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Global regulations and guidance

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

  1. ema-ema-prepares-for-brexitEMA prepares for Brexit
  2. Re-analysis of data on use of breast cancer medicine Tyverb following treatment with…
  3. European Medicines Agency replies to concerns of Sane Vax Inc.
  4. EU/3/21/2508 - orphan designation for prevention of bronchopulmonary dysplasia
  5. Paediatric Committee (PDCO): 25-28 February 2020
  6. EU/3/17/1909 - orphan designation for treatment of glioma
  7. Promoting high-quality clinical research to develop more and better medicines for children
  8. Global regulators work towards alignment on policy approaches and regulatory flexibility…
  9. EMEA-002510-PIP01-18 - paediatric investigation plan
  10. Order regarding Drugs Inspector's/Technical officer's transfers
  11. MB02 (Bevacizumab Biosimilar Drug)
  12. PSUSA/00010511/202107 - periodic safety update report single assessment
  13. EMEA-001828-PIP01-15-M03 - paediatric investigation plan
  14. EMA to issue electronic certificates for medicines
  15. Evoltra - withdrawal of application for variation to marketing authorisation
  16. EU/3/20/2274 - orphan designation for treatment of haemophilia A
  17. Committee for Orphan Medicinal Products (COMP): 6-8 December 2016
  18. FTC Bans Noncompetes – How Will This Impact HTM?
  19. cfr-21-cfr-812-150-reports21 CFR 812.150: Reports.
  20. EU/3/21/2485 - orphan designation for treatment of myotonic disorders
  21. cdsco-lnp3794LNP3794
  22. EMEA-001689-PIP01-14 - paediatric investigation plan
  23. AAMI News, May 2020, Vol. 55, No. 5
  24. Bovimectin Injection and its associated names - referral
  25. EU/3/17/1834 - orphan designation for treatment of primary ciliary dyskinesia
  26. September 26, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  27. Joint EMA / European Directorate for the Quality of Medicines and Healthcare workshop on…
  28. ema-ztalmyZtalmy
  29. Submission of notarized/apostilled document for import and registration of medical devices…
  30. ema-cpmp-membersCPMP members
  31. PSUSA/00010209/201902 - periodic safety update report single assessment
  32. EU/3/08/592 - orphan designation for treatment of hairy cell leukaemia
  33. EMEA-000550-PIP02-10-M01 - paediatric investigation plan
  34. Orphan designation: research and development
  35. European Medicines Agency Paediatric Working Party meets for last time ahead of creation…
  36. EU/3/16/1714 - orphan designation for treatment of mucopolysaccharidosis type I
  37. EU/3/20/2354 - orphan designation for treatment of microvillus inclusion disease
  38. Clinical data for two more medicines now available online
  39. EMEA-001693-PIP02-20 - paediatric investigation plan
  40. PSUSA/00002357/202008 - periodic safety update report single assessment
  41. Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for…
  42. Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication
  43. ema-colistin-oral-referralColistin oral - referral
  44. EU/3/15/1570 - orphan designation for treatment of nasopharyngeal carcinoma
  45. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 January 2014
  46. Establishment of maximum residue limits for Salmonidae and other fin fish - Scientific…
  47. PSUSA/00010225/201501 - periodic safety update report single assessment
  48. 21 CFR 862.3850: Sulfonamide test system.
  49. EMA recommends approval of Bimervax as a COVID-19 booster vaccine
  50. ema-republic-of-koreaRepublic of Korea
  51. PSUSA/00000314/201605 - periodic safety update report single assessment
  52. 02.06. 2023 G.S.R 409(E) Medical Devices
  53. Amoxycillin Trihydrate IP eq. to Amoxycillin + Potassium Clavulanate diluted IP eq. to…
  54. Joint European Medicines Agency / Heads of Medicines Agencies workshop on requirements for…
  55. Dexamethasone sodium phosphate
  56. ema-meloxidolorMeloxidolor
  57. 21 CFR 880.6350: Battery-powered medical examination light.
  58. cdsco-sar443122SAR443122
  59. ema-abp-710ABP 710
  60. European Medicines Agency statement following seizure of Avandamet tablets by US Food and…
  61. Seasonal influenza vaccines - quality module
  62. HTM Retention: Avoiding Burnout, Payout, and the Great Resignation
  63. EU/3/13/1126 - orphan designation for treatment of non-dystrophic myotonia
  64. EU/3/04/248 - orphan designation for treatment of multiple myeloma
  65. Metabolic and cardiovascular complications of antiretroviral combination therapy in…
  66. European Medicines Agency Human Scientific Committees' Working Parties with Patients' and…
  67. "RAQA 4.0" is Now! Artificial Intelligence Can Help
  68. EMEA-000440-PIP02-11-M05 - paediatric investigation plan
  69. 21 CFR 895.105: Electrical stimulation devices for self-injurious or aggressive behavior.
  70. ICH E2E Pharmacovigilance planning (Pvp) - Scientific guideline
  71. Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022
  72. Notification Fees for Great Britain and Northern Ireland
  73. Draft Guidance for Industry on Fixed Dose Combinations
  74. Gregory Herr: HTM Must Rethink Its Role to Thrive in Modern Healthcare
  75. 21 CFR 12.26: Modification or revocation of regulation or order.
  76. Vildagliptin + Pioglitazone Hydrochloride IP eq. to Pioglitazone uncoated tabletsPhase…
  77. ema-viani-evohaler-referralViani Evohaler - referral
  78. ema-byfavoByfavo
  79. 21 CFR 866.5910: Quality control material for cystic fibrosis nucleic acid assays.
  80. PIC/S Work Plan for 2022
  81. Clinical investigation of medicines for the treatment of Alzheimer's disease - Scientific…
  82. GL-07-R2 Guidelines Risk Classification SAMD-CDSS (2025 Jul) PUB
  83. ema-azilectAzilect
  84. Global public meeting on draft ICH guideline on clinical trials
  85. Proteq West Nile - opinion on variation to marketing authorisation
  86. EU/3/23/2811 - orphan designation for treatment of ovarian cancer
  87. TNF Blockers - Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in…
  88. 21 CFR 862.2560: Fluorometer for clinical use.
  89. EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made…
  90. Questions and answers: Article 29(4) referral procedures
  91. EU/3/05/284 - orphan designation for prevention of radiation proctitis
  92. ema-revitacamRevitaCAM
  93. Clinical Trials Regulations enforcement provisions
  94. Good distribution practice
  95. EMEA-001121-PIP01-10 - paediatric investigation plan
  96. European Medicines Agency recommends withdrawal of medicinal products containing…
  97. EU/3/14/1399 - orphan designation for treatment of amyotrophic lateral sclerosis
  98. PSUSA/00002454/202009 - periodic safety update report single assessment
  99. PSUSA/00000050/202105 - periodic safety update report single assessment
  100. EU/3/14/1281 - orphan designation for treatment of cystic fibrosis
  101. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 December 2016
  102. Revision of "Points to consider for application for approval of drugs to be administered…
  103. EU/3/21/2426 - orphan designation for treatment of amyotrophic lateral sclerosis
  104. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  105. 21 CFR 884.2620: Fetal electroencephalographic monitor.
  106. 21 CFR 870.4390: Cardiopulmonary bypass pump tubing.
  107. Cefepime 2gm and Enmetazobactam 500mg Dry Powder for Injection
  108. EU/3/09/640 - orphan designation for treatment of haemophilia B
  109. EU/3/14/1237 - orphan designation for diagnosis of gastro-entero-pancreatic neuroendocrine…
  110. 21 CFR 886.4670: Phacofragmentation system.
  111. EU/3/22/2591 - orphan designation for treatment of tenosynovial giant cell tumour…
  112. EMEA-001291-PIP01-12 - paediatric investigation plan
  113. EMEA-001911-PIP01-15-M04 - paediatric investigation plan
  114. Referral procedures: Regulatory and procedural guidance
  115. Preparation of a Quality System Dossier (GUIDE-MQA-019)
  116. Inductos to be suspended in the EU
  117. Getting involved in EMA activities as a patient, consumer or career
  118. EMEA-001147-PIP01-11-M07 - paediatric investigation plan
  119. European Medicines Agency's 2009 budget approved
  120. 21 CFR 814.110: New indications for use.
  121. Common issues identified during clinical trial applications: Common issues: Validation
  122. 21 CFR 16.42: Presiding officer.
  123. Chamomilla containing herbal medicinal products - Scientific guideline
  124. EU/3/22/2705 - orphan designation for treatment of myelofibrosis
  125. Pramipexole dihydrochloride monohydrate - paediatric investigation plan
  126. cdsco-lumateperonedLumateperoned
  127. Get to Know the AAMI Standards Team: Hae Choe, director
  128. Announcement of the National Medical Products Administration on Issuing Measures to…
  129. Pediatric Medical Device Pitch Competition Offers $150K in Grants to Spur Innovation
  130. ICH / Global Co-operation Group Association of Southeast Asian Nations workshop: ICH Q5C…
  131. Committee for Advanced Therapies (CAT): 9-10 December 2010
  132. cfr-21-cfr-16-1-scope21 CFR 16.1: Scope.
  133. Biphasic Insulin Aspart Injection (30/70) IP 100IU/mL (30% as soluble Insulin Aspart & 70%…
  134. PSUSA/00010815/202207 - periodic safety update report single assessment
  135. ACT EU PA08 multi-stakeholder methodology workshop
  136. EMEA-001120-PIP01-10 - paediatric investigation plan
  137. 21 CFR 1.633: How will FDA monitor recognized accreditation bodies?
  138. EMEA-000020-PIP01-07-M05 - paediatric investigation plan
  139. Precautionary measures to address potential risk of neurodevelopmental disorders in…
  140. EU/3/02/123 - orphan designation for treatment of steroid resistant graft versus host…
  141. EMEA-001481-PIP01-13-M04 - paediatric investigation plan
  142. cdsco-denosumabrdnaDenosumabrdna
  143. GN-13-R2 Guidance on the Risk Classification of General Medical Devices [ARCHIVED on 25…
  144. EMEA-000830-PIP02-10-M02 - paediatric investigation plan
  145. Committee for Advanced Therapies (CAT): 7-9 December 2022
  146. Committee for Orphan Medicinal Products (COMP): 10-12 September 2024
  147. Management Board delays formal adoption of European Medicines Agency publication of…
  148. ema-news-and-eventsNews and events
  149. ema-opsiriaOpsiria
  150. EMEA-002054-PIP03-20-M02 - paediatric investigation plan
  151. 21 CFR 880.6990: Infusion stand.
  152. ema-porcilis-pcv-m-hyo-idPorcilis PCV M Hyo ID
  153. cdsco-regn7999REGN7999
  154. PSUSA/00000536/201604 - periodic safety update report single assessment
  155. Forodesine hydrochloride - paediatric investigation plan
  156. 21 CFR 866.2390: Transport culture medium.
  157. Chapter 6 - Ingredient Guidance Northern Ireland: Chapter 6 - Ingredient Guidance - NI
  158. General Office of the State Council Issued the Key Tasks for Deepening the Reform of the…
  159. PSUSA/00002203/202104 - periodic safety update report single assessment
  160. Computerized Systems in Drug Establishments (2/83)
  161. EMEA-001501-PIP06-20 - paediatric investigation plan
  162. Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting
  163. Report safety concerns with insulin pumps and continuous glucose monitoring equipment
  164. EMEA-000808-PIP01-09-M01 - paediatric investigation plan
  165. 21 CFR 1.601: Who is subject to this subpart?
  166. EMEA-002910-PIP01-20 - paediatric investigation plan
  167. EU/3/14/1289 - orphan designation for treatment of pre-eclampsia
  168. PSUSA/00010271/202307 - periodic safety update report single assessment
  169. EU/3/15/1572 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
  170. cdsco-g-s-r-600-eG.S.R. 600(E)
  171. EU/3/15/1444 - orphan designation for treatment of narcolepsy
  172. Cefepime Zidebactam vs. Meropenem
  173. EU/3/18/2018 - orphan designation for treatment of follicular lymphoma
  174. PSUSA/00010285/202107 - periodic safety update report single assessment
  175. Committee for Herbal Medicinal Products (HMPC): 24-25 November 2010
  176. Drug Alert list for month of November 2022
  177. EU/3/18/2007 - orphan designation for treatment of glycogen storage disease type II…
  178. PSUSA/00001204/201602 - periodic safety update report single assessment
  179. GABAPENTINE ER TABLETS 300MG/600MGCT/SND/03/2024
  180. First electronic product information (ePI) published for selected human medicines
  181. Cosmetics Good Manufacturing Practice Regulations, Cosmetics Good Manufacturing Practice…
  182. Hexal AG withdraws its marketing authorisation application for Ibandronic acid Hexal…
  183. cdsco-sotaterceptSotatercept
  184. ema-pantecta-controlPantecta Control
  185. EU/3/15/1462 - orphan designation for treatment of retinitis pigmentosa
  186. Proposed Australian Approved Name (AAN) application form
  187. Takeda withdraws its marketing authorisation application for Ramelteon
  188. Explanation of Electronic Study Data (Form A)
  189. European Medicines Agency recommends extending use of Nexavar to include treatment of…
  190. PSUSA/00002076/202206 - periodic safety update report single assessment
  191. Olaparib product-specific bioequivalence guidance
  192. cdsco-ocrelizumabOcrelizumab
  193. Problem with Quality of Mammograms at J. Bruce Jacobs M.D., Inc., doing business as…
  194. ema-skysonaSkysona
  195. Organisation of the Dossier
  196. THE NEW DRUGS AND CLINICAL TRIALS RULES, 2019
  197. cdsco-iberdomidebriIberdomidebri
  198. mhra-export-medical-devicesExport medical devices
  199. EMA Management Board – highlights of March 2021 meeting
  200. CMDh endorses new advice to minimise risk of next-morning impaired driving ability and…
  201. Committee for Proprietary Medicinal Products (CPMP) 21st plenary meeting
  202. ema-eu-enlargementEU enlargement
  203. IVD Diagnostic Kit Alert for Comipack ABD
  204. 21 CFR 17.54: Deposit in the Treasury of the United States.
  205. Form MD-7 Specimen proforma for Medical Devices
  206. PSUSA/00010613/201810 - periodic safety update report single assessment
  207. PSUSA/00010488/201805 - periodic safety update report single assessment
  208. Recommendation-NB-MED-2_5_5-1_rev5 Conformity assessment procedures of breast implants
  209. PROPOSAL FOR CREATION OF IT ENABLED SYSTEM
  210. CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited…
  211. PSUSA/00002696/201703 - periodic safety update report single assessment
  212. First European Medicines Agency and Nuclear Medicines Europe bilateral meeting
  213. Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018
  214. EMEA-002447-PIP01-18-M01 - paediatric investigation plan
  215. Second biannual Big Data Steering Group and industry stakeholders meeting 2022
  216. 21 CFR 1.924: What process applies to a petition requesting a waiver?
  217. EudraVigilance training on electronic reporting of ICSRs in the European Economic Area
  218. PSUSA/00010358/202211 - periodic safety update report single assessment
  219. EMA tightens rules on 'revolving door' for committee members and experts
  220. EMEA-000006-PIP02-10 - paediatric investigation plan
  221. Approval of Favipiravir Tablets to Glenmark Pharmaceuticals and Remdesivir Injection to…
  222. EMEA-002560-PIP01-19 - paediatric investigation plan
  223. Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation…
  224. 21 CFR 74.303: FD&C Red No. 3.
  225. EMEA-000265-PIP01-08-M04 - paediatric investigation plan
  226. 21 CFR 870.1650: Angiographic injector and syringe.
  227. Bupropion Hydrochloride IP (as extended release) + Dextromethorphan Hydrobromide IP…
  228. EU/3/13/1148 - orphan designation for treatment of amyotrophic lateral sclerosis
  229. Carbimazole related agranulocytosis - Recommendations for the change in Prescribing…
  230. 21 CFR 70.50: Application of the cancer clause of section 721 of the act.
  231. EU/3/20/2283 - orphan designation for treatment of neonatal encephalopathy
  232. PSUSA/00000997/202110 - periodic safety update report single assessment
  233. ema-palforziaPalforzia
  234. sImeglimin Hydrochloride 500 tablets
  235. Teriflunomide tab 14 mg
  236. Lansoprazol HEXAL 15 mg and 30 mg - referral
  237. ema-ontozryOntozry
  238. FDA Medical Devices Advisory Committee Seeks Panelists
  239. DR_G.S.R. 379 (E) dt_18.06.2013 _Suspension of manufacture, sale, distribution of…
  240. EMEA-002975-PIP01-21 - paediatric investigation plan
  241. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  242. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  243. 21 CFR 17.31: Form, filing, and service of papers.
  244. Rilvegostomig, Tremelimumab
  245. Susan Klacik: A Lifelong Commitment to Sterile Processing and Patient Safety
  246. PSUSA/00000876/201910 - periodic safety update report single assessment
  247. Refusal of orphan designation for prevention of patent ductus arteriosus in premature…
  248. PSUSA/00010326/201907 - periodic safety update report single assessment
  249. cdsco-brazikumabBrazikumab
  250. Addendum to the note for guidance on evaluation of medicinal products indicated for…
  251. ema-truvadaTruvada
  252. 21 CFR 17.2: Maximum penalty amounts.
  253. First treatment for rare metabolic disorder alkaptonuria
  254. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 7-9 December 2010
  255. 21 CFR 830.110: Application for accreditation as an issuing agency.
  256. ema-sortis-referralSortis - referral
  257. EU/3/16/1749 - orphan designation for treatment of soft tissue sarcoma
  258. EU/3/05/328 - orphan designation for treatment of peripheral T-cell lymphoma (nodal, other…
  259. EU/3/17/1920 - orphan designation for treatment of West syndrome
  260. 21 CFR 870.2850: Extravascular blood pressure transducer.
  261. Bright Idea: Automated Emails for Monitoring Virtual Machines
  262. Insulin Aspart Injection (100 IU/mL)
  263. 21 CFR 807.97: Misbranding by reference to premarket notification.
  264. EU/3/11/878) - orphan designation for treatment of acute lymphoblastic leukaemia
  265. EMEA-002594-PIP03-21 - paediatric investigation plan
  266. PSUSA/00000284/202211 - periodic safety update report single assessment
  267. Guidance on drug establishment licences (GUI-0002)
  268. Adjuvants in vaccines for human use - Scientific guideline
  269. High Purity Water Systems (7/93)
  270. EU/3/20/2264 - orphan designation for treatment of autosomal recessive congenital…
  271. Sodium Fusidate eq. To Fusidic acid 2% w/w (Sofinox gel)
  272. Learning from Experience: A Conversation with Marjorie Wall
  273. Availability of medicines during COVID-19
  274. Caution When Using Robotically-Assisted Surgical Devices in Women's Health including…
  275. 21 CFR 1.910: What training requirements apply to carriers engaged in transportation…
  276. European Medicines Agency closed 9-11 May 2018
  277. European Medicines Agency workshop on modelling in paediatric medicines
  278. ema-sutentSutent
  279. cdsco-dec-12-2014-gsr-889-eDec 12 2014 GSR 889(E)
  280. European Medicines Agency publishes report on sales of veterinary antimicrobials in 25…
  281. GVK Biosciences review: some Member States suspend marketing authorisations for concerned…
  282. Focus group meeting of Committee for Medicinal Products for Veterinary Use experts and…
  283. Committee for Medicinal Products for Human Use (CHMP): 19-22 September 2011
  284. ema-trizivirTrizivir
  285. ema-cardiostad-referralCardiostad - referral
  286. Clindamycin benzoyal peroxide
  287. EMEA-001510-PIP01-13 - paediatric investigation plan
  288. First listen-and-learn focus group meeting of the Quality Innovation Group
  289. Semaglutide IGlar SGT2i
  290. Using Brain Science, AAMI Will Change How Manufacturers Understand Standards
  291. ema-imatinib-koanaaImatinib Koanaa
  292. Miscellaneous Food Products - Vol. 1 (5/95)
  293. PSUSA/00001388/201703 - periodic safety update report single assessment
  294. Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 December 2014
  295. cdsco-faricimab-ro686746Faricimab (RO686746
  296. 21 CFR 1.664: When would FDA withdraw accreditation?
  297. 21 CFR 10.85: Advisory opinions.
  298. EMEA-003069-PIP01-21 - paediatric investigation plan
  299. EU/3/19/2188 - orphan designation for treatment of neuroblastoma
  300. 21 CFR 861.36: Effective dates.
  301. Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patient…
  302. ema-daurismoDaurismo
  303. Tramadol / paracetamol - paediatric investigation plan
  304. Working with stakeholders to improve availability of medicines in the EU
  305. Guidance 20: Radiopharmaceuticals
  306. ema-ebilfuminEbilfumin
  307. EU/3/13/1142 - orphan designation for treatment of retinitis pigmentosa
  308. Pemetrexed Fresenius Kabi
  309. EMA workshop on prevention of product shortages due to manufacturing and quality problems…
  310. CPC Central Committee and the State Council Issued Opinions on Facilitating the…
  311. Are You on the Standards Menu, or Have You Joined AAMI at the Table?
  312. 21 CFR 868.1100: Arterial blood sampling kit.
  313. PSUSA/00002036/202111 - periodic safety update report single assessment
  314. cdsco-topical-1-akp-11Topical 1% AKP-11
  315. Notifying Health Canada of Foreign Actions - Guidance Document for Industry
  316. PSUSA/00002951/201701 - periodic safety update report single assessment
  317. CMS, FCC Push for Permanent Telehealth Expansion
  318. Good Machine Learning Practice for Medical Device Development: Guiding Principles
  319. EMEA-000857-PIP01-10-M01 - paediatric investigation plan
  320. Zoledronic acid Teva Generics
  321. Committee for Proprietary Medicinal Products (CPMP) 33rd plenary meeting
  322. EU/3/11/931 - orphan designation for adjunctive treatment to cytotoxic therapy in acute…
  323. ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for…
  324. First EMA regular press briefing on COVID-19
  325. Team-NB-Position-paper-new MDR
  326. 21 CFR 862.1545: Parathyroid hormone test system.
  327. EMEA-001772-PIP01-15 - paediatric investigation plan
  328. Substance and product data management services
  329. EU/3/22/2622 - orphan designation for treatment of osteogenesis imperfecta
  330. PIC/S Aide Memoire on Remote Assessment
  331. EMEA-000894-PIP01-10 - paediatric investigation plan
  332. 21 CFR 882.4190: Clip forming/cutting instrument.
  333. Sanofi-Aventis withdraws marketing authorisation application for MULTAQ
  334. 21 CFR 17.7: Service of complaint.
  335. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Teneligliptin Hydrobromide…
  336. Glimepiride IP + Metformin Hydrochloride IP (As sustained release) + Sitagliptin Phosphate…
  337. Sixth annual workshop of the European Network of Paediatric Research at the European…
  338. PSUSA/00001259/202110 - periodic safety update report single assessment
  339. Questions and answers (Q&A) on CoDx and corresponding therapeutic products
  340. EMEA-001012-PIP01-10-M01 - paediatric investigation plan
  341. Drug Alert for the Month of March 2024
  342. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations…
  343. Paediatric Committee (PDCO): 21-24 February 2023
  344. EU/3/15/1564 - orphan designation for treatment of glioma
  345. Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for…
  346. EMEA-001495-PIP02-21 - paediatric investigation plan
  347. PSUSA/00001721/202009 - periodic safety update report single assessment
  348. Radiotherapy Planning Software Approved for Marketing
  349. 21 CFR 1.512: What FSVP may I have if I am a very small importer or I am importing certain…
  350. DR_G.S.R. 677(E) dt_15.09.2009_Restriction for Oseltamivir Phosphate and Zanamivir
  351. European Medicines Agency closed 25 August 2014
  352. 21 CFR 862.1020: Acid phosphatase (total or prostatic) test system.
  353. A vector vaccine for the prevention of the coronavirus infection
  354. Ecomectin 18.7mg/g Oral Paste for Horses - referral
  355. PSUSA/00001242/202203 - periodic safety update report single assessment
  356. Refusal of orphan designation for treatment of status epilepticus
  357. PSUSA/00000405/201901 - periodic safety update report single assessment
  358. 21 CFR 862.1355: Integrated continuous glucose monitoring system.
  359. EMEA-001724-PIP01-14 - paediatric investigation plan
  360. EMEA-000352-PIP01-08-M01 - paediatric investigation plan
  361. 21 CFR 876.5540: Blood access device and accessories.
  362. Annex A2 Guidance on Process Validation Scheme for Aseptically Processed Products
  363. EU/3/24/2890 - orphan designation for treatment of ovarian cancer
  364. Phaseoli fructus (sine semine) - herbal medicinal product
  365. Partial revision of "Planning of the Pediatric Drug Development Program during Development…
  366. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 September 2024
  367. 21 CFR 874.3950: Transcutaneous air conduction hearing aid system.
  368. PSUSA/00002492/201909 - periodic safety update report single assessment
  369. 21 CFR 868.2350: Gas calibration flowmeter.
  370. GBCA - New recommendations for using gadolinium-based contrast agents in patients with…
  371. March 17, 2017: Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices…
  372. Metoclopramide-containing medicines - referral
  373. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  374. Investigation of manufacturing processes for plasma-derived medicinal products with regard…
  375. Appendix 7 Points to Consider for Singapore Labelling
  376. October 17 2016 GSR 983(E)
  377. PSUSA/00002152/202202 - periodic safety update report single assessment
  378. Endpoints in clinical studies with haematopoietic growth factors for mobilisation of…
  379. AAMI Standards Monitor Digest: Highlights for the standards community
  380. First treatment for rare disease characterised by high levels of triglycerides in blood
  381. ema-temozolomide-sunTemozolomide Sun
  382. Hepatitis B and C viruses IVD self-tests
  383. EU/3/22/2607 - orphan designation for treatment of Fabry disease
  384. Strimvelis - direct healthcare professional communication (DHPC)
  385. EU/3/18/2078 - orphan designation for treatment of multiple myeloma
  386. 21 CFR 5.1110: FDA public information offices.
  387. PSUSA/00000076/201712 - periodic safety update report single assessment
  388. 21 CFR 1.96: Granting of authorization to relabel and recondition.
  389. PSUSA/00002213/202205 - periodic safety update report single assessment
  390. 21 CFR 1.1405: Under what circumstances will FDA waive one or more of the requirements of…
  391. 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (TT/DT)
  392. EU/3/09/646 - orphan designation for treatment of amyotrophic lateral sclerosis
  393. Multi-sponsor investigator-initiated trials
  394. SIAMED 2000: speeding up drug regulation in Europe
  395. AS F0005.1.001: Assessment Program Flowchart
  396. PSUSA/00002101/201703 - periodic safety update report single assessment
  397. Calendulae herba - herbal medicinal product
  398. Committee for medicinal products for veterinary use: Meeting of 18 to 20 April 2006
  399. Accelerating stakeholder collaboration to enhance the clinical trials environment in the…
  400. EMEA-002974-PIP01-21 - paediatric investigation plan
  401. ema-kivexaKivexa
  402. 21 CFR 876.2100: Pressure ulcer management tool.
  403. Requirements for demonstrating therapeutic equivalence between orally inhaled products…
  404. Submission of ppt via E-Vartalap Sugam Portal
  405. "(i) Delafloxacin Tablets 450 mg (ii) Delafloxacin for Injection 300 mg/vial"
  406. 21 CFR 876.5600: Sorbent regenerated dialysate delivery system for hemodialysis.
  407. Guidance Document - Fees for the Review of Medical Device Licence Applications
  408. cdsco-feibaFEIBA
  409. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June…
  410. Expert meeting on clinical investigation of new drugs for the treatment of chronic…
  411. Clinical investigations: statistical considerations
  412. EMEA-000966-PIP01-10 - paediatric investigation plan
  413. Point of care testing with blood glucose meters: leaflet
  414. General: Regulatory and procedural guidance
  415. Registration and Labelling requirements of Medical Devices
  416. EMEA-000085-PIP01-07 - paediatric investigation plan
  417. Frequently Asked Questions - Health Products and Food Branch Inspectorate
  418. 21 CFR 882.4325: Cranial drill handpiece (brace).
  419. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF SEP-2017
  420. EMEA-002181-PIP01-17 - paediatric investigation plan
  421. No evidence that Fluad vaccine caused deaths in Italy
  422. ema-clynavClynav
  423. Trends in initial evaluation of veterinary medicines by EMA in 2013
  424. Decentralised manufacture: Clinical Trial Authorisation (CTA) and Good Clinical Practice…
  425. ema-solensiaSolensia
  426. 21 CFR 870.2345: Electrocardiograph software for over-the-counter use.
  427. ema-actrapidActrapid
  428. Rise in applications for medicines in 2006, concerns over budget situation for 2007 and…
  429. PSUSA/00010486/202301 - periodic safety update report single assessment
  430. European Medicines Agency recommends interim measures for Pandemrix
  431. List of approved veterinary vaccines
  432. ema-viani-diskus-referralViani Diskus - referral
  433. 21 CFR 20.60: Applicability of exemptions.
  434. Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
  435. Decision of CFDA on Adjusting Approval Procedures for Certain Administrative Examination…
  436. EMEA-000901-PIP02-10 - paediatric investigation plan
  437. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18…
  438. ema-homeopathic-workshopHomeopathic Workshop
  439. Sennae folium - herbal medicinal product
  440. EU/3/13/1173 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
  441. PSUSA/00000384/202010 - periodic safety update report single assessment
  442. PSUSA/00002555/201711 - periodic safety update report single assessment
  443. Notice and additional set of FAQ Cosmetics division dated 06.08.2021
  444. Australian Dental Sector Working Group, Meeting statement, Meeting 3, 27 August 2021
  445. Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical…
  446. PSUSA/00000911/202103 - periodic safety update report single assessment
  447. Donald Armstrong: Transitions Are Exciting—and Scary
  448. 21 CFR 1.1380: What process applies to a petition requesting modified requirements or an…
  449. Benidipine HCl Chlorthalidone IPTelmisartan IP Film coated bilayered tablets
  450. In Memoriam: Ruey Dempsey
  451. ema-acticamActicam
  452. UPDATE on Life-Threatening Injuries Associated with the ShoulderFlex Massager: FDA Safety…
  453. ema-dectovaDectova
  454. Report available on activities on medicines for children during 2011
  455. PSUSA/00010288/201805 - periodic safety update report single assessment
  456. Committee for Orphan Medicinal Products - June 2007 Meeting
  457. EU/3/18/1977 - orphan designation for treatment of fragile X syndrome
  458. ema-guidance-documentsGuidance documents
  459. cfr-21-cfr-821-1-scope21 CFR 821.1: Scope.
  460. Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety…
  461. ema-chinaChina
  462. Innovative Patient Room Technology Improves Clinical Safety
  463. Team-NB MD Sector Survey PressRelease 20200505
  464. 21 CFR 866.3020: Adenovirus serological reagents.
  465. 21 CFR 866.4540: Immunonephelometer equipment.
  466. ema-parallel-distributionParallel distribution
  467. EMEA-001687-PIP01-14-M06 - paediatric investigation plan
  468. 21 CFR 892.2070: Medical image analyzer.
  469. Mike Busdicker: Building an In-House Program Doesn’t Mean Cutting Ties with Service…
  470. Innovative Product Cryoablation Apparatus Approved for Marketing
  471. Tenth industry stakeholder platform on research and development support
  472. Sodium Zirconium Cyclosilicate
  473. Paediatric Committee (PDCO): 23-26 June 2026
  474. 21 CFR 814.42: Filing a PMA.
  475. ema-genotropin-referralGenotropin - referral
  476. EU/3/14/1346 - orphan designation for treatment of short bowel syndrome
  477. FDA requires expanded labeling about weight loss risk in patients younger than 6 years…
  478. Science, Medicines, Health: Patients at the heart of future innovation
  479. ema-switzerlandSwitzerland
  480. Maximum shelf-life for sterile products for human use after first opening or following…
  481. PSUSA/00001839/201910 - periodic safety update report single assessment
  482. FDA Recognizes Cybersecurity and Data Security AAMI Standards for Health Technology
  483. HMPC: meeting archive 2012-2014
  484. FDA Warns that Strong Magnets May Affect Pacemakers and Other Implanted Medical Devices
  485. AAMI Roundtable on AI in Healthcare
  486. Committee for Orphan Medicinal Products (COMP) elects new chair
  487. DR_G.S.R. 658(E) dt_19.10.1993_ Rule 49_Qulaification of Inspectors
  488. Joint Biologics Working Party / Quality Working Party workshop with stakeholders in…
  489. ema-cozaar-referralCozaar - referral
  490. ema-zereneZerene
  491. Industry stakeholder platform on the operation of the centralised procedure
  492. PSUSA/00000295/201712 - periodic safety update report single assessment
  493. 21 CFR 860.200: Purpose and applicability.
  494. FDA Drug Safety Communication: Ongoing safety review of the angiotensin receptor blockers…
  495. Scientific and regulatory meetings procedures
  496. VICH GL9 Good clinical practices - Scientific guideline
  497. EU/3/08/582 - orphan designation for treatment of mucopolysaccharidosis, type IIIA…
  498. EMEA-001247-PIP01-11 - paediatric investigation plan
  499. EU/3/20/2331 - orphan designation for treatment of multiple myeloma
  500. 21 CFR 888.3640: Shoulder joint metal/metal or metal/polymer constrained cemented…
  501. EU/3/21/2567 - orphan designation for treatment of pre-eclampsia
  502. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  503. EU/3/19/2200 - orphan designation for treatment of nontuberculous mycobacterial lung…
  504. EMEA-001071-PIP03-14-M01 - paediatric investigation plan
  505. ema-emplicitiEmpliciti
  506. Medical device incident reporting (MDIR) guide
  507. Gam COVID Vac Combined vector vaccine component one and component two
  508. Drug Alert list for month of August 2023
  509. Ipilimumab (r-DNAorigin) Injection, 50mg/10mL(5mg/mL)
  510. First Stakeholders National Consultation meeting of SNCM on 25th_july 2019 at ICMR New…
  511. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  512. EU/3/21/2410 - orphan designation for treatment of medullary thyroid carcinoma
  513. PSUSA/00002217/201802 - periodic safety update report single assessment
  514. Q&A Regarding Notification on Electronic Study Data
  515. Drug Alert for the Month of January 2024
  516. ICH Q9 Quality risk management - Scientific guideline
  517. PSUSA/00010364/201509 - periodic safety update report single assessment
  518. PSUSA/00001349/201712 - periodic safety update report single assessment
  519. 510(k)s for Sterile Devices: FDA Releases 2024 Final Guidance
  520. Notice regarding Evaluation of Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which…
  521. EMEA-001578-PIP01-13 - paediatric investigation plan
  522. ema-artesunate-amivasArtesunate Amivas
  523. eXtended EudraVigilance Medicinal Product Dictionary training course
  524. 21 CFR 892.1970: Radiographic ECG/respirator synchronizer.
  525. Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety…
  526. NSQ ALERT FOR THE MONTH OF Feb-2025
  527. How incidents with medicines are managed in the EU – a ten-year analysis
  528. JETSTREAM™ PVCN100 Console and JETSTREAM™ Over-The-Wire Atherectomy Catheter Approved for…
  529. Requirement of process validation report for permission to conduct Clinical trial BA-BE…
  530. ema-lysodrenLysodren
  531. EU/3/16/1762 - orphan designation for treatment of paroxysmal nocturnal haemoglobinuria
  532. Medical devices: software applications (apps)
  533. European Medicines Agency responds to criticism of staff member
  534. 21 CFR 82.1602: D&C Violet No. 2.
  535. Details of IEC/GSTN code of all the beneficiaries (Stakeholders/importers/exporters…
  536. Rose Seavey: Key to Effective Sterilization Lies in Clear, Practical Guidance
  537. GN 21-R4.3 Guidance on Change Notification for Registered Medical Devices [ARCHIVED on 20…
  538. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July…
  539. Committee for Advanced Therapies (CAT): 17-19 June 2020
  540. Information on suspected side effects of nationally authorised medicines now available…
  541. Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man
  542. 21 CFR 880.6910: Wheeled stretcher.
  543. ema-vorinostat-msdVorinostat MSD
  544. Implementation and effective use of RTI-MIS Portal (e-Portal) for disposal of all RTI…
  545. Guidance for industry to prevent and mitigate medicine shortages
  546. Extraordinary meeting to finalise review of Anorectic Agents
  547. European Medicines Agency recommends new malaria treatment for approval
  548. Ken Maddock: Great Potential for Benchmarking Tool
  549. EMEA-001216-PIP01-12 - paediatric investigation plan
  550. 21 CFR 1.505: What evaluation for foreign supplier approval and verification must I…
  551. PSUSA/00000771/202112 - periodic safety update report single assessment
  552. 2018.07.11_Draft GSR 629 (E)Information to be uploaded on SUGAM by license
  553. EMEA-001425-PIP01-13-M05 - paediatric investigation plan
  554. 21 CFR 14.84: Nominations and selection of nonvoting members of standing technical…
  555. EMEA-002562-PIP01-19 - paediatric investigation plan
  556. EU/3/07/466 - orphan designation for treatment of orthostatic hypotension in patients with…
  557. Psychedelics and their therapeutic use - Linkedin Live interview with Steffen Thirstrup…
  558. PSUSA/00001756/201410 - periodic safety update report single assessment
  559. dvisory to follow the Apprentices Act, 1961-Regarding
  560. Avinash Konkani: Noise in Hospital Intensive Care Units
  561. FDA Recommends Transition Away from Processing Single-Use Respirators
  562. ema-ikervisIkervis
  563. EU/3/09/686 - orphan designation for treatment of hepatocellular carcinoma
  564. Safety Working Party (SWP-V)
  565. La FDA advierte a los proveedores de atención médica que no deben basarse únicamente en…
  566. Progress in the area of antimicrobial resistance – veterinary medicines
  567. 21 CFR 864.6400: Hematocrit measuring device.
  568. European Medicines Agency welcomes publication of the Clinical Trials Regulation
  569. Procurement activities 2017
  570. Rabies Vaccine, Human I.P. (Purified Chick Embryo Cell Culture Rabies Vaccine) [PCECVPM]
  571. ema-clevorClevor
  572. cdsco-iptacopaniptacopan
  573. EMEA-002544-PIP01-18-M02 - paediatric investigation plan
  574. Questions and answers: Article 35 veterinary referral procedures
  575. EU/3/01/054 - orphan designation for treatment of meconium aspiration syndrome
  576. Reflection paper on nucleic acids (siRNA)-loaded nanotechnology-based drug products
  577. Committee for Herbal Medicinal Products (HMPC): 16-18 November 2026
  578. EU/3/14/1377 - orphan designation for treatment of glioma
  579. FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet)…
  580. Use of methyl- and propylparaben as excipients in human medicinal products for oral use…
  581. PSUSA/00000794/202209 - periodic safety update report single assessment
  582. EMEA-001961-PIP01-16 - paediatric investigation plan
  583. cdsco-es16001ES16001
  584. Committee for Orphan Medicinal Products: April 2006 meeting
  585. PSUSA/00001404/202003 - periodic safety update report single assessment
  586. cfr-21-cfr-73-2030-annatto21 CFR 73.2030: Annatto.
  587. EMEA-003260-PIP02-23 - paediatric investigation plan
  588. 29th meeting of the committee for veterinary medicinal products
  589. 21 CFR 872.3670: Resin impression tray material.
  590. Surrender of cosmetic Registration Certificate No. RC/COS-003938 dated 23.08.2023
  591. EMA and heads of national competent authorities discuss consequences of Brexit
  592. EU/3/23/2765 - orphan designation for treatment of gastrointestinal stromal tumours
  593. EMEA-001418-PIP02-15-M03 - paediatric investigation plan
  594. Regulatory information - Transitioning to mandatory use of electronic application forms
  595. PSUSA/00010292/202303 - periodic safety update report single assessment
  596. DR_G.S.R. 45(E) dt_24.01.2011_Amendment Rule 122E_Addition of Vaccines and r-DNA
  597. Medical Device Act Enforcement Regulation
  598. 2025.09.23_S.O. 4338(E)_prohibit the import, manufacture, sale and distribution of certain…
  599. Guide to Fees for Human Products
  600. 21 CFR 803.1: What does this part cover?
  601. Details of IECGSTN code of all the beneficiaries (Stakeholders Importers Exporters Customs…
  602. FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease…
  603. Registration and notification guide for donor sperm and ova establishments (GUI-0128)
  604. cdsco-ino-4800INO-4800
  605. 21 CFR 862.3270: Codeine test system.
  606. EMEA-002391-PIP02-19 - paediatric investigation plan
  607. 21 CFR 864.9175: Automated blood grouping and antibody test system.
  608. ema-luveniqLuveniq
  609. EMA business hours over King's Day holiday
  610. cdsco-acalabrutinibzAcalabrutinibz
  611. April 13th 2017 GSR 367(E)
  612. EU/3/13/1127 - orphan designation for treatment of B-cell acute lymphoblastic leukaemia
  613. EMEA-001784-PIP01-15-M04 - paediatric investigation plan
  614. EMEA-002817-PIP04-20 - paediatric investigation plan
  615. ICH guideline E19 on a selective approach to safety data collection in specific late-stage…
  616. 21 CFR 860.133: Procedures when the Commissioner initiates a proceeding to require…
  617. Polymyxin-containing medicines - referral
  618. European Medicines Agency closed 16 May 2016
  619. cfr-21-cfr-58-1-scope21 CFR 58.1: Scope.
  620. Paediatric Committee (PDCO): 19-22 April 2022
  621. Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 1
  622. 21 CFR 866.5640: Infectious mononucleosis immunological test system.
  623. EMEA-000118-PIP03-15 - paediatric investigation plan
  624. EU/3/02/116 - orphan designation for treatment of renal-cell carcinoma
  625. Allii cepae bulbus - herbal medicinal product
  626. Regulatory information - Adjusted fees for applications to European Medicines Agency from…
  627. Research on Sterility and Infection Control Ramps Up
  628. Polivy - direct healthcare professional communication (DHPC)
  629. Development of a reflection paper on modern manufacturing techniques used for herbal…
  630. EU/3/15/1494 - orphan designation for treatment of diffuse large B-cell lymphoma
  631. Regulatory information - EMA announces next steps for the maintenance of information on…
  632. 21 CFR 73.1647: Copper powder.
  633. cdsco-druvalumabDruvalumab
  634. EU/3/11/886 - orphan designation for treatment of post-polycythaemia vera myelofibrosis
  635. Committee for Advanced Therapies (CAT) meeting with interested parties, May 2023
  636. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 May 2025
  637. ema-sondelbaySondelbay
  638. Andy Armenta: A New Discipline on the Horizon?
  639. EMEA-002258-PIP01-17 - paediatric investigation plan
  640. Human Insulin Short acting
  641. Common issues identified during clinical trial applications: Common issues: Pharmaceutical
  642. ema-vectormune-ndVectormune ND
  643. PSUSA/00010558/202006 - periodic safety update report single assessment
  644. Estradiol-containing (0.01% w/w) medicinal products for topical use - referral
  645. 21 CFR 878.4015: Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC)…
  646. European Medicines Agency gives first positive opinion for paediatric-use marketing…
  647. Committee for Medicinal Products for Human Use (CHMP): 12-15 November 2018
  648. Orencia - withdrawal of application for variation to marketing authorisation
  649. 21 CFR 26.64: Transitional arrangements.
  650. EU/3/15/1459 - orphan designation for treatment of amyotrophic lateral sclerosis
  651. EMEA-000319-PIP01-08-M03 - paediatric investigation plan
  652. 21 CFR 1.280: How must you submit prior notice?
  653. EU/3/22/2659 - orphan designation for treatment of autoimmune haemolytic anaemia
  654. ema-ivabradine-accordIvabradine Accord
  655. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  656. Wil Vargas: Tackling the Tower of Babel with Health Software Defects
  657. EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
  658. European Medicines Agency revises three guidance documents to include orphan-related…
  659. Guidance for HCSA Licensees and Telemedicine Service Providers on Advertisement Controls…
  660. PSUSA/00010226/201605 - periodic safety update report single assessment
  661. PSUSA/00001711/201807 - periodic safety update report single assessment
  662. cdsco-avt16-inn-vedolizumabAVT16 (INN Vedolizumab)
  663. SME workshop on quality of medicines takes place this Friday
  664. EMA Account Management training webinar
  665. EU/3/15/1605 - orphan designation for treatment of congenital alpha-1 antitrypsin…
  666. ema-vectormune-fp-iltVectormune FP ILT
  667. EU/3/02/094 - orphan designation for treatment of renal-cell carcinoma
  668. ema-eluciremElucirem
  669. 21 CFR 12.85: Disclosure of data and information by the participants.
  670. FDA Issues Industry Final Guidance on Requesting Nonbinding Feedback
  671. 21 CFR 884.4350: Fetal head elevator.
  672. ema-paxlovidPaxlovid
  673. PSUSA/00010491/202004 - periodic safety update report single assessment
  674. EU/3/14/1276 - orphan designation for treatment of mucormycosis
  675. ema-imprida-hctImprida HCT
  676. Financial management and budgetary reporting
  677. EMEA-002059-PIP02-19-M01 - paediatric investigation plan
  678. EMEA-003059-PIP01-21 - paediatric investigation plan
  679. Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and…
  680. 21 CFR 876.1080: Gastroenterology-urology accessories to a biopsy instrument.
  681. EU/3/14/1272 - orphan designation for treatment of epidermolysis bullosa
  682. EU/3/06/387 - orphan designation for treatment of Pseudomonas aeruginosa lung infection in…
  683. ema-turvelTurvel
  684. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL-2023
  685. ema-abevmyAbevmy
  686. Insulin Injection,Biphasic Isophane Ph.Eur 100IU/ml
  687. 21 CFR 73.1070: Calcium carbonate.
  688. Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
  689. Executive Steering Group on Shortages of Medical Devices
  690. Sodium Hyaluronate BP + Chontroitin Sulfate Sodium BP + Poloxamer IP per 10ml oral liquid…
  691. 21 CFR 878.4320: Removable skin clip.
  692. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  693. cdsco-tirzepatideTirzepatide
  694. 21 CFR 880.2910: Clinical electronic thermometer.
  695. European Medicines Agency recommends approval of 44 medicines for human use and six…
  696. Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety…
  697. Mate folium - herbal medicinal product
  698. Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (SI 538/2007)…
  699. EMEA-002389-PIP01-18 - paediatric investigation plan
  700. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - August 2015
  701. Cisti cretici herba - herbal medicinal product
  702. Committee for Medicinal Products for Human Use (CHMP): 16-19 April 2012
  703. PSUSA/00010288/202211 - periodic safety update report single assessment
  704. EMEA-002559-PIP01-19 - paediatric investigation plan
  705. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 March 2010
  706. Management Board meeting: 11 - 12 December 2024
  707. UPDATED MEETING DATE AND PUBLIC PARTICIPATION INFORMATION: May 5, 2025 Joint Meeting of…
  708. Pregabalin IP (as granules) + Duloxetine hydrochloride IP+ Methylcobalamin IP (as…
  709. 2013.23.12_S.O. 3793(E)_Omissions of Sterile Word in section 3 (b) (iv)_amendment in…
  710. cdsco-pnb001PNB001
  711. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28…
  712. Quarterly system demo - Q1 2022
  713. Regulations for Management of Medical Device Safety Surveillance, Items that shall be…
  714. 21 CFR 860.134: Procedures for reclassification of “postamendments devices” under section…
  715. FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
  716. Esmprazole Dual release Gastro Resistant Tablets 80 mg
  717. PSUSA/00001124/201711 - periodic safety update report single assessment
  718. 21 CFR 866.5765: Retinol-binding protein immunological test system.
  719. Dextromethorphan Hydrobromide IP 10mg + Phenylephrine Hydrochloride IP 5mg per 5mL Syrup
  720. PSUSA/00001848/202212 - periodic safety update report single assessment
  721. European Medicines Agency recommends approval of new medicine for Cushing's disease
  722. Aide Memoire on Inspection of Quality Control Laboratories
  723. Sitagliptin / Metformin hydrochloride Accord
  724. Lorazepam Macure 4 mg/ml, solution for injection - referral
  725. Use of fumigants - Scientific guideline
  726. PSUSA/00001701/201801 - periodic safety update report single assessment
  727. Studies assessed by the European Medicines Agency indicate no increased risk of developing…
  728. PSUSA/00001660/201501 - periodic safety update report single assessment
  729. 21 CFR 882.1900: Evoked response auditory stimulator.
  730. PSUSA/00003167/202212 - periodic safety update report single assessment
  731. Noise Control Mufflers for Bleeders on Retorts and Sterilizers
  732. cdsco-bilastine-20-mgBilastine 20 mg
  733. Financial advantages of SME status
  734. EU/3/16/1766 - orphan designation for treatment of diffuse large B-cell lymphoma
  735. PSUSA/00000966/202107 - periodic safety update report single assessment
  736. Frequently Asked Questions
  737. Guidance Document: Quality Management System - Medical Devices - Guidance on the Control…
  738. EU/3/16/1736 - orphan designation for treatment of cystic fibrosis
  739. ema-slentrolSlentrol
  740. Hemodialysis urea clearance calculation software approved for marketing
  741. European Medicines Agency recommends approval of first treatment for pseudobulbar affect
  742. 21 CFR 884.5050: Metreurynter-balloon abortion system.
  743. Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 July 2008
  744. FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking…
  745. Comments invited on reflection paper on risk of antimicrobial resistance transfer from…
  746. EU/3/01/044 - orphan designation for treatment of emphysema secondary to congenital…
  747. 21 CFR 1.1305: What foods and persons are exempt from this subpart?
  748. ema-zontivityZontivity
  749. Workshop on the development of new medicines to treat tuberculosis
  750. Drug Alert list for month of February 2023
  751. Marketing authorisation templates
  752. The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and…
  753. ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide…
  754. MDS - G20: Guidance on Requirements for Clinical Investigations of Medical Devices
  755. Notice to Stakeholders: Foreign Sites - Expiring; Change to Expiry Calculation
  756. PSUSA/00010606/201906 - periodic safety update report single assessment
  757. A Case for Securing Medical Devices Across their Lifecycle
  758. EMEA-001380-PIP01-12 - paediatric investigation plan
  759. New safety advice for diclofenac – CMDh endorses PRAC recommendation
  760. EMEA/DIA Joint Workshop on: EMEA new Guidelines for development and approval of…
  761. EMEA-000922-PIP01-10 - paediatric investigation plan
  762. Refusal of orphan designation for treatment of uveal melanoma
  763. The 2018 Drug Review Annual Report released
  764. EMEA-001867-PIP01-15 - paediatric investigation plan
  765. Dexpramipexole dihydrochloride monohydrate
  766. PSUSA/00010292/202103 - periodic safety update report single assessment
  767. Animal Drug Manufacturing Inspections
  768. 21 CFR 876.1075: Gastroenterology-urology biopsy instrument.
  769. EU/3/22/2629 - orphan designation for treatment of SCN8A developmental and epileptic…
  770. PSUSA/00002060/202305 - periodic safety update report single assessment
  771. EMEA-001596-PIP02-17-M02 - paediatric investigation plan
  772. Management Board meeting: 1-2 October 2015
  773. PSUSA/00000742/201508 - periodic safety update report single assessment
  774. cfr-21-cfr-26-2-purpose21 CFR 26.2: Purpose.
  775. How to draft a direct healthcare professional communication: Guidance on letter drafting…
  776. ema-epoetin-alfa-hexalEpoetin Alfa Hexal
  777. EMEA-000097-PIP01-07 - paediatric investigation plan
  778. First treatment for children with Progeria or progeroid like syndromes (rare premature…
  779. Why Cybersecurity Is ‘A Two-Way Street’
  780. Multi-stakeholder workshop to support implementation of the Medical Devices Regulation on…
  781. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  782. Workshop on the draft guideline on registry-based studies
  783. CDRH Releases 2022 Annual Report
  784. ema-research-and-developmentResearch and development
  785. Accelerated development of appropriate patient therapies: a sustainable, multi-stakeholder…
  786. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 July 2024
  787. EMEA-001374-PIP01-12 - paediatric investigation plan
  788. EMEA recommends new warnings and contraindications for ergot-derived dopamine agonists
  789. ema-nemdatineNemdatine
  790. (DOC Version - 136 K)
  791. 21 CFR 886.5844: Prescription spectacle lens.
  792. Regulatory information – User testing of electronic application forms underway
  793. cdsco-alert-noticeAlert Notice
  794. EU/3/16/1778 - orphan designation for treatment of primary IgA nephropathy
  795. cdsco-filgotinibFilgotinib
  796. ema-loullaLoulla
  797. 21 CFR 73.3123: 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3…
  798. Paediatric anticoagulation therapy expert meeting
  799. cdsco-asunerceptAsunercept
  800. Recombinant GrowthHormone(ALT-P1)
  801. European Medicines Agency/CHMP Working Group with Healthcare Professionals' Organisations…
  802. Blood pressure measurement devices
  803. ema-improvacImprovac
  804. European Medicines Agency recommends authorisation of first medicine specifically for…
  805. Stickering on Medical Products due to reduction in Goods Service Tax (GST) rate
  806. cdsco-inc280INC280
  807. 2019 China Cancer Immunotherapy Workshop Successfully Held
  808. 21 CFR 864.2240: Cell and tissue culture supplies and equipment.
  809. Medical Device Alert dated 29 Dec 2022
  810. Medical Devices Regulations 2021 (SI 261/2021) [General]
  811. 21 CFR 864.7300: Fibrin monomer paracoagulation test.
  812. 21 CFR 892.1880: Wall-mounted radiographic cassette holder.
  813. Measles, Mumps and Rubella vaccine (Live) I.P. (Freeze Dried)
  814. 2021.03.19_S.O.1260(E)_Notification of Debasis Maitti and Hitesh Khare as Govt. Analysts…
  815. EMEA-002385-PIP01-18 - paediatric investigation plan
  816. EU/3/13/1217 - orphan designation for treatment of primary sclerosing cholangitis
  817. How Combining Clinical Informatics and Medical Devices Can Improve Care
  818. EMEA-001452-PIP01-13-M04 - paediatric investigation plan
  819. PSUSA/00002181/201501 - periodic safety update report single assessment
  820. Better training tools recommended to support patients using adrenaline auto-injectors
  821. ema-duocoverDuoCover
  822. EMEA-002919-PIP01-20 - paediatric investigation plan
  823. Committee for Orphan Medicinal Products (COMP) January 2012 highlights
  824. PSUSA/00010292/201703 - periodic safety update report single assessment
  825. ema-kaulivKauliv
  826. Details of Manufacturers whose permissions have been suspended / cancelled 2021
  827. Dan DeMaria Reflects on HTM, Gratitude, and the Dan Plan
  828. ema-arimidex-referralArimidex - referral
  829. Committee for Proprietary Medicinal Products (CPMP) 43rd plenary meeting
  830. Ambroxol and bromhexine expectorants: safety information to be updated
  831. ema-simbrinzaSimbrinza
  832. EMEA-002735-PIP03-20-M02 - paediatric investigation plan
  833. European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 June 2005
  834. EMEA-001699-PIP01-14 - paediatric investigation plan
  835. 21 CFR 1.710: How will FDA notify the public about the fee schedule?
  836. 21 CFR 20.103: Correspondence.
  837. cdsco-capmatinibCapmatinib
  838. ema-odomzoOdomzo
  839. EU/3/04/225 - orphan designation for treatment of systemic monochloroacetate poisoning
  840. Metoprolol Succinate IP (ER) + Azelnidipine IP film coated bilayered tablets (Phase III)
  841. Standards for biological raw materials
  842. Cancidas (previously Caspofungin MSD)
  843. ema-idefirixIdefirix
  844. Meningococcal (A, C, Y, W, X) Polysaccharide Conjugate Vaccine (Freeze Dried)
  845. 21 CFR 20.63: Personnel, medical, and similar files, disclosure of which constitutes a…
  846. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  847. EU/3/24/2919 - orphan designation for treatment of epidermolysis bullosa
  848. ema-mediaMedia
  849. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
  850. Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2…
  851. Aide-Memoire Inspection of Utilities
  852. PRAC: meeting archive 2012-2014
  853. EU/3/08/544 - orphan designation for treatment of congenital muscular dystrophy with…
  854. 21 CFR 73.90: β-Apo-8′-carotenal.
  855. cdsco-20152015
  856. cdsco-odm-203ODM-203
  857. Zolgensma - direct healthcare professional communication (DHPC)
  858. VR Device Looks Promising to Treat Lazy Eye in Children
  859. Mike Busdicker: Is ‘Right to Repair’ the Core Issue?
  860. 21 CFR 876.5920: Protective garment for incontinence.
  861. EMEA workshop on homeopathic medicinal products concludes to strengthen harmonisation, but…
  862. CHMP recommendations for the pharmacovigilance plan as part of the Risk Management Plan to…
  863. 2022.09.20_Draft_GSR 710(E)_Exemption of certain Class A medical device from licensing…
  864. EMA confirms recommendations to minimise risk of brain infection PML with Tysabri
  865. ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance…
  866. Committee for Orphan Medicinal Products (COMP): 10-12 February 2015
  867. EMEA-001862-PIP01-15-M02 - paediatric investigation plan
  868. ema-moxifloxacin-referralMoxifloxacin - referral
  869. Object Head wise Budget allocation for the year2021-22 under Revenue & Capital Expenditure…
  870. PSUSA/00010289/201502 - periodic safety update report single assessment
  871. cdsco-myl-1701pMYL-1701P
  872. Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods
  873. Standards Leader Elisabeth George to Receive Röntgen Award
  874. Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use…
  875. 21 CFR 880.5200: Intravascular catheter.
  876. Shaping a European innovation ecosystem: EU-Innovation network multi-stakeholder meeting
  877. 2024.08.12_S.O. 3284(E)_Notification reg Prohibiton of Etodolac
  878. EU/3/04/240 - orphan designation for treatment of Lennox-Gastaut syndrome
  879. 21 CFR 16.120: Judicial review.
  880. cdsco-vay736-ianalumabVAY736 (Ianalumab)
  881. 10-valent Pneumococcal Conjugate Vaccine
  882. EMEA-003270-PIP01-22 - paediatric investigation plan
  883. EU/3/02/088 - orphan designation for treatment of Pseudomonas aeruginosa lung infection…
  884. Public consultation: Draft report on the development of a harmonised approach to exposure…
  885. Workshop on adaptive pathways - discussing a concept for development of medicines…
  886. cdsco-sun-pharmaSun Pharma
  887. EMA Veterinary Medicines Info Day 2024
  888. Committee for Orphan Medicinal Products (COMP): 12-13 March 2013
  889. PSUSA/00002188/202208 - periodic safety update report single assessment
  890. cdsco-herpes-zoster-vaccineHerpes Zoster vaccine
  891. 21 CFR 880.5760: Chemical cold pack snakebite kit.
  892. NMPA Issued the Guiding Principles for Capacity Building of Drug Inspection and Testing…
  893. Guideline for preclinical safety assessment of oligonucleotide therapeutics
  894. Rhamni purshianae cortex - herbal medicinal product
  895. EMEA Tenth Anniversary / Scientific conference - A scientific perspective on the future of…
  896. EMEA-003373-PIP01-22 - paediatric investigation plan
  897. EU/3/23/2769 - orphan designation for treatment of primary CTLA-4 checkpoint related…
  898. Committee for Medicinal Products for Human Use (CHMP): 23-26 February 2026
  899. 21 CFR 880.5180: Burn sheet.
  900. ema-amyvidAmyvid
  901. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9…
  902. EU/3/06/391 - orphan designation for prevention of pulmonary fungal infection in patients…
  903. EU/3/20/2391 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's…
  904. Committee for Medicinal Products for Human Use (CHMP): 11-14 September 2023
  905. ema-imatinib-medacImatinib medac
  906. EU/3/21/2563 - orphan designation for treatment of invasive Scopulariopsis
  907. NMPA Minister Jiao Hong Attended A Special Press Briefing on the Vaccine Administration…
  908. EU/3/07/505 - orphan designation for treatment of acute respiratory distress syndrome…
  909. 21 CFR 12.80: Filing and service of submissions.
  910. HTM Professionals a ‘Key Piece of the Puzzle’ to Improving Medical Devices
  911. EU/3/20/2348 - orphan designation for treatment of homocystinuria
  912. FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
  913. Transparency (veterinary medicines)
  914. EU/3/18/2067 - orphan designation for treatment in haematopoietic stem cell…
  915. EMEA-001054-PIP01-10-M03 - paediatric investigation plan
  916. EU/3/16/1670 - orphan designation for treatment of Langerhans' cell histiocytosis
  917. ema-nivolumab-bmsNivolumab BMS
  918. 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2023 work plan
  919. First therapy to treat transplant patients with post-transplant lymphoproliferative…
  920. Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 2
  921. 21 CFR 866.3240: Equine encephalomyelitis virus serological reagents.
  922. Poly (2-Hydroxyethyl Methacrylate) (pHEMA)
  923. COVID-19 vaccines approved in the country
  924. 21 CFR 74.2336: D&C Red No. 36.
  925. November 10th 2017 GSR 1380(E)
  926. EMEA-002200-PIP02-19 - paediatric investigation plan
  927. Update on reshaping the organisation of the European Medicines Agency
  928. Balaglitazone - paediatric investigation plan
  929. EMEA-001490-PIP01-13-M04 - paediatric investigation plan
  930. cfr-21-cfr-26-77-fees21 CFR 26.77: Fees.
  931. Classification of Medical Device pertaining to Gastroenterology under the provisions of…
  932. COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood…
  933. PSUSA/00009231/201905 - periodic safety update report single assessment
  934. 21 CFR 1.613: What protections against conflicts of interest must an accreditation body…
  935. Regulatory workshop for Parallel Distributors
  936. EMEA-001070-PIP01-10-M02 - paediatric investigation plan
  937. EMEA-000016-PIP01-07-M08 - paediatric investigation plan
  938. Office memorandum regarding Strict regulatory control over manufacture, sale and…
  939. Qualification of non-genotoxic impurities - Scientific guideline
  940. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 February 2017
  941. Vynpenta (previously AvacopanChemoCentryx)
  942. ema-exkivityExkivity
  943. 21 CFR 862.3880: Theophylline test system.
  944. ema-repaglinide-sunRepaglinide Sun
  945. 21 CFR 20.81: Data and information previously disclosed to the public.
  946. European Medicines Agency closed 9-10 May 2013
  947. Eleutherococci radix - herbal medicinal product
  948. GN-16-R3 Guidance on Essential Principles for Safety and Performance of Medical…
  949. 21 CFR 866.3045: In vitro diagnostic device for Bacillus spp. detection.
  950. PSUSA/00000611/201707 - periodic safety update report single assessment
  951. PSUSA/00000427/201512 - periodic safety update report single assessment
  952. Janice Courtois: What Are You Afraid Of?
  953. Anoro Ellipta (previously Anoro)
  954. Reference Medicinal Products (RMPs)
  955. cfr-21-cfr-60-3-definitions21 CFR 60.3: Definitions.
  956. Data Analysis and Real World Interrogation Network (DARWIN EU)
  957. EMA pilots scientific advice for certain high-risk medical devices
  958. cdsco-ensitrelvir-s-217622Ensitrelvir, S-217622
  959. PSUSA/00002171/201503 - periodic safety update report single assessment
  960. Access to MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin for therapeutic…
  961. Committee for Advanced Therapies (CAT): 16-17 April 2019
  962. Paediatric Committee (PDCO): 24-27 March 2020
  963. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  964. PSUSA/00002269/201505 - periodic safety update report single assessment
  965. Scientific recommendations on classification of advanced therapy medicinal products
  966. ema-izbaIzba
  967. Committee for veterinary medicinal products: Meeting of 17 to 19 June 2003
  968. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15…
  969. Risk-Adapted Approach to clinical trials and Risk Assessments: Example 3: Type A Protocol…
  970. EU/3/14/1340 - orphan designation for treatment of limbal stem cell deficiency
  971. EMEA-002946-PIP01-20 - paediatric investigation plan
  972. EMA regular press briefing on COVID-19
  973. Drug Safety Update: monthly PDF newsletter: Drug Safety Update November 2019
  974. PSUSA/00002436/201703 - periodic safety update report single assessment
  975. State Drug Alert for the Month of October 2024
  976. cdsco-rlx030RLX030
  977. List of approved Clinical Trial Sites and Investigators
  978. 21 CFR 868.1975: Water vapor analyzer.
  979. PSUSA/00001826/201705 - periodic safety update report single assessment
  980. Melatonin (Circadin) - paediatric investigation plan
  981. PSUSA/00000461/201812 - periodic safety update report single assessment
  982. ema-sibnayalSibnayal
  983. cfr-21-cfr-26-1-definitions21 CFR 26.1: Definitions.
  984. ema-ketekKetek
  985. Nor Ursodeoxycholic acid tablets 500 mg (NAFLD)
  986. GL-06-R2 Medical Devices Product Classification Guide (2023 Oct) PUB
  987. EU/3/14/1249 - orphan designation for treatment of familial chylomicronaemia syndrome
  988. GN-25-R1 Guidance on the Cancellation of Medical Device Listing
  989. EMEA public statement on the suspension of the marketing authorisation for Optison…
  990. EU Network Training Centre (EU NTC)

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