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Global regulations and guidance

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

  1. Abaloparatide Injection 3120 mcg/1.56mL
  2. Glycini semen - herbal medicinal product
  3. Teneligliptin and Sitagliptin
  4. EMEA-002769-PIP01-20 - paediatric investigation plan
  5. PSUSA/00002065/202208 - periodic safety update report single assessment
  6. DR_G.S.R. 810(E) dt_13.12.2004_26A_reg Rofecoxib and its formulations
  7. 21 CFR 862.2800: Refractometer for clinical use.
  8. 21 CFR 884.3575: Vaginal pessary.
  9. PSUSA/00002472/202210 - periodic safety update report single assessment
  10. EMEA-000979-PIP01-10-M02 - paediatric investigation plan
  11. European Medicines Agency statement on the suspension of use of Bextra
  12. Notice Dated 11.09.2015 regarding DTAB
  13. EMEA-002347-PIP01-18 - paediatric investigation plan
  14. EU/3/12/1094 - orphan designation for treatment of achondroplasia
  15. Medicine evaluation figures
  16. Dengue Tetravalent Vaccine (Live, Attenuated) Serum
  17. EMEA-002540-PIP01-18 - paediatric investigation plan
  18. EMEA-001441-PIP07-21 - paediatric investigation plan
  19. cdsco-iqviaIQVIA
  20. LEE011M/s Novartis Healthcare
  21. Guidance on Classification of GMP Deficiencies
  22. EMEA-003028-PIP01-21 - paediatric investigation plan
  23. Clinical investigation of medicinal products for the treatment of chronic constipation…
  24. AAMI News, February 2020, Vol. 55, Issue 2
  25. 21 CFR 74.1255: D&C Orange No. 5.
  26. Announcement of the National Medical Products Administration, Ministry of Agriculture and…
  27. 21 CFR 890.3420: External limb prosthetic component.
  28. Non-clinical testing for inadvertent germline transmission of gene transfer vectors…
  29. PSUSA/00002895/201511 - periodic safety update report single assessment
  30. ACMD meeting statement, Meeting 27, 24 June 2016
  31. FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like…
  32. Cholic acid product-specific bioequivalence guidance
  33. 21 CFR 874.4420: Ear, nose, and throat manual surgical instrument.
  34. EU/3/16/1795 - orphan designation for treatment of achromatopsia caused by mutations in…
  35. EMEA-001630-PIP01-14 - paediatric investigation plan
  36. Reporting suspected side effects of medicines in patients with COVID-19
  37. Mattress decontamination: poster
  38. Committee for Advanced Therapies (CAT): 15-16 May 2012
  39. EU/3/06/408 - orphan designation for prevention of congenital cytomegalovirus infection…
  40. Working together for safe medicines in the EU
  41. EMEA-002469-PIP01-18 - paediatric investigation plan
  42. 21 CFR 882.1020: Rigidity analyzer.
  43. A Future of VR in Healthcare? Insights from the American Medical Extended Reality…
  44. EudraVigilance information day
  45. Categorisation of antibiotics used in animals promotes responsible use to protect public…
  46. 30 mg bid of evenamide (NW-3509)
  47. 21 CFR 866.3373: Nucleic acid-based in vitro diagnostic devices for the detection of…
  48. Inspection and Field Testing of Radiation-Emitting Electronic Products (updated 01/01/23)
  49. EU/3/01/059 - orphan designation for treatment of anthracycline extravasations
  50. EU/3/22/2690 - orphan designation for treatment of chondrosarcoma
  51. ema-wilzinWilzin
  52. Procedure to be followed for subsequnt applicants in respect of FDCs falling under…
  53. EU/3/12/1097 - orphan designation for treatment of follicular lymphoma
  54. Why ASCA is Here to Stay, and How it Can Help You
  55. cdsco-rilpivirineRilpivirine
  56. 21 CFR 872.3661: Optical Impression Systems for CAD/CAM.
  57. Brexpiprazole tablets 1mg,2mg,3mg and 4 mg
  58. Committee for Orphan Medicinal Products (COMP): 17-19 March 2015
  59. EU/3/13/1198 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's…
  60. Drug Alert for the Month of February 2023 (Revised)
  61. EU/3/12/1016 - orphan designation for treatment of neuroblastoma
  62. EMEA-002798-PIP02-21 - paediatric investigation plan
  63. ema-trifexisTrifexis
  64. EMEA-000434-PIP01-08-M09 - paediatric investigation plan
  65. Medical Foods - Import and Domestic
  66. Unapproved biologicals: pathways for access
  67. EMEA-002309-PIP01-17 - paediatric investigation plan
  68. Acebrophylline 100mg + Erdosteine 300mg film coated tablets
  69. 21 CFR 866.2320: Differential culture medium.
  70. European Medicines Agency closed 1 May 2013
  71. Medicinal Products (Prescription and Control of Supply) (Amendment) (No 7) Regulations…
  72. ema-methylphenidate-referralMethylphenidate - referral
  73. EMEA-000716-PIP01-09-M05 - paediatric investigation plan
  74. ema-thorinaneThorinane
  75. EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19
  76. Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2016
  77. ARGB Appendix 4 - Guidance on TGO 88
  78. EU/3/05/317 - orphan designation for treatment of graft-versus-host disease
  79. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  80. PSUSA/00010003/201508 - periodic safety update report single assessment
  81. PSUSA/00010650/202202 - periodic safety update report single assessment
  82. EU/3/11/928 - orphan designation for treatment of cystic fibrosis
  83. EU/3/10/784 - orphan designation for treatment of haemophilia A
  84. cdsco-ruxolitinibRuxolitinib
  85. Hydroxyprogesterone caproate-containing medicinal products - referral
  86. EU/3/15/1528 - orphan designation for treatment of primary hyperoxaluria type 1
  87. Closer ties on medicines safety between EU and Japan
  88. 21 CFR 73.2645: Aluminum powder.
  89. First joint meeting of the EMA Scientific Committees' Working Party with Patients' and…
  90. Questions and answers on the CHMP recommendation to allow Viracept back onto the market
  91. ema-general-proceduresGeneral procedures
  92. cdsco-linaclotide-capsulesLinaclotide Capsules
  93. EMEA-003224-PIP01-22 - paediatric investigation plan
  94. Fluconazol Tiefenbacher 50mg, 100mg, 150mg, 200mg capsules, hard - referral
  95. European Medicines Agency receives first pandemic influenza vaccine application
  96. Don Armstrong: How Are You?
  97. Quarterly System Demo – Q3 2024
  98. cfr-21-cfr-21-45-fees21 CFR 21.45: Fees.
  99. Sept_9,2009(G.S.R_651(E)
  100. EMEA-002252-PIP01-17 - paediatric investigation plan
  101. 21 CFR 890.3110: Electric positioning chair.
  102. Agni casti fructus - herbal medicinal product
  103. 21 CFR 862.1280: Estrone test system.
  104. European Medicines Agency and COCIR bilateral meeting
  105. PSUSA/00000599/201512 - periodic safety update report single assessment
  106. EMEA-002217-PIP01-17-M02 - paediatric investigation plan
  107. EMEA recommends changes in the storage conditions for Neupro (rotigotine)
  108. 21 CFR 872.3165: Precision attachment.
  109. ema-parsabivParsabiv
  110. Core summary of product characteristics for human tick-borne encephalitis immunoglobulin…
  111. Gazette notification G.S.R 763(E) dated 15.12.2020_Cosmetics Rules 2020
  112. 21 CFR 874.3730: Laryngeal prosthesis (Taub design).
  113. EU/3/18/2020 - orphan designation for treatment of AL amyloidosis
  114. Posting of clinical trial summary results in European Clinical Trials Database (EudraCT)…
  115. The Expanding Importance of IT Skills for HTM Professionals
  116. ema-atacand-referralAtacand - referral
  117. 21 CFR 866.3361: Mass spectrometer system for clinical use for the identification of…
  118. ARGB Appendix 5 - Guidance on TGO 85
  119. EU/3/13/1169 - orphan designation for treatment of osteosarcoma
  120. Safety Is a Must when Repairing or Replacing Equipment in an Isolation or COVID-19 Room
  121. ema-seffalair-spiromaxSeffalair Spiromax
  122. 21 CFR 808.20: Application.
  123. 21 CFR 884.6200: Assisted reproduction laser system.
  124. 21 CFR 866.3290: Gonococcal antibody test (GAT).
  125. European Medicines Agency workshop on the collaboration with general practitioners /…
  126. Therapeutic goods and use of human embryos or human embryonic stem cells or material…
  127. PSUSA/00001858/201609 - periodic safety update report single assessment
  128. EU/3/01/078 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's…
  129. Industry stakeholder teleconference on Brexit and operation of the centralised procedure…
  130. ema-lenalidomide-accordLenalidomide Accord
  131. EMEA-002421-PIP01-18 - paediatric investigation plan
  132. Intravascular Imaging Device Approved for Marketing
  133. PSUSA/00010288/201705 - periodic safety update report single assessment
  134. 21 CFR 868.5280: Breathing tube support.
  135. Facilitating the development of gene therapies
  136. ENCePP e-register reaches 100 post-authorisation studies
  137. TEAM-NB-Member-List-37-web
  138. ema-tasignaTasigna
  139. Expert workshop on subgroup analysis
  140. New layout for EMA scientific guidelines
  141. cdsco-revefenacinRevefenacin
  142. Electronic Application Form and Cover Letter Tool
  143. ema-baracludeBaraclude
  144. Order: Timeline for communication of recommendation to the stakeholders based on the…
  145. Committee for Orphan Medicinal Products (COMP): 14-16 April 2025
  146. EU/3/17/1945 - orphan designation for treatment of Allan-Herndon-Dudley syndrome
  147. 21 CFR 866.3415: Pseudomonas spp. serological reagents.
  148. EU/3/08/597 - orphan designation for treatment of Huntington’s disease
  149. 21 CFR 868.2900: Gas pressure transducer.
  150. PSUSA/00010299/202003 - periodic safety update report single assessment
  151. HTM Leaders Demonstrate Promising STEM Career Paths for Students
  152. Platform for post-authorisation studies registered as EU trade mark
  153. Manufacturing and marketing of un-approved drug products containing Enclomiphene and its…
  154. Committee for Orphan Medicinal Products (COMP): 16-18 February 2016
  155. Leqvio - direct healthcare professional communication (DHPC)
  156. European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment)…
  157. Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19)…
  158. 21 CFR 880.5430: Nonelectrically powered fluid injector.
  159. 21 CFR 801.109: Prescription devices.
  160. EU/3/21/2409 - orphan designation for treatment of creatine deficiency syndromes
  161. The Ironic State of Cybersecurity in Medical Devices
  162. EU/3/10/809 - orphan designation for treatment of pancreatic cancer
  163. 21 CFR 80.21: Request for certification.
  164. Aide Memoire on the Inspection of Health Based Exposure Limit (HBEL) Assessments and Use…
  165. ema-class-waiversClass waivers
  166. Drug Alert list for month of April 2016
  167. Pharmacovigilance Risk Assessment Committee (PRAC): 5 August 2021
  168. Combimox Lactating Cow - referral
  169. ema-bovilis-btv8Bovilis BTV8
  170. Drug Safety Update: monthly PDF newsletter: Drug Safety Update March 2020
  171. EU/3/08/586 - orphan designation for treatment of Duchenne muscular dystrophy
  172. 21 CFR 864.9050: Blood bank supplies.
  173. EU/3/11/913 - orphan designation for treatment of hepatocellular carcinoma
  174. Assistive technology: definitions, examples and safe use
  175. EMEA-001239-PIP01-11 - paediatric investigation plan
  176. Call for patient organisation representatives to join the Committee for Orphan Medicines
  177. European Medicines Agency acts on deficiencies in Roche medicines-safety reporting
  178. EU/3/14/1405 - orphan designation for treatment of non-infectious uveitis
  179. The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in…
  180. ema-avamysAvamys
  181. Basic Concept on Bioequivalence Evaluation for Addition of Formulations with Different…
  182. EMEA-001410-PIP02-17-M04 - paediatric investigation plan
  183. 21 CFR 1.23: Procedures for requesting variations and exemptions from required label…
  184. EMA closed 18-22 April 2019
  185. Prunus avium peduncle - herbal medicinal product
  186. Committee for Medicinal Products for Human Use (CHMP): 22-25 March 2021
  187. 2018 Annual workshop of the European Network of Paediatric Research at the European…
  188. ema-ibliasIblias
  189. Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE)…
  190. Potential medication errors in the context of benefit risk balance and risk minimisation…
  191. FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of…
  192. PSUSA/00001989/201808 - periodic safety update report single assessment
  193. EMEA-000478-PIP02-18 - paediatric investigation plan
  194. Ad hoc CHMP Expert Group Meeting on 'Nanomedicines'
  195. AVT06 Compared with EU-Eylea
  196. PSUSA/00000026/201805 - periodic safety update report single assessment
  197. ema-world-health-day-2015World Health Day 2015
  198. Regulatory information - adjusted fees for applications to European Medicines Agency from…
  199. Pertuzumab and Trastuzumab Solution for Injection (600 mg + 600 mg/10 mL Vial)
  200. Committee for Orphan Medicinal Products (COMP): 13-15 June 2023
  201. Medicinal products (non-steroidal anti-inflammatory compounds) for the treatment of…
  202. Draft Guidelines on Good Clinical Practices
  203. Healthcare professionals' working party elects co-chair
  204. Pantoprazole Olinka (EMEA/H/A-29/1170) - referral
  205. Consultation and Notice to Stakeholders: Release of Guidance Documents for Consultation…
  206. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9…
  207. FDA warns about increased risk of cancer relapse with long-term use of azithromycin…
  208. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 July 2020
  209. Advate / Rixubis - direct healthcare professional communication (DHPC)
  210. cdsco-endoxifen2Endoxifen2
  211. Mark Heston: Want to Help Patients? Start Thinking Like One
  212. Bempedoic acid 180 mg tablet
  213. ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle…
  214. 21 CFR 862.2265: High throughput genomic sequence analyzer for clinical use.
  215. EMEA-002834-PIP01-20 - paediatric investigation plan
  216. Medical Devices alert july 2019
  217. Influenza (Flu) vaccine factsheet - Information for patients, parents and carers
  218. 21 CFR 870.4100: Extracorporeal circuit and accessories for long-term…
  219. Efficacy and target animal safety data requirements for applications for non-immunological…
  220. ema-efgratinEfgratin
  221. Sepracor Pharmaceuticals Ltd withdraws its marketing authorisation application for Lunivia…
  222. ema-lemtrada-referralLemtrada - referral
  223. EU/3/16/1733 - orphan designation for treatment of glioma
  224. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  225. cdsco-vay736-ianalumabVAY736 (Ianalumab)
  226. 21 CFR 892.2060: Radiological computer-assisted diagnostic software for lesions suspicious…
  227. Devices in practice: checklists for using medical devices
  228. Drug Safety Update: monthly PDF newsletter: Drug Safety Update March 2022
  229. Updated guidance on how to apply for a manufacturer’s certificate to export
  230. EU/3/06/417 - orphan designation for treatment of renal-cell carcinoma
  231. EU/3/22/2588 - orphan designation for treatment of idiopathic pulmonary fibrosis
  232. cdsco-ylb113YLB113
  233. Insulin Human Long Marvel
  234. 21 CFR 862.1590: Porphobilinogen test system.
  235. ema-zoloft-referralZoloft - referral
  236. Revised version of application form for initial evaluation of human medicines available
  237. EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and…
  238. EMEA-000645-PIP04-20-M02 - paediatric investigation plan
  239. European Medicines Agency to host workshop on regulatory options in the fight against…
  240. Development of block-copolymer-micelle medicinal products - Scientific guideline
  241. ema-emtrivaEmtriva
  242. Points to consider for assessors - New factor VIII and factor IX products: potency…
  243. Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
  244. Researcher considerations for medical devices
  245. More information about the MHRA
  246. ema-sunlencaSunlenca
  247. Clinical development of products for specific immunotherapy for the treatment of allergic…
  248. Reporting safety information on clinical trials
  249. PSUSA/00001234/202306 - periodic safety update report single assessment
  250. EU/3/16/1705 - orphan designation for treatment of ornithine transcarbamylase deficiency
  251. ETF recommends updating COVID-19 vaccines to target new JN.1 variant
  252. Pantoprazole Bluefish - referral
  253. PSUSA/00010109/201701 - periodic safety update report single assessment
  254. Validation Master Plan Installation and Operational Qualification Non-Sterile Process…
  255. ema-neuproNeupro
  256. Ketoconazole HRA recommended for approval in Cushing's syndrome
  257. EMEA-001390-PIP01-12 - paediatric investigation plan
  258. Implementation Opinions of NMPA on "Artificial Intelligence + Drug Regulation"
  259. EU’s May 2022 Deadline for Implementing New IVDR Regulations Remains Challenging
  260. ema-vaniqaVaniqa
  261. PRAC recommends strengthening the restrictions on the use of valproate in women and girls
  262. Central repository for safety reports - one year to go before mandatory use
  263. Paediatric Committee (PDCO): 18-21 January 2022
  264. Medical devices: UK approved bodies: UK approved bodies for medical devices
  265. PSUSA/00010078/201703 - periodic safety update report single assessment
  266. PSUSA/00010628/202203 - periodic safety update report single assessment
  267. ema-cinqaeroCinqaero
  268. Press briefing on the conclusion of the assessment of the Pharmacovigilance Risk…
  269. Online training: How to submit initial and follow-up scientific advice applications…
  270. ema-optimarkOptimark
  271. Ontilyv - withdrawal of application for variation to marketing authorisation
  272. cdsco-chemoradiationChemoradiation
  273. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30…
  274. ema-joicelaJoicela
  275. Borderlines between medical devices and medicinal products
  276. EU/3/22/2685 - orphan designation for treatment of urea cycle disorders
  277. ema-lamivudine-tevaLamivudine Teva
  278. EU/3/16/1722 - orphan designation for treatment of amyotrophic lateral sclerosis
  279. Regulatory information – 0.3% and 5.3% increase in general fees from 1 April 2022
  280. Ensuring compliance after removing the product information insert
  281. Clinical trials for medicines: MHRA phase I accreditation scheme
  282. European Medicines Agency concludes review of modified-release oral opioids of the WHO…
  283. The Enforcement Decree of Medical Device Act
  284. EU/3/14/1389 - orphan designation for treatment of mucopolysaccharidosis, type IIIA…
  285. Bisoprolol fumarate / acetylsalicylic acid - paediatric investigation plan
  286. EMEA-002861-PIP02-20-M05 - paediatric investigation plan
  287. EU/3/07/446 - orphan designation for treatment of metachromatic leukodystrophy
  288. Guidance document: Electronic Canadian Drug Facts Table Technical Standards
  289. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  290. Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2012
  291. Drug Alert for the Month of Revised Dec 2023
  292. Appendix 18A Dossier Clarification Supplement
  293. EU/3/08/593 - orphan designation for treatment of multiple myeloma
  294. TEAM NB Draft PositionPaper Authorized Representatives Audit 1
  295. Committee for veterinary medicinal products: 38th meeting
  296. Non-clinical studies required before first clinical use of gene therapy medicinal products…
  297. ema-ogivriOgivri
  298. EMEA-002726-PIP01-19-M03 - paediatric investigation plan
  299. ema-zeffixZeffix
  300. EMEA-000986-PIP02-13 - paediatric investigation plan
  301. ema-topotecan-hospiraTopotecan Hospira
  302. Green light given for new EudraVigilance system for collection and monitoring of suspected…
  303. Integrated management system
  304. NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs…
  305. Committee for Medicinal Products for Human Use (CHMP): 20-23 October 2014
  306. EMEA Creates new Communications and Networking Unit
  307. Committee for Orphan Medicinal Products (COMP): 1-3 December 2026
  308. EU/3/21/2417 - orphan designation for treatment of Krabbe disease
  309. EMEA-003184-PIP01-22 - paediatric investigation plan
  310. ema-forsteoForsteo
  311. EMA regular press briefing on COVID-19
  312. 21 CFR 80.22: Samples to accompany requests for certification.
  313. cdsco-mdr-tb-drugsMDR-TB Drugs
  314. PSUSA/00000110/202101 - periodic safety update report single assessment
  315. 21 CFR 814.124: Institutional Review Board requirements.
  316. PSUSA/00010000/201901 - periodic safety update report single assessment
  317. Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
  318. Meeting highlights from the Committee for Medicinal Products for Human Use,20-23 July 2009
  319. European Medicines Agency's workshop on conflicts of interests today
  320. EMEA-000801-PIP03-16-M01 - paediatric investigation plan
  321. ema-divence-tetraDivence Tetra
  322. 21 CFR 870.1380: Catheter stylet.
  323. Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 May 2022
  324. 21 CFR 886.1630: AC-powered photostimulator.
  325. FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious…
  326. 21 CFR 74.1254: D&C Orange No. 4.
  327. Mitigating AI’s Achilles’ Heel to Realize Its True Potential in Medical Devices
  328. Regulations for Medical Device Recalls
  329. EMEA-002597-PIP01-19-M01 - paediatric investigation plan
  330. UK-wide licensing for human medicines: supplementary guidance
  331. COMP: meeting archive 2007-2011
  332. Committee for Orphan Medicinal Products (COMP): 3-5 October 2017
  333. EMEA-002135-PIP01-17 - paediatric investigation plan
  334. PSUSA/00002204/201504 - periodic safety update report single assessment
  335. Clinical efficacy and safety: rheumatology/musculoskeletal system
  336. Pharmacovigilance Risk Assessment Committee (PRAC): 29 August-1 September 2017
  337. Neurodegenerative diseases
  338. Report of National List of Essential Medicines 2022
  339. Committee for Orphan Medicinal Products (COMP): 14-16 July 2026
  340. Liquid ROTAVAC 5CM (Live Attenuated Rotavirus Vaccine)
  341. Paediatric Committee (PDCO): 24-27 July 2018
  342. ema-benzyl-alcoholBenzyl alcohol
  343. Demonstration of target animal safety and efficacy of veterinary medicinal products…
  344. EMEA-000371-PIP01-08 - paediatric investigation plan
  345. Regulating medical devices in the UK
  346. PSUSA/00010330/201701 - periodic safety update report single assessment
  347. EMEA-001674-PIP01-14 - paediatric investigation plan
  348. EU/3/13/1209 - orphan designation for treatment of cystic fibrosis
  349. EMEA-000876-PIP02-11-M01 - paediatric investigation plan
  350. Patients' and Consumers' Working Party and Healthcare Professionals' Working Party joint…
  351. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  352. Meeting highlights from the Committee for Medicinal Products for Human Use,15-18 October…
  353. Leaflet IVDR Performance 3
  354. Harmonising the approach to VeDDRA coding workshop
  355. EU/3/14/1292 - orphan designation for treatment of AL amyloidosis
  356. cdsco-ceftazidimeCeftazidime
  357. ema-hervelousHervelous
  358. PSUSA/00003135/202212 - periodic safety update report single assessment
  359. 21 CFR 864.4400: Enzyme preparations.
  360. Dextropropoxyphene - referral
  361. EMEA-003207-PIP01-22 - paediatric investigation plan
  362. mhra-mhra-innovation-officeMHRA Innovation Office
  363. Ketorolac Tromethamine 30mg
  364. PSUSA/00000284/201611 - periodic safety update report single assessment
  365. Regulation on Medical Device Re-examination
  366. EMA Management Board: highlights of December 2023 meeting
  367. PSUSA/00000628/201711 - periodic safety update report single assessment
  368. New guide on biosimilar medicines for healthcare professionals
  369. 2025.12.04_ G.S.R. 883(E)_Draft Notification for amendment in Medical Device Rules, 2017
  370. Send and receive information on adverse drug reactions (ADRs)
  371. EMA statement on ongoing review of GLP-1 receptor agonists
  372. PSUSA/00002077/201801 - periodic safety update report single assessment
  373. Workshop for micro, small and medium-sized enterprises (SMEs) - European Medicines Agency…
  374. Enforceable undertaking guidelines
  375. EU/3/09/719 - orphan designation for treatment of polycythaemia vera
  376. Annual Rate Contract for Hiring taxies 2 Last Date ( 27 Jul 2012 )
  377. Feb 5 2015 GSR SO 376(E)
  378. EU/3/15/1436 - orphan designation for prevention of necrotising enterocolitis
  379. 21 CFR 822.23: Is the information in my submission considered confidential?
  380. Committee for Orphan Medicinal Products (COMP): 16-18 March 2021
  381. EMEA-001710-PIP02-14-M07 - paediatric investigation plan
  382. Methotrexate containing medicinal products - referral
  383. Updated AAMI ST91 for Endoscope Reprocessing: An HTM Perspective
  384. Recombinant Insulin Aspart
  385. EMEA-001536-PIP01-13 - paediatric investigation plan
  386. 21 CFR 880.5400: Neonatal incubator.
  387. Committee for Medicinal Products for Human Use (CHMP): 24-27 June 2019
  388. Committee for medicinal products for veterinary use: Meeting of 10-12 February 2009
  389. EU/3/11/933 - orphan designation for treatment of pancreatic cancer
  390. EU/3/14/1353 - orphan designation for treatment of myotonic disorders
  391. Regulatory information - European Medicines Agency introduces digital signatures for…
  392. Overview of the Mandatory reporting of serious adverse drug reactions and medical device…
  393. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 January 2014
  394. EMEA-001797-PIP01-15-M01 - paediatric investigation plan
  395. European network of paediatric research at the European Medicines Agency (Enpr-EMA)…
  396. 21 CFR 870.4875: Intraluminal artery stripper.
  397. Notice regarding Fixing of limit of impurities in the specification of INDs
  398. 21 CFR 864.8200: Blood cell diluent.
  399. 'Major Overhaul' for AAMI Guidance on EO, Other Chemical Modalities in Hospitals
  400. 2019.03.06 Draft G.S.R.188(E) Amendment in Form MD-10 to replace the SLA as issuing…
  401. Platform trials - Scientific guideline
  402. Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for…
  403. EMEA-001115-PIP01-10-M08 - paediatric investigation plan
  404. EU/3/16/1636 - orphan designation for treatment of soft tissue sarcoma
  405. New from the AAMI Foundation: Anthology of Complex Technology Solutions
  406. Imcivree - opinion on variation to marketing authorisation
  407. 21 CFR 888.3580: Knee joint patellar (hemi-knee) metallic resurfacing uncemented…
  408. Regulatory information – reflection on chemical structure and properties to be considered…
  409. PSUSA/00002911/202310 - periodic safety update report single assessment
  410. 21 CFR 1.600: What definitions apply to this subpart?
  411. EU/3/06/368 - orphan designation for treatment of Fabry disease
  412. Introduction to the European Union regulatory system and European Medicines Agency for…
  413. EU/3/16/1747 - orphan designation for treatment of mucopolysaccharidosis, type IIIA…
  414. Recommendations from the independent Expert Advisory Group on the use of Paclitaxel…
  415. PSUSA/00010002/201803 - periodic safety update report single assessment
  416. cdsco-somapacitanSomapacitan
  417. Reclast (zoledronic acid) - New contraindication and updated warning on kidney impairment…
  418. EU/3/22/2674 - orphan designation for treatment of familial adenomatous polyposis (FAP)
  419. EU/3/19/2156 - orphan designation for treatment of propionic acidaemia
  420. EU/3/16/1622 - orphan designation for treatment of haemophilia A
  421. Paediatric Committee (PDCO): 15-18 August 2017
  422. ema-bronchitolBronchitol
  423. EMEA-002903-PIP02-21 - paediatric investigation plan
  424. Liraglutide injection 6mg/ml
  425. 21 CFR 73.520: Soy leghemoglobin.
  426. 21 CFR 888.3300: Hip joint metal constrained cemented or uncemented prosthesis.
  427. PSUSA/00001048/201509 - periodic safety update report single assessment
  428. 21 CFR 872.3110: Dental amalgam capsule.
  429. Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - direct healthcare professional…
  430. Tislelizumab Injection 100mg(10ml)/Vial
  431. EU/3/04/231 - orphan designation for treatment of traumatic spinal cord injury
  432. Cosmetic injectables: import and supply in Australia
  433. PSUSA/00000444/201912 - periodic safety update report single assessment
  434. Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer
  435. 21 CFR 870.2800: Medical magnetic tape recorder.
  436. ICH 4 QB Annex 9 Tablet friability - Scientific guideline
  437. World Arthritis Day: 12 October 2013
  438. EMA Human Scientific Committees' Working Parties with Patients' and Consumers'…
  439. Revise list drug alert January-2025
  440. Guidance for Retention of Therapeutic Product on the Product Register
  441. PSUSA/00002907/201512 - periodic safety update report single assessment
  442. Technical Anonymisation Group (TAG): First meeting
  443. European Medicines Agency establishes Geriatric Expert Group
  444. PSUSA/00002974/202205 - periodic safety update report single assessment
  445. NMPA Issued the Announcement on Revising the Package Inserts of Prescription and…
  446. European Medicines Agency strengthens rules on conflicts of interests of its scientific…
  447. PSUSA/00009271/202103 - periodic safety update report single assessment
  448. 21 CFR 99.201: Manufacturer's submission to the agency.
  449. EU/3/22/2714 - orphan designation for treatment of familial cerebral cavernous…
  450. Priyanka Upendra: Taking Care of Your Teams (and Yourself) During Challenging Times
  451. 21 CFR 866.3900: Varicella-zoster virus serological reagents.
  452. EU/3/14/1306 - orphan designation for treatment of Huntington’s disease
  453. ema-exforgeExforge
  454. Introduction to pharmacovigilance and rules for expedited reporting of individual case…
  455. ema-azacitidine-celgeneAzacitidine Celgene
  456. Committee for veterinary medicinal products: 39th meeting
  457. cdsco-azelnidipineAzelnidipine
  458. 21 CFR 803.22: What are the circumstances in which I am not required to file a report?
  459. PSUSA/00002436/202303 - periodic safety update report single assessment
  460. Introduction to Organisation Management Service (OMS): Industry webinar
  461. PSUSA/00010468/201901 - periodic safety update report single assessment
  462. EMEA-001654-PIP01-14-M04 - paediatric investigation plan
  463. EMEA-001501-PIP09-21 - paediatric investigation plan
  464. Evaluation of certain pre 1988 permitted Fixed Dose Combinations FDCs de novo for…
  465. ema-quality-drafting-groupQuality Drafting Group
  466. EMEA-002027-PIP02-17-M01 - paediatric investigation plan
  467. ema-uprimaUprima
  468. EU/3/18/2061 - orphan designation for treatment of glioma
  469. 21 CFR 870.2790: Photoplethysmograph analysis software for over-the-counter use.
  470. Implementation of medical devices future regime
  471. 21 CFR 882.1410: Electroencephalograph electrode/lead tester.
  472. Guidance on the handling of applications for Centrally Authorised Products (CAPs)
  473. cdsco-aqchAQCH
  474. EMA welcomes Italy's Minister of Health Beatrice Lorenzin
  475. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March…
  476. James Rudolph: Understanding the Infusion Pump Crisis
  477. ema-toluraTolura
  478. PSUSA/00001278/202203 - periodic safety update report single assessment
  479. Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA…
  480. ema-trumenbaTrumenba
  481. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - June 2016
  482. cfr-21-cfr-74-250-orange-b21 CFR 74.250: Orange B.
  483. European Medicines Agency recommends suspension of all buflomedil-containing medicines
  484. Permission for conducting a clinical study entitle d, "A multicentric , Randomized…
  485. PSUSA/00001798/201703 - periodic safety update report single assessment
  486. EU/3/19/2185 - orphan designation for treatment of marginal zone lymphoma
  487. EU/3/02/098 - orphan designation for treatment of ovarian cancer
  488. Assessment of human dietary exposure to residues of veterinary medicines in the EU
  489. EMEA-001223-PIP01-11 - paediatric investigation plan
  490. 2024 Nominees Sought for AAMI Board of Directors
  491. Cyberattack on EMA - update 1
  492. ema-vipdometVipdomet
  493. ema-tysabri-referralTysabri - referral
  494. NV-CoV-2 Oral Syrup Oral Gummy(Chewable gel)
  495. EU/3/21/2415 - orphan designation for treatment of small cell lung cancer
  496. First oral treatment for Fabry disease recommended for approval in the EU
  497. Chloroprocaine hydrochloride - paediatric investigation plan
  498. EU/3/19/2230 - orphan designation for treatment of immune thrombocytopenia
  499. EU/3/21/2544 - orphan designation for treatment of epidermolysis bullosa
  500. Standards for Biological Raw Materials, Operational Guideline
  501. Medicinal Products (Control of Manufacture) Regulations 2007 (SI 539/2007) [Establishment…
  502. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 February 2019
  503. EU/3/07/480 - orphan designation for treatment of renal-cell carcinoma
  504. PSUSA/00001908/202202 - periodic safety update report single assessment
  505. Route B substantial modification pilot
  506. Paediatric Committee (PDCO): 19-21 March 2014
  507. cdsco-selonsertibSelonsertib
  508. EU/3/15/1521 - orphan designation for treatment of malaria
  509. Recall Policy for health products (POL-0016)
  510. Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle…
  511. 21 CFR 820.40: Document controls.
  512. Data requirements for veterinary medicinal products intended to reduce the risk of…
  513. Use of antimicrobials in animals - public consultations on two guidelines
  514. cdsco-20162016
  515. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  516. ema-sifrolSifrol
  517. Rules for the sale, supply and administration of medicines: Rules for the sale, supply and…
  518. Curcumae longae rhizoma - herbal medicinal product
  519. Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine…
  520. European Medicines Agency Human Scientific Committees' Working Parties with Patients' and…
  521. ema-pelzontPelzont
  522. ema-alprolixAlprolix
  523. Carboxymethylcellulose Sodium IP 5mg + Glycerin IP 10 mg + Sodium Perborate BP 0.028% w/v…
  524. G0002.1004 Companion Document
  525. ICH Q4B Annex 8 Sterility test - Scientific guideline
  526. PSUSA/00001642/202009 - periodic safety update report single assessment
  527. European Medicines Agency launches new electronic form for submission of…
  528. NMPA Promulgated the Guidelines for Clinical Safety Literature Evaluation of Marketed…
  529. Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental…
  530. 21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented…
  531. EU/3/18/2122 - orphan designation for treatment of autosomal dominant polycystic kidney…
  532. ema-evipleraEviplera
  533. Workshop on clinical outcome measures and endpoints for efficacy assessment in spinal…
  534. Uniform recall procedure for therapeutic goods (URPTG)
  535. ema-pomalidomide-viatrisPomalidomide Viatris
  536. EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
  537. Demonstration of efficacy for veterinary medicinal products containing antimicrobial…
  538. EU/3/19/2186 - orphan designation for treatment of acute myeloid leukaemia
  539. Alternative Sterilization Modalities to EtO: Let’s Compare & Contrast
  540. European Union International Organization for Standardization (ISO) for the identification…
  541. cdsco-ibrutinibIbrutinib
  542. AMENDMENT OF MEETING NOTICE: October 11-12, 2017: Patient Engagement Advisory Committee…
  543. PSUSA/00010358/201711 - periodic safety update report single assessment
  544. Policy Initiatives Planned for 2015
  545. ema-nobivac-bbNobivac Bb
  546. Centralised procedure procedures
  547. 21 CFR 11.100: General requirements.
  548. EMEA-001252-PIP01-11 - paediatric investigation plan
  549. 21 CFR 870.4400: Cardiopulmonary bypass blood reservoir.
  550. 21 CFR 876.4400: Hemorrhoidal ligator.
  551. EMEA-000774-PIP01-09-M03 - paediatric investigation plan
  552. Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication
  553. Paediatric Committee (PDCO): 9-11 September 2015
  554. EMEA-001553-PIP01-13-M02 - paediatric investigation plan
  555. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 February 2010
  556. EMEA-000236-PIP05-18 - paediatric investigation plan
  557. EMEA-000045-PIP01-07 - paediatric investigation plan
  558. EMEA-001395-PIP01-12 - paediatric investigation plan
  559. AAMI eXchange 2022: What SPD Professionals Shouldn’t Miss
  560. Notifying a change of marketing status and sunset clause (veterinary medicines)
  561. EU/3/13/1191 - orphan designation for treatment of sarcoidosis
  562. EU/3/13/1125 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
  563. ema-ixiaroIxiaro
  564. EMEA-001259-PIP02-13-M02 - paediatric investigation plan
  565. EU/3/09/713 - orphan designation for treatment of chronic lymphocytic leukaemia
  566. 21 CFR 860.230: Accepting a De Novo request.
  567. Guide for Distributors of Medical Devices
  568. ema-roactemraRoActemra
  569. Pharmacovigilance in the paediatric population workshop
  570. Meeting highlights from the Paediatric Committee: 2 - 4 July 2008
  571. October 30, 2026: Dermatologic and Ophthalmic Drugs Advisory Committee Meeting…
  572. National competent authorities (veterinary)
  573. ema-calcitugg-referralCalcitugg - referral
  574. Drospirenone - Updated information about the FDA-funded study on risk of blood clots in…
  575. ema-gentamicin-referralGentamicin - referral
  576. EU/3/21/2530 - orphan designation for treatment of chronic myeloid leukaemia
  577. EMEA-001418-PIP01-13-M05 - paediatric investigation plan
  578. Antimicrobial resistance in the environment: considerations for current and future risk…
  579. Drugs Alert for the month of March 2014
  580. EMEA-000828-PIP07-21 - paediatric investigation plan
  581. Committee for Herbal Medicinal Products (HMPC): 19-20 September 2016
  582. EU/3/01/079 - orphan designation for treatment of acute lung Injury
  583. Vildagliptin (as sustained release) + Dapagliflozin (100mg+5mg & 100mg + 10mg) tablets…
  584. 21 CFR 880.5965: Subcutaneous, implanted, intravascular infusion port and catheter.
  585. Working together for people with rare and complex diseases
  586. Committee for Medicinal Products for Veterinary Use (CVMP): 6-7 October 2020
  587. Brukinsa - opinion on variation to marketing authorisation
  588. Paediatric-use marketing authorisations
  589. 21 CFR 822.24: What are my responsibilities once I am notified that I am required to…
  590. European Medicines Agency reaffirms efficacy and safety of H1N1 pandemic vaccines
  591. EMEA-000317-PIP01-08-M13 - paediatric investigation plan
  592. EU/3/09/659 - orphan designation for treatment of acute myeloid leukaemia
  593. cfr-21-cfr-56-101-scope21 CFR 56.101: Scope.
  594. Order M/s Hasan Trading Inc Chennai
  595. Winners of AAMI High School Essay Contest Share Moving Stories
  596. CTI Life Sciences Ltd. withdraws its marketing authorisation application for Opaxio…
  597. April 10th 2018 GSR 360(E)
  598. 2025.12.29_ S.O. 6091(E)_Notification regarding Nimesulide above 100 mg in immediate…
  599. EU/3/04/242 - orphan designation for treatment of mastocytosis
  600. EMEA-000402-PIP02-11-M05 - paediatric investigation plan
  601. ema-dicuralDicural
  602. 21 CFR 872.3580: Preformed gold denture tooth.
  603. EU/3/17/1862 - orphan designation for treatment of Asherman's syndrome
  604. PSUSA/00001519/202301 - periodic safety update report single assessment
  605. FDA Issues Vulnerability Alert for Axeda agent and Axeda Desktop Server
  606. EU/3/01/023 - orphan designation for treatment of acromegaly
  607. ema-marketing-authorisationMarketing authorisation
  608. 21 CFR 890.3475: Limb orthosis.
  609. Big Data Steering Group and industry stakeholders meeting 2022
  610. Prometax - withdrawal of application for variation to marketing authorisation
  611. EMEA-000049-PIP01-07-M03 - paediatric investigation plan
  612. Committee for Herbal Medicinal Products (HMPC): 18-20 September 2023
  613. Angiotensin Receptor Blocker (ARB)
  614. 21 CFR 20.21: Uniform access to records.
  615. Competency Assessments Pave Clear Career Paths at the VA
  616. 21 CFR 862.1160: Bicarbonate/carbon dioxide test system.
  617. Explanatory Guidance to the Health Products (Advertisement of Therapeutic Products)…
  618. 21 CFR 862.1215: Creatine phosphokinase/creatine kinase or isoenzymes test system.
  619. European Medicines Agency veterinary medicines info day 2022
  620. Kexxtone 32.4 g continuous-release intraruminal device for cattle - referral
  621. European SME Week 2012: 15-21 October
  622. In-use stability testing of veterinary medicinal products (excluding immunological…
  623. UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least…
  624. European Medicines Agency addresses development of new antibacterials
  625. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 March 2017
  626. Ozempic - direct healthcare professional communication (DHPC)
  627. EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine…
  628. Committee for Orphan Medicinal Products adopts 100th positive opinion on designation
  629. EMEA-001741-PIP05-17 - paediatric investigation plan
  630. Advanced therapy classification
  631. Product Management Services (PMS) Sub-Groups (SG) Webinar
  632. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 May 2014
  633. ema-roctavianRoctavian
  634. Thomas Lönngren reappointed as Executive Director of the European Medicines Agency
  635. Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for…
  636. Bifril, Teoula, Zofepril, Zopranol - referral
  637. ema-diovan-referralDiovan - referral
  638. First specific replacement therapy to treat rare bleeding disorder
  639. GUIDELINES FOR VALIDATION AND BATCH TESTING OF COVID-19 DIAGNOSTIC KITS
  640. 21 CFR 801.128: Exceptions or alternatives to labeling requirements for medical devices…
  641. 21 CFR 26.42: Exchange and endorsement of product evaluation reports.
  642. EMEA-002524-PIP02-19 - paediatric investigation plan
  643. Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC…
  644. Vildagliptin + Dapagliflozin + Metformin Hydrochloride IP tablets (Phase III)
  645. EU/3/16/1760 - orphan designation for treatment in haematopoietic stem cell…
  646. Committee for Advanced Therapies (CAT): 8-10 December 2021
  647. Benzocaine sprays - FDA continues to receive reports of serious and potentially fatal…
  648. PSUSA/00002171/201803 - periodic safety update report single assessment
  649. PSUSA/00001744/201508 - periodic safety update report single assessment
  650. cdsco-hydrocortisone-acetateHydrocortisone Acetate
  651. EMEA-000265-PIP02-11-M04 - paediatric investigation plan
  652. EU/3/09/662 - orphan designation for treatment of acute myeloid leukaemia
  653. Capacity utilization for quality control testing for biological at NIB Noida
  654. EU/3/22/2587 - orphan designation for treatment of narcolepsy
  655. Euphrasiae herba - herbal medicinal product
  656. 21 CFR 21.41: Processing of requests.
  657. ICH Q4B Annex 5 Disintegration test - Scientific guideline
  658. 21 CFR 862.2100: Calculator/data processing module for clinical use.
  659. GN-35-R5 Guidance on Special Access Routes (2025 Sep) PUB
  660. Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (as extended release) +…
  661. Extrapolation of efficacy and safety in paediatric medicine development - Scientific…
  662. Insulin Aspart Mix 30, 100IU/mL
  663. Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies
  664. AAMI News, October 2019, Volume 54, Issue 10
  665. 21 CFR 864.3600: Microscopes and accessories.
  666. EU/3/13/1133 - orphan designation for treatment of cytomegalovirus disease in patients…
  667. MHRA fees: Payment easements and waivers for Small and Medium Companies
  668. Management Board meeting: 13-14 December 2017
  669. EMA recommends withdrawal of pholcodine medicines from EU market
  670. EMA Management Board: highlights of December 2020 meeting
  671. PSUSA/00001999/202001 - periodic safety update report single assessment
  672. Note for guidance on clinical safety data management: definitions and standards for…
  673. 2023.06.02_DR_S.O. 2394(E) to 2407(E)_Banning of 14 FDCs
  674. cdsco-transfer-orderTransfer order
  675. PSUSA/00000608/201810 - periodic safety update report single assessment
  676. 21 CFR 60.24: Revision of regulatory review period determinations.
  677. Clopidogrel Teva Generics B.V.
  678. Quality and equivalence of topical products - Scientific guideline
  679. Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis
  680. EMEA-000412-PIP01-08-M01 - paediatric investigation plan
  681. EMEA-001998-PIP01-16 - paediatric investigation plan
  682. Vildagliptin (as sustained release) + Pioglitazone Hydrochloride eq. to Pioglitazone IP…
  683. FDC of Metoprolol Succinate ER + Cilnidipine +Telmisartan (25mg + 10mg + 40mg & 50mg +…
  684. AS P0016.006: Assessment Audit (Stage 2, Surveillance, Re-Recognition, Critical Locations)
  685. ema-iffeza-referralIffeza - referral
  686. 21 CFR 868.5260: Breathing circuit bacterial filter.
  687. 21 CFR 868.5665: Powered percussor.
  688. Carcinogenicity evaluation of medicinal products for the treatment of HIV infection…
  689. Committee for Advanced Therapies (CAT): 19-21 February 2020
  690. ema-fiaspFiasp
  691. 21 CFR 870.5700: Steerable cardiac ablation catheter remote control system.
  692. PSUSA/00001362/201707 - periodic safety update report single assessment
  693. 14 March 2013: World Kidney Day: 'Acute kidney injury: stop kidney attack!'
  694. EMEA-003189-PIP01-22-M01 - paediatric investigation plan
  695. European Medicines Agency adopts first positive opinion for mock-up pandemic influenza…
  696. EMEA-002634-PIP01-19-M02 - paediatric investigation plan
  697. European Sales and Use of Antimicrobials for Veterinary Medicine Working Group
  698. 21 CFR 872.6510: Oral irrigation unit.
  699. GD211 Training, Module 4 - Audit Findings
  700. Committee for Advanced Therapies (CAT): 16-17 October 2014
  701. Prohibition of 328 fixed dose combinations by the central Government vide Gazette…
  702. Publication of notified medicine shortages: Updated protocol
  703. Committee for Medicinal Products for Human Use (CHMP): 09-12 November 2026
  704. European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021
  705. Pre-authorisation guidance
  706. Submitting data in the NeeS format
  707. EMEA-002338-PIP01-18 - paediatric investigation plan
  708. First European Medicines Agency-EuropaBio annual bilateral meeting
  709. cdsco-baricitinibBaricitinib
  710. Gabapentin IP (as extended release) + Duloxetine Hydrochloride IP eq. to Duloxetine (as…
  711. EMEA-000115-PIP01-07-M13 - paediatric investigation plan
  712. 2024.09.25 S.O. 4197(E) Amendment for Government Analysts at CDL Kolkata
  713. Marketing-authorisation procedures for advanced-therapy medicinal products
  714. Manufacturing and marketing of unapproved FDCs regarding
  715. cdsco-pimodivir15Pimodivir15
  716. Harnessing the potential of real world data through a ‘learning healthcare system’
  717. Sixth Industry Standing Group (ISG) meeting
  718. EMEA-000371-PIP04-16 - paediatric investigation plan
  719. Excellence in pharmacovigilance: Clinical trials and post-marketing
  720. Committee for Medicinal Products for Human Use (CHMP): 18-21 March 2013
  721. cdsco-20132013
  722. Industry stakeholder platform meetings
  723. Drug Alerts for the month of January 2014
  724. ema-somatropin-referralSomatropin - referral
  725. PSUSA/00003012/202308 - periodic safety update report single assessment
  726. PSUSA/00010483/201806 - periodic safety update report single assessment
  727. Guideline on clinical trials with immunological veterinary medicinal products - Scientific…
  728. EU/3/24/2899 - orphan designation for treatment of acute respiratory distress syndrome…
  729. PSUSA/00010710/202201 - periodic safety update report single assessment
  730. PSUSA/00002396/201905 - periodic safety update report single assessment
  731. EU/3/17/1853 - orphan designation for treatment of retinitis pigmentosa
  732. ema-fendrixFendrix
  733. 21 CFR 888.3045: Resorbable calcium salt bone void filler device.
  734. EMEA-000282-PIP01-08-M02 - paediatric investigation plan
  735. Mavacamten Capsules 2.5 mg, 5 mg, 10 mg and 15 mg
  736. 21 CFR 20.104: Summaries of oral discussions.
  737. EU/3/22/2657 - orphan designation for treatment of schwannoma
  738. Updated Information: November 8, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory…
  739. Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors
  740. 21 CFR 820.186: Quality system record.
  741. ema-zelerisZeleris
  742. Paediatric Committee (PDCO): 15-18 October 2019
  743. 21 CFR 880.2930: Apgar timer.
  744. European Medicines Agency-EuropaBio information day
  745. EU/3/15/1548 - orphan designation for treatment of snakebite envenomation
  746. European Medicines Agency finalises review of medicines concerned by Roche…
  747. EU/3/06/395 - orphan designation for treatment of acute lung Injury
  748. EU/3/17/1879 - orphan designation for treatment of epidermolysis bullosa
  749. Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 September 2021
  750. European Medicines Agency recommends lifting of supply and treatment restrictions for…
  751. Drug Safety Update: monthly PDF newsletter: Drug Safety Update June 2020
  752. ema-cvmp-documentsCVMP Documents
  753. PSUSA/00001850/202307 - periodic safety update report single assessment
  754. Committee for Herbal Medicinal Products (HMPC): 28-29 September 2015
  755. 32nd meeting of the committee for veterinary medicinal products
  756. Procaine benzylpenicillin - referral
  757. Clinical investigation of medicinal products for prevention of venous thromboembolism…
  758. ema-norditropin-referralNorditropin - referral
  759. 21 CFR 868.6400: Calibration gas.
  760. New Initiatives Advance Guardrails for Artificial Intelligence
  761. Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 February…
  762. 21 CFR 866.3309: Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.
  763. Medical Devices Licence Amendment Fax-back Form - Guidance For Non-significant…
  764. cdsco-insulin-degludecInsulin degludec
  765. Glimepiride IP + Metformin Hydrochloride IP + Sitagliptin Phosphate Monohydrate IP Tablets…
  766. cdsco-aug-07-2014-gsr-570-eAug 07 2014 GSR 570(E)
  767. Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized)
  768. Vaccines and Related Biological Products Advisory Committee October 6, 2022 Meeting…
  769. Team-NB Position Paper on MDR IVDR Implementation V3
  770. cdsco-efpeglenatideEfpeglenatide
  771. EU/3/18/2092 - orphan designation for treatment of glioma
  772. 2019.03.18 Final G.S.R.223(E) Inclusion of Form 39A_Report of analysis by approved…
  773. EU/3/16/1630 - orphan designation for treatment of cutaneous T-cell lymphoma
  774. Additional measures to allow experts to focus on COVID-19 activities
  775. Scientific advice procedures
  776. PRAC recommends restricting use of domperidone
  777. PSUSA/00010437/202104 - periodic safety update report single assessment
  778. 21 CFR 870.2910: Radiofrequency physiological signal transmitter and receiver.
  779. EU/3/13/1160 - orphan designation for treatment of lymphoplasmacytic lymphoma
  780. SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service (XEVMPD) for…
  781. United Therapeutics Europe Ltd withdraws its marketing authorisation application for…
  782. PSUSA/00001696/201711 - periodic safety update report single assessment
  783. 21 CFR 878.4740: Surgical stapler.
  784. European Medicines Agency and Food and Drug Administration publish implementation plan for…
  785. EU/3/03/168 - orphan designation for adjunctive treatment in haematopoietic cell…
  786. Montelukast Sodium IP + Bilastine orodispersible tablets (Phase IV)
  787. New AAMI Consensus Report: Guidance on Risk Management for AI, ML
  788. EU/3/16/1645 - orphan designation for prevention of graft-versus-host disease
  789. EU/3/19/2173 - orphan designation for treatment of acute radiation syndrome
  790. cdsco-molnupiravir-mild2Molnupiravir Mild2
  791. cfr-21-cfr-860-3-definitions21 CFR 860.3: Definitions.
  792. EMA recommends authorisation of COVID-19 medicine Evusheld
  793. cfr-21-cfr-17-32-motions21 CFR 17.32: Motions.
  794. Guidance on CTGTP Registration and Variation Applications in Singapore [PDF, 536.07 KB]
  795. EMEA-000062-PIP01-07 - paediatric investigation plan
  796. New View: HTM from the Patient Perspective
  797. EMEA-003079-PIP01-22 - paediatric investigation plan
  798. 21 CFR 862.1377: Urinary homocystine (nonquantitative) test system.
  799. Development and manufacture of oligonucleotides - Scientific guideline
  800. 21 CFR 870.3945: Prosthetic heart valve sizer.
  801. 2020 annual meeting of the members and Coordinating Group of the European network of…
  802. Quality: availability (minor uses/minor species)
  803. 21 CFR 1.1420: What process applies to a request for a waiver for an individual entity?
  804. Referral procedures: human medicines
  805. Marketing authorisation guidance documents
  806. From data to evidence in medicines regulation
  807. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 August 2024
  808. Guidance on equipment for temperature screening in the context of the COVID-19 pandemic
  809. PSUSA/00002114/202308 - periodic safety update report single assessment
  810. PSUSA/00001606/201409 - periodic safety update report single assessment
  811. Drug Alert list for month of September 2019
  812. The Biometaverse: Using AR and VR Applications to Create Better HTM Professionals
  813. ema-olanzapine-mylanOlanzapine Mylan
  814. PSUSA/00000167/201501 - periodic safety update report single assessment
  815. Dabigatran etexilate product-specific bioequivalence guidance
  816. European Medicines Agency and United States Food and Drug Administration to share…
  817. Committee for Medicinal Products for Human Use (CHMP): 09-12 December 2019
  818. EMEA-001980-PIP01-16 - paediatric investigation plan
  819. EU/3/21/2472 - orphan designation for treatment of glycogen storage disease type III
  820. 21 CFR 872.6865: Powered toothbrush.
  821. cfr-21-cfr-25-5-terminology21 CFR 25.5: Terminology.
  822. PSUSA/00001586/201705 - periodic safety update report single assessment
  823. EU/3/05/329 - orphan designation for treatment of localised scleroderma
  824. Pharmacovigilance Risk Assessment Committee confirms Chair and Vice-chair for new three…
  825. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10…
  826. EU/3/22/2652 - orphan designation for treatment of multiple system atrophy
  827. Focus on the Future: “HTM, I See You”
  828. 21 CFR 73.1030: Annatto extract.
  829. PSUSA/00000130/201609 - periodic safety update report single assessment
  830. Remifentanil Hydrochloride 1mg/2mg for injection
  831. NMPA Announcement on Issuing the Working Procedures for the Administration of…
  832. EMA hosts workshop on adaptive pathways
  833. ema-darunavir-krka-d-dDarunavir Krka d.d.
  834. 21 CFR 82.1317: D&C Red No. 17.
  835. PSUSA/00003013/201711 - periodic safety update report single assessment
  836. European Medicines Agency: Committee for Medicinal Products for Human Use 12-15 September…
  837. EU/3/16/1782 - orphan designation for treatment of facioscapulohumeral muscular dystrophy
  838. European Communities (In Vitro Diagnostic Medical Devices) (Amendment) (No 2) Regulations…
  839. EU/3/04/212 - orphan designation for treatment of hepatic veno-occlusive disease
  840. 21 CFR 16.26: Denial of hearing and summary decision.
  841. Notice regarding grant of licence for manufacture of new drugs including FDCs without…
  842. Hexavalent DtwP-HepB-IPV-Heb Liq.Hexa vaccine
  843. Levodopa/Carbidopa/Entacapone Orion
  844. 21 CFR 1.234: How and when do you update your facility's registration information?
  845. European expert group proposes reduction of use in animals of last resort antibiotic…
  846. ACTR for Pharmaceuticals Registration Quality
  847. Chlamydia, gonorrhoea and syphilis IVD self-tests
  848. ema-bydureonBydureon
  849. Management Board meeting: 10 December 2009
  850. 21 CFR 74.2705: FD&C Yellow No. 5.
  851. EU/3/20/2270 - orphan designation for treatment of pyruvate kinase deficiency
  852. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 October 2013
  853. EMEA-002757-PIP02-21 - paediatric investigation plan
  854. DR_G.S.R. 337(E) dt_15.04.2010_Amendment in Schedule I_Ayurvedic , Siddha Pharmacopoeia…
  855. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  856. Data Protection Scheme for assessed listed medicines
  857. EMA traineeship programme informative session
  858. AI System Quickly Recognizes Pneumonia in X-Rays
  859. ema-pemetrexed-sandozPemetrexed Sandoz
  860. EU/3/12/1027 - orphan designation for treatment of congenital hypotransferrinaemia
  861. Pharmacovigilance inspections for veterinary medicines
  862. corrigendum with respect to revised specification/criteria of acceptance for quality test…
  863. PSUSA/00000444/202212 - periodic safety update report single assessment
  864. List of approved countries for authorised human medicines
  865. European Antibiotic Awareness Day: Statement by Guido Rasi, Executive Director of the…
  866. HIMSS22: The Price of Cyberthreats
  867. EU/3/07/444 - orphan designation for treatment of peripheral T-cell lymphoma (nodal, other…
  868. Kaletra - direct healthcare professional communication (DHPC)
  869. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 12-14 July 2011
  870. Chair of the European Network of Paediatric Research at EMA re-elected
  871. Committee for Orphan Medicinal Products: January 2004 meeting
  872. Human variations electronic application forms Q&A clinics – session 4
  873. EMEA-003234-PIP01-22 - paediatric investigation plan
  874. Facilitating submission of post-approval data
  875. cdsco-gepotidacinGepotidacin
  876. Notice regarding Online application for registration of Notified Body through SUGAM Portal…
  877. Team-NB sector survey in 2017
  878. EMEA publishes first summaries of opinions for designated orphan medicines
  879. ema-zeposiaZeposia
  880. 21 CFR 876.2040: Enuresis alarm.
  881. AEMS guidance for sponsors
  882. EU and Switzerland to improve information-sharing on good manufacturing practice through…
  883. Change of name of liposomal medicines at high risk of medication errors
  884. Dydrogesterone Modified Release Tablet 30mgCT-SND/22/2023
  885. EMA multi-stakeholder workshop on Acute Respiratory Distress Syndrome
  886. Management Board meeting: 17 March 2016
  887. Favipiravirtablet 200 mg
  888. EU/3/14/1330 - orphan designation for treatment of pyruvate kinase deficiency
  889. cdsco-romiplostim-enz210Romiplostim (ENZ210)
  890. Regulatory information – Rules on fees are revised
  891. PSUSA/00001921/202209 - periodic safety update report single assessment
  892. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.11) Regulations…
  893. Glimepiride IP + Metformin Hydrochloride IP + Sitagliptin Phosphate Monohydrate IP eq. to…
  894. Cenobamate Tablets 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg
  895. European Medicines Agency gives guidance for use of antiviral medicines in case of a novel…
  896. DARWIN EU® welcomes first data partners
  897. ema-cortadermCortaderm
  898. EU/3/17/1938 - orphan designation for treatment of epidermolysis bullosa
  899. 11th meeting of the committee for veterinary medicinal products
  900. ema-yttrigaYttriga
  901. GN 23-D1.1 Guidance on Labelling for Medical Devices [ARCHIVED on 31 May 2018] [PDF, 654…
  902. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  903. EMEA-001337-PIP01-12 - paediatric investigation plan
  904. Tenofovir Alafenamide TAF
  905. Closamectin Pour-on Solution and associated names - referral
  906. November 7, 2016: Risk Communication Advisory Committee Meeting Announcement - 11/07/2016
  907. First industry standing group (ISG) meeting
  908. ema-vitrakviVitrakvi
  909. The Application of ISO 11138-7 for Industrial Ethylene Oxide Sterilization Qualification
  910. WHO Alert on falsified DEFITELIO (DEFIBROTIDE) 80 mg/ml concentrate for solution for…
  911. EU/3/08/588 - orphan designation for treatment of thrombotic thrombocytopenic purpura
  912. PSUSA/00001404/202303 - periodic safety update report single assessment
  913. 21 CFR 870.1240: Flow-directed catheter.
  914. cdsco-noticeNotice
  915. EU/3/21/2411 - orphan designation for treatment of spinal cord injury
  916. AAMI Hosts HTM Week 2024
  917. Cellular, Tissue, and Gene Therapies Advisory Committee July 29, 2026 Meeting…
  918. Design Space, 'Creating a shared vision between industry and regulators'
  919. EMEA-001584-PIP01-13-M06 - paediatric investigation plan
  920. 21 CFR 882.4360: Electric cranial drill motor.
  921. EMEA-000294-PIP02-12-M01 - paediatric investigation plan
  922. 4-year overview of pharmacovigilance activities in the EU shows robust and effective…
  923. EMEA-002889-PIP02-20 - paediatric investigation plan
  924. ema-xigduoXigduo
  925. EU/3/18/2006 - orphan designation for treatment of malignant mesothelioma
  926. EU/3/18/2012 - orphan designation for treatment of epidermolysis bullosa
  927. ema-versican-plus-dhppi-l4rVersican Plus DHPPi/L4R
  928. cdsco-csj117CSJ117
  929. ema-spheroxSpherox
  930. EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
  931. cdsco-ianalumabianalumab
  932. EU/3/18/2041 - orphan designation for treatment of behavioural variant frontotemporal…
  933. EU/3/21/2456 - orphan designation for treatment of Friedreich's ataxia
  934. Committee for Medicinal Products for Human Use (CHMP): 15-18 September 2025
  935. ema-respiporc-flupan-h1n1Respiporc FLUpan H1N1
  936. Special Provisions for TCM Registration released
  937. EMEA-001072-PIP01-10-M04 - paediatric investigation plan
  938. EU/3/21/2441 - orphan designation for treatment of Leber's congenital amaurosis
  939. Committee for Orphan Medicinal Products (COMP): 18-20 June 2024
  940. EMEA-001196-PIP03-21 - paediatric investigation plan
  941. Production of tallow derivatives for use in pharmaceuticals - Scientific guideline
  942. Blood Establishment Registration Application: Form and Instructions - (FRM-0353)
  943. New Online Export NOC System on SUGAM Portal
  944. Public Statement on Trovan / Trovan IV / Turvel / Turvel IV (Trovafloxacin/Alatrofloxacin)…
  945. EMEA-002823-PIP01-20 - paediatric investigation plan
  946. EU/3/04/198 - orphan designation for treatment of cutaneous T-cell lymphoma
  947. 21 CFR 1.403: What requirements apply to an informal hearing?
  948. cdsco-ab1001AB1001
  949. 21 CFR 58.107: Test and control article handling.
  950. EMEA-003017-PIP01-21 - paediatric investigation plan
  951. Apply for manufacturer or wholesaler of medicines licences
  952. The HHS Reorg: Streamlining Cybersecurity, Data, and AI Strategy
  953. 21 CFR 812.30: FDA action on applications.
  954. Summary reporting provisions of the Medical Devices Regulations: Notice to industry
  955. PSUSA/00002669/201412 - periodic safety update report single assessment
  956. 21 CFR 886.1250: Euthyscope.
  957. 2022.08.10_Final GSR 623(E)_To include colour of disinfectants in rule 127 of Drugs Rules…
  958. ema-ozurdexOzurdex
  959. FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers…
  960. EU/3/16/1780 - orphan designation for treatment of graft-versus-host disease
  961. ema-fruzaqlaFruzaqla
  962. PSUSA/00002125/202308 - periodic safety update report single assessment
  963. 21 CFR 803.12: How do I submit initial and supplemental or followup reports?
  964. ema-neorecormonNeoRecormon
  965. EU/3/09/681 - orphan designation for treatment of Huntington’s disease
  966. Sanofi Aventis withdraws its marketing authorisation application for Sliwens…
  967. 21 CFR 880.2740: Surgical sponge scale.
  968. Inhaled corticosteroids containing medicinal products indicated in the treatment of…
  969. Statutory advisory committee forms
  970. ema-genvoyaGenvoya
  971. Molluscan Shellfish Compliance Program
  972. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 May…
  973. Importing investigational medicinal products into Great Britain from approved countries…
  974. Good Manufacturing Practices Guidance Document
  975. EU/3/18/2058 - orphan designation for treatment of beta thalassaemia intermedia and major
  976. EU/3/16/1621 - orphan designation for treatment of glioma
  977. PSUSA/00003043/201608 - periodic safety update report single assessment
  978. EU/3/19/2227 - orphan designation for treatment of tenosynovial giant cell tumour…
  979. ema-alsitekAlsitek
  980. 21 CFR 26.10: Regulatory authorities not listed as currently equivalent.
  981. AAMI Publishes First National Standard on Water Quality for Medical Device Processing
  982. ema-senstendSenstend
  983. EMEA-002713-PIP01-19-M02 - paediatric investigation plan
  984. ema-senshioSenshio
  985. ema-zoledronic-acid-tevaZoledronic acid Teva
  986. PSUSA/00002849/202111 - periodic safety update report single assessment
  987. VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in…
  988. 21 CFR 830.200: When FDA will act as an issuing agency.
  989. 21 CFR 1.20: Presence of mandatory label information.
  990. EMEA-002292-PIP01-17 - paediatric investigation plan
  991. PSUSA/00000401/201705 - periodic safety update report single assessment
  992. cdsco-ly2605541LY2605541
  993. Management Board prepares groundwork in anticipation of a busy 2006
  994. Beyfortus - opinion on variation to marketing authorisation

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