric investigation plan
  593. 21 CFR 886.4392: Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
  594. ema-tepmetkoTepmetko
  595. EU/3/13/1119 - orphan designation for treatment of follicular thyroid cancer
  596. Marketing Authorisation Application submission dates for 150-days national and European…
  597. EU/3/06/374 - orphan designation for treatment of graft-versus-host disease
  598. FDA Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary…
  599. PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for…
  600. European Medicines Agency closed 28 March - 1 April 2013
  601. EMEA-001625-PIP03-21 - paediatric investigation plan
  602. Meeting management procedures
  603. ema-cerezymeCerezyme
  604. Appendix 11 Guidance on Drug Master File
  605. EMEA-001255-PIP01-11-M03 - paediatric investigation plan
  606. Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution, evolution…
  607. ema-macugenMacugen
  608. EMEA-002949-PIP01-20 - paediatric investigation plan
  609. EMEA-001716-PIP03-18 - paediatric investigation plan
  610. NMPA Issues Announcement on Revising Package Insert of Vitamin B2 Injection
  611. EU/3/19/2155 - orphan designation for treatment of amyotrophic lateral sclerosis
  612. cdsco-ozanimodOzanimod
  613. ema-prohippurProhippur
  614. PSUSA/00010068/201607 - periodic safety update report single assessment
  615. EMEA-002177-PIP01-17 - paediatric investigation plan
  616. EU/3/22/2589 - orphan designation for treatment of sickle cell disease
  617. European Medicines Agency agrees to precautionary recall of Advagraf 0.5 mg capsule…
  618. ema-international-agreementsInternational agreements
  619. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26…
  620. PSUSA/00010342/201809 - periodic safety update report single assessment
  621. EMEA-000696-PIP02-10-M08 - paediatric investigation plan
  622. EMEA-000132-PIP01-07-M04 - paediatric investigation plan
  623. Incident management plan (veterinary medicines)
  624. ema-lumarkLumark
  625. cdsco-gemcitabine-revisedGemcitabine revised
  626. Committee for Medicinal Products for Human Use (CHMP): 25-28 March 2019
  627. eXtended EudraVigilance medicinal product dictionary face-to-face training course
  628. FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can…
  629. EMEA-002113-PIP01-16-M01 - paediatric investigation plan
  630. 21 CFR 26.21: Safeguard clause.
  631. Team-NB PositionPaper Article117 NB Opinion Template V1
  632. EMEA-000380-PIP09-21 - paediatric investigation plan
  633. Electronic instructions for use of medical devices: guidance on regulations: Guidance on…
  634. EMEA-003151-PIP01-21 - paediatric investigation plan
  635. EMEA-003275-PIP01-22 - paediatric investigation plan
  636. EU/3/15/1554 - orphan designation for treatment of aneurysmal subarachnoid haemorrhage
  637. ema-trovan-ivTrovan IV
  638. Stem-cell-therapy treatments
  639. EU/3/09/688 - orphan designation for treatment of fallopian tube cancer
  640. Tocilizumab, Concentrate solution for infusion, 80mg/4mL
  641. European Medicines Agency starts review of Protelos / Osseor
  642. EU/3/15/1441 - orphan designation for treatment of sickle cell disease
  643. cfr-21-cfr-814-2-purpose21 CFR 814.2: Purpose.
  644. EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
  645. Updated advice on body fat changes and lactic acidosis with HIV medicines
  646. Documents to be submitted for the application for GMP compliance inspection (Aug.2 ,2023)…
  647. cdsco-ly3437943LY3437943
  648. Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024
  649. EU/3/01/070 - orphan designation for treatment of familial adenomatous polyposis (FAP)
  650. cdsco-c21C21
  651. EU/3/08/531 - orphan designation for treatment of Charcot-Marie-Tooth disease type 1A
  652. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005 (SI…
  653. CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway…
  654. ema-loargysLoargys
  655. European Medicines Agency statement on recent publication on cardiac safety of…
  656. ema-tavlesseTavlesse
  657. EMEA-000746-PIP01-09-M04 - paediatric investigation plan
  658. EMEA-003062-PIP01-21 - paediatric investigation plan
  659. Clinical efficacy and safety: haematology and blood products (including biotech…
  660. Quality: post approval change management protocols
  661. 21 CFR 82.1328: D&C Red No. 28.
  662. EMEA-000950-PIP01-10 - paediatric investigation plan
  663. Supplementary information for pharmaceutical wholesalers on the Windsor Framework
  664. EMEA-002959-PIP01-21 - paediatric investigation plan
  665. PSUSA/00009236/201506 - periodic safety update report single assessment
  666. EMEA-000911-PIP01-10 - paediatric investigation plan
  667. Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 April 2023
  668. 21 CFR 864.9900: Cord blood processing system and storage container.
  669. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 June 2017
  670. EU/3/04/214 - orphan designation for treatment of acute myeloid leukaemia
  671. ema-clopidogrel-hexalClopidogrel Hexal
  672. Sitagliptin (phosphate monohydrate) - paediatric investigation plan
  673. 21 CFR 860.125: Consultation with panels.
  674. ema-vimizimVimizim
  675. 2019.02.26_Draft G.S.R.152(E)_Condition of licence for undertaking on brand or trade names…
  676. Budesonide/Formoterol Teva Pharma B.V.
  677. EU/3/08/603 - orphan designation for treatment of non-papillary transitional cell…
  678. Team-NB-PositionPaper-IVDR-Certification-Process-Consensus-Document-V1-20250409
  679. EMEA-002684-PIP01-19-M01 - paediatric investigation plan
  680. Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety…
  681. cdsco-gia632GIA632
  682. Update: Risk of False Positive Lead Test Results with Certain Capillary Blood Collection…
  683. PSUSA/00001996/201711 - periodic safety update report single assessment
  684. February 16, 2016: Risk Communication Advisory Committee Meeting Announcement - 02/16/2016
  685. ema-ultifend-nd-ibdUltifend ND IBD
  686. Notice regarding COVID-19 outbreak
  687. Implementation of PGA e-SANCHIT - Paperless Processing under SWIFT-Uploading of…
  688. Committee for Advanced Therapies (CAT): 4-6 October 2023
  689. Datopotamab Deruxtecan (DATO-DXD, DS-1062) and Osimertinib
  690. 21 CFR 892.1920: Radiographic head holder.
  691. COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events…
  692. 21 CFR 888.3340: Hip joint metal/composite semi-constrained cemented prosthesis.
  693. cdsco-sun-pharmaSun Pharma
  694. (Appendix 15) The Standards for Marketing Approval of Antipruritic and Anti-inflammatory…
  695. Reporting a falsified product to EMA
  696. ema-rheumocamRheumocam
  697. Launching of National Single Window System (NSWS) Portal
  698. PSUSA/00010290/201601 - periodic safety update report single assessment
  699. Veterinary medicinal products containing tylosin base (as a single active substance)…
  700. Paediatric Committee (PDCO): 25-28 February 2025
  701. EMEA-002002-PIP02-17 - paediatric investigation plan
  702. Paediatric Committee (PDCO): 15-17 January 2014
  703. EMEA-001075-PIP01-10 - paediatric investigation plan
  704. EU/3/05/307 - orphan designation for treatment of primary growth hormone insensitivity…
  705. Lenvatinib Capsules 4 mg and 10 mg
  706. Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
  707. cdsco-tofacitinibtofacitinib
  708. Regulations Governing Accreditation and Outsourced Accreditation Management of Food…
  709. ema-granpidamGranpidam
  710. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12…
  711. Human Variations electronic application forms Q&A Clinics – Session 3 (focus: access…
  712. EMEA-000782-PIP01-09-M04 - paediatric investigation plan
  713. CHMP confirms recommendations for use of Zydelig
  714. ema-livogivaLivogiva
  715. Committee for Proprietary Medicinal Products (CPMP) 31st plenary meeting
  716. 21 CFR 17.28: Protective order.
  717. Mysimba recommended for approval in weight management in adults
  718. ema-meronem-referralMeronem - referral
  719. EU/3/18/2117 - orphan designation for treatment of cystic fibrosis
  720. PSUSA/00010710/202001 - periodic safety update report single assessment
  721. 21 CFR 868.5795: Tracheal tube cleaning brush.
  722. ema-levemirLevemir
  723. November 15, 2018: Patient Engagement Advisory Committee Meeting Announcement - 11/15/2018
  724. cfr-21-cfr-808-55-california21 CFR 808.55: California.
  725. cdsco-tofacitinib-gel-2-w-wTofacitinib Gel 2% w/w
  726. tropifexor (LJN452) and cenicriviroc (CVC)
  727. EU/3/21/2419 - orphan designation for treatment of ATTR amyloidosis
  728. NOTICE to all State Drugs Controller
  729. 21 CFR 13.40: Administrative record of a Board.
  730. EU/3/23/2859 - orphan designation for treatment of amyotrophic lateral sclerosis
  731. PSUSA/00010392/202205 - periodic safety update report single assessment
  732. HRF-10071 and Lamivudine
  733. PSUSA/00002472/202110 - periodic safety update report single assessment
  734. PSUSA/00010299/201703 - periodic safety update report single assessment
  735. ema-ameluzAmeluz
  736. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  737. ema-agilusAgilus
  738. Candesartan/Hydrochlorothiazide - paediatric investigation plan
  739. EMEA-002575-PIP01-19 - paediatric investigation plan
  740. GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD using the…
  741. Committee for Herbal Medicinal Products (HMPC): 14-16 January 2019
  742. 21 CFR 1.934: What procedures apply if we determine that a waiver should be modified or…
  743. Fourth industry stakeholder platform on the operation of the centralised procedure for…
  744. EMEA-000639-PIP02-09-M02 - paediatric investigation plan
  745. Committee for Advanced Therapies (CAT): 18-20 May 2020
  746. Seventh meeting of the industry stakeholder platform on the operation of the centralised…
  747. EU/3/14/1383 - orphan designation for treatment of pleural empyema
  748. 21 CFR 73.3111: Chromium oxide greens.
  749. nbcg-survey-2021Survey 2021
  750. September 15, 2016: National Mammography Quality Assurance Advisory Committee Meeting…
  751. GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines…
  752. ema-careersCareers
  753. EMEA-000309-PIP06-21 - paediatric investigation plan
  754. European Medicines Agency now publishing meeting agendas for all scientific committees
  755. aami-2019-the-year-in-review2019—The Year in Review
  756. Guidance Document - Health Canada and Advertising Preclearance Agencies' Roles Related to…
  757. 21 CFR 892.1320: Nuclear uptake probe.
  758. Committee for Medicinal Products for Human Use (CHMP): 13-16 September 2021
  759. semaglutide 25 mg compared with 14 mg
  760. Medical Device Materials Compatibility Insights Promised with Industry-Academic…
  761. EU/3/02/092 - orphan designation for treatment of chronic iron overload requiring…
  762. Herbal medicines: regulatory and scientific support
  763. 21 CFR 71.37: Exemption of color additives for investigational use.
  764. Matricariae aetheroleum - herbal medicinal product
  765. cdsco-serpin-pcinvenSerpin PCInven
  766. Arpida A/S withdraws its marketing authorisation application for Mersarex (iclaprim)
  767. Rozlytrek - opinion on variation to marketing authorisation
  768. Recruitment procedure for new Executive Director of the European Medicines Agency started
  769. 21 CFR 1.506: What foreign supplier verification and related activities must I conduct?
  770. William Hyman: When Are the Risks Worth the Benefits?
  771. 21 CFR 862.1815: Vitamin E test system.
  772. EU/3/10/776 - orphan designation for treatment of ovarian cancer
  773. Medical Device Shortages SPOC Working Party meetings
  774. EU/3/08/528 - orphan designation for treatment chronic lymphocytic leukaemia
  775. Tenofovir Alafenamide, Emtricitabine and Bictegravir
  776. 21 CFR 862.3900: Tobramycin test system.
  777. 21 CFR 73.1991: Zinc oxide.
  778. Notice to Stakeholders: Name change for the Post-Market Reporting Compliance (PMRC)…
  779. Control of impurities of pharmacopoeial substances: compliance with the European…
  780. Safety and residue data requirements for veterinary medicinal products intended for minor…
  781. ema-rixubisRixubis
  782. NMPA Announcement on Issuing the Requirements for Change Items and Application Dossiers of…
  783. Visit of the East African Community (EAC)
  784. EU/3/21/2494 - orphan designation for treatment of myelodysplastic syndromes
  785. Enforcement Rules of Medical Devices Act
  786. Abbe Meehan: Tips for Onboarding New Employees
  787. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MAR-2022
  788. PSUSA/00010163/202308 - periodic safety update report single assessment
  789. 21 CFR 71.22: Deception as a basis for refusing to issue regulations; deceptive use of a…
  790. EMEA-001776-PIP03-17 - paediatric investigation plan
  791. EMEA-002740-PIP01-19 - paediatric investigation plan
  792. The Good, the Bad, and the Ugly of Industrial Sterilization
  793. Special Condition under which the permission for import of drug with residual shelf life…
  794. ema-geriatric-expert-groupGeriatric Expert Group
  795. ema-rivastigmine-hexalRivastigmine Hexal
  796. 21 CFR 880.5570: Hypodermic single lumen needle.
  797. cdsco-ql2107-injectionQL2107 Injection
  798. Transfer of certain functions and delegation of powers to the zonal offices of CDSCO under…
  799. EMEA-000744-PIP01-09 - paediatric investigation plan
  800. Improved Inventory Tracking Plays Vital Role in Battle Against COVID-19 at Banner Health
  801. EMEA-002597-PIP06-21 - paediatric investigation plan
  802. ema-indiaIndia
  803. Drug Alert list for month of May 2023
  804. 21 CFR 872.5470: Orthodontic plastic bracket.
  805. Changing the sponsor of therapeutic goods
  806. Naftifine Hydrochloride Gel 2%
  807. 21 CFR 872.3680: Polytetrafluoroethylene (PTFE) vitreous carbon materials.
  808. EMEA-001741-PIP02-16-M02 - paediatric investigation plan
  809. ema-twinrix-adultTwinrix Adult
  810. ICH: M 4 S: Common technical document for the registration of pharmaceuticals for human…
  811. Third Industry Standing Group (ISG) meeting
  812. Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5%
  813. 21 CFR 868.5780: Tube introduction forceps.
  814. ema-cyramzaCyramza
  815. Recommendation-NB-MED-2_13-2_rev3 CE-Marking of established IVD devices
  816. Risk based classification list of Class A(non-sterile and non-measuring) medical device
  817. EU/3/16/1692 - orphan designation for treatment of idiopathic pulmonary fibrosis
  818. EU/3/01/061 - orphan designation for treatment of malignant gastrointestinal stromal…
  819. ema-elonvaElonva
  820. Methylene Blue - Serious CNS reactions possible when methylene blue is given to patients…
  821. EU/3/14/1287 - orphan designation for treatment of Prader-Willi syndrome
  822. Simpler website navigation for regulatory information on veterinary medicines
  823. Accelerating Clinical Trials in the EU (ACT EU)
  824. EU/3/14/1245 - orphan designation for treatment of adrenoleukodystrophy
  825. 21 CFR 1.1149: What oversight standards apply to sampling?
  826. EMEA-001415-PIP02-21 - paediatric investigation plan
  827. New measures to facilitate conduct of ENCePP studies
  828. PSUSA/00000958/202309 - periodic safety update report single assessment
  829. Magnetic Resonance Imaging System Approved for Marketing
  830. EMEA-002814-PIP02-21-M01 - paediatric investigation plan
  831. 21 CFR 874.4800: Bone particle collector.
  832. Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver…
  833. EMEA-003257-PIP01-22 - paediatric investigation plan
  834. EU/3/17/1929 - orphan designation for treatment of mastocytosis
  835. International regulators and WHO call for wider public access to clinical data
  836. PSUSA/00002024/201710 - periodic safety update report single assessment
  837. Advancing international collaboration on COVID-19 real-world evidence and observational…
  838. Novo Nordisk withdraw their application to extend the marketing authorisation for…
  839. EU/3/17/1903 - orphan designation for treatment of mucopolysaccharidosis VI…
  840. Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and…
  841. Suboxone - direct healthcare professional communication (DHPC)
  842. EU/3/18/2106 - orphan designation for treatment of sudden sensorineural hearing loss
  843. FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa…
  844. 21 CFR 870.2300: Cardiac monitor (including cardiotachometer and rate alarm).
  845. 21 CFR 866.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  846. Topamax - Risk of oral clefts in children born to mothers taking Topamax (topiramate)
  847. KSHN001034 Injection 113 mg/mL (Eq. to 100mg Fulvestrant)
  848. PSUSA/00001416/201805 - periodic safety update report single assessment
  849. EMEA Management Board adopts fee implementing rule and looks at the Agency's corporate…
  850. EMA recommends measures to minimise serious outcomes of known side effect with painkiller…
  851. EU/3/06/375 - orphan designation for treatment of chronic myeloid leukaemia
  852. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 2016
  853. December 28 2016 GSR 1179(E)
  854. cdsco-bdb001BDB001
  855. 21 CFR 71.6: Extension of time for studying petitions; substantive amendments; withdrawal…
  856. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety…
  857. 21 CFR 882.5850: Implanted spinal cord stimulator for bladder evacuation.
  858. ema-entolimod-tmcEntolimod TMC
  859. European Medicines Agency recommends measures to reduce risk of heart problems with…
  860. ema-masicanMasican
  861. Regulations Governing the Inspection of the Medical Device Quality Management System and…
  862. Meetings with stakeholders and other organisations
  863. ema-proliaProlia
  864. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018
  865. Cyberthreats Inspire a New Course for HTM Professionals
  866. 21 CFR 3.10: Stay of review time.
  867. EU/3/19/2232 - orphan designation for treatment of amyotrophic lateral sclerosis
  868. PSUSA/00003090/201501 - periodic safety update report single assessment
  869. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24…
  870. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training…
  871. EU/3/20/2380 - orphan designation for treatment of haemophilia A
  872. Condition for supply of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of…
  873. New medicine for rare eye disease
  874. Amedment to the Drugs and Cosmetics rules, 1945 regarding uploading data of Drug…
  875. FDA Drug Safety Communication: FDA recommends separating dosing of potassium-lowering drug…
  876. EU/3/11/943 - orphan designation for treatment of peripheral T-cell lymphoma (nodal, other…
  877. Career Center: Understanding the Stages of ACI Certification
  878. Cobalt Chromium (CoCr)
  879. 21 CFR 866.2440: Automated medium dispensing and stacking device.
  880. Committee for veterinary medicinal products: 43rd meeting
  881. European Medicines Agency recommends restricting use of thiocolchicoside by mouth or…
  882. 21 CFR 19.5: Reference to Department regulations.
  883. Definition of substances capable of pharmacological action in the context of Council…
  884. PSUSA/00001236/201703 - periodic safety update report single assessment
  885. UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of…
  886. EU/3/01/022 - orphan designation for treatment of mucopolysaccharidosis type I
  887. SfSAP Pursues Meaningful Learning Frameworks for Device Sterility Assurance
  888. Tammy M. Pelnik: The Key to Fewer Do-Overs and More Satisfied Customers
  889. Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 May 2013
  890. DR_G.S.R.218(E) dt_16.03.2011_26A_reg Gatifloxacin and its formulations, Tegaserod and its…
  891. PSUSA/00000597/202101 - periodic safety update report single assessment
  892. Emer Cooke takes office as head of EMA
  893. 21 CFR 882.1630: Cranial motion measurement device.
  894. 21 CFR 15.40: Administrative record.
  895. 2025.01.04_G.S.R. 10(E)_ Notification for Extension of Schedule M
  896. Chimeric antigen receptor (CAR) T-cell therapy registries workshop
  897. ema-herceptinHerceptin
  898. Update from the European Medicines Agency on COX-2 inhibitors
  899. Pegylated r-Human Granulocyte Colony Stimulating Factor (Pegfilgrastim) Solution for…
  900. ema-sycrestSycrest
  901. ema-prac-ticPrac-tic
  902. EMEA-002254-PIP01-17 - paediatric investigation plan
  903. 21 CFR 880.5445: Intravascular administration set, automated air removal system.
  904. Experts Address Roadblocks to Harmonization of EU Medical Device Standards
  905. EMA business hours on Europe Day, Tuesday 9 May
  906. EU/3/17/1925 - orphan designation for treatment of multiple myeloma
  907. EU/3/16/1702 - orphan designation for treatment of congenital hyperinsulinism
  908. Medical Product Shortages Compromise Patient Safety, Says Survey
  909. Alternative measures for investigational product management for clinical trials of locally…
  910. PSUSA/00002695/201901 - periodic safety update report single assessment
  911. Adverse Reaction Reporting and Health Product Safety Information - Guide for Health…
  912. ema-vantas-referralVantas - referral
  913. cdsco-s007-1500S007-1500
  914. cdsco-ofatumumabOfatumumab
  915. Medical devices post-market vigilance - statistics for 2017
  916. 21 CFR 868.1720: Oxygen gas analyzer.
  917. List of Debarment of Principal Investigators by CLA
  918. ema-sineremSinerem
  919. 21 CFR 862.1680: Testosterone test system.
  920. EU/3/15/1546 - orphan designation for treatment of acute lymphoblastic leukaemia
  921. Fragrances containing allergens
  922. 21 CFR 890.5940: Chilling unit.
  923. Developing Artificial Intelligence Standards: A World-Wide Endeavor Is Beginning
  924. September 9, 2024: Meeting of the Antimicrobial Drugs Advisory Committee Meeting…
  925. Export of human substances guidance
  926. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19…
  927. ACMD meeting statement, Meeting 37, 1 December 2017
  928. HT Connect Peripheral Guidewire
  929. Guideline on clinical investigation of steroid contraceptives in women
  930. Classification of Medical Device pertaining to Neurological under the provisions of…
  931. PSUSA/00001760/201901 - periodic safety update report single assessment
  932. Transferring a veterinary marketing authorisation
  933. EMEA-001174-PIP03-18 - paediatric investigation plan
  934. ema-gefzurisGefzuris
  935. 21 CFR 862.1780: Urinary calculi (stones) test system.
  936. 21 CFR 866.5160: Beta-globulin immunological test system.
  937. China Medical Device Standards Management Annual Report (2023)
  938. Winning the Gold, AAMI Foundation Scholarship Program Expands
  939. Management Board meeting: 12 June 2014
  940. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: Hands-on…
  941. NMPA Issued the Notice on Enabling the Import and Export Permit Management System
  942. May 23 2014 G.S.R 350(E)
  943. 6th industry stakeholder platform - Operation of EU pharmacovigilance legislation
  944. Remimazolam Besylate 20mg lyophilized powder for injection
  945. ema-olanzapine-tevaOlanzapine Teva
  946. EMEA-003294-PIP01-22 - paediatric investigation plan
  947. Glycopyrrolate IP eq. to Glycopyrronium _+ Formoterol Fumarate Dihydrate IP eq. to…
  948. Linguistic review - Veterinary
  949. EMA 25th anniversary symposium: New approaches in patient-focused cancer drug development
  950. 21 CFR 880.5100: AC-powered adjustable hospital bed.
  951. Winning HTM Week Videos Offer Creative Look at Work of Biomeds
  952. Manufacturing and marketing of unapproved drug Meropenam 1gm + EDTA for Injection
  953. Pregabalin IP + Duloxetine Hydrochloride IP eq. to Duloxetine (as gastro resistant…
  954. 21 CFR 884.5970: Clitoral engorgement device.
  955. Advertising compliance checklist - consumer advertising
  956. Passiflorae herba - herbal medicinal product
  957. 21 CFR 878.4685: Extracorporeal shock wave device for treatment of chronic wounds.
  958. Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing…
  959. Vildagliptin IP + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin film coated…
  960. PSUSA/00001442/201709 - periodic safety update report single assessment
  961. EMEA-001740-PIP01-14 - paediatric investigation plan
  962. 21 CFR 890.1600: Intermittent pressure measurement system.
  963. Meeting highlights from the Paediatric Committee: 15 - 17 October 2008
  964. ema-insulatardInsulatard
  965. PSUSA/00010586/201904 - periodic safety update report single assessment
  966. Second Meeting of the Management Board of the European Agency for the Evaluation of…
  967. SAR441566 100 mg Tablets
  968. Determination checklist: for sponsor seeking priority review determination
  969. Pyrotinib Maleate Tablets 80mg
  970. Trastuzumab Rezetecan for Injection 100mg/vial
  971. Second annual scientific workshop at EMA: Applying regulatory science to neonates
  972. Zykadia recommended for approval in advanced non small cell lung cancer
  973. EMEA-003031-PIP01-21 - paediatric investigation plan
  974. EU/3/21/2499 - orphan designation for treatment of Burkitt's lymphoma
  975. European Medicines Agency gives new temporary treatment recommendations for Fabrazyme
  976. EU/3/17/1842 - orphan designation for treatment of bronchiolitis obliterans syndrome
  977. EMEA-001711-PIP01-14 - paediatric investigation plan
  978. EU/3/22/2650 - orphan designation for treatment of myasthenia gravis
  979. MHRA / HRA Coordinated pathway
  980. European Medicines Agency welcomes new Head of IT Development Department
  981. 21 CFR 862.3220: Carbon monoxide test system.
  982. eXtended EudraVigilance Medicinal Product Dictionary Training Course
  983. Predictive biomarker-based assay development in the context of drug development and…
  984. Jennifer Jackson: The Gravitational Pull Toward Connectivity
  985. Quality of biological active substances produced by transgene expression in animals…
  986. EU/3/14/1247 - orphan designation for treatment of glioma
  987. cdsco-notice-26-12-2016Notice 26.12.2016
  988. 21 CFR 870.2310: Apex cardiograph (vibrocardiograph).
  989. Mifepristone and Misoprotol
  990. Casopitant - paediatric investigation plan
  991. Getting involved in EMA activities as a healthcare professional
  992. EMEA-002443-PIP01-18-M02 - paediatric investigation plan
  993. 21 CFR 26.50: Alert system and exchange of postmarket vigilance reports.
  994. Availability of veterinary medicinal products - extrapolation of maximum residue limits…
  995. ema-silodosin-recordatiSilodosin Recordati
  996. Core summary of product characteristics (SmPC) and package leaflet for gadoteric acid…
  997. E-cigarettes: regulations for consumer products

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