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Global regulations and guidance

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

  1. EU/3/11/927 - orphan designation for treatment of cystic fibrosis
  2. EU/3/13/1199 - orphan designation for treatment of follicular thyroid cancer
  3. Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling - FDA Safety…
  4. 21 CFR 99.205: Application for exemption from the requirement to file a supplemental…
  5. ema-blincytoBlincyto
  6. PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously…
  7. ema-cufenceCufence
  8. Leaflet Clinical Data Training 2022
  9. 21 CFR 25.21: Extraordinary circumstances.
  10. Antimicrobial Sales and Use Platform
  11. 21 CFR 876.4480: Electrohydraulic lithotriptor.
  12. Points to Consider for the Preparation of Applications for Marketing Approval of…
  13. Reporting adverse incidents: neurostimulators: Adverse incidents with neurostimulators
  14. Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2023
  15. 21 CFR 1.655: How must an accredited third-party certification body monitor its own…
  16. Transporting Sterile Devices - TIR109 Provides New Guidance
  17. Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent…
  18. GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical…
  19. ema-zenhaleZenhale
  20. Gendux Molecular Limited withdraws its marketing authorisation application for Advexin…
  21. FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated…
  22. cdsco-jnj-63723283JNJ-63723283
  23. Brentuximab vedotin powder for concentrate for solution for infusion 50 mg (r-DNA origin)
  24. Availability of medicines before and during crises
  25. 2026.06.01 G.S.R. 444(E)_Notification for amendment in Schedule V w.r.t. unit of…
  26. Committee for Medicinal Products for Human Use (CHMP): 14-17 December 2015
  27. EU/3/17/1950 - orphan designation for treatment of Leber's congenital amaurosis
  28. EU/3/16/1811 - orphan designation for treatment of glioma
  29. New treatment option recommended for patients with advanced melanoma
  30. ema-versican-plus-dhppiVersican Plus DHPPi
  31. PSUSA/00002843/201504 - periodic safety update report single assessment
  32. ema-pregabalin-accordPregabalin Accord
  33. Introducing DADI: webinar on the digital application dataset integration (DADI) network…
  34. Guidance Document: Safety and Effectiveness Requirements for High-Level Disinfectants and…
  35. Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018
  36. Webinar on Nationally Authorised Products (NAPs) release on Product Lifecycle Management…
  37. EMEA-001838-PIP01-15-M03 - paediatric investigation plan
  38. ICH M2 Business requirements - Scientific guideline
  39. MDR_G.S.R. 102(E) dt_11.02.2020_Registration of certain medical devices
  40. Fostering medicines for children
  41. 37th meeting of the Committee for Orphan Medicinal Products
  42. ema-blenrepBlenrep
  43. EU/3/04/252 - orphan designation for treatment of chronic myeloid leukaemia
  44. Team-NB-List-PositionPapers-20241210
  45. Lasmiditan Tablets 50 mg and 100 mg
  46. Clinical Investigators and Sponsor-Investigators
  47. Compliance: post-authorisation
  48. Investigation into reports of serious adverse events following use of Fluad
  49. Training on electronic submission of information on medicines - new pharmacovigilance…
  50. cdsco-bevacizumab-25mg-mlBevacizumab 25mg/ml
  51. Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2022
  52. Major Artificial Intelligence Initiatives Could Shape the Future of Health Care
  53. Quarterly system demo - Q1 2023
  54. AAMI News, August 2022, Vol.57, No.8
  55. European Medicines Agency concludes new advice to doctors and patients for Champix needed
  56. 21 CFR 892.1390: Radionuclide rebreathing system.
  57. ema-multaqMultaq
  58. EU/3/16/1715 - orphan designation for treatment of retinitis pigmentosa
  59. EMEA-002350-PIP04-21 - paediatric investigation plan
  60. 21 CFR 21.53: Notation and disclosure of disputed records.
  61. EMEA-003413-PIP01-23 - paediatric investigation plan
  62. ema-cC
  63. Water for injection prepared by reverse osmosis
  64. Joint meeting of Good-clinical-practice compliance Inspectors Working Group and eClinical…
  65. EU/3/20/2385 - orphan designation for treatment of invasive candidiasis
  66. 21 CFR 866.5380: Free secretory component immunological test system.
  67. EMEA-001182-PIP01-11 - paediatric investigation plan
  68. EMEA-000485-PIP01-08-M04 - paediatric investigation plan
  69. Regulatory Guideline For 3D-Printed Medical Devices
  70. ema-herwendaHerwenda
  71. EU/3/07/502 - orphan designation for treatment of small cell lung cancer
  72. Specifications for additional efficacy studies for medicines published in the Official…
  73. EMEA-001118-PIP01-10 - paediatric investigation plan
  74. Development of antibiotics for children - towards a global approach
  75. The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment…
  76. EU/3/23/2819 - orphan designation for treatment of Huntington’s disease
  77. How Marketing Authorisation Applications referred under Article 29 are handled
  78. Public Notice for comments on proposed notification
  79. Veterinary medicinal products containing tylosin to be administered orally via feed or the…
  80. EMEA-002370-PIP03-22 - paediatric investigation plan
  81. Chemotherapeutics in Aquaculture Seafood
  82. EMEA-000499-PIP04-17 - paediatric investigation plan
  83. Vonoprazan Tablets 20mg
  84. Meeting Notice related to Draft Guidance for Industry Document for Veterinary Biologicals
  85. Committee for Herbal Medicinal Products (HMPC): 17-18 July 2017
  86. ema-lutatheraLutathera
  87. Risks of Picato for actinic keratosis outweigh benefits
  88. EU/3/05/287 - orphan designation for treatment of pancreatic cancer
  89. European Commission legalisation of EMEA certificates to end
  90. Can Artificial Intelligence ‘Rehumanize’ Healthcare?
  91. Combined hormonal contraceptives
  92. ema-fingolimod-mylanFingolimod Mylan
  93. PSUSA/00002311/202105 - periodic safety update report single assessment
  94. ema-respreezaRespreeza
  95. Innovative Medical Devices Embrace the World: The 1st Training of GHWP (Guangzhou) Academy…
  96. Apply to release a vaccine or a blood product to market
  97. Second international symposium on biopharmaceutical statistics
  98. Guidance on Clinical Evaluation of Travelers’ Vaccines, etc.
  99. Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 January 2023
  100. PSUSA/00001783/202305 - periodic safety update report single assessment
  101. EMEA-002690-PIP02-22 - paediatric investigation plan
  102. EMEA-001214-PIP01-11-M11 - paediatric investigation plan
  103. SaMD: Times They Are A’Changin’ — What You Need to Know
  104. EU/3/14/1329 - orphan designation for treatment of primary biliary cirrhosis
  105. EU/3/13/1172 - orphan designation for treatment of nodal marginal-zone lymphoma
  106. Empagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (25mg + 100mg &…
  107. cdsco-lumasiranLumasiran
  108. ema-januviaJanuvia
  109. EMEA-003008-PIP01-21 - paediatric investigation plan
  110. EU/3/14/1396 - orphan designation for treatment of glioma
  111. Public Notice regarding D-Penicillamine
  112. Equip WNV (previously Duvaxyn WNV)
  113. Bisoprolol fumarate / acetylsalicylic acid - paediatric investigation plan
  114. March 8, 2018: Meeting of the Gastrointestinal Drugs Advisory Committee Meeting…
  115. EU/3/17/1934 - orphan designation for treatment of amyotrophic lateral sclerosis
  116. 21 CFR 56.113: Suspension or termination of IRB approval of research.
  117. EU/3/04/207 - orphan designation for treatment of renal-cell carcinoma
  118. 21 CFR 886.4335: Operating headlamp.
  119. 21 CFR 862.2680: Microtitrator for clinical use.
  120. PSUSA/00000230/202202 - periodic safety update report single assessment
  121. NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs…
  122. Provisional registration process
  123. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 June 2020
  124. 2019.03.11 Draft G.S.R. 214(E) Notification of ICD Dhannad Indore in Madhya Pradesh for…
  125. 21 CFR 812.35: Supplemental applications.
  126. Human Factors Engineering: Essential Elements in the Product Development Process
  127. Good Manufacturing Practices - Audit Report Form (FRM-0211) Instructions for Completing…
  128. ema-viraferonViraferon
  129. COVID-19 vaccines: studies for approval
  130. European and international experts discuss the way forward in developing ophthalmology…
  131. Good pharmacogenomic practice - Scientific guideline
  132. Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end…
  133. 21 CFR 862.1470: Lipid (total) test system.
  134. Trevicta (previously Paliperidone Janssen)
  135. EU/3/22/2584 - orphan designation for treatment of spinal cord injury
  136. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 March 2012
  137. cdsco-c-o-m-b-a-tC.O.M.B.A.T
  138. PSUSA/00002064/201810 - periodic safety update report single assessment
  139. cfr-21-cfr-58-120-protocol21 CFR 58.120: Protocol.
  140. EU/3/14/1392 - orphan designation for treatment of Huntington’s disease
  141. Dapagliflozin + Metformin XR versus Metformin XR
  142. Guidance on the risk-based classification system for non-in vitro diagnostic devices…
  143. Q&A on the Master File (MF) System, Part III
  144. PSUSA/00001744/201603 - periodic safety update report single assessment
  145. EU/3/16/1686 - orphan designation for treatment of osteogenesis imperfecta
  146. Provisions for Medical Device Adverse Event Monitoring and Re-evaluation
  147. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 September 2014
  148. F0031.2.001 DPO Process
  149. Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors
  150. Paediatric Committee (PDCO): 18-21 July 2023
  151. Short-acting beta-agonists - referral
  152. Dispelling GMP myths of human blood, blood components, tissues, cells and gene therapies
  153. Regulatory information – European Medicines Agency organises training sessions on…
  154. Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium + Chlorthalidone IP Film…
  155. 21 CFR 820.50: Purchasing controls.
  156. Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia…
  157. Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare…
  158. EU/3/15/1452 - orphan designation for treatment of fragile X syndrome
  159. EMEA-000499-PIP02-10-M01 - paediatric investigation plan
  160. Similar biological medicinal products containing biotechnology-derived proteins as active…
  161. 21 CFR 882.4560: Stereotaxic instrument.
  162. European Communities (Medical Devices) (Amendment) Regulations 2020 (SI 144/2020)…
  163. Pilot study on Paracetamol Injection for IM route Pilot study
  164. PSUSA/00010558/201706 - periodic safety update report single assessment
  165. PSUSA/00002165/202306 - periodic safety update report single assessment
  166. 21 CFR 866.5320: Properdin factor B immunological test system.
  167. 21 CFR 807.37: Public availability of establishment registration and device listing…
  168. Draft risk based classification list Cardiovascular and Neurological dated 01 04 2025 for…
  169. EU/3/03/154 - orphan designation for treatment of sickle cell syndrome
  170. Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis: FDA Safety…
  171. Paediatric Committee (PDCO): 9-11 October 2013
  172. Medical Device Cleaning Efficacy: Understanding Germany’s Decades of Improvement
  173. PSUSA/00000827/201505 - periodic safety update report single assessment
  174. Confidentiality arrangement between EU and Brazilian regulatory authorities
  175. EMEA-002795-PIP02-21-M01 - paediatric investigation plan
  176. Recommendation to restrict the use of Protelos / Osseor (strontium ranelate)
  177. Details of rejected applications of Human Vaccine Manufacturers or Importers (Form…
  178. EMEA-002187-PIP01-17 - paediatric investigation plan
  179. VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies…
  180. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL-2019
  181. ema-betmigaBetmiga
  182. Respreeza - direct healthcare professional communication (DHPC)
  183. SEMAGLUTIDE INJECTION 2MG/1.5MLCT/SND/13/2024
  184. 21 CFR 882.5893: Thermal vestibular stimulator for headache.
  185. Quality and safety assessment for the plasma master file (PMF) certification with regard…
  186. Addendum on terms and concepts of pharmacogenomic features related to metabolism to the…
  187. European Medicines Agency excellence in pharmacovigilance: Clinical trials and…
  188. 21 CFR 1.920: What information submitted in a petition requesting a waiver or submitted in…
  189. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations…
  190. Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very…
  191. ACT EU multi-stakeholder meeting on decentralised clinical trials
  192. EMEA-001433-PIP01-13 - paediatric investigation plan
  193. ICH M11 guideline, clinical study protocol template and technical specifications…
  194. 21 CFR 71.2: Notice of filing of petition.
  195. 21 CFR 886.4280: Intraocular pressure measuring device.
  196. ema-quality-innovation-groupQuality Innovation Group
  197. EU/3/05/336 - orphan designation for treatment of soft tissue sarcoma
  198. PSUSA/00002174/201802 - periodic safety update report single assessment
  199. ema-halavenHalaven
  200. Netarsudil Ophthalmic sol 0.02%`w/v
  201. cdsco-public-noticePublic Notice
  202. Methodology European Specialised Expert Community
  203. Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs
  204. Use of porcine trypsin used in the manufacture of human biological medicinal products…
  205. EU/3/01/021 - orphan designation for treatment of chronic myeloid leukaemia
  206. Daxocox - opinion on variation to marketing authorisation
  207. Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
  208. 38th meeting of the Committee for Orphan Medicinal Products
  209. Expert group meeting on paediatric heart failure
  210. EMEA-002661-PIP01-19 - paediatric investigation plan
  211. Points to Consider in the Clinical Development of In Vivo Diagnostics (Early…
  212. ema-tepadinaTepadina
  213. HRF-10071, Darunavir and Ritonavir
  214. PSUSA/00001635/201702 - periodic safety update report single assessment
  215. NDCTR_G.S.R. 21(E) dt_18.01.2022_Amendment in Eighth Schedule, Form CT-03
  216. First RSV vaccine to protect infants up to 6 months of age and older adults
  217. 21 CFR 882.3: Effective dates of requirement for premarket approval.
  218. Committee for Advanced Therapies (CAT): 18-19 February 2016
  219. Guide to Good Practices for the Preparation of Medicinal Products in Healthcare…
  220. Joint PIC/S-EMA Concept Paper On The Revision Of Annex 1 (Manufacture of Sterile Medicinal…
  221. Recombinant Rabies G Protein Vaccine 50 μg /0.5 mL
  222. 21 CFR 807.34: Summary of requirements for owners or operators granted a waiver from…
  223. Call for expressions of interest for Committee for Orphan Medicinal Products (COMP)…
  224. 21 CFR 862.1700: Total thyroxine test system.
  225. ema-cyanokitCyanokit
  226. Mycophenolate mofetil Teva
  227. EMEA-001523-PIP03-18-M02 - paediatric investigation plan
  228. Celdoxome pegylated liposomal
  229. AAMI Signs MOU with GCEA, Will Support Clinical Engineering Abroad
  230. cdsco-zintrodiazineZintrodiazine
  231. 21 CFR 884.2050: Obstetric data analyzer.
  232. UPDATED PUBLIC PARTICIPATION INFORMATION: January 10, 2025: Meeting of the Anesthetic and…
  233. Updated IEC 60601-1-8 Breaks New Ground in Development of Alarm Sounds
  234. Comirnaty / Spikevax (previously COVID-19 Vaccine Moderna) - direct healthcare…
  235. Third stakeholder forum on the implementation of the new 2010 pharmacovigilance…
  236. Workshop on patient-support programmes (PSPs) and market-research programmes (MSPs)…
  237. EU/3/10/744 - orphan designation for treatment of acute lung Injury
  238. Good clinical practice for clinical trials
  239. ema-aripiprazole-mylanAripiprazole Mylan
  240. EU/3/16/1812 - orphan designation for treatment of pancreatic cancer
  241. 21 CFR 820.75: Process validation.
  242. Evaluation of control samples for non-clinical safety studies: checking for contamination…
  243. EMEA-002957-PIP02-21 - paediatric investigation plan
  244. Antipsychotic medicines: licensed products, uses and side effects: Pharmacovigilance…
  245. ema-raxoneRaxone
  246. 21 CFR 13.50: Record for administrative decision.
  247. cdsco-bevacizumabbioBevacizumabbio
  248. Team-NB PositionPaper LegacyMD Surveillance Transfer Agreement V1
  249. EU/3/21/2403 - orphan designation for treatment of pancreatic cancer
  250. EU/3/19/2164 - orphan designation for treatment of Cushing's syndrome
  251. 21 CFR 16.40: Commissioner.
  252. Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved…
  253. EU/3/12/1030 - orphan designation for treatment of haemophilia A
  254. European Antibiotic Awareness Day 2014
  255. ema-nobivac-myxo-rhd-plusNobivac Myxo-RHD Plus
  256. EU/3/14/1291 - orphan designation for treatment of gastric cancer
  257. PSUSA/00001834/201510 - periodic safety update report single assessment
  258. EU/3/13/1099 - orphan designation for treatment of achromatopsia caused by mutations in…
  259. EMEA-000117-PIP02-10-M07 - paediatric investigation plan
  260. 21 CFR 890.3750: Mechanical table.
  261. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2015
  262. cdsco-mrg-001MRG-001,
  263. Committee for Orphan Medicinal Products: May 2004 meeting
  264. Oncology European Specialised Expert Community
  265. Call for Healthcare Technology’s ‘Bright Ideas,’ 2023
  266. EMEA-001310-PIP01-12-M03 - paediatric investigation plan
  267. EU/3/19/2162 - orphan designation for treatment of Stargardt's disease
  268. ema-tolucombiTolucombi
  269. Product Management Service (PMS) progress webinar
  270. European medicines regulatory network adopts EU common standard for electronic product…
  271. 21 CFR 82.102: FD&C Blue No. 2.
  272. Use of raw data in medicine evaluation
  273. 2021.06.22_SO 2450(E) Notification of Dilip Kr Panda Suparna Maitra as GA for CDL Kolkata
  274. ema-pulsafloxPulsaflox
  275. cdsco-finerenonefinerenone
  276. EU/3/08/540 - orphan designation for treatment of congenital muscular dystrophy with…
  277. ema-suvaxyn-prrs-mlvSuvaxyn PRRS MLV
  278. EU/3/00/016 - orphan designation for treatment of acute respiratory distress syndrome…
  279. 21 CFR 860.220: De Novo request content.
  280. ema-denagard-45-referralDenagard 45% - referral
  281. ema-plivensiaPlivensia
  282. PSUSA/00001990/202402 - periodic safety update report single assessment
  283. RESOLUTION RDC NO. 687, 13 MAY 2022
  284. Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products…
  285. Lux Biosciences GmbH withdraws its marketing authorisation application for Luveniq…
  286. AAMI Faculty Spotlight: Margaret Koga Ward
  287. Paediatric Committee (PDCO): 14-16 May 2012
  288. 21 CFR 870.3850: Carotid sinus nerve stimulator.
  289. Novantrone and associated names - referral
  290. ema-flixabiFlixabi
  291. Committee for Orphan Medicinal Products (COMP): 15-17 July 2025
  292. Drug Alert list for month of January 2018
  293. ema-tekinexTekinex
  294. EMEA-000275-PIP01-08 - paediatric investigation plan
  295. cfr-21-cfr-860-120-general21 CFR 860.120: General.
  296. cdsco-bms-986504BMS-986504
  297. International collaboration on GMP inspections
  298. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  299. Notification of serious breach
  300. EMEA-002594-PIP01-19 - paediatric investigation plan
  301. Guidance for Application to Import a Therapeutic Product on Consignment Basis
  302. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - August 2018
  303. Amlodipine besilate / bisoprolol fumarate - paediatric investigation plan
  304. Registration opens for FDA/EMA orphan product designation and grant workshop
  305. Drug Alert for the Month of Revised March 2023
  306. 21 CFR 872.3420: Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture…
  307. Revision of the “Guidelines for Clinical Evaluation of Drugs for the Treatment of Heart…
  308. PSUSA/00000613/202305 - periodic safety update report single assessment
  309. Cucurbitae semen - herbal medicinal product
  310. ema-enzalutamide-viatrisEnzalutamide Viatris
  311. EU/3/11/905 - orphan designation for treatment of alpha-sarcoglycanopathy
  312. EU/3/22/2581 - orphan designation for treatment of diffuse large B-cell lymphoma
  313. ema-adasuveAdasuve
  314. ema-tuznueTuznue
  315. PRIME enables earlier availability of life-changing medicines
  316. Interstate Travel Program - Conveyances and Support Facilities
  317. cdsco-pretomanid-bjPretomanid BJ
  318. EU/3/05/288 - orphan designation for treatment of Huntington’s disease
  319. EMEA-002066-PIP01-20 - paediatric investigation plan
  320. Survey: Hospital-Based Use of AI Is Reaching a ‘Tipping Point’
  321. Committee for Medicinal Products for Human Use (CHMP): 23-26 January 2017
  322. cdsco-sar445229-amlitelimabSAR445229 /amlitelimab
  323. ICH Q11 Development and manufacture of drug substances (chemical entities and…
  324. PSUSA/00001720/202211 - periodic safety update report single assessment
  325. EU/3/04/213 - orphan designation for treatment of hypereosinophilic syndrome
  326. ema-about-this-websiteAbout this website
  327. Seminar on pre-clinical evaluation of vaccines: current experience, new adjuvants and…
  328. ema-ravictiRavicti
  329. PSUSA/00002105/201802 - periodic safety update report single assessment
  330. Abasaglar (previously Abasria)
  331. EMEA-001019-PIP01-10-M05 - paediatric investigation plan
  332. EU/3/02/113 - orphan designation for treatment of adrenal cortical carcinoma
  333. cdsco-noticeNotice
  334. cdsco-randomized-sarsRandomized SARS
  335. ema-bortezomib-sunBortezomib Sun
  336. 21 CFR 868.5150: Anesthesia conduction needle.
  337. 21 CFR 892.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  338. EU/3/18/2099 - orphan designation for treatment of primary mediastinal large B-cell…
  339. ema-dna-vaccinesDNA vaccines
  340. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 10, 2025: General…
  341. 2025.04.24_G.S.R. 259(E)_Notification reg rules for Compounding of offences under Jan…
  342. EU/3/21/2557 - orphan designation for prevention of retinopathy of prematurity
  343. October 6, 2021: Patient Engagement Advisory Committee Meeting Announcement - 10/06/2021
  344. EU/3/23/2813 - orphan designation for treatment of spinal muscular atrophy
  345. EU/3/14/1253 - orphan designation for prevention of graft rejection following solid organ…
  346. Paediatric Committee (PDCO): 14-17 October 2025
  347. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016
  348. 21 CFR 19.45: Temporary disqualification of former employees.
  349. NOTICE - regarding Draft guidance documents on essential principles for safety and…
  350. Public statement on the use of herbal medicinal products containing toxic, unsaturated…
  351. Biologicals (including tissues), human blood and blood components report form
  352. EMEA-001918-PIP01-15-M02 - paediatric investigation plan
  353. NMPA Issued the Announcement on Registration Application Situation and Self-Examination &…
  354. EMA recommends approval of Imvanex for the prevention of monkeypox disease
  355. Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 January 2019
  356. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  357. Determining the fate of veterinary medicinal products in manure - Scientific guideline
  358. EU/3/23/2761 - orphan designation for treatment of erythropoietic protoporphyria
  359. ema-viagraViagra
  360. Bravecto - withdrawal of application for variation to marketing authorisation
  361. GN-04-R2.2 Guidance on Medical Device Recall [PDF, 340 KB]
  362. The Target Development Profile Toolkit
  363. EU/3/07/524 - orphan designation for treatment of tuberculosis
  364. Recommendation-NB-MED-2_2 Rec1 EMC requirements
  365. EMA is closed on Assumption Day, 15 August
  366. Medicine Shortages Single Point of Contact (SPOC) Working Party
  367. (Attachment) Questions and Answers (Q & A) on Guidelines for the Development of…
  368. NBM-046-18 One Year of Application
  369. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May…
  370. ema-steglujanSteglujan
  371. EMEA-001978-PIP02-19 - paediatric investigation plan
  372. European Medicines Agency recommends first-in-class medicine for treatment of cystic…
  373. 21 CFR 14.130: Conduct of TEPRSSC meeting; availability of TEPRSSC records.
  374. Pregabalin and risks in pregnancy
  375. Management Board meeting: 17-18 March 2010
  376. EU/3/19/2214 - orphan designation for treatment of soft tissue sarcoma
  377. 21 CFR 822.26: If my company changes ownership, what must I do?
  378. Committee for medicinal products for veterinary use: Meeting of 11-13 March 2008
  379. 21 CFR 15.45: Examination of administrative record.
  380. November 14th 2017 S.O 3609(E)
  381. 21 CFR 801.435: User labeling for latex condoms.
  382. cdsco-molnupiravir-mildMolnupiravir Mild
  383. EU/3/19/2245 - orphan designation for treatment of Alström syndrome
  384. TEAM-NB-Statement-6-October-Common-Position-of-the-Council-IVD
  385. VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food…
  386. Clinical Trials Information System (CTIS) bitesize talk: Training materials, CTIS…
  387. EMEA-002797-PIP01-20 - paediatric investigation plan
  388. EU/3/04/227 - orphan designation for treatment to mobilize progenitor cells prior to stem…
  389. 2022.05.25_Draft_GSR 393(E)_Exemption under Schedule K of the Drugs Rules, 1945 for OTC…
  390. European Communities (Medical Devices) (Tissues of Animal Origin) Regulations 2003 (SI…
  391. Imlygic - direct healthcare professional communication (DHPC)
  392. Additional manufacturing site for COVID-19 Vaccine Janssen
  393. Desvenlafaxine succinate monohydrate - paediatric investigation plan
  394. EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
  395. ema-omontysOmontys
  396. EMEA-002963-PIP01-21 - paediatric investigation plan
  397. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
  398. Seasonal influenza vaccines - quality module
  399. ema-caystonCayston
  400. EMEA-002015-PIP01-16 - paediatric investigation plan
  401. EU/3/10/819 - orphan designation for treatment of hyperargininaemia
  402. Sixth meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
  403. Reflection paper on investigation of pharmacokinetics in the obese population - Scientific…
  404. EMEA-002057-PIP01-16 - paediatric investigation plan
  405. 2020.01.31_S.O. 481(E)_Sushil Kumar Sahu GA, CDL Kasauli
  406. Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2022
  407. EU/3/04/260 - orphan designation for treatment of alpha-mannosidosis
  408. First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU
  409. ema-cytopointCytopoint
  410. EU/3/14/1390 - orphan designation for treatment of hereditary haemorrhagic telangiectasia
  411. Paediatric Committee (PDCO): 13-15 March 2013
  412. Methylphenidate Hexal - referral
  413. 21 CFR 26.67: Suspension of listed conformity assessment bodies.
  414. EMEA-003023-PIP01-21 - paediatric investigation plan
  415. EMEA-002976-PIP02-21 - paediatric investigation plan
  416. 21 CFR 888.1100: Arthroscope.
  417. Arzerra - withdrawal of application for variation to marketing authorisation
  418. Committee for Orphan Medicinal Products (COMP): 7-8 February 2012
  419. 21 CFR 801.61: Statement of identity.
  420. 21 CFR 73.345: Paprika oleoresin.
  421. ema-inhixaInhixa
  422. EMA business hours over holiday period
  423. 21 CFR 1.624: How must a recognized accreditation body protect against conflicts of…
  424. 21 CFR 886.3200: Artificial eye.
  425. ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies…
  426. cdsco-semaglutideSemaglutide
  427. Needs for paediatric medicines
  428. VICH GL7 Efficacy of anthelmintics: general requirements - Scientific guideline
  429. PMDA’s support to Venture companies
  430. 21 CFR 880.6450: Skin pressure protectors.
  431. Reporting adverse incidents: inferior vena cava filter (IVC): Adverse incidents with IVCs
  432. EU/3/05/305 - orphan designation for treatment of dermatofibrosarcoma protuberans
  433. cfr-21-cfr-812-140-records21 CFR 812.140: Records.
  434. Checklist for Form MD-24 IVD (Application for grant of permission to conduct clinical…
  435. Empagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin (10mg + 100mg &…
  436. EMEA-001262-PIP01-12-M03 - paediatric investigation plan
  437. 21 CFR 830.220: Termination of FDA service as an issuing agency.
  438. EU/3/12/964 - orphan designation for treatment of leishmaniasis
  439. CIRCABC RemoteAudit Analysis
  440. Entecavir product-specific bioequivalence guidance
  441. Bupivacaine Hydrochloride IP eq. to anhydrous Bupivacaine Hydrochloride Fentanyl Citrate…
  442. EMEA-002836-PIP01-20 - paediatric investigation plan
  443. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - October…
  444. EMEA-003247-PIP02-23 - paediatric investigation plan
  445. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg + Pioglitazone…
  446. PSUSA-00001781-201701 - periodic safety update report single assessment
  447. FDA warns about several safety issues with opioid pain medicines; requires label changes
  448. EMEA-000019-PIP01-07 - paediatric investigation plan
  449. Roflumilast - paediatric investigation plan
  450. Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
  451. Drug Safety Update: monthly PDF newsletter: Drug Safety Update July 2020
  452. EMEA-001868-PIP02-16 - paediatric investigation plan
  453. Provisions for Supervision and Administration of Medical Device Manufacturing
  454. Guidelines on Cancer Immunotherapy Development
  455. Kevin Krauth: Confessions of a Millennial with Big Dreams
  456. 2Ó-Methyl-Phosphorothioate Anti Sense Oligoribonucleotide for treating patients with…
  457. PSUSA/00000303/201803 - periodic safety update report single assessment
  458. Reflection paper on the use of artificial intelligence in the lifecycle of medicines
  459. EMEA-000885-PIP01-10 - paediatric investigation plan
  460. Committee for Medicinal Products for Human Use (CHMP): 11-14 November 2019
  461. EU/3/12/1065 - orphan designation for treatment of glioma
  462. 2024.02.27_DR_G.S.R. 139(E)_Notification of Bengaluru, Visakhapatnam, Cochin and…
  463. Authorised Prescriber: online system guidance
  464. Transcatheter Mitral Valve Repair System Approved for Marketing
  465. EU/3/13/1147 - orphan designation for treatment of pulmonary alveolar proteinosis
  466. PSUSA/00010572/202006 - periodic safety update report single assessment
  467. EU/3/18/2001 - orphan designation for prevention of ricin poisoning
  468. NMPA Announcement on the Applicability of ICH Guideline M12: Drug Interaction Studies and…
  469. European Medicines Agency and European Commission renew confidentiality arrangement with…
  470. Kevzara - direct healthcare professional communication (DHPC)
  471. 2026.03.09 G.S.R. 164(E)_Draft Notification regarding Blood product testing under Drugs…
  472. EU/3/13/1175 - orphan designation for treatment of autosomal dominant polycystic kidney…
  473. EMEA-002938-PIP01-20 - paediatric investigation plan
  474. Tremelimumab ± Lenvatinib
  475. ema-vaxelisVaxelis
  476. EU/3/17/1845 - orphan designation for treatment of hereditary haemorrhagic telangiectasia
  477. Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 (SI 163/2013)…
  478. EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary…
  479. Ninth meeting of the industry stakeholder platform on the operation of the centralised…
  480. 21 CFR 878.4790: Powered surgical instrument for improvement in the appearance of…
  481. 21 CFR 880.6080: Cardiopulmonary resuscitation board.
  482. Methylthioninium chloride Proveblue
  483. Permission for conducting a clinical study entitled , "A multicenter Phase-4 , Open-label…
  484. EU/3/12/995 - orphan designation for treatment of haemophilia A
  485. 2021.09.01_Draft GSR 611(E)_Notification of ICD Tihi Indore under Rule 43A
  486. Appendix 14B Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation…
  487. European public health agencies evaluate antibiotic resistance of Staphylococcus aureus
  488. EMEA-000670-PIP01-09-M02 - paediatric investigation plan
  489. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 June 2020
  490. 3rd meeting of the Committee for Orphan Medicinal Products
  491. cdsco-sar441344-frexalimabSAR441344 /frexalimab
  492. Guidance 7: Certified product details
  493. Development and manufacture of synthetic peptides - Scientific guideline
  494. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.12) Regulations…
  495. EU/3/06/402 - orphan designation for treatment of meningococcal disease
  496. Guideline on good pharmacovigilance practices (GVP): module v - risk management systems…
  497. EU/3/20/2351 - orphan designation for treatment of RDH12 mutation associated retinal…
  498. EMEA-001370-PIP02-13 - paediatric investigation plan
  499. Committee for Medicinal Products for Human Use (CHMP): 11-14 April 2011
  500. Strontium ranelate - paediatric investigation plan
  501. 21 CFR 878.4495: Stainless steel suture.
  502. Mary Logan: ‘Build to Evolve, Not to Last’
  503. PSUSA/00003168/202202 - periodic safety update report single assessment
  504. Stalevo - Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
  505. Release of Clinical Trial Guidance to Facilitate the Speedy and Accurate Approval and…
  506. PSUSA/00000876/201410 - periodic safety update report single assessment
  507. European Medicines Agency publishes new versions of controlled vocabularies used to comply…
  508. Anand Oswal: Weaving Wireless Technology into a Location Fabric
  509. ema-jaypircaJaypirca
  510. COVID-19 vaccines approved for Manufacture for Sale or for Distribution in the country as…
  511. Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment…
  512. 21 CFR 73.2550: Silver nitrate.
  513. Introducing Bella the BMET, the Fictional HTM Pro for Young Readers
  514. 21 CFR 862.1240: Cystine test system.
  515. EU/3/21/2413 - orphan designation for treatment of Gaucher disease
  516. Aide Memoire on Inspection of Biotech
  517. Submitting changes to labelling and patient information leaflets: Notification of Changes…
  518. Clinical Trials Information System (CTIS) sponsor end user training programme - November…
  519. New Equipment Kenics Static Mixers
  520. EMA/FVE info session on restrictions for the use of certain antimicrobials in animals
  521. EU/3/15/1584 - orphan designation for treatment of primary sclerosing cholangitis
  522. 18th meeting of the Committee for Orphan Medicinal Products
  523. Healthcare Professionals' Organisations Working Group (HCP WG)
  524. 21 CFR 886.1120: Ophthalmic camera.
  525. EMEA-002054-PIP02-18 - paediatric investigation plan
  526. EMA welcomes new Head of International Affairs
  527. AAMI Committee Publishes New HTM Team Building Guide
  528. Committee for Orphan Medicinal Products: March 2006 meeting
  529. EU/3/18/2051 - orphan designation for treatment of Duchenne muscular dystrophy
  530. cdsco-etofenamate-gel-10-w-wEtofenamate Gel 10%w/w
  531. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 February 2017
  532. ema-lonquexLonquex
  533. 21 CFR 54.5: Agency evaluation of financial interests.
  534. Clinical Trials Information System (CTIS): Walk-in clinic - January 2023
  535. PSUSA/00010349/201504 - periodic safety update report single assessment
  536. PSUSA/00010486/201801 - periodic safety update report single assessment
  537. CircoMax - opinion on variation to marketing authorisation
  538. PSUSA/00001529/202311 - periodic safety update report single assessment
  539. 21 CFR 14.22: Meetings of an advisory committee.
  540. PSUSA/00001084/201705 - periodic safety update report single assessment
  541. Committee for veterinary medicinal products: 76th meeting
  542. EMEA-001192-PIP01-11 - paediatric investigation plan
  543. PSUSA/00010288/202111 - periodic safety update report single assessment
  544. New gene therapy to treat spinal muscular atrophy (corrected)
  545. Committee for Herbal Medicinal Products (HMPC): 23-25 September 2024
  546. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 May 2012
  547. Insulin Injection IP 100 IU/mL
  548. EMEA-000517-PIP01-08 - paediatric investigation plan
  549. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18…
  550. Add or remove a connection to your manufacturing organisation
  551. Reclassification of spinal implantable medical devices
  552. 21 CFR 862.1465: Lipase test system.
  553. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  554. A Global Perspective on Clinical Engineering at ICEHTMC IV
  555. European Medicines Agency website unavailable 8-9 September
  556. ema-oraneraOraNera
  557. EMEA-001752-PIP01-15 - paediatric investigation plan
  558. 21 CFR 801.433: Warning statements for prescription and restricted device products…
  559. Register to make submissions to the MHRA
  560. Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices
  561. Notification, Feb 18, 2011 (G.S.R.101(E))
  562. Dietary Supplements - Foreign and Domestic Inspections, Sampling, and Imports
  563. ema-prevymisPrevymis
  564. Committee for Advanced Therapies (CAT): 16-17 August 2012
  565. EU/3/20/2384 - orphan designation for treatment of fragile X syndrome
  566. First qualification opinion on a statistical methodology for dose finding released for…
  567. European Union (Clinical Trials on Medicinal Products for Human Use) Regulations 2022 (SI…
  568. The Drugs & Cosmetics (Amendment) Act, 2008 and Guidelines
  569. EMA response to the monkeypox public health emergency
  570. CMC Requirements for CTGTP for Clinical Trials and Product Registration [PDF, 526 KB]
  571. Purna Prasad: EMR and the Clinical Internet of Things
  572. EU/3/10/756 - orphan designation for prevention of scarring post glaucoma filtration…
  573. FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed…
  574. Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in Clinical…
  575. 2019.11.26_S.O. 4271(E)_ Govt. Analyst at NIB Noida
  576. EMEA-001319-PIP01-12 - paediatric investigation plan
  577. EU/3/07/501 - orphan designation for treatment of ovarian cancer
  578. PSUSA/00003102/201611 - periodic safety update report single assessment
  579. cdsco-sofosbuvirSofosbuvir
  580. EMA recommends revoking conditional marketing authorisation for Ocaliva
  581. EU/3/16/1744 - orphan designation for treatment of periventricular leukomalacia
  582. EMEA-000990-PIP02-10 - paediatric investigation plan
  583. Third industry stakeholder platform on research and development support
  584. EMEA-002884-PIP01-20 - paediatric investigation plan
  585. May 11, 2023: Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement - 05/11/2023
  586. ema-roteasRoteas
  587. Introduction to the Permissible Ingredients Determination
  588. 21 CFR 868.6810: Tracheobronchial suction catheter.
  589. EU/3/09/629 - orphan designation for treatment of thrombotic thrombocytopenic purpura
  590. Public statement on infliximab (Remicade): Update on safety concerns
  591. EMEA-001798-PIP02-16-M01 - paediatric investigation plan
  592. Amlodipine / Valsartan Mylan
  593. EU/3/14/1312 - orphan designation for treatment of congenital factor VII deficiency
  594. Guideline on medicinal gases: pharmaceutical documentation (including recommendation on…
  595. European Medicines Agency updates on pandemic medicines
  596. December 12, 2017: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices…
  597. Committee for Medicinal Products for Human Use (CHMP): 17-20 October 2011
  598. 21 CFR 892.1700: Diagnostic x-ray high voltage generator.
  599. EU/3/15/1560 - orphan designation for treatment of Duchenne muscular dystrophy
  600. Esmya: new measures to minimise risk of rare but serious liver injury
  601. Drug Safety Update: monthly PDF newsletter: Drug Safety Update December 2021
  602. PSUSA/00001321/201410 - periodic safety update report single assessment
  603. Clinical Trials Information System (CTIS) sponsor end user training programme - October…
  604. PSUSA/00000188/201703 - periodic safety update report single assessment
  605. Carisbamate - paediatric investigation plan
  606. ema-winrevairWinrevair
  607. Osimertinib Versus lazertinib
  608. European Union clinical trials portal and Union database: meeting with stakeholders
  609. DR_G.S.R. 478(E) dt 06.08.1981_insertion of rule 43A
  610. EU/3/20/2361 - orphan designation for treatment of congenital pulmonary hypoplasia
  611. Add or remove an Agent from your organisation
  612. PSUSA/00002866/201603 - periodic safety update report single assessment
  613. ema-ich-guidelinesICH guidelines
  614. Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials…
  615. Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
  616. EudraVigilance Information Day
  617. cdsco-datopotamab-deruxtecanDatopotamab/Deruxtecan
  618. EU/3/15/1556 - orphan designation for treatment of achromatopsia caused by mutations in…
  619. Biosimilar medicines: marketing authorisation
  620. 21 CFR 820.180: General requirements.
  621. New treatment option for patients with advanced lung cancer
  622. EU/3/14/1409 - orphan designation for treatment of malignant mesothelioma
  623. DADI PDF electronic application forms (eAF) training webinar
  624. HMPC: Working parties and other groups
  625. 21 CFR 868.5120: Anesthesia conduction catheter.
  626. cdsco-insulin-aspart-biaspInsulin Aspart BIAsp
  627. Tramadol hydrochloride, Paracetamol - paediatric investigation plan
  628. Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2016
  629. Appointment of CPIO and CAPIO for the purpose of RTI for the O/o. Asstt. Drugs Controller…
  630. PSUSA/00000082/201509 - periodic safety update report single assessment
  631. EMA website briefly unavailable on 20 December
  632. Chimpanzee Adenovirus Vectored COVID-19 Vaccine
  633. Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis…
  634. PSUSA/00010207/201911 - periodic safety update report single assessment
  635. EMEA-002168-PIP01-17-M04 - paediatric investigation plan
  636. EU/3/18/2121 - orphan designation for treatment of biliary tract cancer
  637. EMA regular press briefing on COVID-19
  638. Points to Consider for Clinical Development of Drugs Intended for Treatment of…
  639. ema-tolvaptan-accordTolvaptan Accord
  640. 21 CFR 882.5050: Biofeedback device.
  641. Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC…
  642. 21 CFR 868.6175: Cardiopulmonary emergency cart.
  643. PSUSA/00001158/201611 - periodic safety update report single assessment
  644. Vilanterol trifenatate eq. to Vilanterol + Glycopyrrolate IP eq. to Glycopyrronium +…
  645. ema-capecitabine-sunCapecitabine SUN
  646. Regulations for Buildings and Facilities of Pharmacies, etc. (Tentative Translation :as of…
  647. 21 CFR 890.5720: Water circulating hot or cold pack.
  648. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Linagliptin + Metformin…
  649. Pseudoephedrine-containing medicinal products - referral
  650. AAMI Publishes Leadership Development Guide for HTM Professionals
  651. 21 CFR 884.1560: Fetal blood sampler.
  652. Assessment of the effect of antimicrobial substances on dairy starter cultures…
  653. cdsco-elagolix-200-mg-tabletElagolix 200 mg tablet
  654. 21 CFR 892.5300: Medical neutron radiation therapy system.
  655. System or procedure packs
  656. ema-restaysisRestaysis
  657. Ranitidine-containing medicinal products - referral
  658. EMEA-003223-PIP01-22 - paediatric investigation plan
  659. ema-purevax-rcpPurevax RCP
  660. Workshop on identifying opportunities for 'big data' in medicines development and…
  661. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - March 2019
  662. EU/3/08/568 - orphan designation for treatment of partial deep dermal and full-thickness…
  663. Registration open for conference on advanced therapies
  664. European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint…
  665. Committee for Herbal Medicinal Products (HMPC): 29-30 September 2014
  666. EMA starts rolling review of the Sputnik V COVID-19 vaccine
  667. European Medicines Agency concludes action on COX-2 inhibitors
  668. Sitagliptin phosphate monohydrate / simvastatin - paediatric investigation plan
  669. 21 CFR 73.3128: Mica-based pearlescent pigments.
  670. Better veterinary medicines for healthier animals and people
  671. European Medicines Agency plans public access to information on side effects
  672. PSUSA/00002171/202103 - periodic safety update report single assessment
  673. PSUSA/00010751/202203 - periodic safety update report single assessment
  674. EMEA-002246-PIP01-17-M03 - paediatric investigation plan
  675. EU/3/03/159 - orphan designation for treatment of primary growth hormone insensitivity…
  676. EMEA-000988-PIP01-10 - paediatric investigation plan
  677. The European Medicines Agency recommends suspension of the marketing authorisation of…
  678. Mary Logan: What the Joys of a Summer Vacation Taught Me about Work
  679. EU/3/18/2064 - orphan designation for treatment of marginal zone lymphoma
  680. Drug Alert list for October 2018
  681. EMEA-002345-PIP01-18 - paediatric investigation plan
  682. ema-prolevareProlevare
  683. Established Medicines marketing authorisation application process changes
  684. 21 CFR 830.100: FDA accreditation of an issuing agency.
  685. Regulatory update - EMA encourages companies to submit type I variations for 2018 by end…
  686. European Medicines Agency publishes initial list of medicines under additional monitoring
  687. Europe to boost cooperation with international partners on generics
  688. Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety…
  689. Public register of parallel distribution now available
  690. 21 CFR 20.110: Data and information about Food and Drug Administration employees.
  691. mhra-contact-mhraContact MHRA
  692. Paediatric Committee (PDCO): 21-24 July 2026
  693. Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2022 (SI…
  694. Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 25.01.2023
  695. Using Organisations Management Service (OMS) data in electronic application forms (eAF)
  696. Blood: authorisations and safety reporting
  697. Management Board meeting: 11 - 12 June 2025
  698. EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
  699. 21 CFR 890.5050: Daily activity assist device.
  700. ema-zolvixZolvix
  701. Committee for Orphan Medicinal Products (COMP): 15-17 June 2021
  702. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - October 2017
  703. Appendix 13B Part B: Checklist on Dossier Requirements for MIV-2 (Notification) Variation…
  704. Compliance and enforcement policy for health products (POL-0001)
  705. ema-sancusoSancuso
  706. EMEA-001241-PIP02-13-M01 - paediatric investigation plan
  707. 21 CFR 1.392: Who receives a copy of the detention order?
  708. Inactivated Influenza Vaccine (Split Virion) I.P. (Tetravalent)
  709. Ken Hoyme: Why Is the 'System' Such a Challenge for Healthcare?
  710. ema-actilyse-referralActilyse - referral
  711. Development of CHMP guideline on dosing delivery of injectable liquids - Scientific…
  712. EMEA-000784-PIP02-11-M01 - paediatric investigation plan
  713. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  714. Procurement activities 2020
  715. AU P0037.001 Guidelines on the use of GHTF/SG3/N19:2012 for MDSAP purposes
  716. List of spurious Drugs for the month of June-2025
  717. Horizon 2020 research funding
  718. Annual workshop of the European network of paediatric research at EMA (Enpr-EMA)
  719. EU/3/16/1672 - orphan designation for treatment of diffuse large B-cell lymphoma
  720. Merged existing Medical Devices risk-classification
  721. AAMI Partners with AmbiFi to Offer Cutting-Edge Process Support Tool
  722. ema-codex-alimentariusCodex Alimentarius
  723. 21 CFR 878.5035: Nonabsorbable expanded polytetrafluoroethylene surgical suture.
  724. 21 CFR 895.21: Procedures for banning a device.
  725. EMEA-000989-PIP01-10-M02 - paediatric investigation plan
  726. 2019.09.13_Final G.S.R. 653(E)-Notification of ICD Dhannad Indore in MP for import of…
  727. Australian Public Assessment Report (AusPAR) guidance
  728. Committee for Advanced Therapies (CAT): 20-22 June 2018
  729. ema-idacioIdacio
  730. cdsco-pradaxa-capsulesPradaxa Capsules
  731. PSUSA/00009205/201509 - periodic safety update report single assessment
  732. DR_G.S.R. 590(E) dt_08.30.2013_Corrigendum to GSR 332(E) 23.05.2013
  733. EMEA-002406-PIP01-18 - paediatric investigation plan
  734. cdsco-sar443765SAR443765
  735. EU/3/20/2324 - orphan designation for treatment of von Hippel-Lindau disease
  736. European Medicines Agency closed 31 August 2015
  737. EMEA-000298-PIP01-08-M06 - paediatric investigation plan
  738. Pegfilgrastim Injection 6mg (Single Use Prefilled Syringe)
  739. Sterile Processing Week: AAMI’s ‘Need to Know’ List for SPDs
  740. FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines…
  741. 21 CFR 886.5310: Intranasal electrostimulation device for dry eye symptoms.
  742. PSUSA/00002066/202010 - periodic safety update report single assessment
  743. 21 CFR 866.3550: Salmonella spp. serological reagents.
  744. 21 CFR 1.645: What records procedures must a third-party certification body have to…
  745. Scientific advice leads to stronger applications from industry
  746. ema-leflunomide-ratiopharmLeflunomide ratiopharm
  747. PSUSA/00000595/201703 - periodic safety update report single assessment
  748. Natpar - direct healthcare professional communication (DHPC)
  749. EU recommendations for 2018/2019 seasonal flu vaccine composition
  750. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  751. New cell-based therapy to support stem cell transplantation in patients with high-risk…
  752. In Memoriam: Michael H. Scholla
  753. ema-artobendArtobend
  754. Zingiberis rhizoma - herbal medicinal product
  755. EU/3/08/604 - orphan designation for prevention of ischaemia/reperfusion injury associated…
  756. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12…
  757. PSUSA/00009162/201503 - periodic safety update report single assessment
  758. Daclatasvir dihydrochloride IP eq. to Daclatasvir + Sofosbuvir film coated tablet with or…
  759. EMA business hours over Ascension Day holidays, 18 and 19 May
  760. Orphan medicines procedures
  761. PSUSA/00001662/201501 - periodic safety update report single assessment
  762. Mary Ann Drosnock: New Amendments and TIR Coming for ANSI/AAMI ST79
  763. European Medicines Agency publishes guidance on preparing and reviewing summaries of…
  764. 21 CFR 866.3946: Dengue virus nucleic acid amplification test reagents.
  765. Comments invited on guideline for the demonstration of efficacy for veterinary medicines…
  766. EMEA-000941-PIP01-10 - paediatric investigation plan
  767. ema-hulioHulio
  768. Paediatric Committee (PDCO): 20-23 February 2024
  769. Clinical investigation of medicinal products in the treatment or prevention of diabetes…
  770. Active substance master file procedure - Scientific guideline
  771. Drug Alert list for month of March 2017
  772. FDA Proposes Updates to Breakthrough Devices Guidance with a Focus on Reducing Disparities…
  773. International regulators and WHO: support healthcare professionals to enhance public…
  774. EMEA-002908-PIP02-22 - paediatric investigation plan
  775. 21 CFR 12.96: Briefs and arguments.
  776. EU/3/14/1352 - orphan designation for treatment of inhalation anthrax disease
  777. EU/3/11/866 - orphan designation for treatment of acute myeloid leukaemia
  778. Amendment to “Basic Principles on Global Clinical Trials (Reference Cases)”
  779. PSUSA/00010484/202205 - periodic safety update report single assessment
  780. Reagents for Detection of Influenza A Viruses Approved by China NMPA
  781. Consultation: Draft Documents for Medical Devices Program
  782. cdsco-bilastine-tablets-40mgBilastine Tablets 40mg
  783. Brinzolamide IP + Brimonidine Tartrate IP Ophthalmic suspension (Phase III)
  784. Sodium Copper Chlorophyllin
  785. Quality of water used in the production of vaccines for parenteral use - Scientific…
  786. EMEA-002559-PIP07-22 - paediatric investigation plan
  787. Regulations of Medical Device Tracking Management
  788. ema-pioglitazone-accordPioglitazone Accord
  789. ema-senvelgoSenvelgo
  790. Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO
  791. ema-levetiracetam-actavisLevetiracetam Actavis
  792. Evaluation of drugs for the treatment of gastroesophageal reflux disease (GORD)…
  793. cdsco-s-o-5980-e-03-12-2018S.O.5980(E)-03-12-2018
  794. Regulation of CT scan equipment_All Implantable Devices_MRI equipment etc. as Drugs with…
  795. PSUSA/00001867/201703 - periodic safety update report single assessment
  796. 21 CFR 56.108: IRB functions and operations.
  797. Clinical efficacy and safety: antineoplastic and immunomodulating agents
  798. 10 years of the Healthcare Professionals' Working Party
  799. Study: New AI Tool Predicts Long Term Lung Cancer Risk
  800. 21 CFR 878.3500: Polytetrafluoroethylene with carbon fibers composite implant material.
  801. Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication
  802. Update of EMA recommendations for 2017/2018 seasonal flu vaccine composition
  803. ema-numientNumient
  804. Aide-Memoire on Packaging
  805. EMEA-000060-PIP07-19 - paediatric investigation plan
  806. Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
  807. Definition of a new biological active substance in terms of active, passive immunity and…
  808. PSUSA/00000294/202009 - periodic safety update report single assessment
  809. PSUSA/00000262/201411 - periodic safety update report single assessment
  810. EMEA-002170-PIP01-17 - paediatric investigation plan
  811. RO7837195 100mg/1ml Powder for solution for injection
  812. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July…
  813. Rosuvastatin IP Teneligliptin Film coated tablet
  814. TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024…
  815. Public Notice regarding Draft CDSCO Guidance for Industry Version 1.2
  816. 7th meeting of the committee for veterinary medicinal products
  817. EU/3/02/093 - orphan designation for treatment of intestinal graft-versus-host disease
  818. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  819. Clinical Trials Information System (CTIS) bitesize talk: How to submit a transitional…
  820. EMEA-002189-PIP03-19 - paediatric investigation plan
  821. Form MD-8 Specimen proforma for Medical Devices
  822. EU/3/11/936 - orphan designation for treatment of sickle cell disease
  823. ema-celvapanCelvapan
  824. cdsco-sar441566SAR441566
  825. PSUSA/00002800/201911 - periodic safety update report single assessment
  826. EU/3/11/924 - orphan designation for treatment of mantle cell lymphoma
  827. cdsco-cenobamateCenobamate
  828. EU/3/09/692 - orphan designation for treatment of neuroblastoma
  829. Human Albumin (r-DNA origin)
  830. 21 CFR 882.5700: Thermal system for insomnia.
  831. Statutory warnings for all medicines containing paracetamol
  832. Points to consider for Class 2 CTGTP Labelling
  833. European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) stakeholders annual…
  834. 21 CFR 12.82: Petition to participate in forma pauperis.
  835. May 24, 2024 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting…
  836. EMEA-002532-PIP01-18-M02 - paediatric investigation plan
  837. PCWP/HCPWP meeting with all eligible organisations: COVID-19 pandemic update
  838. ema-vitektaVitekta
  839. Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for…
  840. Webinar presentation: Code tables for GMP Clearances
  841. 21 CFR 886.4155: Scleral plug.
  842. Eighth Industry Standing Group (ISG) meeting
  843. ema-wW
  844. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course
  845. EMA sets up task force on Zika virus
  846. EU/3/18/2128 - orphan designation for treatment of Rett syndrome
  847. PSUSA/00001048/201809 - periodic safety update report single assessment
  848. (Appendix 7) The Standards for Marketing Approval of Antivertigo Medicines
  849. 21 CFR 800.75: Requests for supervisory review of certain decisions made by the Center for…
  850. EMEA-002002-PIP01-16 - paediatric investigation plan
  851. Spurious Drugs -- Reward Scheme for Whistle Blowers
  852. Paediatric Committee (PDCO): 12-15 December 2023
  853. CHMP: meeting archive 2013-2015
  854. EU/3/01/060 - orphan designation for treatment of malignant mesothelioma
  855. 21 CFR 882.1561: Evoked photon image capture device.
  856. 21 CFR 868.5720: Bronchial tube.
  857. EMEA-001822-PIP01-15-M01 - paediatric investigation plan
  858. Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the…
  859. EU/3/05/266 - orphan designation for prevention of graft rejection after lung…
  860. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 15-17 March 2016
  861. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 16-18 February 2016
  862. Lincocin and its associated names - referral
  863. cdsco-ct-07-2024-zydusCT-07-2024 Zydus
  864. AAMI News, January 2022, Vol.57, No.1
  865. EMEA-001748-PIP02-18 - paediatric investigation plan
  866. Improving the availability of vaccines for animals within the EU
  867. Volrustomig (MEDI5752) Lyophilized product for concentrate for solution for infusion 250…
  868. EMEA-002569-PIP04-19 - paediatric investigation plan
  869. Osimertinib Vs Savolitinib
  870. EU/3/05/283 - orphan designation for treatment of idiopathic thrombocytopenic purpura
  871. PSUSA/00001413/201512 - periodic safety update report single assessment
  872. Chelidonii herba - herbal medicinal product
  873. ema-aravaArava
  874. 21 CFR 26.49: Regulatory cooperation.
  875. European Medicines Agency holds Focus Group meeting on fibrosarcoma occurring at sites of…
  876. EMEA-001214-PIP07-21 - paediatric investigation plan
  877. Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA…
  878. ema-actelsar-hctActelsar HCT
  879. Plant testing strategy for veterinary medicinal products
  880. Advisory Notice regarding voluntary registration of personal protection equipment…
  881. EU recommendations for 2017/2018 seasonal flu vaccine composition
  882. Committee for Medicinal Products for Veterinary Use: Meeting of 8-10 December 2009
  883. MEDICAL DEVICE ALERT FOR " Beacon Tip Torcon NB Advantage Catheter
  884. Regulation impact statement: Proposal to clarify that certain sports supplements should be…
  885. Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 November 2012
  886. ema-etoricoxib-referralEtoricoxib - referral
  887. EU/3/16/1666 - orphan designation for treatment of graft-versus-host disease
  888. PSUSA/00000749/202402 - periodic safety update report single assessment
  889. Committee for Medicinal Products for Human Use (CHMP): 19-22 January 2015
  890. How big data can be used for the development and regulation of medicines
  891. ema-idfluIDflu
  892. European Medicines Agency sees strong level of applications in 2007
  893. European and international experts discuss the way forward in stem-cell research and…
  894. Drospirenone - Safety Review of possible increased risk of blood clots with birth control…
  895. Experts and regulators discuss role of modelling and simulation in medicine development…
  896. EMEA-002655-PIP02-20 - paediatric investigation plan
  897. European Medicines Agency workshop on first-in-man clinical trials draft guideline
  898. Inviting comments on consideration of the proposal regarding Issue of use of brand name…
  899. 21 CFR 17.30: Computation of time.
  900. ema-esignature-webinareSignature webinar
  901. Avinash Konkani: Improving Manufacturers' Response Time in Correcting Problems
  902. Respirator Demand Still Exceeds Supply—and Fraud Is A Challenge
  903. ema-viramuneViramune
  904. Ozempic / Victoza - direct healthcare professional communication (DHPC)
  905. European Medicines Agency-industry stakeholders platform meeting on paediatric medicines
  906. Clinical efficacy and safety: cardiovascular system
  907. EU/3/02/127 - orphan designation for treatment of inborn errors in primary bile acid…
  908. EU/3/04/254 - orphan designation for treatment of myelodysplastic syndromes
  909. Category of Accreditation of Foreign Manufacturers
  910. EMEA-001726-PIP01-14 - paediatric investigation plan
  911. EU/3/23/2804 - orphan designation for treatment of nontuberculous mycobacterial lung…
  912. 21 CFR 866.3520: Rubeola (measles) virus serological reagents.
  913. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  914. EU/3/22/2640 - orphan designation for treatment of ATTR amyloidosis
  915. RoActemra - withdrawal of application for variation to marketing authorisation
  916. EMEA-003186-PIP01-22 - paediatric investigation plan
  917. EU/3/14/1302 - orphan designation for treatment of Prader-Willi syndrome
  918. Decree of State Food and Drug Administration
  919. cdsco-ly3437943eliLY3437943eli
  920. First European Medicines Agency - European Confederation of Pharmaceutical Entrepreneurs…
  921. European Medicines Agency and U.S. Food and Drug Administration extend confidentiality…
  922. PSUSA/00001721/201409 - periodic safety update report single assessment
  923. EMEA-002363-PIP01-18 - paediatric investigation plan
  924. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  925. EMEA-001624-PIP02-19 - paediatric investigation plan
  926. EU/3/22/2681 - orphan designation for treatment of frontotemporal dementia
  927. Insulin degludec and Insulin aspart Injection
  928. AAMI Statement Against Racism and Intolerance
  929. How to submit information on authorised and investigational medicines
  930. 21 CFR 890.5700: Cold pack.
  931. PSUSA/00001191/201805 - periodic safety update report single assessment
  932. ema-zinacef-referralZinacef - referral
  933. GN-09-R4 Guidance on the Component Elements of a DHCPL (2025 Jul) PUB
  934. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20…
  935. EU/3/17/1843 - orphan designation for treatment of achondroplasia
  936. EMEA-000297-PIP02-12-M02 - paediatric investigation plan
  937. Pregabalin IP (as prolonged release) + Etoricoxib IP film coated bilayered tablets (Phase…
  938. EU/3/23/2821 - orphan designation for treatment of pancreatic cancer
  939. cfr-21-cfr-10-204-general21 CFR 10.204: General.
  940. ema-equilis-prequenza-teEquilis Prequenza Te
  941. Saxagliptin / metformin - paediatric investigation plan
  942. ema-tadalafil-mylanTadalafil Mylan
  943. Menyanthidis trifoliatae folium - herbal medicinal product
  944. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 April 2025
  945. 21 CFR 21.32: Personnel records.
  946. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August…
  947. Press Release on COMTESS/COMTAN (Entacapone) - Update of Product Information
  948. William Hyman: What Do FDA Inspections of Hospitals for MDR Compliance Tell Us?
  949. EMEA-001790-PIP01-15 - paediatric investigation plan
  950. Level of purification of extracts to be considered as herbal preparations - Scientific…
  951. European Medicines Agency statement on new information on Rotarix oral vaccine
  952. EMEA-000380-PIP08-21 - paediatric investigation plan
  953. Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines…
  954. March 01 2016 GSR 268(E)
  955. Committee for veterinary medicinal products: 63rd meeting
  956. ema-hepacareHepacare
  957. PSUSA/00001654/201602 - periodic safety update report single assessment
  958. 2021.02.04_S.O. 529(E)_Notification of Dr. Sandeep Singh & Dr. Sweta Raghuvanshi for…
  959. ema-nespoNespo
  960. Multidisciplinary guidelines
  961. 21 CFR 878.4380: Drape adhesive.
  962. Relamorelin gastroparesis
  963. GN-23-R2 Guidance on Labelling for Medical Devices(2022 Sep) PUB
  964. EU/3/14/1374 - orphan designation for treatment of Gaucher disease
  965. FDA Drug Safety Communication: Risk of serious and potentially fatal blood disorder…
  966. Paediatric Committee elects new Chair and Vice-Chair
  967. nbcg-team-nb-member-listTEAM-NB Member List
  968. EU/3/18/2010 - orphan designation for treatment of spinal muscular atrophy
  969. EMEA-001748-PIP03-19 - paediatric investigation plan
  970. EU/3/23/2776 - orphan designation for treatment of hypomyelinating leukodystrophy-18
  971. (Appendix 5) The Standards for Marketing Approval of Gastrointestinal Medicines
  972. 21 CFR 874.3340: Active implantable bone conduction hearing system.
  973. Committee for Orphan Medicinal Products (COMP): 16-18 January 2018
  974. EMEA-002208-PIP01-17-M02 - paediatric investigation plan
  975. Committee for Orphan Medicinal Products: October 2006 meeting
  976. EU/3/12/1084 - orphan designation for treatment of lead toxicity
  977. 21 CFR 870.1915: Thermodilution probe.
  978. Order regarding receipt related to SAE of Clinical Trials
  979. Pediatric Advisory Committee Meeting Announcement - 09/19/2023
  980. NMPA Announcement on Revising the Package Inserts of 14 Drug Varieties Including…
  981. EMEA-003408-PIP01-23 - paediatric investigation plan
  982. PSUSA/00010353/201505 - periodic safety update report single assessment
  983. Update on treatments and vaccines against COVID-19 under development
  984. Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and…
  985. 21 CFR 874.4680: Bronchoscope (flexible or rigid) and accessories.
  986. The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS…
  987. Hepatitis A (Live) Vaccine, Freeze-Dried
  988. 21 CFR 73.100: Cochineal extract; carmine.
  989. Submission of marketing-authorisation applications for pandemic influenza vaccines through…
  990. ema-longrangeLongrange
  991. 21 CFR 866.3365: Multiplex nucleic acid assay for identification of microorganisms and…
  992. EU/3/14/1325 - orphan designation for treatment of diffuse large B-cell lymphoma
  993. First aid kits that contain medical devices and/or medicines
  994. cdsco-dienogest-visanneDienogest (Visanne®)

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