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Global regulations and guidance

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

  1. Management Board: Meetings 2010
  2. European Medicines Agency updates guideline on drug interactions
  3. Workshop: advancing regulatory science to 2025 for veterinary medicines
  4. Aflibercept solution for injection (40 mg/ml) in a single dose vial
  5. EU/3/15/1435 - orphan designation for treatment of systemic sclerosis
  6. EU/3/16/1769 - orphan designation for treatment of sickle cell disease
  7. 21 CFR 870.3375: Cardiovascular intravascular filter.
  8. 21 CFR 870.4510: Apical closure device.
  9. EU/3/14/1240 - orphan designation for treatment of cystic fibrosis
  10. Points to Consider for Clinical Development of Drugs Intended for Treatment of Psoriatic…
  11. ema-biresp-spiromaxBiResp Spiromax
  12. Nicotine vaping products and vaping devices
  13. ema-travatanTravatan
  14. Provisions for Administration of Medical Device Recall
  15. Team-NB-PositionPaper-HybridAudits-V2-20230516
  16. PSUSA/00001009/201811 - periodic safety update report single assessment
  17. EU/3/21/2412 - orphan designation for treatment of Leber's congenital amaurosis
  18. EMEA-002997-PIP02-22 - paediatric investigation plan
  19. EU/3/10/733 - orphan designation for treatment of carbamoyl-phosphate synthase-1…
  20. FDA strengthens warning that untreated constipation caused by schizophrenia medicine…
  21. Ticagrelor 120/180 mg SR Tablet
  22. The annual European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)…
  23. Processing of application for product approved as medical device in the country of origin…
  24. Workshop: addressing unmet needs of children with pulmonary arterial hypertension
  25. 21 CFR 58.61: Equipment design.
  26. Only For Children Pharmaceuticals withdraws its marketing-authorisation application for…
  27. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28…
  28. ema-zirabevZirabev
  29. 2014.12.29_S.O. 3298 (E) _Reconstitution of DTAB
  30. 21 CFR 876.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  31. EU/3/24/2935 - orphan designation for treatment of pachyonychia congenita
  32. 21 CFR 862.2730: Osmometer for clinical use.
  33. ema-tracleerTracleer
  34. 21 CFR 882.4750: Skull punch.
  35. Transjugular Intrahepatic Puncture Device Approved for Marketing
  36. Working Group on Quality Review of Documents
  37. PSUSA/00010390/201601 - periodic safety update report single assessment
  38. Titanium
  39. ema-ocalivaOcaliva
  40. Early dialogue with regulators and HTA bodies
  41. Veterinary medicinal products containing paromomycin to be administered parenterally to…
  42. EU/3/21/2458 - orphan designation for treatment of biliary tract cancer
  43. Notice inviting quotation Chemicals for Central Drugs Laboratory, Kolkata 27 April
  44. Meeting highlights from the Paediatric Committee: 1 - 3 April 2009
  45. 21 CFR 882.4305: Powered compound cranial drills, burrs, trephines, and their accessories.
  46. International Clinical Trials Day: 20 May 2013
  47. cdsco-evenamideEvenamide
  48. Crizotinib product-specific bioequivalence guidance
  49. 21 CFR 1.1160: How will FDA review test results and analytical reports?
  50. ema-information-managementInformation management
  51. Avatrombopag Tablets 20 mg
  52. HTM Educators Take Note: VR Learning Could Jumpstart Your Program
  53. ema-ogivriOgivri
  54. 21 CFR 21.71: Disclosure of records in Privacy Act Record Systems; accounting required.
  55. EU/3/14/1361 - orphan designation for treatment of systemic sclerosis
  56. Highlights of 100th Management Board meeting: June 2018
  57. Appendices to Guideline on epidemiological data on blood transmissible infections
  58. Clinical Trials Information System (CTIS) sponsor end user training programme - September…
  59. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5…
  60. Risk of loss of coordination during water-related activities in Parkinson’s Patients with…
  61. Need for a paediatric addendum of the guideline on clinical investigation of medicinal…
  62. 21 CFR 892.1420: Radionuclide test pattern phantom.
  63. Relugolix,Estradiol and Norethindrone Acetate Tablets
  64. EU/3/17/1897 - orphan designation for treatment of hepatocellular carcinoma
  65. EMEA-001546-PIP01-13 - paediatric investigation plan
  66. 21 CFR 872.6730: Endodontic dry heat sterilizer.
  67. Committee for Medicinal Products for Human Use (CHMP): 20-23 August 2012
  68. 21 CFR 20.26: Electronic availability and indexes of certain records.
  69. Meningococcal Conjugate Vaccine
  70. PSUSA/00009182/201712 - periodic safety update report single assessment
  71. Regulations of Medicament Manufacturer Inspection
  72. ema-logo-and-visual-identityLogo and visual identity
  73. PSUSA/00003047/202312 - periodic safety update report single assessment
  74. Navigating New Requirements for In Vitro Diagnostics
  75. PSUSA/00002780/201503 - periodic safety update report single assessment
  76. Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment
  77. EMEA-000876-PIP06-15 - paediatric investigation plan
  78. EMEA-002765-PIP01-19 - paediatric investigation plan
  79. EMEA-002755-PIP01-19-M01 - paediatric investigation plan
  80. Imcivree - withdrawal of application for variation to marketing authorisation
  81. CDRH’s “Digital Transformation Initiative” Moves Forward
  82. PSUSA/00000212/201412 - periodic safety update report single assessment
  83. ema-vidprevtyn-betaVidPrevtyn Beta
  84. EMEA-000081-PIP01-07-M11 - paediatric investigation plan
  85. European Medicines Agency adopts positive opinion for avian influenza vaccines for use in…
  86. EMEA-002749-PIP01-19-M02 - paediatric investigation plan
  87. Guidance on regulatory classification of point-of-use hospital water filters in the UK
  88. PSUSA/00002767/202204 - periodic safety update report single assessment
  89. Checklist for Form MD-16 MD
  90. PSUSA/00010291/202006 - periodic safety update report single assessment
  91. NMPA Issues Announcement on Revising Package Insert of Sodium Thiosulfate Injection
  92. August 10, 2016: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical…
  93. UPDATE on Serious Complications Associated with Negative Pressure Wound Therapy Systems…
  94. ema-albriozaAlbrioza
  95. PSUSA/00001971/202110 - periodic safety update report single assessment
  96. Gaucher disease: a strategic collaborative approach from the European Medicines Agency and…
  97. EMA and European medicines regulatory network lift COVID-19 business continuity status
  98. EMEA-002112-PIP01-16-M01 - paediatric investigation plan
  99. ema-sovaldiSovaldi
  100. PSUSA/00000384/201510 - periodic safety update report single assessment
  101. EMEA-001036-PIP01-10 - paediatric investigation plan
  102. EMEA-001668-PIP01-14 - paediatric investigation plan
  103. Paediatric Committee (PDCO): 5-7 September 2012
  104. Announcement of National Medical Products Administration and National Health Commission on…
  105. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  106. Ecansya (previously Capecitabine Krka)
  107. Standards Governing the Drug Abuse Urine Testing Laboratories Established by Government…
  108. ema-recuvyraRecuvyra
  109. 21 CFR 10.95: Participation in outside standard-setting activities.
  110. Relaunched EMA website now live
  111. Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with…
  112. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 12-13 October 2010
  113. Duloxetine (as delayed release pellets) IP + Pregabalin IP hard gelatin capsules (Phase…
  114. Q&A: Article 20 pharmacovigilance procedures
  115. cdsco-grc-65327GRC 65327
  116. ema-karvezideKarvezide
  117. Cosmetics Good Manufacturing Practice Regulations
  118. 21 CFR 866.5600: Low-density lipoprotein immunological test system.
  119. ema-adenuricAdenuric
  120. 21 CFR 874.3310: Hearing aid calibrator and analysis system.
  121. EU/3/14/1315 - orphan designation for treatment of apolipoprotein A-I deficiency
  122. EMEA-000564-PIP01-09 - paediatric investigation plan
  123. Clopidogrel Teva Pharma (previously Clopidogrel HCS)
  124. Niclosamide IM depot Injection
  125. Guidance on air freight of medicines
  126. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 August 2010
  127. Clinical Trials Information System
  128. 21 CFR 1.285: What happens to food that is imported or offered for import from…
  129. EU/3/04/222 - orphan designation for treatment of malabsorption due to exocrine pancreatic…
  130. EMEA-000126-PIP01-07 - paediatric investigation plan
  131. Committee for Orphan Medicinal Products (COMP): 18-20 January 2022
  132. ema-ranibizumab-midasRanibizumab Midas
  133. EMEA-001534-PIP01-13 - paediatric investigation plan
  134. Team-NB MD Sector Survey PressRelease
  135. RO7790121/F05, 225 mg/1.5 ml (antibody) (RVT-3101, ANTI TL1A)
  136. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28…
  137. FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon)…
  138. Antiviral medicines for pandemic influenza
  139. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
  140. Why Is Protecting Intellectual Property Important? A Patent Lawyer Explains
  141. Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment…
  142. Northwest Territories Engineer Recognized with Humanitarian AAMI & ACCE Award
  143. EU/3/16/1748 - orphan designation for treatment of acute myeloid leukaemia
  144. PSUSA/00002036/201811 - periodic safety update report single assessment
  145. EU/3/22/2646 - orphan designation for treatment of ornithine transcarbamylase deficiency
  146. ema-envarsusEnvarsus
  147. 21 CFR 878.5030: Natural nonabsorbable silk surgical suture.
  148. 21 CFR 864.5700: Automated platelet aggregation system.
  149. Clinical investigation of medicinal products for the treatment of psoriatic arthritis…
  150. PSUSA/00009099/202204 - periodic safety update report single assessment
  151. ema-pholcodine-referralPholcodine - referral
  152. European Medicines Agency welcomes new Head of Finance and Budget
  153. Clinical investigation of steroid contraceptives in women - Scientific guideline
  154. Committee for Herbal Medicinal Products (HMPC): 24 November 2014
  155. Letter for States regarding Regulatory Inspection Procedure
  156. Committee for Proprietary Medicinal Products (CPMP) 26th plenary meeting
  157. ema-syvazul-btvSyvazul BTV
  158. cfr-21-cfr-58-90-animal-care21 CFR 58.90: Animal care.
  159. ema-fampridine-accordFampridine Accord
  160. EMEA-001163-PIP01-11 - paediatric investigation plan
  161. EU/3/06/350 - orphan designation for treatment of emphysema secondary to congenital…
  162. PSUSA/00002569/201710 - periodic safety update report single assessment
  163. William A. Hyman: Human Factors for Manual Safety Systems
  164. AAMI Honors Leaders Who Inspire the Field to 'Aim Higher'
  165. Emergency Planning and Response Activities
  166. ema-amifampridine-serbAmifampridine SERB
  167. Committee for veterinary medicinal products: Meeting of 22 to 24 July 2003
  168. GSR 433 (E) dated 7.June 2012
  169. Committee for veterinary medicinal products: 46th meeting
  170. Determination of withdrawal periods for milk - Scientific guideline
  171. Prepare for the Future of HTM with AAMI President Pamela Arora & Guests
  172. EU/3/13/1233 - orphan designation for prevention of graft-versus-host disease
  173. Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing…
  174. Drug Safety Update: monthly PDF newsletter: Drug Safety Update August 2022
  175. Parallel joint scientific consultation with regulators and health technology assessment…
  176. European Medicines Agency closed 29 March to 2 April 2018
  177. EU/3/17/1941 - orphan designation for treatment of Prader-Willi syndrome
  178. EudraVigilance training on electronic reporting of ICSRs in the EEA
  179. The Kilmer Fund Committee Awards its First Kilmer Research Grant
  180. EMEA-002114-PIP01-16 - paediatric investigation plan
  181. EU/3/12/1068 - orphan designation for treatment of African trypanosomiasis
  182. ema-topotecan-eagleTopotecan Eagle
  183. ema-zartraZartra
  184. EU/3/08/577 - orphan designation for treatment of propionic acidaemia
  185. FDA Recognizes AAMI Ethylene Oxide, Materials Compatibility Guidance
  186. RESOLUTION RDC NO. 23, 04 APRIL 2012
  187. PSUSA/00010390/2018 - periodic safety update report single assessment
  188. Update on the implementation of EMA policy on publication of clinical data (Policy 0070)…
  189. ema-zulvac-btvZulvac BTV
  190. PSUSA/00001164/202209 - periodic safety update report single assessment
  191. CDRH Establishes Digital Health Center of Excellence
  192. EU/3/20/2390 - orphan designation for treatment of idiopathic pericarditis
  193. Vildagliptin (SR) + Pioglitazone Hydrochloride IP film coated bilayered tablets (Phase…
  194. Committee for Veterinary Medicinal Products - focus on reducing the risk of antimicrobial…
  195. The Distinction Between Advertising and Other Activities
  196. 21 CFR 73.295: Tagetes (Aztec marigold) meal and extract.
  197. 21 CFR 74.1707: D&C Yellow No. 7.
  198. April 4-5, 2023: Science Advisory Board to the National Center for Toxicological Research…
  199. October 18, 2018: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting…
  200. Schering-Plough Europe withdraws its marketing authorisation application for Zenhale…
  201. ema-vafseoVafseo
  202. EU/3/01/083 - orphan designation for treatment of high-grade glioma with subsequent use of…
  203. EU/3/20/2287 - orphan designation for treatment of Canavan disease
  204. EU/3/23/2767 - orphan designation for treatment of gastrointestinal stromal tumours
  205. ema-enthryvEnthryv
  206. Datopotamab Deruxtecan (Dato-DXd)100mg/vial,Durvalumab (MEDI4736) 500mg/vial
  207. Clinical Trials Information System (CTIS): online training modules
  208. 21 CFR 876.4630: Ureteral stent accessories.
  209. ema-pidolma-referralPidolma - referral
  210. 21 CFR 821.60: Retention of records.
  211. VICH GL54 Studies to evaluate the safety of residues of veterinary drugs in human food…
  212. ema-clopidogrel-teva-pharmaClopidogrel Teva Pharma
  213. First webinar on regulatory and procedural aspects of type I variations
  214. EU/3/11/877 - orphan designation for treatment of mucopolysaccharidosis, type IIIA…
  215. Enpr-EMA Coordinating Group and networks meeting
  216. ema-tasmarTasmar
  217. EMEA-001271-PIP01-12-M01 - paediatric investigation plan
  218. EMEA-001453-PIP01-13-M01 - paediatric investigation plan
  219. EMA review of Zinbryta confirms medicine's risks outweigh its benefits
  220. EMEA-002961-PIP01-21-M02 - paediatric investigation plan
  221. European and US regulators agree on mutual recognition of inspections of medicines…
  222. cdsco-gemcitabineGemcitabine
  223. ema-eurican-l4Eurican L4
  224. Guidance on new provisions for traditional herbal medicinal products and homeopathic…
  225. Committee for Medicinal Products for Human Use (CHMP): 22-25 January 2018
  226. PSUSA/00001867/202203 - periodic safety update report single assessment
  227. 21 CFR 50.27: Documentation of informed consent.
  228. Veterinary pharmacovigilance inspections: Q&As
  229. cdsco-tetracosactideTetracosactide
  230. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting
  231. 21 CFR 82.1206: D&C Green No. 6.
  232. VA Strengthens HTM Learning and Development
  233. cfr-21-cfr-880-1-scope21 CFR 880.1: Scope.
  234. Primulae flos - herbal medicinal product
  235. PSUSA/00009074/202401 - periodic safety update report single assessment
  236. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2016
  237. April 12th 2018 GSR 366(E)
  238. EU/3/16/1775 - orphan designation for treatment of facioscapulohumeral muscular dystrophy
  239. Expert meeting on specific immunotherapy
  240. EMEA-001169-PIP01-11-M05 - paediatric investigation plan
  241. 21 CFR 870.4340: Cardiopulmonary bypass level sensing monitor and/or control.
  242. cdsco-umifenovirUmifenovir
  243. EU/3/16/1713 - orphan designation for treatment of scedosporiosis
  244. PSUSA/00000295/202212 - periodic safety update report single assessment
  245. EMEA-002753-PIP01-19 - paediatric investigation plan
  246. Myoson and associated names - referral
  247. VR for the VA? Veterans Health Administration Launches Virtual Reality Therapy Collab
  248. Patient Involvement Strategy
  249. Establishment Standards for Cosmetics Manufactory, Establishment Standards for Cosmetics…
  250. World Alzheimer's Day: 21 September 2011
  251. Guideline on comparability of biotechnology-derived medicinal products after a change in…
  252. 21 CFR 7.45: Food and Drug Administration-requested recall.
  253. Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins
  254. PSUSA/00010431/202010 - periodic safety update report single assessment
  255. PSUSA/00010206/201805 - periodic safety update report single assessment
  256. PSUSA/00001921/201709 - periodic safety update report single assessment
  257. Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and…
  258. cdsco-levetiracetamLevetiracetam
  259. AAMI Foundation Seeks Applicants for 2024 Logan Grants
  260. Data from patient registries to replace clinical trials in previously untreated…
  261. Dalcetrapib - paediatric investigation plan
  262. Review of emergency contraceptives started
  263. EMA Management Board: highlights of June 2015 meeting
  264. PSUSA/00000277/202312 - periodic safety update report single assessment
  265. cdsco-ab001-400mg-tabletsAB001 400mg Tablets
  266. A 'Whole Community' Approach to Cybersecurity in Medical Imaging
  267. Recognition and Use of Standards under the Medical Devices Regulations
  268. Product information: Reference documents and guidelines
  269. Regulation of sport supplements in Australia: information for importers and sellers
  270. 21 CFR 812.66: Significant risk device determinations.
  271. 21 CFR 878.5010: Nonabsorbable polypropylene surgical suture.
  272. NMPA Issues Guidance for On-Site Inspection of Independent Software Appended in Good…
  273. Guideline on clinical investigation of medicinal products in the treatment of Parkinson's…
  274. SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Service (OMS)
  275. Details of Manufacturers whose permissions have been suspended / cancelled 2024
  276. PSUSA/00000477/201903 - periodic safety update report single assessment
  277. 21 CFR 866.2330: Enriched culture medium.
  278. PSUSA/00000166/201412 - periodic safety update report single assessment
  279. ema-cibinqoCibinqo
  280. EMEA-000637-PIP01-09-M01 - paediatric investigation plan
  281. Clinical performance requirements and risk mitigation strategies for HIV tests
  282. Committee for Orphan Medicinal Products: October 2005 meeting
  283. EMEA-001003-PIP01-10-M02 - paediatric investigation plan
  284. A Shocking Vulnerability Demonstrated at eXchange REWIRED
  285. EMEA-002092-PIP01-16 - paediatric investigation plan
  286. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 January 2012
  287. Who Supports the AAMI Foundation? Meet TRIMEDX’s Dawn Griffin
  288. Committee for medicinal products for veterinary use: Meeting of 13-15 January 2009
  289. PSUSA/00010242/202008 - periodic safety update report single assessment
  290. 21 CFR 26.61: Purpose of this part.
  291. 21 CFR 884.4910: Specialized surgical instrumentation for use with urogynecologic surgical…
  292. EMEA-001034-PIP01-10 - paediatric investigation plan
  293. DR_G.S.R. 848(E) dt_09.12.2021_Notification of ICD Tihi,M.P. in rule 43A of Drugs Rules
  294. 21 CFR 872.6100: Anesthetic warmer.
  295. cdsco-baricitinibBaricitinib
  296. ema-cotronakCotronak
  297. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  298. Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide…
  299. 21 CFR 892.1330: Nuclear whole body scanner.
  300. EU/3/20/2291 - orphan designation for treatment of glioma
  301. Bisoprolol IP + Telmisartan IP tablets (Phase III)
  302. Documentary Requirements for Class 1 CTGTP Notification and Updates [PDF, 357.05 KB]
  303. European Medicines Agency reorganisation
  304. PSUSA/00010484/201611 - periodic safety update report single assessment
  305. ema-aerivio-spiromaxAerivio Spiromax
  306. EU/3/17/1944 - orphan designation for treatment of Duchenne muscular dystrophy
  307. EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of…
  308. UPDATE: Potential Eye Damage from Alcon CyPass Micro-Stent Used to Treat Open-Angle…
  309. ema-minjuviMinjuvi
  310. Training session on the new pharmaceutical legislation
  311. FDA Issues Final Rule, Guidance on Over-the-Counter Hearing Aids
  312. PSUSA/00000769/201912 - periodic safety update report single assessment
  313. FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible…
  314. 21 CFR 886.5905: Oral electronic vision aid.
  315. Nitazoxanide 500 mg Tablets
  316. EMEA-002364-PIP02-18 - paediatric investigation plan
  317. EMEA-002798-PIP03-22 - paediatric investigation plan
  318. 21 CFR 872.3260: Cavity varnish.
  319. EMEA Workshop on Pharmacovigilance Systems and Inspections for Veterinary Medicinal…
  320. Countries should reduce use of colistin in animals to decrease the risk of antimicrobial…
  321. Clinical Trials Information System (CTIS): Walk-in clinic - September 2022
  322. EMA receives application for conditional marketing authorisation of COVID-19 Vaccine…
  323. 21 CFR 890.3410: External limb orthotic component.
  324. EU/3/10/798 - orphan designation for treatment of adrenocorticotropin-dependent Cushing's…
  325. 21 CFR 864.7440: Electrophoretic hemoglobin analysis system.
  326. Drug Alert list for month of June 2019
  327. PSUSA/00010558/201806 - periodic safety update report single assessment
  328. EMA’s work on new veterinary regulation advances
  329. Annex 11 to the good manufacturing practices guide: Computerized Systems: GUI-0050
  330. 21 CFR 866.3870: Trypanosoma spp. serological reagents.
  331. Sterilization to Take Center Stage at AAMI Exchange
  332. PSUSA/00003162/202001 - periodic safety update report single assessment
  333. 21 CFR 12.98: Official transcript.
  334. 21 CFR 872.4630: Dental operating light.
  335. Procedure to be followed for regularisation of FDCs declared as rational in respect to 294…
  336. 21 CFR 864.5800: Automated sedimentation rate device.
  337. PSUSA/00001242/201703 - periodic safety update report single assessment
  338. Andrew Ellis: The True Meaning of Allyship in HTM
  339. 21 CFR 878.4755: Absorbable lung biopsy plug.
  340. EU/3/23/2868 - orphan designation for treatment of peripheral T-cell lymphoma
  341. PSUSA/00000463/201704 - periodic safety update report single assessment
  342. EU/3/16/1620 - orphan designation for treatment of retinitis pigmentosa
  343. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2025 (SI…
  344. 21 CFR 12.89: Participation of nonparties.
  345. EU/3/04/210 - orphan designation for treatment of bronchiolitis obliterans syndrome
  346. Tinofovir Pivafen Fumarate 50 mg
  347. ema-accofilAccofil
  348. EMEA-002414-PIP01-18 - paediatric investigation plan
  349. 21 CFR 866.2480: Quality control kit for culture media.
  350. Report from the ADHOC working group meeting on herbal medicinal products 1997 - 1998
  351. Balcinrenone 15 mg+Dapagliflozin 10 mg
  352. Change of time zone due to EMA's relocation in March 2019
  353. The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3)…
  354. 21 CFR 886.1100: Retinal diagnostic software device.
  355. 21 CFR 73.2991: Zinc oxide.
  356. ema-doxorubicin-sunDoxorubicin SUN
  357. Tropifexor (LJN452) & licogliflozin
  358. Facilitating development of medicines for autism spectrum disorder
  359. ema-avaglimAvaglim
  360. Donald Armstrong: For Career Growth, Give Management a Shot
  361. New fee regulation: webinar for veterinary marketing authorisation holders
  362. EMEA-003144-PIP01-21 - paediatric investigation plan
  363. 2022.03.29_Draft GSR 227(E)_To include colour of disinfectants in rule 127 of Drugs Rules…
  364. 21 CFR 866.3500: Rickettsia serological reagents.
  365. Drug Safety Update: monthly PDF newsletter: Drug Safety Update December 2019
  366. EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesevimab for COVID-19
  367. 21 CFR 872.3920: Porcelain tooth.
  368. European Medicines Agency 2009 mid-year report shows it is still on target, despite…
  369. EU/3/12/958 - orphan designation for diagnosis of positive folate-receptor status in…
  370. UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA…
  371. PSUSA/00001815/202110 - periodic safety update report single assessment
  372. P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver…
  373. 21 CFR 1.1115: How will FDA evaluate applications for recognition and renewal of…
  374. Draft GSR 412 (E) Dt.27.04.2018_Reg. performance evaluation report of IVD medical devices
  375. New medicine for cystic fibrosis patients
  376. ema-vedropVedrop
  377. Committee for Medicinal Products for Human Use (CHMP): 07-10 December 2026
  378. EMEA-001746-PIP01-15 - paediatric investigation plan
  379. Medicines and Healthcare Products Regulatory Agency information day: Medical Dictionary…
  380. EMA advises companies on steps to take to avoid nitrosamines in human medicines
  381. Call for civil society members to join two EMA committees
  382. How The Mayo Clinic Leads in Medical Device Cybersecurity
  383. Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit
  384. NMPA Announcement on Issues about Implementing the Rules for Registration and Notification…
  385. European Medicines Agency prepares for approval of pandemic vaccines
  386. 21 CFR 21.54: Amended or disputed records received from other agencies.
  387. EMA suspends Picato as a precaution while review of skin cancer risk continues
  388. PSUSA/00003078/201807 - periodic safety update report single assessment
  389. European Medicines Agency recommends approval of a new medicine for multidrug-resistant…
  390. Soiae oleum raffinatum - herbal medicinal product
  391. Partial revision of "Guidance on Drug-Agnostic Companion Diagnostics"
  392. Apremilast Tablets 10/20/30mg Phase IV .
  393. EMEA-002361-PIP01-18 - paediatric investigation plan
  394. ema-brinavessBrinavess
  395. Meeting highlights from the Paediatric Committee: 17 - 19 September 2008
  396. ema-immunogamImmunoGam
  397. Paliperidone palmitate product-specific bioequivalence guidance
  398. Rare Disease Day: 29 February 2012
  399. 21 CFR 880.6775: Powered patient transfer device.
  400. Core summary of product characteristics for human normal immunoglobulin for subcutaneous…
  401. ICMR Convalescent plasma _protocol_v1.5.pdf
  402. Meridia (sibutramine) - FDA Recommends Against the Continued Use of Meridia (sibutramine)
  403. 21 CFR 71.26: Revocation of exemption from certification.
  404. SAR440340/REGN3500/itepekimabd
  405. ema-valdyn-previously-kudeqValdyn (previously Kudeq)
  406. Details of clinical trial Permissions of Year 2023
  407. Mepact - direct healthcare professional communication (DHPC)
  408. Refusal of orphan designation for prevention of spaceflight-related radiation and…
  409. PSUSA/00010130/202002 - periodic safety update report single assessment
  410. The new EudraVigilance system and the electronic reporting of individual case safety…
  411. Ticagrelor SR Tablets 120mg/180mg
  412. Committee for Advanced Therapies (CAT): 11-12 May 2010
  413. Team-NB Press Release Survey Capacities February
  414. European Medicines Agency holds first meeting of Committee for Advanced Therapies (CAT)
  415. 21 CFR 882.5940: Electroconvulsive therapy device.
  416. Solifenacin Succinate IP + Silodosin film coated bilayered tablets (Phase III)
  417. Influenza vaccines - non-clinical and clinical module - Scientific guideline
  418. ema-avalox-referralAvalox - referral
  419. cdsco-denosumab-120mg-1-7mlDenosumab 120mg/1.7mL
  420. Consumer Medicine Information (CMI) - How to use the improved CMI template
  421. cdsco-pdp-1-17PDP-1 17
  422. EMEA-002549-PIP01-19 - paediatric investigation plan
  423. UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety…
  424. ema-finteplaFintepla
  425. ema-puldysaPuldysa
  426. Committee for Proprietary Medicinal Products (CPMP) 39th plenary meeting
  427. NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products
  428. PSUSA/00009182/201612 - periodic safety update report single assessment
  429. Cost Recovery Implementation Statement, 2023-2024
  430. ema-pecfentPecFent
  431. EMEA-001124-PIP01-10-M05 - paediatric investigation plan
  432. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 May 2014
  433. cdsco-vicadrostat-bi-690517vicadrostat (BI 690517)
  434. 21 CFR 880.5740: Suction snakebite kit.
  435. UPDATED AGENDA INFORMATION: March 5, 2024: Meeting of the Medical Imaging Drugs Advisory…
  436. ema-telmisartan-actavisTelmisartan Actavis
  437. 2021.07.22_Draft_GSR 502(E)_Rule 127 to insert IS4707(Part 1) by BIS
  438. PSUSA/00002188/201708 - periodic safety update report single assessment
  439. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (SI…
  440. PSUSA/00001392/201608 - periodic safety update report single assessment
  441. EMA business hours over King's Day and Labour Day, 27 April and 1 May
  442. Unfettered Access Procedure for marketing authorisations approved in Northern Ireland
  443. cfr-21-cfr-12-99-motions21 CFR 12.99: Motions.
  444. Sitagliptin Phosphate IP eq. to Sitagliptin + Dapagliflozin tablets (Phase III)
  445. Mycobacterium w (Heat Killed) Injection2
  446. Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high…
  447. Surrender of Cosmetic Registration Certificate No RC/COS-002707 dated 06-Oct. 2021 and…
  448. Pharmacovigilance procedures
  449. PSUSA/00010656/202201 - periodic safety update report single assessment
  450. 2024 AAMI eXchange Swings into Action with Second Annual Golf Tournament
  451. ema-poulvac-procerta-hvt-ibdPoulvac Procerta HVT-IBD
  452. ema-zulvac-1-8-bovisZulvac 1+8 Bovis
  453. Supporting medicine developers in generating quality data packages in early access…
  454. Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan)
  455. Medicinal Products (Control of Manufacture) (Amendment) Regulations 2019 (SI 219/2019)…
  456. European Medicines Agency and Swissmedic agree sharing of information on H1N1 pandemic…
  457. cdsco-lou064-remibrutinibLOU064 (Remibrutinib)
  458. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin…
  459. Nobilis Multriva RT+IBm+ND+EDS
  460. PSUSA/00002100/202312 - periodic safety update report single assessment
  461. ema-tiamutin-referralTiamutin - referral
  462. ema-tofidenceTofidence
  463. PSUSA/00002695/201801 - periodic safety update report single assessment
  464. EMEA-001129-PIP01-11-M05 - paediatric investigation plan
  465. EU/3/22/2677 - orphan designation for treatment of haemophilia A
  466. EMEA-002465-PIP01-18 - paediatric investigation plan
  467. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 May 2020
  468. 21 CFR 73.125: Sodium copper chlorophyllin.
  469. European Medicines Agency publishes guideline on clinical investigation of medicines for…
  470. Oversight and monitoring of investigational medical product trials: Example where…
  471. cfr-21-cfr-11-3-definitions21 CFR 11.3: Definitions.
  472. 21 CFR 801.119: In vitro diagnostic products.
  473. 21 CFR 1.380: Where and under what conditions must the detained article of food be held?
  474. Isotretinoin for severe acne: uses and effects
  475. EMA/OD/0000149115 - orphan designation for treatment of amyotrophic lateral sclerosis
  476. PSUSA/00001642/202309 - periodic safety update report single assessment
  477. Report on origins of clinical trial participants updated
  478. Guidance on the Implementation of DS GMP evidence for Chemical DS manufacturers with FAQ
  479. Declaration of Conformity
  480. ema-cinacalcet-mylanCinacalcet Mylan
  481. cdsco-ht-6184HT-6184
  482. Defect with Buccolam oral syringes
  483. ema-temodalTemodal
  484. EMEA-001915-PIP01-15-M03 - paediatric investigation plan
  485. 21 CFR 886.1510: Eye movement monitor.
  486. FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading…
  487. 21 CFR 862.1315: Galactose-1-phosphate uridyl transferase test system.
  488. EU/3/16/1653 - orphan designation for treatment of cutaneous T-cell lymphoma
  489. Conduct of efficacy studies for non-steroidal anti-inflammatory drugs (NSAIDs)…
  490. ema-rivastigmine-tevaRivastigmine Teva
  491. Common issues identified during clinical trial applications: Common issues: Non-Clinical
  492. EMEA-001327-PIP01-12 - paediatric investigation plan
  493. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14…
  494. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MAR-2022
  495. ema-erlotinib-accordErlotinib Accord
  496. EMEA-001207-PIP03-20 - paediatric investigation plan
  497. 17list of vaccine manufacturing units inspected-rotated_2
  498. Fexofenadine Hydrochloride IP 180mg + Montelukast Sodium IP eq. to Montelukast 10mg…
  499. EMEA-003001-PIP01-21-M01 - paediatric investigation plan
  500. ema-quality-packagingQuality: packaging
  501. Isophane Insulin Human suspension (100 IU/mL)
  502. Efficacy Working Party (EWP)
  503. cfr-21-cfr-866-1-scope21 CFR 866.1: Scope.
  504. ema-fulvestrant-mylanFulvestrant Mylan
  505. EU/3/17/1848 - orphan designation for treatment of Niemann-Pick disease
  506. EMEA-002945-PIP01-20 - paediatric investigation plan
  507. Respirators No Longer Need to Do Double Duty, FDA Says
  508. Paediatric Committee (PDCO): 13-15 January 2010
  509. The 'Art' of Interoperability: Finding Common Ground
  510. Circular-Retention of license or certificates under Medical Devices Rules, 2017
  511. China Domestic ECMO products approved for marketing
  512. 21 CFR 1.511: What FSVP must I have if I am importing a food subject to certain…
  513. PSUSA/00001309/201604 - periodic safety update report single assessment
  514. EMEA-001033-PIP02-11 - paediatric investigation plan
  515. As FDA Eyes Biological Evaluation Standards, Here’s What You Should Know
  516. Public information on medicine shortages
  517. New pharmacovigilance legislation comes into operation
  518. EMEA-003072-PIP01-21 - paediatric investigation plan
  519. ema-how-we-workHow we work
  520. EU/3/12/1010 - orphan designation for treatment of Becker muscular dystrophy
  521. Emergency Preparedness Resource Helps HTM Departments Start the New Year Confidently
  522. EMEA-001000-PIP01-10 - paediatric investigation plan
  523. Management Board meeting: 12 - 13 June 2024
  524. ema-halagonHalagon
  525. Radiation Protection Terminology
  526. EU/3/12/990 - orphan designation for treatment of acute myeloid leukaemia
  527. ema-docetaxel-kabiDocetaxel Kabi
  528. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF FEB-2018
  529. Regulatory information – adjusted fees for pharmacovigilance applications from 18 October…
  530. Pemetrexed Pfizer (previously Pemetrexed Hospira)
  531. 21 CFR 862.1570: Phosphohexose isomerase test system.
  532. ema-zoledronic-acid-medacZoledronic acid medac
  533. 21 CFR 868.2380: Nitric oxide analyzer.
  534. European Medicines Agency launches consultation on its Road Map to 2015
  535. cdsco-ylb113YLB113
  536. EU/3/16/1755 - orphan designation for treatment of Smith-Magenis syndrome
  537. PSUSA/00003013/201611 - periodic safety update report single assessment
  538. Olanzapine Glenmark Europe
  539. ema-oxbrytaOxbryta
  540. Transfer of a marketing authorisation templates
  541. European Medicines Agency recommends withdrawal of benfluorex from the market in European…
  542. EU/3/23/2830 - orphan designation for treatment of pancreatic cancer
  543. DARWIN EU Advisory Board meeting: 28 June 2021
  544. Positron Emission Tomography
  545. Prednisone delayed Release Tablet 5 mg
  546. Circular Temperature Recording Chart Measurements
  547. Management Board finalises its long-term plan and adopts workprogramme and budget for 2005
  548. EMEA-003410-PIP01-23 - paediatric investigation plan
  549. Arif Subhan: Educating Future Generations of Healthcare Technology Management…
  550. ema-clobutinol-referralClobutinol - referral
  551. COVID-19: EMA starts rolling review of molnupiravir
  552. 21 CFR 74.3206: D&C Green No. 6.
  553. Polytetrafluoroethylene (PTFE)
  554. EMEA-001693-PIP01-14 - paediatric investigation plan
  555. cdsco-oral-semaglutideoral Semaglutide
  556. ema-etopophos-referralEtopophos - referral
  557. Notice regarding Revisit of Drugs and Cosmetics Act 1940 and Rules 1945
  558. ema-augmentin-referralAugmentin - referral
  559. Increased fees coming into effect on 1 April 2011
  560. ema-livmarliLivmarli
  561. Cardiovascular safety of Oral Semaglutide
  562. 21 CFR 1.725: What are the consequences of not paying a user fee under this subpart on…
  563. EMEA-002268-PIP03-18 - paediatric investigation plan
  564. Two new medicines for advanced kidney cancer
  565. Guiding Processing Tattoo Machines and Accessories: Join AAMI’s New Working Group
  566. GD211 Training, Module 2 - Information about the manufacturer
  567. EU/3/20/2321 - orphan designation for treatment of Wilson's disease
  568. Tripartite Meeting (JPMA/PhRMA/EBC-PC) hosted by EMEA: 'Approving Innovative Medicines in…
  569. Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed
  570. ema-durveqtixDurveqtix
  571. Regulatory information – EMA improves its guidance for post-authorisation activities
  572. EMEA-000334-PIP01-08-M11 - paediatric investigation plan
  573. Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals
  574. 21 CFR 876.1330: Colon capsule endoscopy system.
  575. In Vitro Diagnostic Medical Devices Regulations 2022 (SI 256/2022) [IVDs]
  576. Update on the implementation of policy on publication of clinical data (Policy 0070)…
  577. Blue Guide: advertising and promoting medicines: Blue Guide: advertising and promotion of…
  578. European Medicines Agency statement on Herceptin
  579. PSUSA/00001445/202311 - periodic safety update report single assessment
  580. cdsco-lidocaine-spray-10-w-vLidocaine Spray 10% w/v
  581. 21 CFR 884.5350: Contraceptive diaphragm and accessories.
  582. 21 CFR 870.1300: Catheter cannula.
  583. Veterinary good pharmacovigilance practices (VGVP)
  584. Plasma master files: application form
  585. 21 CFR 886.1940: Tonometer sterilizer.
  586. cfr-21-cfr-73-1095-carotene21 CFR 73.1095: β-Carotene.
  587. 21 CFR 886.4355: Corneal inlay inserter handle.
  588. EU/3/15/1582 - orphan designation for treatment of acute myeloid leukaemia
  589. Injectable veterinary medicinal products containing vitamin A for use in food producing…
  590. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  591. EMEA-000715-PIP05-13-M05 - paediatric investigation plan
  592. ema-seroquel-xr-referralSeroquel XR - referral
  593. Medical Device Rule 2017 - GSR 78(E) Dated- 31.01.2017
  594. Intravenous Allogeneic Mesenchymal
  595. cfr-21-cfr-895-20-general21 CFR 895.20: General.
  596. Maximum residue limits (MRL)
  597. Allogenic mesenchymal stem cell-based products for veterinary use: specific questions on…
  598. EMEA-002266-PIP01-17 - paediatric investigation plan
  599. EU/3/15/1456 - orphan designation for prevention of bronchopulmonary dysplasia
  600. 21 CFR 862.3450: Gentamicin test system.
  601. EMEA-000781-PIP01-09 - paediatric investigation plan
  602. Acetaminophen - Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage…
  603. European Society of Cardiology (ESC) bilateral meeting
  604. Bedaquiline, Delamanid, Linezolid and Clofazimine
  605. PSUSA/00001166/201902 - periodic safety update report single assessment
  606. cdsco-sar442168SAR442168
  607. EU/3/08/536 - orphan designation for treatment of pancreatic cancer
  608. Validity of a marketing authorisation (veterinary medicines)
  609. EMEA-000917-PIP02-11 - paediatric investigation plan
  610. Azilsartan Kamedoxomil eq. to Azilsartan Medoxomil Cilnidipine film coated bilayaered…
  611. ema-ipiqueIpique
  612. EU/3/01/076 - orphan designation for prevention of Pseudomonas aeruginosa infections in…
  613. FDA warns about a serious lung condition in infants and newborns treated with Proglycem…
  614. EU/3/14/1365 - orphan designation for treatment of post-polycythaemia vera myelofibrosis
  615. EMEA-002229-PIP02-21-M01 - paediatric investigation plan
  616. EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine…
  617. EU/3/15/1448 - orphan designation for treatment of facioscapulohumeral muscular dystrophy
  618. Women, See Yourself in HTM
  619. November 1st 2017 GSR 1357(E)
  620. ema-bravectoBravecto
  621. 21 CFR 16.5: Inapplicability and limited applicability.
  622. Glycopyrronium (As Glycopyrrolate IP) 12.5mcg + Formoterol Fumarate Dihydrate IP 6mcg…
  623. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 March 2014
  624. 21 CFR 809.10: Labeling for in vitro diagnostic products.
  625. cdsco-granexin-gelGranexin Gel
  626. EMEA-000719-PIP02-10 - paediatric investigation plan
  627. Orphan designation: marketing authorisation
  628. 21 CFR 807.94: Format of a class III certification.
  629. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 8-10 March 2011
  630. PSUSA/00010606/202206 - periodic safety update report single assessment
  631. Ketoconazole-containing medicines - referral
  632. EMEA-001417-PIP01-12-M04 - paediatric investigation plan
  633. 21 CFR 888.4200: Cement dispenser.
  634. First Teen BMET Apprentice Joins AAMI National Program
  635. ema-fanaptumFanaptum
  636. EU/3/18/1995 - orphan designation for treatment of salivary gland cancer
  637. 21 CFR 880.6305: Ingestible event marker.
  638. EU/3/06/415 - orphan designation for prevention of rejection for corneal transplant
  639. Management Board: Meetings 2011
  640. AAMI News, December 2021, Vol.56, No.12
  641. EU/3/11/860 - orphan designation for treatment of Leber's hereditary optic neuropathy
  642. Hydrocortisone aceponate Ecuphar (previously Cortacare)
  643. EU/3/22/2671 - orphan designation for treatment of mucopolysaccharidosis type IV A…
  644. 21 CFR 26.71: Exchange of information.
  645. Guidance for the interpretation of significant change of a medical device
  646. PSUSA/00000461/201512 - periodic safety update report single assessment
  647. NMPA Announcement on Further Strengthening the Supervision and Administration of Entrusted…
  648. EMEA-000936-PIP01-10 - paediatric investigation plan
  649. PSUSA/00010239/201708 - periodic safety update report single assessment
  650. PSUSA/00010710/202401 - periodic safety update report single assessment
  651. Committee for medicinal products for veterinary use: Meeting of 4 to 6 October 2005
  652. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration…
  653. Two further modules on good pharmacovigilance practices released for public consultation
  654. cdsco-ranibizumabRanibizumab
  655. Workshop on the application of the General Data Protection Regulation (GDPR) in the area…
  656. NMPA Announcement on Matters Concerning the Implementation of the Provisions for Medical…
  657. Seventh Meeting of the Management Board
  658. 21 CFR 17.25: Exchange of witness lists, witness statements, and exhibits.
  659. Further guidance on interpretation of the data from VICH GL27 - Scientific guideline
  660. EU/3/05/285 - orphan designation for treatment of acute lung Injury
  661. Facilitating Decentralised Clinical Trials in the EU
  662. Adverse incidents: in vitro diagnostic (IVD) blood glucose meters: Adverse incidents with…
  663. Committee for Medicinal Products for Human Use (CHMP): 15-18 December 2014
  664. EU/3/14/1366 - orphan designation for treatment of primary myelofibrosis
  665. Team-NB Press Release July Survey Capacities 20180820
  666. ema-retsevmoRetsevmo
  667. Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 June 2018
  668. EU/3/04/230 - orphan designation for treatment of cystic fibrosis
  669. Notice to stakeholders - Draft guidance document for consultation: Guide to Good…
  670. EMEA-002881-PIP01-20-M01 - paediatric investigation plan
  671. Learnings initiative webinar for optimal use of big data for regulatory purpose
  672. Meeting highlights from the Paediatric Committee: 24 - 26 June 2009
  673. European Union (National Research Ethics Committees For Performance Studies of In Vitro…
  674. cdsco-lenalidomideLenalidomide
  675. 21 CFR 876.4680: Ureteral stone dislodger.
  676. EMEA-000887-PIP01-10 - paediatric investigation plan
  677. ema-pirfenidone-viatrisPirfenidone Viatris
  678. EMA/FDA analysis shows high degree of alignment in marketing application decisions between…
  679. 21 CFR 866.5170: Breast milk immunological test system.
  680. STATE NSQ ALERT FOR THE MONTH OF FEBRUARY-2025
  681. 21 CFR 888.3630: Resorbable shoulder spacer.
  682. Report published on the uses of medicines for children in the European Union
  683. cdsco-filgotinibfilgotinib
  684. cfr-21-cfr-820-140-handling21 CFR 820.140: Handling.
  685. EMEA-001973-PIP01-16 - paediatric investigation plan
  686. 21 CFR 892.1900: Automatic radiographic film processor.
  687. ema-zomaristZomarist
  688. Martina Schüssler-Lenz re-elected as chair of Committee for Advanced Therapies
  689. EU/3/12/1079 - orphan designation for treatment of malaria
  690. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24…
  691. ema-levviaxLevviax
  692. ema-pelgrazPelgraz
  693. EU/3/21/2442 - orphan designation for treatment of Rett syndrome
  694. Chapter 9 - General advice on due diligence Northern Ireland
  695. EU/3/14/1271 - orphan designation for treatment of follicular lymphoma
  696. Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from…
  697. Knee Replacement Surgical Navigation Positioning System Approved for Marketing
  698. EMEA-000840-PIP01-10 - paediatric investigation plan
  699. Regulatory information - Management of changes to risk management plans and certain…
  700. EU/3/12/1077 - orphan designation for treatment of Duchenne muscular dystrophy
  701. Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing…
  702. Medical Device Adverse Event reporting form
  703. RLS Protein Subunit Vaccine against SARS CoV 2 Virus
  704. The new EudraVigilance System and the electronic reporting of the individual case safety…
  705. EU/3/17/1878 - orphan designation for treatment of Niemann-Pick disease
  706. 21 CFR 74.1328: D&C Red No. 28.
  707. EU/3/12/1053 - orphan designation for treatment of ovarian cancer
  708. PSUSA/00010117/201704 - periodic safety update report single assessment
  709. EMA recommends changes to prescribing information for vancomycin antibiotics
  710. Procedural advice on the submission of variations for annual update of human influenza…
  711. EU/3/20/2377 - orphan designation for treatment of progressive myoclonic epilepsy type 2…
  712. EMEA-002396-PIP01-18 - paediatric investigation plan
  713. 21 CFR 882.4215: Clip rack.
  714. John Wilkinson: Are Today's Regulatory Paradigms Fit for the Future?
  715. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August-1…
  716. European Medicines Agency launches public consultation on new transparency policy
  717. dlnsulin Glargine 100U/mL
  718. cfr-21-cfr-82-51-lakes-fd-c21 CFR 82.51: Lakes (FD&C).
  719. EMEA-000194-PIP03-10 - paediatric investigation plan
  720. 21 CFR 880.2420: Electronic monitor for gravity flow infusion systems.
  721. Granupas (previously Para-aminosalicylic acid Lucane)
  722. EU/3/05/313 - orphan designation for treatment of severe combined immunodeficiency (SCID)…
  723. ema-remeron-referralRemeron - referral
  724. Reporting requirements for marketing-authorisation holders
  725. 21 CFR 882.1460: Nystagmograph.
  726. Refusal of orphan designation for treatment of P-gp positive breast cancer
  727. FDA review of study sheds light on two deaths associated with the injectable schizophrenia…
  728. GN-10-R4 Guidance on Medical Device Field Safety Corrective Action (2025 Jul) PUB
  729. ema-darzalexDarzalex
  730. Requesting scientific advice or protocol assistance from EMA
  731. 21 CFR 884.2640: Fetal phonocardiographic monitor and accessories.
  732. 21 CFR 870.3535: Intra-aortic balloon and control system.
  733. Cyproterone- and ethinylestradiol-containing medicines - referral
  734. 21 CFR 864.9400: Stabilized enzyme solution.
  735. Drug Alert for the month of May,2018
  736. PSUSA/00000449/202104 - periodic safety update report single assessment
  737. EMEA-001300-PIP01-12 - paediatric investigation plan
  738. ema-emselexEmselex
  739. EMA and EUnetHTA finalise joint work plan for 2017-2020
  740. On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation…
  741. ema-velsipityVelsipity
  742. Regulatory information – New guidance on type II variations and marketing authorisation…
  743. EU/3/13/1139 - orphan designation for treatment of amyotrophic lateral sclerosis
  744. AAMI All Star: Larry Talapa
  745. ema-ema-in-london-1995-2019EMA in London (1995-2019)
  746. cdsco-sco-120SCO-120
  747. cdsco-insulinaspartmix30InsulinaspartMix30
  748. ema-nordimetNordimet
  749. cdsco-azd5462AZD5462
  750. Symptoms sometimes referred to as Breast Implant Illness
  751. 21 CFR 19.21: Duty to report violations.
  752. European Agency for the evaluation of medicinal products: Committee for Proprietary…
  753. Committee for Medicinal Products for Human Use (CHMP): 20-23 July 2020
  754. EMEA-001080-PIP03-18 - paediatric investigation plan
  755. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - July 2023
  756. EMA starts review of Paxlovid for treating patients with COVID-19
  757. ema-indimacis-125Indimacis 125
  758. CVMP: meeting archive 2013-2015
  759. European Medicines Agency review of pandemic vaccines underway
  760. Encorafenib Plus Cetuximab
  761. PSUSA/00001195/201711 - periodic safety update report single assessment
  762. European Medicines Agency launches consultation on its position on replacement of animal…
  763. 2022.02.09_Draft GSR 104(E)_Regulation of sale of medical devices via registration of…
  764. European Medicines Agency closed 1 May 2015
  765. Quality Control Testing of viral load monitoring kits HIV, HBV, HCV
  766. Committee for Advanced Therapies (CAT): 15-16 February 2018
  767. Forum Participants Tackle HTM Personnel Pipeline Shortage
  768. First treatment for rare inherited muscle contraction disorders
  769. Drug Alert list for month of March 2013
  770. FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by…
  771. First EMEA workshop with industry on Orphan Medicinal Products
  772. EU/3/15/1485 - orphan designation for treatment of neuroblastoma
  773. ema-yescartaYescarta
  774. Questions and answers on Ethanol in the context of the revision of the guideline on…
  775. 21 CFR 25.52: Environmental impact statements.
  776. Ulipristal acetate tablet 30mgIII
  777. EU/3/00/003 - orphan designation for treatment of Fabry disease
  778. Reflecting on CyberInsights with Axel Wirth
  779. cdsco-vay736-ianalumabVAY736 (Ianalumab)
  780. 21 CFR 872.3530: Mechanical denture cleaner.
  781. ema-varilrix-referralVarilrix - referral
  782. Ten recommendations to unlock the potential of big data for public health in the EU
  783. 14th Joint European Medicines Agency/European network for Health Technology Assessment…
  784. PSUSA/000000330/202206 - periodic safety update report single assessment
  785. ema-prevexxion-rnPrevexxion RN
  786. Use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies…
  787. 21 CFR 866.4700: Automated fluorescence in situ hybridization (FISH) enumeration systems.
  788. Use of the Texas Instruments Model 59 Programmable Calculator in the Enforcement of the…
  789. Webinar presentation: How to improve your GMP compliance for listed medicines and GMP…
  790. cdsco-molnupiravir-mildaMolnupiravir Milda
  791. DR_G.S.R. 1230(E) dt_21.12.2018_Rule 170_Prohibition of advt. of Aurvedic, Siddha and…
  792. ema-purevax-rcchPurevax RCCh
  793. ema-vectra-felisVectra Felis
  794. PSUSA/00003048/201703 - periodic safety update report single assessment
  795. Paediatric Committee (PDCO): 6-8 June 2012
  796. EU/3/16/1807 - orphan designation for treatment of functional single ventricle congenital…
  797. Sertaconazole Nitrate + Terbinafine HCl cream (Phase III Clinical Trial)
  798. Exploring new ways to fight antimicrobial resistance
  799. （In Japanese） Ministerial Ordinance on Good Clinical Practice for Drugs
  800. Polygoni avicularis herba - herbal medicinal product
  801. Good Label and Package Practices Guide for Prescription Drugs
  802. 21 CFR 71.15: Confidentiality of data and information in color additive petitions.
  803. EU/3/15/1479 - orphan designation for prevention of graft rejection following solid organ…
  804. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 2-4 June 2015
  805. Notice regarding New Drugs dated 18.02.2020
  806. ema-ruviseRuvise
  807. 21 CFR 878.4960: Operating tables and accessories and operating chairs and accessories.
  808. First gene therapy to treat haemophilia B
  809. 2013.11.07_S.O. 3395(E)_Notification for Appointment of Drugs Inspectors
  810. EU/3/14/1426 - orphan designation for prevention of graft-versus-host disease
  811. Important safety label changes to cholesterol-lowering statin drugs
  812. ema-zalastaZalasta
  813. PSUSA/00002664/201711 - periodic safety update report single assessment
  814. EU/3/04/196 - orphan designation for treatment of atopic keratoconjunctivitis
  815. GN-07-R3 Guidance on Complaint Handling (2023 Sep) PUB [PDF, 238 KB]
  816. ECDC and EMA issue advice on fourth doses of mRNA COVID-19 vaccines
  817. EMEA-000249-PIP01-10 - paediatric investigation plan
  818. 21 CFR 862.3100: Amphetamine test system.
  819. Sitagliptin phosphate monohydrate / simvastatin - paediatric investigation plan
  820. Management Board meeting: 1 October 2009
  821. EMEA-003206-PIP01-22 - paediatric investigation plan
  822. EMEA-002054-PIP01-16-M03 - paediatric investigation plan
  823. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2013
  824. cdsco-azacitidineAzacitidine
  825. Povidone Iodine throat spray 0.45% w/vCT/SND/24/2023
  826. First Fully Disposable Duodenoscope Receives FDA Clearance
  827. AS P0021.003: Appeals Procedure
  828. Regulation on Medical Device Re-evaluation
  829. DBS Lead Approved for Marketing
  830. Committee for Advanced Therapies (CAT): 4-6 November 2020
  831. EU/3/12/949 - orphan designation for treatment of citrullinaemia type 1
  832. Joint scientific report of the European Centre for Disease Prevention and Control (ECDC)…
  833. EU/3/18/2102 - orphan designation for treatment of short bowel syndrome
  834. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.8) Regulations…
  835. NMPA Issued the Announcement on Medical Device GMP Appendix: Independent Software
  836. ema-surfaxinSurfaxin
  837. VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity…
  838. Zirconium Niobium Alloy Femoral Head Approved for Marketing
  839. Furosemide Vitabalans - referral
  840. January 16 2017 GSR 36(E)
  841. LY3502970 Compared with Placebo
  842. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16…
  843. Website outages and upgrades
  844. Spring Sterilization Standards Week 2024: What You Should Know
  845. 15th meeting of the Committee for Orphan Medicinal Products
  846. NOTICE regarding Adhering to Rule 28 and 28A of Drugs and Cosmetics Act and Rules 1945
  847. EMA regular press briefing on COVID-19
  848. Exelon - withdrawal of application for variation to marketing authorisation
  849. Registration open for workshop on the clinical investigation of medicines for the…
  850. Committee for Medicinal Products for Veterinary Use (CVMP): 14-15 June 2022
  851. Camelliae sinensis non fermentatum folium - herbal medicinal product
  852. EudraVigilance Information Day
  853. ema-pemetrexed-baxterPemetrexed Baxter
  854. EMEA-002094-PIP01-16 - paediatric investigation plan
  855. Sanofi-aventis withdraws its marketing authorisation application forAquilda (satavaptan)
  856. PSUSA/00001924/201605 - periodic safety update report single assessment
  857. EU/3/18/2111 - orphan designation for treatment of limbal stem cell deficiency
  858. PSUSA/00003185/201502 - periodic safety update report single assessment
  859. EMEA-002052-PIP02-23 - paediatric investigation plan
  860. Committee for Advanced Therapies (CAT): 12-13 May 2015
  861. Metformin Hydrochloride IP (as prolonged release) + Teneligliptin IP + Dapagliflozin…
  862. September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement…
  863. ema-mpoxMpox
  864. Ch. 4 - Advisory Actions
  865. Lisinopril Biochemie - referral
  866. EU/3/18/1991 - orphan designation for treatment of sickle cell disease
  867. The Fun (Yes, Fun) of International Standards Development: A Conversation with Damien Berg
  868. PSUSA/00002064/202110 - periodic safety update report single assessment
  869. European Medicines Agency phasing out follow-up measures
  870. European Medicines Agency discusses pharmacovigilance with French General Inspectorate of…
  871. EU/3/06/383 - orphan designation for treatment of T-cell and NK-cell neoplasms
  872. Linagliptin + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin tablets (Phase…
  873. EMEA-001302-PIP01-12 - paediatric investigation plan
  874. European Medicines Agency publishes 2012 annual report
  875. Team-NB Position Paper Artificial Intelligence
  876. Working with stakeholders
  877. Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2023
  878. ema-recothromRecothrom
  879. New medicine for the prevention of migraine
  880. Vedolizumab powder for concentrate for solution for infusion 300mg/vial (r-DNA origin)
  881. Breast implant associated cancer: health professionals information
  882. 21 CFR 868.5620: Breathing mouthpiece.
  883. 21 CFR 888.4600: Protractor for clinical use.
  884. Chemical structure and properties criteria to be considered for the evaluation of new…
  885. ema-pedmarqsiPedmarqsi
  886. ema-parvodukParvoduk
  887. ema-how-to-payHow to pay
  888. 21 CFR 14.122: Functions of TEPRSSC.
  889. ema-nobivac-piroNobivac Piro
  890. European Medicines Agency makes recommendations on the use ofantimicrobials in livestock…
  891. ema-forcaltoninForcaltonin
  892. Use of medicines in pregnancy and breastfeeding
  893. EMA confirms measures to minimise the risk of serious side effects with medicines…
  894. Committee for Orphan Medicinal Products (COMP): 22-24 January 2019
  895. EMEA-003371-PIP01-22 - paediatric investigation plan
  896. 21 CFR 880.5730: Alternate controller enabled infusion pump.
  897. Current status of European Medicines Agency policy on publication of clinical data…
  898. EMEA-000300-PIP01-08-M04 - paediatric investigation plan
  899. EU/3/06/404 - orphan designation for treatment of Li Fraumeni Syndrome
  900. Simvastatin / sitagliptin phosphate monohydrate - paediatric investigation plan
  901. Public Statement on Levacetylmethadol (Orlaam) - Life Threatening Cardiac Rhythm Disorders
  902. ema-apretudeApretude
  903. EMEA-002636-PIP01-19 - paediatric investigation plan
  904. ema-btvpur-alsap-2-4BTVPUR AlSap 2-4
  905. Draxxin - withdrawal of application for variation to marketing authorisation
  906. Committee for Medicinal Products for Human Use (CHMP): 21-24 October 2013
  907. EMEA-000641-PIP01-09 - paediatric investigation plan
  908. 21 CFR 2.35: Use of secondhand containers for the shipment or storage of food and animal…
  909. EMEA-001257-PIP01-11 - paediatric investigation plan
  910. 21 CFR 884.1040: Viscometer for cervical mucus.
  911. cdsco-aur106AUR106
  912. U.S. FDA Recognizes ANSI/AAMI ST91:2021 and More Among Updated List of ‘Appropriate’…
  913. EU/3/06/384 - orphan designation for treatment of pancreatic cancer
  914. PSUSA/00002991/202206 - periodic safety update report single assessment
  915. cdsco-pxl01PXL01
  916. EMEA-002090-PIP01-16 - paediatric investigation plan
  917. PSUSA/00001500/202304 - periodic safety update report single assessment
  918. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January…
  919. EU/3/11/937 - orphan designation for treatment of Leigh syndrome
  920. EU/3/09/722 - orphan designation for treatment of diffuse large B-cell lymphoma
  921. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  922. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 October 2026
  923. 21 CFR 892.1660: Non-image-intensified fluoroscopic x-ray system.
  924. ema-jayempiJayempi
  925. ema-plerixafor-accordPlerixafor Accord
  926. Treatment and prophylaxis of respiratory syncytial virus (RSV) disease - Scientific…
  927. PSUSA/00001910/202312 - periodic safety update report single assessment
  928. Sterilization-Related Challenges of Off-Site Transportation of Medical Equipment
  929. PSUSA/00001971/201510 - periodic safety update report single assessment
  930. The use of GMDN codes for IVD medical devices in Australia
  931. Training session on the review of product information (for patient and consumer…
  932. EU/3/07/473 - orphan designation for treatment of sarcoidosis
  933. EU/3/01/025 - orphan designation for treatment of mucopolysaccharidosis VI (Maroteaux-Lamy…
  934. EMEA-003051-PIP05-22 - paediatric investigation plan
  935. Briviact (in Italy: Nubriveo)
  936. NMPA Issued 27 Medical Device Industry Standards (Covering YY 0096-2019 Co-60 Teletherapy…
  937. ema-viraceptViracept
  938. Explanation of Electronic Study Data (Form B)
  939. Repurposing of medicines pilot project webinar
  940. Guideline on data monitoring committees
  941. EU/3/19/2142 - orphan designation for treatment of epidermolysis bullosa
  942. Ibrutinib product-specific bioequivalence guidance
  943. ema-prezistaPrezista
  944. EMEA-002541-PIP01-18 - paediatric investigation plan
  945. ema-myfenaxMyfenax
  946. ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 - Public Consultation
  947. European Medicines Agency publishes updated set of mandatory Article 57(2) requirements…
  948. Advertising health services
  949. EMEA-001659-PIP01-15-M06 - paediatric investigation plan
  950. Malvae sylvestris flos - herbal medicinal product
  951. Public statement on supply of Norvir hard capsules
  952. ema-somatropin-biopartnersSomatropin Biopartners
  953. EU/3/10/761 - orphan designation for treatment of cystic fibrosis
  954. EMEA-002537-PIP02-19 - paediatric investigation plan
  955. Partial Revision of “Handling of Re-Examination Period”
  956. cdsco-cariprazineCariprazine
  957. 21 CFR 886.1750: Skiascopic rack.
  958. PSUSA/00010080/201707 - periodic safety update report single assessment
  959. 21 CFR 862.3320: Digoxin test system.
  960. 21 CFR 884.5210: Pressure wedge for the reduction of cesarean delivery.
  961. Regulatory information – Green light for reliance on Article 57 database for key…
  962. PSUSA/00001128/201505 - periodic safety update report single assessment
  963. EU/3/08/542 - orphan designation for treatment of acute myeloid leukaemia
  964. ema-agamreeAgamree
  965. ema-gluscan-500-referralGluscan 500 - referral
  966. COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
  967. Combination: Thymi herba and Primulae radix - herbal medicinal product
  968. Point-of-care Manufacturing of Medical Devices Steering Committee, Meeting statement…
  969. EMEA-002472-PIP02-19 - paediatric investigation plan
  970. PSUSA/00001711/202207 - periodic safety update report single assessment
  971. 21 CFR 868.2700: Pressure regulator.
  972. Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting…
  973. EMA confirms withdrawal of two court cases concerning access to clinical-trial data
  974. EMEA-002512-PIP01-18 - paediatric investigation plan
  975. Diamorphine hydrochloride - paediatric investigation plan
  976. PSUSA/00001499/201902 - periodic safety update report single assessment
  977. Prilocaine, Lidocaine - paediatric investigation plan
  978. PSUSA/00002472/202010 - periodic safety update report single assessment
  979. EMEA-003232-PIP01-22 - paediatric investigation plan
  980. cfr-21-cfr-1-80-cosmetics21 CFR 1.80: Cosmetics.
  981. EMEA-002424-PIP02-19 - paediatric investigation plan
  982. NMPA and NHC Issued the Announcement on Good Clinical Practice
  983. Committee for Advanced Therapies (CAT): 13-14 March 2014
  984. Medical devices regulations: compliance and enforcement: Report a non-compliant or…
  985. EU/3/05/331 - orphan designation for treatment of malabsorption due to exocrine pancreatic…
  986. Committee for Medicinal Products for Human Use (CHMP): 12-15 September 2016
  987. NMPA’s Opinions on Deepening the Reform of Cosmetics Regulation and Promoting High-Quality…
  988. Introducing the AAMI Fellows Class of 2022
  989. EU/3/19/2139 - orphan designation for treatment of non-traumatic osteonecrosis
  990. EU/3/12/1019 - orphan designation for treatment of hepatocellular carcinoma
  991. European Medicines Agency public statement on update on hexavalent vaccines: Hexavac and…
  992. EU/3/21/2510 - orphan designation for treatment of hypoparathyroidism
  993. Receipt of Cough Syrup of same batch No.by two different NABL Accredited Government…
  994. Clinical trials for medicines: Diagnostic Radiopharmaceutical Investigation Medicinal…
  995. Strengthening of Materiovigilance Programme of India (MvPI) in the country
  996. EU/3/20/2251 - orphan designation for treatment of malaria
  997. Veterinary Big Data stakeholder forum
  998. cdsco-corrigendumCorrigendum
  999. Have your say and help shape EMA’s future communications

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