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Global regulations and guidance

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

  1. PRAC recommends new measures to avoid topiramate exposure in pregnancy
  2. ema-forcerisForceris
  3. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: Hands-on…
  4. Methods found suitable within the European Union for demonstrating freedom from extraneous…
  5. Nor-ursodeoxycholic acid
  6. Regulatory framework for personalised medical devices: Frequently asked questions
  7. COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements
  8. Regulations Governing Accreditation and Outsourced Accreditation Management of Cosmetic…
  9. Medical devices: information for users and patients
  10. EU/3/11/872 - orphan designation for treatment of hepatocellular carcinoma
  11. Inviting stakeholders comments for Invitro Diagnostic Medical Device adverse event…
  12. PSUSA/00010332/201704 - periodic safety update report single assessment
  13. EMEA-001964-PIP01-16-M04 - paediatric investigation plan
  14. Committee for Herbal Medicinal Products (HMPC): 20-22 January 2025
  15. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
  16. Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee…
  17. Infringement notice - Omega Pharma Limited
  18. Strict compliance with the Drugs Rules 1945 for testing of raw materials and finished…
  19. 21 CFR 866.5550: Immunoglobulin (light chain specific) immunological test system.
  20. 21 CFR 862.1560: Urinary phenylketones (nonquantitative) test system.
  21. IT systems unavailable from 28 October to 1 November 2016
  22. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 December 2011
  23. European Medicines Agency workshop on the investigation of subgroups in confirmatory…
  24. EU/3/05/309 - orphan designation for treatment of 5q spinal muscular atrophy
  25. Multistakeholder workshop on EMA’s extended mandate
  26. EMEA-002203-PIP01-17 - paediatric investigation plan
  27. ema-vocabriaVocabria
  28. EU/3/10/786 - orphan designation for treatment of tuberculosis
  29. 21 CFR 880.6800: Washers for body waste receptacles.
  30. EMEA-003137-PIP01-21 - paediatric investigation plan
  31. Guidance document for obtaining Market Standing certificate & Non conviction certificate…
  32. Drug Alert list for month of March 2022
  33. AAMI, GCEA Translate Healthcare Technology Guide into Japanese, Turkish
  34. 21 CFR 866.4900: Support gel.
  35. NMPA Issued Guidelines for Technical Review of the Registration of Custom-Made and…
  36. ema-stribildStribild
  37. 21 CFR 803.20: How do I complete and submit an individual adverse event report?
  38. Committee for Orphan Medicinal Products (COMP): 21-23 January 2025
  39. Requirements for combined vaccines and associations of immunological veterinary medicinal…
  40. Finke, Healthcare Technology Management Leader, Retires from VA
  41. EMEA-002909-PIP01-20 - paediatric investigation plan
  42. Insuman - direct healthcare professional communication (DHPC)
  43. Simvastatin / fenofibrate - paediatric investigation plan
  44. 2006 EU-Swiss GMP China Training Workshop
  45. Nelarabine Injection (250 mg/50 ml)
  46. Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 November 2013
  47. 21 CFR 886.1342: Strabismus detection device.
  48. EMEA-000008-PIP01-07 - paediatric investigation plan
  49. 21 CFR 892.5770: Powered radiation therapy patient support assembly.
  50. Orphan medicines in the EU – leaving no-one behind
  51. EU/3/17/1955 - orphan designation for treatment of mucopolysaccharidosis type I
  52. eXtended EudraVigilance Medicinal Product Dictionary training course
  53. EU/3/15/1599 - orphan designation for treatment of haemophilia B
  54. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 December 2013
  55. European Medicines Agency scientific debate
  56. 2018-09-07_Draft GSR 848(E)_Rule 3, Rule 59, Fourth ScheduleSeventh Schedule of MDR 2017
  57. Notice Order regarding SUGAM ONLINE
  58. EMEA-003077-PIP01-21 - paediatric investigation plan
  59. ema-rivastigmine-1-a-pharmaRivastigmine 1 A Pharma
  60. European Medicines Agency IT systems unavailable from 16 April to 17 April 2016
  61. Clinical Trials Information System (CTIS) sponsor end user training programme - March 2022
  62. ema-international-activitiesInternational activities
  63. ema-vepuredVepured
  64. ACT EU Training for non-commercial sponsors: Transitioning trials to the CTR (CTIS)
  65. Advisory on labeling requirements for combi kit of Misoprostol and Mifepristone tablets…
  66. DR_G.S.R. 313 (E) dt_16.03.2016_Amendment Rule 122DA_Ethics Committee
  67. ema-iclusig-referralIclusig - referral
  68. Product Lifecycle Management (PLM) Value Stream Deep-Dive Webinar
  69. Paediatric Committee (PDCO): 27-29 April 2016
  70. ema-omnitropeOmnitrope
  71. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017
  72. European Medicines Agency and US Food and Drug Administration release joint proposal to…
  73. Changing a registered complementary medicine RCM: application levels and changes tables
  74. cdsco-evenamide-nw-3509-2Evenamide (NW-3509)2
  75. EU/3/22/2658 - orphan designation for treatment in solid organ transplantation
  76. EMEA-000253-PIP01-08 - paediatric investigation plan
  77. ema-russiaRussia
  78. EU/3/13/1223 - orphan designation for treatment of chronic lymphocytic leukaemia / small…
  79. Paediatric Committee (PDCO): 16-19 October 2018
  80. EMEA-000464-PIP02-10 - paediatric investigation plan
  81. EU/3/09/717 - orphan designation for treatment of Lesch-Nyhan disease
  82. Seizure risk for multiple sclerosis patients who take Ampyra (dalfampridine)
  83. European Medicines Agency recommends restricting the use of methysergide-containing…
  84. Sevohale (previously known as Sevocalm)
  85. DR_G.S.R. 724(E) dt_07.11.2013_amendment Rule 122E,Sch DHSX_Addition of Sindoor Ketamine
  86. 21 CFR 882.5895: Vibratory counter-stimulation device.
  87. Plasma Master File dossier format and submission requirements
  88. Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 January 2020
  89. EMEA-002640-PIP01-19 - paediatric investigation plan
  90. EMEA-001134-PIP01-11 - paediatric investigation plan
  91. Thirteenth Meeting of the Management Board
  92. European Medicines Agency website unavailable intermittently Saturday 6 October
  93. VICH GL25 Biologicals: testing of residual formaldehyde - Scientific guideline
  94. NMPA Announcement on Revising the Package Inserts for Polyene Phosphatidylcholine…
  95. EMEA-002283-PIP01-17-M04 - paediatric investigation plan
  96. Import Acidified and Low-Acid Canned Foods Program
  97. EMEA-002854-PIP01-20 - paediatric investigation plan
  98. EMEA-002724-PIP01-19-M02 - paediatric investigation plan
  99. EMEA-000380-PIP10-23 - paediatric investigation plan
  100. Advice for Producers of E-Cigarette/Vape Products
  101. Future-Proofing Biomedical Engineering Education
  102. U.S. Agencies, Associations Urge Hospital Vigilance Against Russian Cyber Attacks
  103. PSUSA/00000883/202202 - periodic safety update report single assessment
  104. EMEA-002817-PIP03-20 - paediatric investigation plan
  105. PSUSA/00000389/202012 - periodic safety update report single assessment
  106. PSUSA/00000051/201710 - periodic safety update report single assessment
  107. ema-seebri-breezhalerSeebri Breezhaler
  108. EMEA-000430-PIP01-08-M11 - paediatric investigation plan
  109. ema-jivadcoJivadco
  110. Beovu - direct healthcare professional communication (DHPC)
  111. EU/3/09/641 - orphan designation for treatment of pouchitis
  112. Paediatric Committee (PDCO): 6-8 November 2013
  113. ema-suvaxyn-csf-markerSuvaxyn CSF Marker
  114. 21 CFR 50.54: Clinical investigations not otherwise approvable that present an opportunity…
  115. Clinical Trials Information System: training and support
  116. ema-xermeloXermelo
  117. EU/3/12/1040 - orphan designation for treatment of Alagille syndrome
  118. E-learning modules: medicines
  119. Paediatric Committee (PDCO): 15-17 July 2015
  120. EMEA-001623-PIP01-14-M06 - paediatric investigation plan
  121. Chapter 10 - General Advice on Vigilance - Great Britain: Chapter 10 - General Advice on…
  122. Xeljanz - direct healthcare professional communication (DHPC)
  123. G.S.R. 729 (E) dated 01.08.2018
  124. Improving bioequivalence studies
  125. Second stakeholder forum on the implementation of the new 2010 pharmacovigilance…
  126. ema-valdoxanValdoxan
  127. ema-qutavinaQutavina
  128. EMA Management Board: highlights of March 2024 meeting
  129. Q&A clinic on Product Management Service (PMS) Product User Interface - 20 June 2024
  130. Everolimus with reduced calcineurin
  131. EU/3/19/2229 - orphan designation for treatment of phenylalanine hydroxylase deficiency
  132. ema-sustivaSustiva
  133. EU/3/22/2741 - orphan designation for treatment of recombination-activating gene 2…
  134. Drug Alert list for month of August 2016
  135. Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 June 2024
  136. cdsco-golimumab-50mg-0-5mlGolimumab 50mg/0.5mL
  137. EMEA-002632-PIP01-19 - paediatric investigation plan
  138. Polypodii rhizoma - herbal medicinal product
  139. ema-kayfandaKayfanda
  140. 21 CFR 886.5540: Low-vision magnifier.
  141. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  142. EU/3/20/2334 - orphan designation for treatment of aspartylglucosaminuria
  143. EMEA-001108-PIP02-15 - paediatric investigation plan
  144. EMEA-002287-PIP01-17-M03 - paediatric investigation plan
  145. PSUSA/00001437/201411 - periodic safety update report single assessment
  146. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - April 2015
  147. EU/3/18/2026 - orphan designation for treatment of transthyretin-mediated amyloidosis…
  148. Clinical Trials Information System (CTIS) demonstration for stakeholders
  149. EU/3/14/1337 - orphan designation for treatment of fragile X syndrome
  150. ema-olanzapine-apotexOlanzapine Apotex
  151. PSUSA/00010396/202204 - periodic safety update report single assessment
  152. Data monitoring committees - Scientific guideline
  153. EU/3/08/554 - orphan designation for treatment of pulmonary arterial hypertension
  154. EU/3/15/1451 - orphan designation for treatment of Alport syndrome
  155. 21 CFR 1.916: When will we consider whether to waive a requirement of this subpart?
  156. Committee for Orphan Medicinal Products (COMP): 5-6 November 2013
  157. EMEA-002984-PIP01-21 - paediatric investigation plan
  158. EMEA-000371-PIP02-09 - paediatric investigation plan
  159. EMEA-002223-PIP01-19 - paediatric investigation plan
  160. Updated recommendations to minimise the risk of the rare brain infection PML with…
  161. EU Clinical Trials Register goes live
  162. Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27…
  163. Product-information requirements for veterinary medicines
  164. ema-xyndariXyndari
  165. EU/3/12/971 - orphan designation for treatment of carbamoyl-phosphate synthase-1…
  166. EMEA-001696-PIP01-14-M02 - paediatric investigation plan
  167. PSUSA/00010484/202005 - periodic safety update report single assessment
  168. ema-cabliviCablivi
  169. EMEA-003125-PIP01-21 - paediatric investigation plan
  170. EU report: more evidence on link between antibiotic use and antibiotic resistance
  171. ema-paediatric-formulationsPaediatric formulations
  172. Telcagepant - paediatric investigation plan
  173. Semaglutide tablets 3 mg, 7 mg and 14 mg
  174. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 September 2015
  175. 21 CFR 7.40: Recall policy.
  176. EMEA-001011-PIP01-10-M01 - paediatric investigation plan
  177. ema-lusdunaLusduna
  178. EMEA-001943-PIP05-21 - paediatric investigation plan
  179. Doctors Are Ready for AI in Medical Devices, But Are Patients? An ISC 2022 Conversation
  180. Rivaroxaban tablets 2.5mg (Xarelto®)
  181. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  182. Serious skin reactions after combination treatment with the Hepatitis C drug Incivek…
  183. cdsco-molnupiravir-mildm1Molnupiravir Mildm1
  184. PSUSA/00010867/202101 - periodic safety update report single assessment
  185. Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg…
  186. Medical devices: software applications (apps): Medical device stand-alone software…
  187. EU/3/05/289 - orphan designation for treatment of hepatocellular carcinoma
  188. Addendum 03 to FAQ on Medical Devices Rules 2017
  189. PSUSA/00010349/202104 - periodic safety update report single assessment
  190. ema-cyltezoCyltezo
  191. PSUSA/00009190/201801 - periodic safety update report single assessment
  192. 21 CFR 866.5930: Newborn screening test for severe combined immunodeficiency disorder…
  193. ema-enrylazeEnrylaze
  194. EMEA-001295-PIP01-12-M01 - paediatric investigation plan
  195. Clinical Trials Information System (CTIS) sponsor end user training programme - October…
  196. Drug establishment good manufacturing practices - Pre-application package (importers…
  197. ema-trobaltTrobalt
  198. Registration open for EMA/EFPIA Info Day: 23 May 2011
  199. 21 CFR 870.2710: Ear oximeter.
  200. 21 CFR 890.5125: Nonpowered sitz bath.
  201. mhra-ai-airlock-pilot-cohortAI Airlock pilot cohort
  202. cdsco-klu156-with-coartemKLU156 with Coartem®
  203. Medical devices: periodic safety update report (PSUR)
  204. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10…
  205. TR-02 R3 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT…
  206. ema-opdivoOpdivo
  207. European Medicines Agency publishes sources for orphan-disease prevalence data
  208. ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for…
  209. cdsco-gepotidacinrevisedGepotidacinrevised
  210. ema-voraxazeVoraxaze
  211. Submission of targeted risk management plans and follow-up commitments for prescription…
  212. Transferring quality control methods validated in collaborative trials to a…
  213. RESOLUTION RDC NO. 183, 17 OCTOBER 2017
  214. ema-quinsairQuinsair
  215. March 16 2016 GSR 312(E)
  216. Regulatory considerations for therapeutic use of bacteriophages in the UK
  217. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
  218. Committee for medicinal products for veterinary use: Meeting of 16-18 June 2009
  219. EMEA-000353-PIP02-16-M03 - paediatric investigation plan
  220. More Than 100 Novel Devices Received FDA Marketing Authorization in 2021
  221. EMEA-002238-PIP01-17-M01 - paediatric investigation plan
  222. ema-gilenyaGilenya
  223. News in Brief - April 2020
  224. ema-triloraleTrilorale
  225. 3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dione…
  226. 21 CFR 862.1400: Hydroxyproline test system.
  227. EMEA-002509-PIP01-18 - paediatric investigation plan
  228. 21 CFR 878.5350: Needle-type epilator.
  229. EMEA-003298-PIP01-22 - paediatric investigation plan
  230. Cyberattack on the European Medicines Agency
  231. cdsco-masitinibMasitinib
  232. Dec_11,2009(G.S.R_885(E)
  233. Preparing for Your IVDR Data Hunt: An ISC 2022 Conversation
  234. DR_G.S.R. 299(E) dt_23.04.1984_Substitution in Second schedule_Class of drugs like…
  235. PSUSA/00010442/201807 - periodic safety update report single assessment
  236. EU/3/14/1311 - orphan designation for treatment of Schnitzler syndrome
  237. EU/3/14/1300 - orphan designation for treatment of beta thalassaemia intermedia and major
  238. SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety…
  239. EU/3/14/1413 - orphan designation for treatment of acute myeloid leukaemia
  240. EU/3/20/2278 - orphan designation for treatment of immune thrombocytopenia
  241. PSUSA/00000748/201706 - periodic safety update report single assessment
  242. cdsco-mod-4023MOD-4023
  243. EU/3/18/1987 - orphan designation for treatment of glioma
  244. ema-movectroMovectro
  245. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2008 (SI…
  246. cdsco-noticeNotice
  247. 2021.12.10_Draft GSR 850(E)_Amendment of rule 36(3) MDR to include United Kingdom
  248. ema-trevaclynTrevaclyn
  249. EMEA-001652-PIP01-14-M05 - paediatric investigation plan
  250. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018
  251. EU/3/11/894 - orphan designation for treatment of gastric cancer
  252. ema-zelborafZelboraf
  253. Stronghold Plus - opinion on variation to marketing authorisation
  254. October 30, 2024: Patient Engagement Advisory Committee Meeting Announcement - 10/30/2024
  255. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  256. European Medicines Agency facilitates interaction between small and medium-sized…
  257. Guidance document applications for medical device investigational testing authorization
  258. European Medicines Agency gives second positive opinion for a paediatric-use marketing…
  259. What HTM Professionals Need to Know about Wireless Technology
  260. ema-qaialdoQaialdo
  261. EMEA-000964-PIP01-10 - paediatric investigation plan
  262. Personal Message from Mr Fernand Sauer, EMEA Executive Director (29 June 2000)
  263. AAMI Seeks Nominations for Awards Programs
  264. Committee for Advanced Therapies-European Society for Gene and Cell Therapy satellite…
  265. Biocides for use in animal husbandry
  266. PSUSA/00002942/201806 - periodic safety update report single assessment
  267. DR_G.S.R. 327(E) dt_03.04.2017_BCS Classification and BABE studies
  268. EMEA-002352-PIP01-18 - paediatric investigation plan
  269. ema-novothirteenNovoThirteen
  270. Extra transparency measures for COVID-19 vaccines and therapeutics
  271. Appendix 13A Part A: Checklist on Dossier Requirements for MIV-1 Variation for Chemical…
  272. ema-telzirTelzir
  273. ema-kantos-master-referralKantos Master - referral
  274. 2018.07.17_Draft_GSR 654(E)_Notifcation of Chaudhary Charan Singh National Institute of…
  275. EMEA-002566-PIP01-19 - paediatric investigation plan
  276. EMEA-002419-PIP02-18 - paediatric investigation plan
  277. 21 CFR 876.5830: Hemodialyzer with disposable insert (Kiil type).
  278. Notice to Industry - Licensing Requirements for Inter-dependent Medical Devices
  279. ema-palladiaPalladia
  280. 21 CFR 870.2210: Adjunctive predictive cardiovascular indicator.
  281. Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of…
  282. Drug Alert list for month of July 2015
  283. EU/3/11/880 - orphan designation for treatment of pancreatic cancer
  284. EU/3/13/1171 - orphan designation for prevention of rejection following solid organ…
  285. FDA warns about possible increased risk of death and serious side effects with cancer drug…
  286. EU/3/14/1267 - orphan designation for treatment of ATTR amyloidosis
  287. 'Send a question' form not working
  288. FXIa inhibitor asundexian (BAY 2433334)
  289. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
  290. Clopidogrel - paediatric investigation plan
  291. Amoxycillin Trihydrate IP eq. to Amoxycillin 600mg + Potassium Clavulanate Diluted IP eq…
  292. Guidance Document GD207: Guidance on the Content of ISO 13485 Quality Management System…
  293. EU/3/07/481 - orphan designation for treatment of cutaneus forms of lupus erythromatosus
  294. EU/3/22/2620 - orphan designation for treatment of noninsulinoma pancreatogenous…
  295. NMPA Announcement on Issuing the Catalogue of Used Cosmetic Raw Materials (Edition 2021)
  296. Handling of Application for Marketing Certification of Medical Device Software
  297. ema-ryzodegRyzodeg
  298. Guidance on MAH and QPPV location
  299. Amivantamab & Carboplatin
  300. Publication of clinical reports
  301. 21 CFR 70.20: Packaging requirements for straight colors (other than hair dyes).
  302. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  303. EMEA-002676-PIP01-19 - paediatric investigation plan
  304. EU/3/07/474 - orphan designation for treatment of cystic fibrosis
  305. February 19, 2016: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices…
  306. 21 CFR 866.5120: Antismooth muscle antibody immunological test system.
  307. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
  308. 2025 AAMI Fellow Application Now Open
  309. ema-filgrastim-ratiopharmFilgrastim ratiopharm
  310. cdsco-retatrutideRetatrutide
  311. New EudraVigilance system improves reporting of side effects and detection of safety…
  312. EMEA-000409-PIP01-08-M06 - paediatric investigation plan
  313. MDR_G.S.R. 30(E) dt_15.01.2019_Rule 3, Rule 59, 4th & 7th Schedules of MDR 2017 for…
  314. Compressed Medical Gases (PDF - 239KB)
  315. Reduction, elimination or substitution of thiomersal in vaccines - Scientific guideline
  316. Almitrine-containing medicines - referral
  317. Nitrosamines Safety Operational Expert Group
  318. EMEA-000245-PIP01-08-M06 - paediatric investigation plan
  319. 21 CFR 822.6: When will you notify me that I am required to conduct postmarket…
  320. 1-Revoke order dated 19-08-2015 for the purpose of conducting clinical trial.
  321. ENCePP releases for public consultation draft Guide on Methodological Standards in…
  322. Enpr-EMA Coordinating Group meeting June 2022
  323. EU/3/10/757 - orphan designation for treatment of primary myelofibrosis
  324. Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
  325. PSUR roadmap: joint industry/assessor training
  326. Typhoid Vi conjugate VaccineRa
  327. May 9, 2017: Science Board to the Food and Drug Administration Meeting Announcement…
  328. Implementation of a Conditional Early Approval System for Pharmaceutical Products
  329. Benzoic acid and benzoates
  330. PSUSA/00002085/202005 - periodic safety update report single assessment
  331. EU/3/13/1214 - orphan designation for treatment of Alagille syndrome
  332. EU/3/12/1070 - orphan designation for treatment of dyskeratosis congenita
  333. PDCO: Committee meeting report archive 2007-2011
  334. PSUSA/00000795/201810 - periodic safety update report single assessment
  335. EU/3/04/205 - orphan designation for treatment of cutaneous T-cell lymphoma
  336. 21 CFR 890.5800: Virtual reality behavioral therapy device for pain relief.
  337. PSUSA/00009191/202007 - periodic safety update report single assessment
  338. EU/3/03/134 - orphan designation for diagnosis of the extent of histologically proven…
  339. Deadlines for placing paediatric medicines on the market
  340. Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs)
  341. EMEA-000839-PIP01-10 - paediatric investigation plan
  342. PSUSA/00010706/202211 - periodic safety update report single assessment
  343. cdsco-ar-301AR-301
  344. Imported CBER-Regulated Products
  345. Full pack dispensing of valproate-containing medicines
  346. Paediatric medicines: Marketing authorisation
  347. Medical devices: software applications (apps): Appendix 3 - ‘drives or influences the use…
  348. cfr-21-cfr-17-35-sanctions21 CFR 17.35: Sanctions.
  349. EU/3/23/2799 - orphan designation for treatment of congenital myasthenic syndromes
  350. EU/3/18/1989 - orphan designation for treatment of C3 glomerulopathy
  351. A Closer Look at ST91:2021 for Endoscope Processing
  352. EU/3/05/338 - orphan designation for treatment of acute lymphoblastic leukaemia
  353. Survey launched for veterinarians on prescribing habits for antimicrobials
  354. Combination: Hyperici herba - herbal medicinal product
  355. ema-sugammadex-piramalSugammadex Piramal
  356. EU/3/08/601 - orphan designation for treatment of multiple myeloma
  357. ema-balimekBalimek
  358. EMEA-000597-PIP02-10-M09 - paediatric investigation plan
  359. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 October 2015
  360. EU/3/22/2590 - orphan designation for treatment of collagen VI-related myopathies
  361. 21 CFR 868.1505: Ventilatory electrical impedance tomograph.
  362. EU/3/19/2199 - orphan designation for treatment of glioma
  363. EU/3/15/1547 - orphan designation for treatment of narcolepsy
  364. EMEA-002039-PIP01-16 - paediatric investigation plan
  365. Baxter recall letter for Product Fibrin Sealant Kit Brand name Tisseel Lyo manufactured in…
  366. The State Council Executive Meeting Passed the Regulation for Supervision of Cosmetics…
  367. Guideline for the Quality, Safety and Efficacy Assurance of Follow-on Biologics
  368. 21 CFR 73.2250: Iron oxides.
  369. Boundary and combination products
  370. Safety and residues: multidisciplinary
  371. PSUSA/00001506/202108 - periodic safety update report single assessment
  372. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17…
  373. FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD…
  374. Clinical investigation of medicinal products indicated for the treatment of social anxiety…
  375. 21 CFR 74.2307: D&C Red No. 7
  376. ema-rotarixRotarix
  377. 21 CFR 830.60: Relabeling of a device that is required to bear a unique device identifier.
  378. BMWP/BWP Workshop on Immunogenicity Assessment of Therapeutic Proteins
  379. Considerations for Pre-specifying the Change Categories for Manufacturing Process…
  380. PSUSA/00003124/202204 - periodic safety update report single assessment
  381. EMEA-001275-PIP01-12 - paediatric investigation plan
  382. EMEA-001292-PIP01-12-M01 - paediatric investigation plan
  383. PSUSA/00000450/201608 - periodic safety update report single assessment
  384. ema-litakLitak
  385. EMEA Management Board considers road map 2010 and welcomes increase in new applications…
  386. PSUSA/00002004/201905 - periodic safety update report single assessment
  387. Gabapentin IP (as sustained release) + Methylcobalamin IP + Nortriptyline Hydrochloride IP…
  388. 21 CFR 876.1735: Electrogastrography system.
  389. NMPA Announcement on the Applicability of ICH Guidelines M9: Biopharmaceutics…
  390. EU/3/17/1919 - orphan designation for treatment of beta thalassaemia intermedia and major
  391. European Union (EU) International Organisation for Standardization (ISO) for…
  392. PSUSA/00002157/201812 - periodic safety update report single assessment
  393. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 March 2013
  394. Medical devices: legal requirements for specific medical products
  395. Metformin Hydrochloride IP (as extended release) + Glimepiride IP + Dapagliflozin…
  396. Crothall Healthcare Seeks Apprentices as AAMI BMET Apprenticeship Program Partner
  397. EU/3/16/1738 - orphan designation for treatment of invasive aspergillosis
  398. Committee for Orphan Medicinal Products: November 2006 meeting
  399. ema-mekinistMekinist
  400. COVID-19 Prompts Creative Defibrillator Replacement Strategy
  401. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 January 2018
  402. European Surveillance of Veterinary Antimicrobial Consumption stakeholders meeting
  403. AAMI Standards Monitor Digest: January 2021
  404. Postapproval Inspections
  405. EMEA-001557-PIP01-13-M06 - paediatric investigation plan
  406. PSUSA/00010390/201701 - periodic safety update report single assessment
  407. cdsco-ut-15cUT-15C
  408. EMEA-000408-PIP02-12 - paediatric investigation plan
  409. EMEA-001264-PIP01-12-M02 - paediatric investigation plan
  410. 21 CFR 868.1690: Nitrogen gas analyzer.
  411. PSUSA/00002396/201505 - periodic safety update report single assessment
  412. Regulatory update - EMA encourages companies to submit type I variations for 2022 by end…
  413. ema-naveruclifNaveruclif
  414. lepodisiran sodium (LY3819469)
  415. Glivec - withdrawal of application for variation to marketing authorisation
  416. EU/3/14/1285 - orphan designation for treatment of familial benign chronic pemphigus…
  417. EU/3/15/1578 - orphan designation for treatment of achromatopsia caused by mutations in…
  418. Guidelines under new penal Provision
  419. EMEA-001408-PIP01-12 - paediatric investigation plan
  420. ema-nenadNenad
  421. Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data
  422. ema-mhyosphere-pcv-idMhyosphere PCV ID
  423. EU/3/10/833 - orphan designation for treatment of hepatocellular carcinoma
  424. What’s Next for the UK’s Harmonization Efforts?
  425. ema-exvieraExviera
  426. Process validation for the manufacture of biotechnology-derived active substances and data…
  427. PSUSA/00010484/201805 - periodic safety update report single assessment
  428. 2005 EMEA/CHMP Workshop on Biomarkers
  429. EMEA-001851-PIP01-15 - paediatric investigation plan
  430. FDA updates prescribing information for all opioid pain medicines to provide additional…
  431. FDA review found no increased cardiovascular risks with Parkinson's disease drug…
  432. Drug Safety Update: monthly PDF newsletter: Drug Safety Update April 2022
  433. EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations…
  434. Drug Alert list for month of July 2020
  435. 21 CFR 880.6060: Medical disposable bedding.
  436. EU/3/22/2632 - orphan designation for treatment of TBR1-related disorder
  437. 21 CFR 71.18: Petition for exemption from certification.
  438. PSUSA/00002117/201511 - periodic safety update report single assessment
  439. PSUSA/00001509/202304 - periodic safety update report single assessment
  440. 21 CFR 882.4030: Skull plate anvil.
  441. EU/3/10/816 - orphan designation for treatment of glioma
  442. FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast…
  443. PSUSA/00010342/201509 - periodic safety update report single assessment
  444. P/23/211 - paediatric investigation plan
  445. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12…
  446. EU/3/09/622 - orphan designation for treatment of acute myeloid leukaemia
  447. M/s Reliance Life Sciences Pvt Ltd.
  448. ema-kiactaKiacta
  449. eXtended EudraVigilance medicinal product dictionary face-to-face training course
  450. PSUSA/00000749/201502 - periodic safety update report single assessment
  451. Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drug
  452. cfr-21-cfr-820-200-servicing21 CFR 820.200: Servicing.
  453. Typhoid Vi Conjugate Vaccine (Typhoid (Vi Capsular Polysaccharide) - Tetanus Toxoid…
  454. 21 CFR 878.3800: External aesthetic restoration prosthesis.
  455. EU/3/07/491 - orphan designation for treatment of idiopathic pulmonary fibrosis
  456. 21 CFR 862.3170: Benzodiazepine test system.
  457. 21 CFR 882.4200: Clip removal instrument.
  458. Webinar presentation: GMP licence applications
  459. cdsco-ozanimodOzanimod
  460. European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006
  461. Synulox Lactating Cow - referral
  462. European Medicines Agency and European Network of Centres for Pharmacoepidemiology and…
  463. 21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
  464. EMEA-001601-PIP01-13 - paediatric investigation plan
  465. ema-diovan-comp-referralDiovan Comp - referral
  466. Committee for Medicinal Products for Human Use (CHMP): 23-26 May 2016
  467. ema-dexamethasone-tawDexamethasone Taw
  468. EMEA-000005-PIP01-07-M01 - paediatric investigation plan
  469. UPDATE: Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors…
  470. 21 CFR 866.5940: Autosomal recessive carrier screening gene mutation detection system.
  471. Committee for Orphan Medicinal Products (COMP): 3-5 December 2019
  472. European Medicines Agency reminds companies of timeframe to submit product-information…
  473. Varying entries in the ARTG - medical devices and IVDs
  474. ema-versiguard-sars-cov2Versiguard SARS CoV2
  475. 21 CFR 1.360: What are the record retention requirements?
  476. NOTICE regading Supreme court hearing in the matters relating to FDC
  477. EMEA-001064-PIP01-10-M03 - paediatric investigation plan
  478. 21 CFR 16.44: Communication to presiding officer and Commissioner.
  479. EMEA-000060-PIP05-14-M01 - paediatric investigation plan
  480. Emtricitabine/Tenofovir disoproxil Mylan
  481. PSUSA/00000967/202009 - periodic safety update report single assessment
  482. Non-conviction Certificate
  483. PSUSA/00002104/202103 - periodic safety update report single assessment
  484. EU/3/03/172 - orphan designation for treatment of Wilson's disease
  485. ema-degarelix-accordDegarelix Accord
  486. Clinical Trials Information System (CTIS): Information day
  487. ema-belanette-referralBelanette - referral
  488. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 November 2010
  489. EU/3/14/1314 - orphan designation for treatment of ATP-binding cassette transporter A1…
  490. EMEA-001268-PIP01-12-M05 - paediatric investigation plan
  491. 21 CFR 892.1940: Radiologic quality assurance instrument.
  492. 21 CFR 1.661: What is the duration of accreditation by a recognized accreditation body?
  493. EU/3/07/503 - orphan designation for prevention of recurrent hepatitis C virus induced…
  494. EMEA-002197-PIP01-17 - paediatric investigation plan
  495. 21 CFR 892.1980: Radiologic table.
  496. cdsco-ticagrelorTicagrelor
  497. Successful Rijeka conference strengthens EU-Croatian cooperation on medicines regulation
  498. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 July 2012
  499. Interim Guidance - Fair Balance in Direct-to-Consumer Advertising of Vaccines
  500. cdsco-101-pgc-005101-PGC-005
  501. Routes of administration of vaccines to poultry - Scientific guideline
  502. La FDA le recomienda a los proveedores de servicios de salud detener el uso de los…
  503. PSUSA/00010693/201904 - periodic safety update report single assessment
  504. A Letter of Thanks to the AAMI Community
  505. Usnoflast 25mg, 50 mg capsules
  506. EMEA-002572-PIP01-19 - paediatric investigation plan
  507. A Tour of the FDA’s Emergency Use Authorization Process
  508. ema-purevax-felvPurevax FeLV
  509. 21 CFR 26.36: Listing of CAB's.
  510. PSUSA/00002408/202107 - periodic safety update report single assessment
  511. Stock Rotomat
  512. NicOx S.A. withdraws its marketing authorisation application for Beprana (naproxcinod)
  513. cdsco-nivolumabNivolumab
  514. European Medicines Agency recommends first vaccine for foot-and-mouth disease for…
  515. 21 CFR 1.1120: How must a recognized accreditation body assess laboratories seeking…
  516. hsa-ngs-ivdsNGS (IVDs)
  517. cdsco-nnc0519-0130NNC0519-0130
  518. Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
  519. Points to Consider for Reprocessed Single-use Medical Devices
  520. 21 CFR 821.4: Imported devices.
  521. New treatment for advanced form of kidney cancer
  522. EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
  523. 21 CFR 868.2875: Differential pressure transducer.
  524. Committee for Orphan Medicinal Products (COMP): 17-19 April 2018
  525. EU 28: science, medicines, health - a regulatory system fit for the future
  526. Regulatory information - Paediatric guidance revised to reflect changes to European…
  527. EMEA-002623-PIP01-19 - paediatric investigation plan
  528. Export certification for medical devices
  529. Helichrysi flos - herbal medicinal product
  530. Importation and Exportation Questions and Answers
  531. Daily Updation of No.of Batches of Cough syrup sample for Export at Different Laboratories…
  532. 2024.09.19_NDCTR_G.S.R. 581E Notification for registration of Clinical Research…
  533. cdsco-omalizumab-injectionOmalizumab Injection
  534. ema-vivaglobin-referralVivaglobin - referral
  535. 28th July 2005(GSR 510 (E))
  536. cdsco-astegolimab-ro7187807Astegolimab (RO7187807)
  537. cdsco-durvalumabDurvalumab
  538. AAMI ARRAY Platform Offers ‘One-Stop Shop’ for Research, Standards, News, and More
  539. EMEA-001639-PIP02-17 - paediatric investigation plan
  540. Meeting of the paediatric human immunodeficiency virus (HIV) expert group
  541. Q&A for basic principles for conducting phase 1 studies in Japanese prior to initiating…
  542. Use of cocrystals of active substances in medicinal products - Scientific guideline
  543. cdsco-tar-200TAR-200
  544. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  545. EMEA-000309-PIP07-21 - paediatric investigation plan
  546. ema-rezzayoRezzayo
  547. EMA and FDA extend pilot programme for parallel assessment of quality-by-design…
  548. EU/3/21/2554 - orphan designation for treatment of idiopathic intracranial hypertension
  549. Innovative Neurosurgical Planning Software Approved for Marketing
  550. European Medicines Agency closed 2-6 April 2015
  551. FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction…
  552. PSUSA/00000389/201712 - periodic safety update report single assessment
  553. Amlodipine Besylate IP eq. to Amlodipine + Bisoprolol Fumarate IP (2.5mg + 2.5mg & 2.5mg +…
  554. ema-deferasirox-mylanDeferasirox Mylan
  555. EU/3/02/114 - orphan designation for treatment of paroxysmal nocturnal haemoglobinuria
  556. EMEA-002324-PIP01-17-M03 - paediatric investigation plan
  557. cfr-21-cfr-12-40-appearance21 CFR 12.40: Appearance.
  558. ema-urorecUrorec
  559. ema-work-programmesWork programmes
  560. NOC update list of Medical Devices 2017
  561. Custom-made medical devices
  562. ema-bosulifBosulif
  563. EMEA-000380-PIP02-09-M04 - paediatric investigation plan
  564. EU/3/20/2284 - orphan designation for treatment of amyotrophic lateral sclerosis
  565. EU/3/21/2571 - orphan designation for treatment of Leber’s hereditary optic neuropathy
  566. Surveillance Inspections of Protein Drug Substance Manufacturers (PDF - 940KB)
  567. ema-clopidogrel-duraClopidogrel DURA
  568. Pharmaceutical Good Manufacturing Practice Regulations
  569. Product authorisation lifecycle procedures
  570. cdsco-imeglimin-tabletsvImeglimin tabletsv
  571. NOTICE regarding System of consultation meetings for cases of drug development of National…
  572. EMEA-001571-PIP01-13 - paediatric investigation plan
  573. PSUSA-00010312-202301 - periodic safety update report single assessment
  574. EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary…
  575. 21 CFR 870.3300: Vascular embolization device.
  576. 21 CFR 880.6730: Body waste receptacle.
  577. ema-oracea-referralOracea - referral
  578. Alert on falsified versions of Adcetris Injection Brentuximab Vedotin Manufactured by M/s…
  579. Regulatory science research needs launch event
  580. EMEA-002320-PIP01-17-M03 - paediatric investigation plan
  581. Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species
  582. EU/3/07/496 - orphan designation for treatment of acute lymphoblastic leukaemia
  583. EU/3/13/1122 - orphan designation for treatment of Duchenne muscular dystrophy
  584. Is Your Medical Device Ready for the Cloud? An ISC 2022 Conversation
  585. ema-feesFees
  586. MHRA guidance on the use of real-world data in clinical studies to support regulatory…
  587. EU/3/14/1393 - orphan designation for treatment of diffuse large B-cell lymphoma
  588. European Agency for the evaluation of medicinal products: Committee for Proprietary…
  589. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Lisbon)
  590. Assessment and procurement of coronavirus (COVID-19) tests: Protocol for evaluation of…
  591. 21 CFR 803.30: If I am a user facility, what reporting requirements apply to me?
  592. EU/3/09/700 - orphan designation for treatment of hepatocellular carcinoma (pexastimogene…
  593. Dexpramipexole dihydrochloride monohydrate
  594. EU/3/10/836 - orphan designation for treatment of systemic sclerosis
  595. EU/3/03/179 - orphan designation for treatment of hereditary factor-XIII deficiency
  596. Paediatric Committee (PDCO): 24-26 April 2023
  597. EU/3/10/824 - orphan designation for treatment of acute myeloid leukaemia
  598. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 September 2011
  599. ema-alcortAlcort
  600. DR_G.S.R. 780(E) dt_01.10.2003_26A_Phenformin
  601. EMEA-001856-PIP02-16-M02 - paediatric investigation plan
  602. New gene therapy treatment for haemophilia B
  603. Appointment of CPIO for the purpose of RTI(Technical) Matters
  604. First gene therapy to treat severe haemophilia A
  605. PSUSA/00010828/202105 - periodic safety update report single assessment
  606. EU/3/20/2277 - orphan designation for treatment of multiple myeloma
  607. Partial Revision of "Standards for Biological Raw Materials, Operational Guideline"
  608. EU/3/07/447 - orphan designation for treatment of gastrointestinal stromal tumours
  609. EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November
  610. EMEA-002410-PIP01-18 - paediatric investigation plan
  611. Committee for Orphan Medicinal Products (COMP): 14-16 February 2017
  612. Handling of Applications for GMP Inspections
  613. Management Board meeting: 4 October 2018
  614. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March…
  615. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2009 (SI…
  616. Drug Alert list for month of July 2013
  617. EU/3/00/001 - orphan designation for aIDS wasting
  618. ema-ebymectEbymect
  619. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29-31…
  620. EU/3/09/644 - orphan designation for treatment of neuroblastoma
  621. Joint European Medicines Agency/Drug Information Association information day on risk…
  622. EU/3/03/147 - orphan designation for treatment of cystic fibrosis
  623. PSUSA/00001731/202011 - periodic safety update report single assessment
  624. EMEA-000872-PIP01-10-M03 - paediatric investigation plan
  625. Firdapse (previously Zenas)
  626. Veterinary medicines containing enrofloxacin to be administered via the drinking water to…
  627. Medical Device Alert dated 08 May 2023
  628. EMEA-000901-PIP01-10 - paediatric investigation plan
  629. Chemical structure and properties criteria to be considered for the evaluation of new…
  630. cdsco-ciprodexCiprodex
  631. PSUSA/00000109/201903 - periodic safety update report single assessment
  632. 21 CFR 58.204: Notice of and opportunity for hearing on proposed disqualification.
  633. Biomaterials and Engineering Laboratory Report: Non-active mammary implants
  634. Hipralona Enro-S - referral
  635. Guidance for Good Laboratory Practice (GLP) facilities in relation to coronavirus…
  636. Guidelines for environmental control of drugs during storage and transportation…
  637. 21 CFR 862.1035: Albumin test system.
  638. cdsco-bevacizumabrlsBevacizumabRLS
  639. Enpr-EMA Coordinating Group meeting March 2024
  640. Compliance: research and development
  641. DR_G.S.R. 86(E) dt_19.02.2010_Recruitement rules for DIs
  642. ema-yervoyYervoy
  643. PSUSA/00010163/201608 - periodic safety update report single assessment
  644. ema-bosatriaBosatria
  645. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017
  646. Committee for Orphan Medicinal Products (COMP): 16-18 July 2024
  647. Priyanka Upendra: Understanding MIoT Security
  648. 21 CFR 803.53: If I am a manufacturer, in which circumstances must I submit a 5-day…
  649. Heidi Horn: Coronavirus Actions All HTM Professionals Need to Take
  650. EMEA-002843-PIP02-20 - paediatric investigation plan
  651. PSUSA/00001924/201905 - periodic safety update report single assessment
  652. February 17, 2021: Circulatory System Devices Panel of the Medical Devices Advisory…
  653. EMA review of Picato concludes medicine’s risks outweigh its benefits
  654. Veterinary Cell Office Order
  655. ema-hiv-and-aidsHIV and AIDS
  656. EMEA-002204-PIP02-20 - paediatric investigation plan
  657. 21 CFR 862.1795: Vanilmandelic acid test system.
  658. Cancer Medicines Forum: June 2022
  659. PSUSA/00001026/201712 - periodic safety update report single assessment
  660. Adempas - withdrawal of application for variation to marketing authorisation
  661. EMEA-003349-PIP01-22 - paediatric investigation plan
  662. PSUSA/00010815/202101 - periodic safety update report single assessment
  663. 21 CFR 81.10: Termination of provisional listings of color additives.
  664. Windsor Framework Webinar Recordings
  665. EMEA Management Board elects new chairman and sets out proposed work programme for 2004
  666. Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018
  667. 21 CFR 803.18: What are the requirements for establishing and maintaining MDR files or…
  668. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 June 2017
  669. Annex to the European Commission guideline on 'Excipients in the labelling and package…
  670. EU/3/17/1869 - orphan designation for treatment in solid organ transplantation
  671. 21 CFR 862.3600: Mercury test system.
  672. Lasmiditan tablets 50 mg / 100 mg
  673. 21 CFR 880.6375: Patient lubricant.
  674. 21 CFR 874.3325: Self-fitting air-conduction hearing aid.
  675. Building a leaner, more streamlined organisation
  676. Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March…
  677. ema-ingelvac-pcv-flexIngelvac PCV FLEX
  678. EMEA-002773-PIP01-20 - paediatric investigation plan
  679. PSUSA/00000431/201609 - periodic safety update report single assessment
  680. PSUSA/00002991/201906 - periodic safety update report single assessment
  681. Use of aminoglycosides in animals in the European Union: development of resistance and…
  682. ema-libmyrisLibmyris
  683. Mary Logan: Help Tackle an 'Alarming' Problem
  684. EU/3/15/1502 - orphan designation for treatment of spinocerebellar ataxia
  685. TGA stakeholder survey report 2023
  686. Dabigatran Etexilate Accord
  687. ema-levact-referralLevact - referral
  688. Appendix 14A Part A: Checklist on Dossier Requirements for MIV-1 Variation for Biological…
  689. European Medicines Agency updates on ongoing benefit-risk review of…
  690. 21 CFR 880.5780: Medical support stocking.
  691. Abatacept 125 mg/mL solution for injection in prefilled syringe
  692. PSUSA/00001243/201704 - periodic safety update report single assessment
  693. EMEA-000292-PIP01-08-M03 - paediatric investigation plan
  694. 21 CFR 866.3410: Proteus spp. (Weil-Felix) serological reagents.
  695. EU/3/14/1235 - orphan designation for prevention of congenital cytomegalovirus infection…
  696. EU/3/22/2653 - orphan designation for treatment of pemphigus
  697. Herbal medicinal products: scientific guidelines
  698. New HHS Rule Issued to Monitor AI Tools Used by EHR Vendors for In-Hospital Patient Care
  699. PIC/S Guidelines for the Pre-Accession Procedure
  700. ema-fablynFablyn
  701. Risperdal and Requip - Medication errors resulting from confusion between risperidone…
  702. First EU treatment for rare sleep-wake disorder
  703. Statement of Policy Intent: Early Access to Innovative Medical Devices
  704. EU/3/11/941 - orphan designation for prevention of sepsis in at-risk premature infants of…
  705. Paediatric requirements for variations and extensions to marketing authorisations
  706. Advancing Pediatric Medical Countermeasures Through the Newly BARDA-Funded Accelerator…
  707. European Medicines Agency reviews further data on narcolepsy and possible association with…
  708. ema-brucellin-aquilonBrucellin Aquilon
  709. EMEA-003153-PIP01-21 - paediatric investigation plan
  710. Draft guidelines: Revised Annex 11 - Computerised systems
  711. First annual bilateral meeting between the European Medicines Agency and the European…
  712. cdsco-wal0921WAL0921
  713. Committee for Advanced Therapies (CAT): 22-24 January 2025
  714. VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens - Scientific…
  715. Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
  716. EU/3/10/788 - orphan designation for treatment of hepatocellular carcinoma
  717. EU/3/10/840 - orphan designation for treatment of acute lymphoblastic leukaemia
  718. Committee for Orphan Medicinal Products (COMP): 6-8 October 2020
  719. Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid…
  720. PSUSA/00010224/202108 - periodic safety update report single assessment
  721. 21 CFR 866.4100: Complement reagent.
  722. cdsco-ly900014LY900014
  723. EMEA-001087-PIP02-12-M03 - paediatric investigation plan
  724. EudraVigilance Training in 2006, A joint initiative of the EMEA with DIA acting as the…
  725. FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are…
  726. Best practices to fight antimicrobial resistance
  727. Guidance on qualified person responsible for pharmacovigilance (QPPV) including…
  728. ema-glubravaGlubrava
  729. TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024…
  730. Clinical trials: how NHS trusts and health boards can maintain compliant electronic health…
  731. ema-pda-ema-2011-conferencePDA/EMA 2011 Conference
  732. EMA/HMA Big Data Stakeholder Forum 2022
  733. ema-zulvac-sbvZulvac SBV
  734. EMEA-000947-PIP01-10 - paediatric investigation plan
  735. Committee for Medicinal Products for Human Use (CHMP): 22-25 June 2020
  736. 21 CFR 20.48: Judicial review of proposed disclosure.
  737. EU/3/05/292 - orphan designation for hearing loss (acute acoustic trauma, sudden deafness…
  738. PSUSA/00000914/201601 - periodic safety update report single assessment
  739. ema-cinryzeCinryze
  740. EU/3/01/062 - orphan designation for treatment of Friedreich's ataxia
  741. Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2011
  742. cdsco-osimertinibOsimertinib
  743. Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis…
  744. Clinical data for two more medicines now available online
  745. EMEA-001441-PIP05-20 - paediatric investigation plan
  746. Rilematovir (JNJ-53718678)
  747. cdsco-olaparibOlaparib
  748. Sterile Processing Department Takes on Vital New Role in COVID-19 Hot Spot
  749. Change Notifications arising from the EU MDRIVDR related changes (2023 Nov) PUB [ARCHIVED…
  750. 150-day assessment for national applications for medicines
  751. EMEA-001811-PIP04-21 - paediatric investigation plan
  752. cdsco-pf-07248144PF-07248144
  753. PSUSA/00000996/202008 - periodic safety update report single assessment
  754. DR_G.S.R. 588(E) dt_30.08.2013_Amendment Rule 65, Rule 97_Inclusion of Sch H1, Labelling…
  755. EMEA-000712-PIP01-09 - paediatric investigation plan
  756. Pharmacovigilance Risk Assessment Committee (PRAC): 30 September-3 October 2019
  757. Public Notice dated 15.02.2024
  758. cdsco-lxe408LXE408
  759. GlaxoSmithKline withdraws its marketing authorisation application for Zunrisa (casopitant…
  760. ema-busulfan-fresenius-kabiBusulfan Fresenius Kabi
  761. European Medicines Agency / Emergency Task Force and European Commission workshop on…
  762. Committee for Orphan Medicinal Products (COMP): 14-15 July 2015
  763. EMEA-001113-PIP01-10-M06 - paediatric investigation plan
  764. EMEA-000366-PIP05-12-M02 - paediatric investigation plan
  765. Safer Medicines in Pregnancy and Breastfeeding Consortium: Safer Medicines in Pregnancy…
  766. EMA - Thalassaemia International Federation (TIF) bilateral meeting
  767. PSUSA/00001493/202303 - periodic safety update report single assessment
  768. EMEA-000970-PIP01-10-M01 - paediatric investigation plan
  769. Medicine shortages: Report on the first 12 months of the mandatory reporting scheme
  770. Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
  771. PSUSA/00001556/201509 - periodic safety update report single assessment
  772. EMEA-000972-PIP01-10-M05 - paediatric investigation plan
  773. Clinical investigation of medicinal products for the treatment of amyotrophic lateral…
  774. POSTPONED: April 16, 2020 Circulatory System Devices Panel of the Medical Devices Advisory…
  775. 2025 Nominees Sought for AAMI Board of Directors
  776. Update on assessment of marketing authorisation application for Moderna’s mRNA-1273…
  777. Guideline on good pharmacovigilance practices (GVP): module vii - periodic safety update…
  778. EMEA-002983-PIP01-21 - paediatric investigation plan
  779. EU/3/10/810 - orphan designation for treatment of post-essential thrombocythaemia…
  780. Partial revision of “Planning of the Pediatric Drug Development Program during Development…
  781. Drugs Alert for the month of April 2013 J& K
  782. EU/3/10/763 - orphan designation for treatment of non-infectious uveitis affecting the…
  783. EU/3/05/321 - orphan designation for treatment of primary malignant bone tumours
  784. 21 CFR 71.20: Publication of regulation.
  785. 21 CFR 884.1550: Amniotic fluid sampler (amniocentesis tray).
  786. 21 CFR 58.130: Conduct of a nonclinical laboratory study.
  787. Hydroxychloroquine Sulfate Tablet 200mg/300 mg
  788. CMDh confirms recommendations on restricting use of domperidone-containing medicines
  789. New Quality Innovation Expert Group (QIG) supports medicine innovation
  790. EU/3/14/1320 - orphan designation for treatment of mastocytosis
  791. Clinical investigations: biological safety assessments
  792. Veterinary medicines: highlights of 2019
  793. Clarification with respect of the manufacturing and marketing of New Drugs
  794. eSubmission Gateway or web client to become mandatory for all eCTD submissions through the…
  795. Committee for Medicinal Products for Human Use (CHMP): 20-23 January 2014
  796. FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions…
  797. 21 CFR 868.6250: Portable air compressor.
  798. New medicine for rare type of eye cancer
  799. EU/3/14/1250 - orphan designation for treatment of ATTR amyloidosis
  800. Launch of new HMA-EMA catalogues of real-world data sources and studies
  801. ema-fundingFunding
  802. EU/3/24/2922 - orphan designation for treatment of MECP2 duplication syndrome
  803. Point of care testing: top 10 tips poster
  804. EMEA-000036-PIP01-07-M06 - paediatric investigation plan
  805. EMEA-002211-PIP01-17 - paediatric investigation plan
  806. 14th meeting of the committee for veterinary medicinal products
  807. State Drug Alert for the Month of December 2024
  808. First non-injectable treatment for severe low blood sugar levels
  809. Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 January 2017
  810. Follow-up of patients administered with gene therapy medicinal products - Scientific…
  811. cdsco-ianalumab-vay736ianalumab (VAY736)
  812. EMA promotes consistent development of bioequivalence studies through product-specific…
  813. ema-celsunaxCelsunax
  814. Lecithinum ex soya - herbal medicinal product
  815. 21 CFR 862.3652: Organophosphate test system.
  816. EMEA-000207-PIP01-08-M08 - paediatric investigation plan
  817. Increased manufacturing capacity for COVID-19 Vaccine Janssen
  818. European Medicines Agency reiterates support for staff member
  819. 21 CFR 866.5785: Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test…
  820. cdsco-adalimumab-injectionAdalimumab injection
  821. 21 CFR 892.1670: Spot-film device.
  822. Azelnidipine tab 8 mg / 16 mg
  823. Committee for Orphan Medicinal Products (COMP): 8-10 September 2020
  824. Zanubrutinib Capsules 80 mg
  825. 21 CFR 868.5250: Breathing circuit circulator.
  826. Computational Tool Comprising Visible Human Project Based Anatomical Female CAD Model and…
  827. Clinical Trials Information System (CTIS): Walk-in clinic - June 2022
  828. Medicines that you cannot export from the UK or hoard
  829. Core summary of product characteristics for human plasma-derived hepatitis B…
  830. 21 CFR 892.1710: Mammographic x-ray system.
  831. EMEA-000183-PIP02-12-M03 - paediatric investigation plan
  832. World AIDS Day: 1 December 2010
  833. 21 CFR 1.695: Are the records obtained by FDA under this subpart subject to public…
  834. ICH M4Q Common technical document for the registration of pharmaceuticals for human use…
  835. Food and Drugs Act (justice.gc.ca)
  836. 21 CFR 80.39: Records of distribution.
  837. Implementing ISO IDMP: introduction to SPOR data services
  838. Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to…
  839. Questions to Think About When Addressing Understaffing in Your Scope Processing Area
  840. 21 CFR 876.5140: Urethral insert with pump for bladder drainage.
  841. Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
  842. Guidance on veterinary antimicrobial sales reporting
  843. Levothyroxine Alapis - referral
  844. Clinical Trials Information System (CTIS) sponsor end user training programme - June 2022
  845. PSUSA/00002797/202312 - periodic safety update report single assessment
  846. cdsco-public-noticePublic Notice
  847. EMA website briefly unavailable on 15 March 2021
  848. EMEA-000783-PIP01-09-M06 - paediatric investigation plan
  849. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  850. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 April 2019
  851. EU/3/07/484 - orphan designation for treatment of Leber's congenital amaurosis
  852. cdsco-pmz-2010PMZ-2010
  853. 21 CFR 870.2350: Electrocardiograph lead switching adaptor.
  854. March 1, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee…
  855. Naxcel - withdrawal of application for variation to marketing authorisation
  856. (Attachment) Guidelines for Clinical Studies of Vaccines for Infectious Disease Prevention
  857. VICH GL33 Safety studies for veterinary drug residues in human food: general approach to…
  858. European Medicines Agency recommends 39 medicines for human use for marketing…
  859. Basic Principles on Global Clinical Trials
  860. ema-celecoxib-referralCelecoxib - referral
  861. cdsco-nexagon-nexagonNexagon® (NEXAGON)
  862. Fucus - herbal medicinal product
  863. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.2) Regulations…
  864. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 17-18…
  865. ema-network-portfolioNetwork Portfolio
  866. EMEA-003384-PIP02-23 - paediatric investigation plan
  867. PSUSA/00010551/201901 - periodic safety update report single assessment
  868. Codeine-containing medicinal products for the treatment of cough or cold in paediatric…
  869. First adapted COVID-19 booster vaccines recommended for approval in the EU
  870. William 'Bill' Hyman, Dedicated Educator, Dies
  871. cdsco-20092009
  872. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14…
  873. Maydis stigma - herbal medicinal product
  874. Drug Alert for the Month of October 2024
  875. Guidance Document for Cell, Tissue and Organ Establishments - Safety of Human Cells…
  876. EU/3/14/1410 - orphan designation for treatment of aspartylglucosaminuria
  877. PSUSA/00001516/201606 - periodic safety update report single assessment
  878. ema-nepextoNepexto
  879. In Vivo Bioequivalence (PDF - 77KB)
  880. Checklist for Grant of Non Conviction Certificate for IVD
  881. Meeting highlights from the Committee for Medicinal Products for Human Use,13-16 November…
  882. ema-dupixentDupixent
  883. Clinical efficacy and safety: nervous system
  884. 21 CFR 862.2300: Colorimeter, photometer, or spectrophotometer for clinical use.
  885. COVID-19 public health emergency of international concern (2020-23)
  886. EMEA-002899-PIP01-20-M02 - paediatric investigation plan
  887. CTIS Bitesize Talk: Alternate IMPD-Q and New guidance AxMP
  888. Azelnidipine IP Metoprolol Succinate IP eq. to Metoprolol Tartrate (SR) film coated…
  889. 2026.06.09 G.S.R. 477(E)_Notification for Removal of Syrup exemption under schedule K in…
  890. 21 CFR 870.2920: Telephone electrocardiograph transmitter and receiver.
  891. Management Board meeting: 14-15 December 2022
  892. EU/3/24/2926 - orphan designation for treatment of xeroderma pigmentosum
  893. 21 CFR 73.2125: Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).
  894. Paediatric Committee (PDCO): 7-10 September 2021
  895. PSUSA/00010339/201807 - periodic safety update report single assessment
  896. PSUSA/00003161/201508 - periodic safety update report single assessment
  897. CagriSema s.c. in doses 2.4/2.4 mg
  898. Medicines under additional monitoring
  899. PSUSA-00002067-202010 - periodic safety update report single assessment
  900. ema-somac-controlSomac Control
  901. NMPA issued the Announcement on Enabling the Pharmaceutical Business Application System
  902. Committee for Medicinal Products for Veterinary Use (CVMP): 05-07 November 2019
  903. Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus…
  904. 21 CFR 870.2855: Implantable Intra-aneurysm Pressure Measurement System.
  905. Guidance on Change of Registrant for Registered Therapeutic Product
  906. European Medicines Agency concludes review of dose recommendations for anti-tuberculosis…
  907. PSUSA/00000435/202008 - periodic safety update report single assessment
  908. Recommendation-NB-MED-2_15-1_rev3 Voluntary certification at an intermediate stage of
  909. European Medicines Agency responds to criticism over clinical trial reporting
  910. Clenil and associated names - referral
  911. Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary…
  912. DR_G.S.R. 897(E) dt_21.09.2016_WHO-COPP
  913. EU/3/20/2259 - orphan designation for treatment of pancreatic cancer
  914. PSUSA/00010252/201806 - periodic safety update report single assessment
  915. cdsco-follitropin-deltaFollitropin delta
  916. Merck Serono Europe Limited withdraws its marketing authorisation application for Movectro…
  917. Two new advice pilots to improve clinical trials in Europe
  918. EMEA-002551-PIP01-18 - paediatric investigation plan
  919. Revising the guideline on first-in-human clinical trials
  920. EMEA-000711-PIP01-09 - paediatric investigation plan
  921. CYB704 (Ocrelizumab) 300mg/ 10 mL concentrate for solution for infusion
  922. cdsco-bay-94-8862-finerenoneBAY 94-8862 /Finerenone
  923. EU/3/13/1153 - orphan designation for treatment of plasma-cell myeloma
  924. ema-orserduOrserdu
  925. What a manufacturer needs to know about conformity assessment and declarations of…
  926. Omnibus Spending Bill Includes Extensions of Pandemic-Era Telehealth Provisions
  927. EU/3/02/122 - orphan designation for treatment of low-flow priapism
  928. EMEA-001181-PIP01-11-M06 - paediatric investigation plan
  929. 2022.01.18_Draft GSR 23(E)_Insert rule 43A for Suspension and cancellation of license in…
  930. Questions and answers on comparability considerations for advanced therapy medicinal…
  931. 21 CFR 884.4500: Obstetric fetal destructive instrument.
  932. Common Valves Used in Process Fluid Systems
  933. Sandimmun Neoral and associated names - referral
  934. EMA working on COVID-19 over holiday period
  935. EMEA-001290-PIP01-12 - paediatric investigation plan
  936. 21 CFR 884.2225: Obstetric-gynecologic ultrasonic imager.
  937. Committee for Herbal Medicinal Products (HMPC): 11-12 March 2013
  938. Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
  939. 21 CFR 1.1131: When will FDA require corrective action, put a recognized accreditation…
  940. EMEA-001895-PIP01-15-M01 - paediatric investigation plan
  941. How an AAMI Mentorship Was Game Changing
  942. EU/3/09/630 - orphan designation for treatment of dystrophic epidermolysis bullosa
  943. NMPA Issued the Guiding Principles for Capacity Building of Medical Device Inspection and…
  944. European Medicines Agency finalises new procedure for EU pharmaceutical guidelines
  945. 2019.01.11_S.O. 180(E) to S.O.259(E)_Prohibition of certain FDCs appeared in the list of…
  946. EMEA-001628-PIP01-14 - paediatric investigation plan
  947. 21 CFR 864.7875: Thrombin time test.
  948. EMEA-001888-PIP01-15-M01 - paediatric investigation plan
  949. cdsco-empagliflozinEMPAgliflozin
  950. EU/3/22/2627 - orphan designation for treatment of chronic myeloid leukaemia
  951. DR_G.S.R 303 (E) dt_07.06.1991_10A_Prohibition of import of Chloral Hydrate as a drug
  952. NMPA Notice on Printing and Issuing the Guidelines for On-Site Inspection of the Good…
  953. Consideration of the directions of Hon'ble Supreme Court in the case of 294 FDCs in…
  954. 21 CFR 814.82: Postapproval requirements.
  955. The Value of Quality Management Systems in Sterilization
  956. 21 CFR 866.3600: Schistosoma spp. serological reagents.
  957. 21 CFR 862.3650: Opiate test system.
  958. EU/3/16/1794 - orphan designation for diagnosis of gastrointestinal stromal tumours
  959. ECHELON Endoscopic Liner Cutter Reloads Black(ECR60T)
  960. FDA Launches Progress Tracking Program for 510(k) Premarket Applications
  961. 21 CFR 1.912: What record retention and other records requirements apply to shippers…
  962. Metformin Hydrochloride IP (Extended release) + Glimepiride IP 1mg + Sitagliptin Phosphate…
  963. Cellular, Tissue, and Gene Therapies Advisory Committee March 10, 2022 Meeting…
  964. ema-ixchiqIxchiq
  965. Non-clinical local tolerance testing of medicinal products - Scientific guideline
  966. ema-janumetJanumet
  967. Committee for Proprietary Medicinal Products (CPMP) 60th plenary meeting
  968. 21 CFR 886.1160: Color vision plate illuminator.
  969. European Medicines Agency: Committee for Medicinal Products for Human Use 18 – 21 April…
  970. cdsco-pb016-and-entyvioPB016 and Entyvio
  971. 21 CFR 822.28: If I stop marketing the device subject to postmarket surveillance, what…
  972. cdsco-t4030T4030
  973. ema-rivastigmine-actavisRivastigmine Actavis
  974. EMA pilot offers enhanced support to academic and non-profit developers of advanced…
  975. EMEA-002530-PIP01-18 - paediatric investigation plan
  976. EMEA-001107-PIP01-10-M04 - paediatric investigation plan
  977. PSUSA/00010224/201808 - periodic safety update report single assessment
  978. Webinar: How can clinical research networks support developers of medicines for children?
  979. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June…
  980. New version 3.4 of Code of Conduct
  981. ema-ogluoOgluo
  982. Application for a New Medical Device Licence for a Private Label Medical Device
  983. PSUSA/00002569/201410 - periodic safety update report single assessment
  984. 21 CFR 1.980: Administrative detention of drugs.
  985. ema-visudyneVisudyne
  986. SAR408701 versus docetaxel
  987. Adjusted fees for applications to European Medicines Agency from 1 April 2015
  988. Handling Application for Confirming Change Plans for Medical Devices
  989. New Version 3.3 of Code of Conduct
  990. 21 CFR 868.5300: Carbon dioxide absorbent.
  991. EMEA-002257-PIP01-17 - paediatric investigation plan
  992. ema-pifeltroPifeltro

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