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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/3/19/2167 - orphan designation for treatment of lymphoplasmacytic lymphoma
  2. 21 CFR 866.5040: Albumin immunological test system.
  3. EMEA-000969-PIP01-10-M06 - paediatric investigation plan
  4. MEMBER EXCLUSIVE: Artificial Intelligence in Healthcare Roundtable
  5. 21 CFR 874.5300: Ear, nose, and throat examination and treatment unit.
  6. EMA regular press briefing on COVID-19
  7. 21 CFR 866.3300: Haemophilus spp. serological reagents.
  8. EMA recommends additional measures to prevent use of mycophenolate in pregnancy
  9. PSUSA/00002655/202306 - periodic safety update report single assessment
  10. European Antibiotic Awareness Day 2015
  11. cdsco-canagliflozinCanagliflozin
  12. ema-docefrezDocefrez
  13. ema-pharmasin-referralPharmasin - referral
  14. EU/3/17/1849 - orphan designation for treatment of Fabry disease
  15. Emiel van Galen elected as chair of the Committee for Herbal Medicinal Products
  16. cdsco-nexobridNexoBrid
  17. EU/3/20/2320 - orphan designation for treatment of Menkes disease
  18. 21 CFR 73.1162: Bismuth oxychloride.
  19. Vaccines and Related Biological Products Advisory Committee March 5, 2024 Meeting…
  20. Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety…
  21. Team-NB-List-PositionPapers-20240221
  22. PSUSA/00000593/201506 - periodic safety update report single assessment
  23. CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer
  24. Human variations electronic application form (eAF) Q&A clinics – session 7
  25. Metformin Hydrochloride IP (As Extended release form) + Pioglitazone Hydrochloride IP eq…
  26. 21 CFR 866.5700: Whole human plasma or serum immunological test system.
  27. EMEA-001089-PIP02-13-M04 - paediatric investigation plan
  28. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 February 2019
  29. PSUSA/00000589/202111 - periodic safety update report single assessment
  30. FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and…
  31. European Medicines Agency and its international partners complete successful inspection…
  32. ema-ivozallIvozall
  33. Committee for Veterinary Medicinal Products (CVMP): 15-17 March 2022
  34. Study: Most Methods for Sterilizing Single-Use N95 Masks Adequate
  35. 2021 Highlights Cybersecurity Threats for Vaccines and Personnel
  36. Central Nervous System Working Party
  37. EU/3/03/135 - orphan designation for treatment of myelodysplastic syndromes
  38. European Medicines Agency closed 23 December 2013 to 2 January 2014
  39. cdsco-isb-1442ISB 1442
  40. Pepaxti - opinion on variation to marketing authorisation
  41. EMEA-001469-PIP02-17 - paediatric investigation plan
  42. Committee for Orphan Medicinal Products (COMP): 5-7 December 2023
  43. Registration open for workshop on access to clinical-trial data and transparency
  44. 21 CFR 880.5680: Pediatric position holder.
  45. PSUSA/00001512/202003 - periodic safety update report single assessment
  46. EMEA-001315-PIP02-16-M02 - paediatric investigation plan
  47. EMEA-002582-PIP01-19-M02 - paediatric investigation plan
  48. Amarin Neuroscience Ltd withdraws its marketing authorisation application for Ethyl…
  49. Alert on theft of Lantus® SoloStar® (Insulin Glargine Injection IP, r‑DNA origin, 100…
  50. ema-velactisVelactis
  51. Meeting highlights from the Committee for Medicinal Products for Human Use,22-25 June 2009
  52. Cancer Medicines Forum: February 2024
  53. 21 CFR 864.9600: Potentiating media for in vitro diagnostic use.
  54. Emergency contraceptives - referral
  55. Measles and Rubella vaccine (Live)
  56. Standards for biological raw materials
  57. Clinical Trials Information System reaches major milestone towards go-live and application…
  58. How tests and testing kits for coronavirus (COVID-19) work
  59. PSUSA/00010236/201901 - periodic safety update report single assessment
  60. ema-intrarosaIntrarosa
  61. EMEA-003132-PIP01-21 - paediatric investigation plan
  62. EMEA-001577-PIP03-17 - paediatric investigation plan
  63. FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem…
  64. Listening to the public's views on the safety of medicines
  65. ema-vaboremVaborem
  66. DR_G.S.R. 603(E) dt_24.08.2001_26A_Reg FDC Metoclopramide and Aspirin+Paracetamol
  67. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  68. Nano Carrier Entrapped Vitamin D3 Oral Dispersion 60000IU
  69. 21 CFR 71.30: Procedure for filing objections to regulations.
  70. 21 CFR 880.5510: Non-AC-powered patient lift.
  71. 21 CFR 862.1550: Urinary pH (nonquantitative) test system.
  72. cdsco-notice-orderNotice Order
  73. EMA provides recommendations on compassionate use of remdesivir for COVID-19
  74. 21 CFR 866.2560: Microbial growth monitor.
  75. PSUSA/00009099/201704 - periodic safety update report single assessment
  76. Constitution of India Drug/Pharamacueticals Association Forum-Reg.
  77. cdsco-secukinumab-sunshinesecukinumab SUNSHINE
  78. 2018.12.10_Draft_GSR 1190(E)_Date of implementation of G.S.R. 277(E) dated 23.03.2018
  79. Drug Alert list for month of Feb 2021
  80. 21 CFR 884.6180: Reproductive media and supplements.
  81. PSUSA/00000306/202112 - periodic safety update report single assessment
  82. Parallel distribution: Regulatory and procedural guidance
  83. Workshop on conflicts of interests: deadline for registration extended
  84. EMEA-001454-PIP03-15-M03 - paediatric investigation plan
  85. cfr-21-cfr-814-84-reports21 CFR 814.84: Reports.
  86. PSUSA/00001506/202304 - periodic safety update report single assessment
  87. Committee for Medicinal Products for Veterinary Use (CVMP): 15-17 June 2010
  88. 21 CFR 12.90: Conduct at oral hearings or conferences.
  89. Importing investigational medicinal products into Great Britain from approved countries…
  90. Regulations for Medicament Recall, Regulations for Medicament Recall(2015-8-5)
  91. ema-rayzonRayzon
  92. ‘The Awesome Power’ of AAMI Standards: An ISC 2022 Conversation
  93. EU/3/14/1391 - orphan designation for treatment of malignant mesothelioma
  94. Pharmacovigilance training materials
  95. Declaration of storage conditions for medicinal products particulars and active substances…
  96. cdsco-niclosamide-tabletsNiclosamide Tablets
  97. EMEA-003409-PIP01-23 - paediatric investigation plan
  98. Regulations of Medical Device Good Distribution Practice
  99. ema-garsunGarsun
  100. cdsco-flu-d-qivFLU D-QIV
  101. Public statement on concerns over unregulated medicinal products containing stem cells
  102. Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and…
  103. EMEA-001935-PIP01-16 - paediatric investigation plan
  104. Paediatric medicines: Workshops
  105. EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
  106. EU/3/11/875 - orphan designation for treatment of pouchitis
  107. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - April 2016
  108. MEDICAL DEVICE ADVERSE EVENT REPORTING FORM Version 1.2
  109. PSUSA/00000078/202101 - periodic safety update report single assessment
  110. EMEA-000848-PIP01-10-M02 - paediatric investigation plan
  111. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018
  112. 21 CFR 876.1725: Gastrointestinal motility monitoring system.
  113. PSUSA/00000485/201811 - periodic safety update report single assessment
  114. Data on medicines (ISO IDMP standards): marketing authorisation
  115. Committee for veterinary medicinal products: 59th meeting
  116. PSUSA/00000312/201604 - periodic safety update report single assessment
  117. ema-drovelisDrovelis
  118. EMEA-001414-PIP01-12-M01 - paediatric investigation plan
  119. Otaki N. Regulatory and Scientific Considerations for Biosimilars in Japan. The 12th Joint…
  120. PSUSA/00002109/202008 - periodic safety update report single assessment
  121. Drug Alert list for month of May 2017
  122. European Agency for the evaluation of medicinal products: Committee for Proprietary…
  123. ema-desloratadine-ratiopharmDesloratadine ratiopharm
  124. EU/3/14/1265 - orphan designation for treatment of ovarian cancer
  125. European Medicines Agency publishes first report on sales of veterinary antimicrobial…
  126. Drugs banned in the Country
  127. Notice that a certificate under subsection 26B(1) of the Therapeutic Goods Act 1989 is not…
  128. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 5) Regulations…
  129. Committee for Medicinal Products for Human Use (CHMP): 13-16 October 2025
  130. EU/3/18/2039 - orphan designation for treatment of mucopolysaccharidosis type I
  131. Bortezomib - paediatric investigation plan
  132. Pregabalin IP (As Prolonged Release) + Etoricoxib IP film coated bilayered tablets (Phase…
  133. AAMI Certification: Your Next Career Milestone
  134. ema-naftidrofuryl-referralNaftidrofuryl - referral
  135. ema-amglidiaAmglidia
  136. EU/3/22/2694 - orphan designation for treatment of acute myeloid leukaemia
  137. Requirement of CMC documents for approval of additional indication of an already drug…
  138. EMEA-002129-PIP02-17 - paediatric investigation plan
  139. cdsco-denosumabDenosumab
  140. Procedures for monograph and list entry establishment
  141. ema-teriparatide-cinnagenTeriparatide Cinnagen
  142. Device to Improve Post-Stroke Hand Grasping Gets De Novo Authorization
  143. EMEA-002790-PIP01-20 - paediatric investigation plan
  144. NSQ of Typhoid Polysaccharide Vaccine TYPBAR
  145. cdsco-aqueous-chlorineAqueous chlorine
  146. PSUSA/00000491/202106 - periodic safety update report single assessment
  147. ema-actraphaneActraphane
  148. Resmetirom tablets 60mg,80mg,100mg
  149. ema-elzonrisElzonris
  150. Committee for Orphan Medicinal Products (COMP): 2-4 December 2025
  151. ema-bovilis-nasalgen-cBovilis Nasalgen-C
  152. Comprehensive Animal Food Inspection
  153. NMPA Announcement on Adopting ICH Guidelines M10 Q&As and FAQs
  154. 21 CFR 73.1575: Titanium dioxide.
  155. Notice regarding consideration of the directions of the Hon'ble Supreme Court of India in…
  156. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27…
  157. Plasma master file certificates
  158. Paracetamol modified-release - referral
  159. EU/3/10/773 - orphan designation for treatment of acute myeloid leukaemia
  160. Matt Dummert: Let’s Collaborate to Create a Health Technology ‘Dream Team’
  161. Therapeutic goods advertising compliance, 2018-19 annual report
  162. cdsco-iptacopan-lnp023Iptacopan (LNP023)
  163. Zeftera (previously Zevtera)
  164. SARS-CoV-2 (Covid-19) Vaccine (Variant JN.1)
  165. EU/3/23/2766 - orphan designation for treatment of hereditary haemorrhagic telangiectasia
  166. Authorised Prescriber Scheme
  167. NDCTR_G.S.R. 605(E) dt_31.08.2021_Standalone Bioanalytical laboratory_Rule2 NDCTR 2019
  168. Drugs Alert for the month of February 2015
  169. 21 CFR 868.2025: Ultrasonic air embolism monitor.
  170. EMEA-000069-PIP02-10-M08 - paediatric investigation plan
  171. Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation…
  172. EU/3/07/459 - orphan designation for treatment of narcolepsy
  173. ema-exondysExondys
  174. EU/3/21/2497 - orphan designation for treatment of diffuse large B-cell lymphoma
  175. ema-gallimune-flu-h5n9-iGallimune Flu H5N9 (i)
  176. ema-revoladeRevolade
  177. PSUSA/00002944/201507 - periodic safety update report single assessment
  178. FDA Grants Breakthrough Device Designation to Abbott’s Deep Brain Stimulation System for…
  179. 21 CFR 10.60: Referral by court.
  180. Esomeprazole magnesium/acetylsalisylic acid - paediatric investigation plan
  181. EMEA-002108-PIP01-16 - paediatric investigation plan
  182. PRAC recommendations on safety signals: monthly overviews: Archive
  183. Proposal to amend the Required Advisory Statements for Medicine Labels (RASML)
  184. Voices of HTM: Colleen Haugen-Ortiz
  185. Call for expressions of interest for civil society representatives to participate in work…
  186. Guidance Document on Grouping of Medical Device
  187. Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2015
  188. EMEA-001805-PIP01-15 - paediatric investigation plan
  189. Rasagiline Viatris (previously Rasagiline Mylan)
  190. EU/3/10/741 - orphan designation for treatment of cutaneous T-cell lymphoma
  191. 21 CFR 870.4310: Cardiopulmonary bypass coronary pressure gauge.
  192. 21 CFR 12.159: Copies of petitions for judicial review.
  193. PSUSA/00010191/201704 - periodic safety update report single assessment
  194. ema-ebglyssEbglyss
  195. European Medicines Agency's Management Board endorses work programme 2012
  196. Trivalent Nanoparticle Influenza (tNIV) Vaccine & Covid Trivalent Influenza Combination…
  197. PSUSA/00000125/202202 - periodic safety update report single assessment
  198. EU/3/22/2654 - orphan designation for treatment of fibrodysplasia ossificans progressiva
  199. EU/3/10/782 - orphan designation for treatment of cystic fibrosis
  200. VICH GL4 Stability testing for new veterinary dosage forms - Scientific guideline
  201. PF-07899801 or Rimegepant
  202. nbcg-mdrf-reportMDRF Report
  203. cdsco-lubt010LUBT010
  204. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 November 2012
  205. Patients' and Consumers' Working Party meetings
  206. Companies stepping up efforts to ensure medicine supply post Brexit
  207. Questions and Answers (Q & A) for Handling of Re-examination Period
  208. Tecentriq - direct healthcare professional communication (DHPC)
  209. EMA recommends Nuvaxovid for authorisation in the EU
  210. Alcaftadine Nasal Spray CT NOC
  211. EU/3/21/2406 - orphan designation for treatment of sickle cell disease
  212. Thiomersal: implementation of the warning statement relating to sensitisation - Scientific…
  213. EU/3/16/1623 - orphan designation for treatment of ornithine transcarbamylase deficiency
  214. 21 CFR 870.1350: Catheter balloon repair kit.
  215. Notice regarding FAQ/Guidance Document for grant/retention of registration…
  216. Applying for marketing authorisation: orphan medicines
  217. Decentralised and mutual recognition reliance procedure for marketing authorisations
  218. EMEA-001773-PIP01-15 - paediatric investigation plan
  219. cfr-21-cfr-10-1-scope21 CFR 10.1: Scope.
  220. EU/3/19/2246 - orphan designation for treatment of systemic sclerosis
  221. EU/3/08/600 - orphan designation for treatment of multiple myeloma
  222. Excluded autologous human cells and tissues
  223. Taxespira (previously Docetaxel Hospira UK Limited )
  224. Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: FDA Safety…
  225. 21 CFR 886.5925: Soft (hydrophilic) contact lens.
  226. cdsco-lcz696LCZ696
  227. ema-colobreatheColobreathe
  228. July 14, 2021: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory…
  229. 21 CFR 866.2450: Supplement for culture media.
  230. ema-velphoroVelphoro
  231. Responding to emerging COVID-19 variants of concern
  232. Indacaterol Acetate eq. to Indacaterol IH+ Glycopyrronium Bromide eq. to Glycopyrronium Ph…
  233. EU/3/16/1784 - orphan designation for treatment of hyperphenylalaninaemia
  234. AAMI News, April 2021, Vol.56, No.4
  235. PSUSA/00001127/202208 - periodic safety update report single assessment
  236. European Medicines Agency informs doctors and patients about drug interaction between…
  237. European Medicines Agency releases revised guidance on advanced-therapy classification for…
  238. EMEA-001037-PIP02-11-M05 - paediatric investigation plan
  239. ema-netvaxNetvax
  240. Checklist for Grant of Free Sale Certificate for IVD
  241. Call for Proposals now OPEN for AAMI eXchange 2024 in Phoenix
  242. PSUSA/00010354/202005 - periodic safety update report single assessment
  243. European Medicines Agency recommends lifting of suspension of Octagam
  244. cdsco-tapinarof-cream-1-w-wTapinarof cream 1% w/w
  245. World AIDS Day 2013 – Revised guidance to facilitate development of new medicines
  246. EU/3/20/2387 - orphan designation for treatment of primary biliary cholangitis
  247. PSUSA/00003167/201912 - periodic safety update report single assessment
  248. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3–5 October 2017
  249. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 21…
  250. ema-corlentorCorlentor
  251. PSUSA/00010191/202204 - periodic safety update report single assessment
  252. Pharmacovigilance inspection program: Guidance for medicine sponsors
  253. 21 CFR 874.1060: Acoustic chamber for audiometric testing.
  254. EMEA-002147-PIP02-17-M01 - paediatric investigation plan
  255. 21 CFR 860.130: General procedures under section 513(e) of the Federal Food, Drug, and…
  256. Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist…
  257. 21 CFR 74.1317: D&C Red No. 17.
  258. Committee for Medicinal Products for Veterinary Use (CVMP): 22-24 January 2019
  259. ema-btvpurBTVPUR
  260. EU/3/09/618 - orphan designation for treatment of acute lymphoblastic leukaemia
  261. COMP: Working parties and other groups
  262. Evaluation of Safety Concerns with Certain Dental Devices Used on Adults - FDA Safety…
  263. EU/3/20/2356 - orphan designation for treatment of sickle cell disease
  264. UPDATED MEETING TIME INFORMATION: October 31, 2024: Meeting of Endocrinologic and…
  265. EU/3/04/194 - orphan designation for treatment of lipoprotein-lipase deficiency
  266. NMPA Announces New and Revised Catalogues of Medical Devices Exempted from Clinical Trials
  267. AdvaMed Announces New Medical Imaging Technology Division
  268. PRAC recommendations on safety signals
  269. Amendments to the pharmacovigilance legislation: new notification requirements for…
  270. EMEA-000380-PIP07-20 - paediatric investigation plan
  271. EMEA-000793-PIP01-09 - paediatric investigation plan
  272. Restrictions in use of cyproterone due to meningioma risk
  273. Guideline on epidemiological data on blood transmissible infections
  274. Public statement on the recommendation to lift the suspension of the marketing…
  275. EMEA-002681-PIP02-21 - paediatric investigation plan
  276. PSUSA/00002649/202205 - periodic safety update report single assessment
  277. Team-NB-Press-Release-Applications-Survey-20180214
  278. Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 April 2021
  279. Concept paper on development and lifecycle of personalised medicines and companion…
  280. EMEA-001858-PIP02-16-M03 - paediatric investigation plan
  281. EU/3/15/1533 - orphan designation for treatment of osteogenesis imperfecta
  282. EMEA-001344-PIP01-12 - paediatric investigation plan
  283. New medicine to prevent cytomegalovirus disease in stem cell transplant patients
  284. cdsco-trimcinolone-acetonideTrimcinolone Acetonide
  285. cdsco-bi456906BI456906
  286. Donald Armstrong: What Makes a Great Biomed?
  287. Dectomax injectable solution and its associated names - referral
  288. Committee for Advanced Therapies (CAT): 19-20 March 2015
  289. Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach_R2 (2022 Apr)…
  290. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11…
  291. PSUSA/00000679/201611 - periodic safety update report single assessment
  292. EMEA-001868-PIP03-16 - paediatric investigation plan
  293. Paediatric Committee (PDCO): 29 May – 1 June 2018
  294. ema-ambrisentan-zentivaAmbrisentan Zentiva
  295. GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB
  296. Submission dates (veterinary medicines)
  297. European Medicines Agency concludes new advice to doctors and patients for Tysabri…
  298. Glimepiride IP + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin…
  299. DR_G.S.R. 104 (E) dt_25.01.2016_corrigendum to GSR 826
  300. VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing…
  301. EMEA-002091-PIP01-16 - paediatric investigation plan
  302. EU/3/04/186 - orphan designation for conditioning treatment prior to…
  303. 21 CFR 812.45: Informing investigators.
  304. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - December 2017
  305. pmda-background-informationBackground information
  306. 2026.07.08 G.S.R. 607(E)_Notification regarding restriction of sale of drug products…
  307. 21 CFR 1.680: How and when will FDA monitor eligible entities?
  308. Mary Logan: Human Factors and Mobile Health
  309. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 January 2012
  310. European Medicines Agency's workshop on nanomedicines
  311. EU/3/11/900 - orphan designation for treatment of ovarian cancer
  312. ema-jakaviJakavi
  313. Mutual recognition agreements (MRA)
  314. Use of real-world evidence in regulatory decision making – EMA publishes review of its…
  315. EMEA-002308-PIP01-17-M02 - paediatric investigation plan
  316. 21 CFR 872.3960: Mandibular condyle prosthesis.
  317. Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices…
  318. cdsco-vay736-ianalumabVAY736 (Ianalumab)
  319. SPOR webinar: How to access and use the SPOR API
  320. Reporting adverse incidents: intraocular lenses
  321. Martina Schüssler-Lenz elected as new chair of Committee for Advanced Therapies
  322. Interim clinical trial results find increased risk of leg and foot amputations, mostly…
  323. September 2021 Sterilization Standards Week Highlights: Progress and New Guidance
  324. NMPA Issues the Notice on Matters Related to Further Strengthening Management for…
  325. Marketing authorisation (veterinary medicines)
  326. DR_G.S.R. 1161(E) dt_03.12.2018_Amendment in Rule 96 & Date of implemention of GSR 222(E)…
  327. 21 CFR 872.4920: Dental electrosurgical unit and accessories.
  328. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Telmisartan IP (10mg + 40mg &…
  329. 21 CFR 886.5600: Ptosis crutch.
  330. Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from…
  331. The Pharmaceutical Inspection Co-operation Scheme
  332. Committee for Herbal Medicinal Products (HMPC): 11-12 July 2016
  333. 21 CFR 882.4650: Neurosurgical suture needle.
  334. Australian code of good manufacturing practice for human blood and blood components, human…
  335. Committee for Proprietary Medicinal Products (CPMP) 14th plenary meeting
  336. PSUSA/00000745/202112 - periodic safety update report single assessment
  337. PSUSA/00010381/202304 - periodic safety update report single assessment
  338. CuraTeq Vedolizumab 300mg/vial
  339. Twenty-seventh meeting of the Management Board
  340. Foreign Medical Device Manufacturers (9/95)
  341. European Medicines Agency and European Network of Centres for Pharmacoepidemiology &…
  342. European Medicines Agency's Implementation Working Group (IWG) with Pharmaceutical…
  343. Notice regarding Examination for safety and Efficacy of FDCs
  344. PSUSA/00001839/202210 - periodic safety update report single assessment
  345. Clinical Trials Information System (CTIS) sponsor end user training programme - November…
  346. ema-pemazyrePemazyre
  347. Clinical Research Materials
  348. Approaches on how to consider excipients in the context of Regulation 2377/90 - Scientific…
  349. 21 CFR 1.1410: When will FDA consider whether to waive a requirement of this subpart?
  350. Notice regarding Examination for safety and efficacy of FDCs licensed for manufacture for…
  351. To Share the list of drug products manufacturing permissions issued by State licensing…
  352. cdsco-nnc0365-3769NNC0365-3769
  353. 21 CFR 866.5180: Fecal calprotectin immunological test system.
  354. PRO Details of Zonal, Sub zonal offices of CDSCO
  355. EU guidance documents referred to in the Human Medicines Regulations 2012
  356. 69th meeting of the Committee for Proprietary Medicinal Products (CPMP)
  357. 21 CFR 882.4100: Ventricular catheter.
  358. Samples declared NSQ 2013-2016
  359. EU/3/02/100 - orphan designation for treatment of emphysema secondary to congenital…
  360. [+]-α-dihydrotetrabenazine [ -α- DHTB -5mg/7.5mg/10mg/15mg/22.5mg
  361. Workshop on paediatric formulations for assessors in national regulatory agencies
  362. Hospitals Without Walls: an eXchange Keynote Presentation
  363. PSUSA/00002311/201805 - periodic safety update report single assessment
  364. EU/3/12/1003 - orphan designation for treatment of adrenoleukodystrophy
  365. Advisory to all Indian Pharmaceutical Industry Associations
  366. Gam-COVID-Vac combined vector vaccine Component I and Component II)
  367. OTC analytical validation summary form
  368. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  369. cdsco-azd1222-vaccineAZD1222 Vaccine
  370. EU/3/23/2777 - orphan designation for treatment of spinal cord injury
  371. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18…
  372. GN-35-R4 Guidance on Special Access Routes (2023 Jan) PUB
  373. Addendum to the guideline on the evaluation of medicinal products indicated for treatment…
  374. cdsco-tk-90m-s-siroTK-90M/s. SiRO
  375. PSUSA/00003143/201703 - periodic safety update report single assessment
  376. 21 CFR 868.2620: Gas pressure calibrator.
  377. Time allowed for applicants to respond to questions and issues raised during the…
  378. Committee for medicinal products for veterinary use: Meeting of 14-16 July 2009
  379. European Medicines Agency recommends new contraindications and warnings for…
  380. ema-carisoprodol-referralCarisoprodol - referral
  381. EU/3/06/397 - orphan designation for treatment of amyotrophic lateral sclerosis
  382. Taraxaci officinalis radix - herbal medicinal product
  383. Standards of Review Fees for the Registration of Western Medicines and Medical Devices
  384. Prontax 10 mg/ml solution for injection for cattle, sheep and pigs - referral
  385. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 January 2015
  386. High-grade glioma expert group
  387. Rebecca Arthur: The Importance of Downtime Strategies for HTM-Supported Clinical…
  388. 2021.09.13_Draft GSR 628(E)_Amendment of Sch K for Liquid Antiseptics at Sr. no 39
  389. Committee for Herbal Medicinal Products (HMPC): 13-14 January 2010
  390. EMEA-003101-PIP01-21 - paediatric investigation plan
  391. 21 CFR 886.1040: Ocular esthesiometer.
  392. Regulatory information - adjusted fees for applications to EMA from 1 April 2016
  393. PSUSA/00000426/201812 - periodic safety update report single assessment
  394. ema-plavixPlavix
  395. Drafting meeting on the framework for the interaction between the Agency and Healthcare…
  396. ema-akantiorAkantior
  397. EMEA-000017-PIP01-07 - paediatric investigation plan
  398. 21 CFR 1.91: Payment for samples.
  399. Breast Cancer Screening - Thermography is Not an Alternative to Mammography: FDA Safety…
  400. cdsco-esk-001ESK-001
  401. Regulations Governing Border Inspection and Examination of Imported Medical Devices
  402. EMA press briefing on EU actions to tackle shortages of GLP-1 receptor agonists
  403. FDA Outlines Priorities, Challenges, and Opportunities
  404. Biologicals packaged or combined with another therapeutic good
  405. Multidisciplinary: orally inhaled products
  406. ema-doxirobeDoxirobe
  407. Foreign Supplier Verification Programs Inspections
  408. Recent Cybersecurity Attacks — Lessons Learned
  409. 21 CFR 882.1320: Cutaneous electrode.
  410. 21 CFR 880.5120: Manual adjustable hospital bed.
  411. 21 CFR 872.3740: Retentive and splinting pin.
  412. 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
  413. All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg…
  414. PSUSA/00002997/201505 - periodic safety update report single assessment
  415. Meeting of the EMEA Working Party on Herbal Medicinal Products 3 and 4 June 2004
  416. EMEA-003292-PIP01-22 - paediatric investigation plan
  417. European Medicines Agency updates patient and prescriber information for Pradaxa
  418. Croatia becomes a new member of the European medicines network
  419. GN-05-R3 Guidance on the Reporting of Adverse Events (2023 Sep) PUB
  420. Committee for veterinary medicinal products: 75th meeting
  421. 21 CFR 862.1705: Triglyceride test system.
  422. PSUSA/00002698/202001 - periodic safety update report single assessment
  423. ema-amsparityAmsparity
  424. Languages on this website
  425. PCR Kits approved for testing of Covid-19 as on 23.08.2021
  426. EU/3/15/1600 - orphan designation for treatment of hyperargininaemia
  427. William Hyman: The FDA’s Scrutiny of Materials
  428. EU/3/21/2445 - orphan designation for treatment of cystinuria
  429. Committee for Medicinal Products for Veterinary Use (CVMP): 2-4 December 2025
  430. User safety of topically administered products - Scientific guideline
  431. Guidance for completing SFDA On-line MDMA Application Form: USA Jurisdiction
  432. Classification of Medical Device Pertaining to Urology Under the provision of Medical…
  433. Four Sterilization Research Projects Funded by AAMI Foundation
  434. ACB meeting statement, Meeting 3, 19 September 2013
  435. TR-02 R2 Contents of a Product Registration Submission for In Vitro Diagnostic Medical…
  436. PSUSA/00010599/202208 - periodic safety update report single assessment
  437. EU/3/01/024 - orphan designation for treatment of haemorrhagic fever with renal syndrome
  438. ema-vaxxitek-hvt-ibdVaxxitek HVT+IBD
  439. DARWIN EU® has completed its first studies and is calling for new data partners
  440. EU/3/21/2449 - orphan designation for treatment of pulmonary arterial hypertension
  441. EU/3/05/334 - orphan designation for treatment of X-linked hypohidrotic ectodermal…
  442. List of Drugs, Medical Devices and Cosmetics declared as Not of Standard…
  443. EU/3/17/1959 - orphan designation for treatment of tuberous sclerosis
  444. Pre-submission meetings with TGA
  445. EMEA-002644-PIP01-19-M01 - paediatric investigation plan
  446. Application for a Manufacturer's Certificate to Cover Export of Medical Devices (GUI-0097)
  447. PSUSA/00000197/201502 - periodic safety update report single assessment
  448. The new EudraVigilance system and the electronic reporting of individual case safety…
  449. Toxic Elements in Food & Foodware and Radionuclides in Food - Import and Domestic
  450. ema-pulmotil-premix-referralPulmotil Premix - referral
  451. dabrafenib plus trametinib
  452. EU and Japan improve information-sharing in the area of good manufacturing practice using…
  453. PSUSA/00000168/201501 - periodic safety update report single assessment
  454. PSUSA/00001804/201512 - periodic safety update report single assessment
  455. PSUSA/00001502/202108 - periodic safety update report single assessment
  456. Clinical investigation of anti-anginal medicinal products in stable angina pectoris…
  457. Clinical trials: Non-investigational medicinal products
  458. ema-sodium-laurilsulfateSodium laurilsulfate
  459. 21 CFR 888.5940: Cast component.
  460. EMEA-000527-PIP05-17 - paediatric investigation plan
  461. EU/3/18/2073 - orphan designation for treatment of mucopolysaccharidosis type I
  462. EMEA-002413-PIP01-18 - paediatric investigation plan
  463. Regulation & Mandatory Registration of Licensed Blood Centres on the e-RaktKosh Portal
  464. 21 CFR 861.30: Development of standards.
  465. Do Not Use Needle-Free Devices for Injection of Dermal Fillers - FDA Safety Communication
  466. TGA key performance indicators and measures: Regulator Performance Framework
  467. Pharmacovigilance Risk Assessment Committee (PRAC): 1-3 October 2012
  468. PSUSA/00001736/201705 - periodic safety update report single assessment
  469. ema-orbecorBec
  470. ema-ruxienceRuxience
  471. 21 CFR 876.5880: Isolated kidney perfusion and transport system and accessories.
  472. EMEA-001045-PIP01-10-M03 - paediatric investigation plan
  473. EMEA-001154-PIP01-11 - paediatric investigation plan
  474. Guidelines Consistency Group
  475. 21st meeting of the committee for veterinary medicinal products
  476. ema-pemetrexed-lillyPemetrexed Lilly
  477. cdsco-otilimabOtilimab
  478. Committee for Advanced Therapies (CAT): 13-14 January 2011
  479. EMEA-001244-PIP01-11-M02 - paediatric investigation plan
  480. PSUSA/00010651/201905 - periodic safety update report single assessment
  481. European Medicines Agency publishes reflection paper on general issues for consideration…
  482. 21 CFR 73.2120: Disodium EDTA-copper.
  483. Linagliptin + Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin tablets (Phase…
  484. Hepcidin Mimetic PTG-300
  485. AAMI eXchange Heads to New Orleans
  486. Ocaliva - direct healthcare professional communication (DHPC)
  487. PSUSA/00003121/202308 - periodic safety update report single assessment
  488. Safety and residues guidelines
  489. cdsco-tenecteplaseTenecteplase
  490. ASEAN Guideline on Analytical Validation Q&A
  491. EU/3/11/908 - orphan designation for treatment of gamma sarcoglycanopathy
  492. European Medicines Agency releases qualification opinion on diagnosis of pre-dementia…
  493. 21 CFR 870.1255: Balloon aortic valvuloplasty catheter.
  494. The Standards Ecosystem of Radiation Sterilization: A Conversation with Emily Craven
  495. EMEA-000311-PIP06-18 - paediatric investigation plan
  496. ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline
  497. 21 CFR 876.4270: Colostomy rod.
  498. EMEA-002866-PIP01-20 - paediatric investigation plan
  499. GN-17 R1.1 Guidance on Preparation of a Product Registration Submission for General…
  500. EU/3/18/2074 - orphan designation for treatment of mastocytosis
  501. PSUSA/00001499/202202 - periodic safety update report single assessment
  502. AAMI Seeks HTM’s Bright Ideas for 2025
  503. Vilanterol Trifenatate eq. to Vilanterol + Fluticasone Furoate per actuation delivers…
  504. Guidance on clinical evidence requirements for medical devices
  505. Paediatric Committee (PDCO): 4-6 December 2013
  506. hsa-form-2Form 2
  507. Working Party on European Union Monographs and European Union List
  508. VICH GL2 Validation of analytical procedures: methodology - Scientific guideline
  509. EMEA-001849-PIP01-15 - paediatric investigation plan
  510. PSUSA/00010508/202009 - periodic safety update report single assessment
  511. 2023.05.11_DR_S.O. 2177(E) _Government Analyst Notification at CDL, Kolkata
  512. EU/3/12/1018 - orphan designation for treatment of glycogen storage disease type II…
  513. PSUSA/00002506/202308 - periodic safety update report single assessment
  514. GN-21-R4.7 Guidance on Change Notification for Registered MD [ARCHIVED on 26 Mar 2021]…
  515. Revised guidelines to encourage development of veterinary medicines for minor uses and…
  516. Notice dated 18-10-2019
  517. EMEA-000876-PIP07-15 - paediatric investigation plan
  518. Guidance 21: Medicines produced by genetic manipulation
  519. ema-afinitorAfinitor
  520. European Medicines Agency and German Society for Transfusion Medicine and…
  521. Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health…
  522. 21 CFR 866.5560: Lactic dehydrogenase immunological test system.
  523. Centaurii herba - herbal medicinal product
  524. EMEA-003383-PIP02-23 - paediatric investigation plan
  525. FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with…
  526. Maximum residue limits procedures
  527. EU/3/24/2911 - orphan designation for treatment of Duchenne muscular dystrophy
  528. Support for advanced-therapy developers
  529. POSTPONED: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory…
  530. October 20, 2021: General and Plastic Surgery Devices Panel of the Medical Devices…
  531. 21 CFR 868.1730: Oxygen uptake computer.
  532. Final Report Form (FRM-0238)
  533. Not All Water Is Equal! Discussing a New Standard for Water Quality and Next Steps
  534. 21 CFR 17.41: The administrative record.
  535. Peg-filgrastim Injection 6 mg/0.6ml
  536. EMEA-001352-PIP01-12-M01 - paediatric investigation plan
  537. EMEA-002572-PIP02-19-M03 - paediatric investigation plan
  538. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  539. European Medicines Agency recommends approval of fourth advanced therapy in Europe
  540. PSUSA/00009256/202004 - periodic safety update report single assessment
  541. 21 CFR 880.2400: Bed-patient monitor.
  542. Looking Back on HSPA 2024 and to the Future
  543. PSUSA/00000398/202101 - periodic safety update report single assessment
  544. Adverse incidents: in vitro diagnostic (IVD) blood glucose meters
  545. ema-akeegaAkeega
  546. Study provides recommendations on European Medicines Agency's communication on medicines
  547. PSUSA/00001557/201509 - periodic safety update report single assessment
  548. PSUSA/00001450/201611 - periodic safety update report single assessment
  549. Q&A for basic principles for conducting phase 1 studies in Japanese prior to initiating…
  550. Cellular, Tissue, and Gene Therapies Advisory Committee September 27, 2023 Meeting…
  551. 21 CFR 21.73: Accuracy, completeness, timeliness, and relevance of records disclosed from…
  552. Facilitating the development of advanced therapies
  553. European Medicines Agency finalises update to Parkinson's disease guideline
  554. EU/3/16/1767 - orphan designation for treatment of multiple myeloma
  555. cdsco-pf-06741086PF-06741086
  556. Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety…
  557. Insulin Glargine Injection BP 100 IU/mL
  558. European Medicines Agency concludes that benefit-risk balance of Invirase remains positive
  559. 21 CFR 862.1360: Gamma-glutamyl transpeptidase and isoenzymes test system.
  560. PSUSA/00009174/202102 - periodic safety update report single assessment
  561. ema-outdated-prac-meetings[OUTDATED] PRAC meetings
  562. Committee for Orphan Medicinal Products - July 2007 Meeting
  563. EMEA reports strong performance in regulatory and public-health activities in 2007; the…
  564. FDA revises warnings regarding use of the diabetes medicine metformin in certain patients…
  565. Stakeholder meeting on product shortages due to manufacturing and quality problems…
  566. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin…
  567. EU/3/10/811 - orphan designation for treatment of post-polycythaemia vera myelofibrosis
  568. Domestic Acidified and Low-Acid Canned Foods
  569. PSUSA/00003141/201701 - periodic safety update report single assessment
  570. New EU rules for safe and high-quality medicines for animals become effective
  571. EU/3/22/2691 - orphan designation for treatment of cryptococcosis
  572. 21 CFR 866.2180: Manual colony counter.
  573. EMEA-002138-PIP01-17-M01 - paediatric investigation plan
  574. EMEA-001325-PIP01-12 - paediatric investigation plan
  575. EU/3/13/1170 - orphan designation for treatment of acromegaly
  576. Committee for Herbal Medicinal Products (HMPC): 4-5 June 2018
  577. Urticae herba - herbal medicinal product
  578. Second Veterinary Big Data stakeholder forum
  579. EU/3/17/1957 - orphan designation for treatment of Huntington’s disease
  580. PIC/S Brochure 2023
  581. 5th industry stakeholder platform - Operation of EU pharmacovigilance legislation
  582. PSUSA/00002786/202103 - periodic safety update report single assessment
  583. cdsco-fitusiranFitusiran
  584. 21 CFR 820.170: Installation.
  585. Champix - direct healthcare professional communication (DHPC)
  586. Varicella Vaccine (Live, Attenuated)
  587. EMEA-000735-PIP01-09 - paediatric investigation plan
  588. FDA and Industry on the Future of Device Maintenance
  589. Code of Conduct Medical Notified Bodies-V4-0
  590. PSUSA/00001826/202005 - periodic safety update report single assessment
  591. cdsco-arv-471-pf-07850327ARV-471 (PF-07850327)
  592. Recombinant Human Parathyroid Hormone (rhPTH1-34) injection (Teriparatide Injection) 750…
  593. Teriparatide injection IP 600mcg/2.4 mL (250mcg/mL) (r-DNA origin)
  594. EU/3/03/175 - orphan designation for treatment of mantle cell lymphoma
  595. Medical devices: off-label use
  596. GN-34 R1.3 Guidance Document for IVD Analysers(Feb-pub)
  597. 21 CFR 868.6885: Medical gas yoke assembly.
  598. Apremilast 60 mg Tablet 60 mg Tablet
  599. NMPA Announcement on the Issuance of Five Guidelines for Technical Review of the…
  600. Bisoprolol fumarate / acetylsalicylic acid - paediatric investigation plan
  601. ema-libtayoLibtayo
  602. ema-cardalisCardalis
  603. Mary Logan: We Need Science, not Scapegoats, in Sterility Assurance Debate
  604. February 19, 2016: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices…
  605. Viagra - withdrawal of application for variation to marketing authorisation
  606. 21 CFR 880.5725: Infusion pump.
  607. EMEA-002600-PIP01-19-M01 - paediatric investigation plan
  608. Cancer Medicines Forum: December 2022
  609. EMEA-003273-PIP02-22 - paediatric investigation plan
  610. Human normal immunoglobulin - paediatric investigation plan
  611. PSUSA/00000022/202303 - periodic safety update report single assessment
  612. EU/3/11/890 - orphan designation for treatment of hepatocellular carcinoma
  613. Consultation procedure for ancillary medicinal substances in medical devices
  614. Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19…
  615. The Yellow Card scheme: guidance for healthcare professionals, patients and the public
  616. EU/3/23/2764 - orphan designation for treatment of vanishing white matter disease
  617. Human and veterinary pharmaceuticals' regulation - towards EU accession: Serbia's…
  618. Points to Consider for Ensuring the Reliability of Post-marketing Database Study for…
  619. ema-rasilez-hctRasilez HCT
  620. EU/3/12/1020 - orphan designation for treatment of idiopathic pulmonary fibrosis
  621. 21 CFR 862.1180: Chymotrypsin test system.
  622. EU/3/10/807 - orphan designation for treatment of frontotemporal dementia with…
  623. EMEA-000671-PIP01-09-M10 - paediatric investigation plan
  624. 21 CFR 882.1440: Neuropsychiatric interpretive electroencephalograph assessment aid.
  625. cfr-21-cfr-806-1-scope21 CFR 806.1: Scope.
  626. cdsco-bi1015550BI1015550
  627. 2026.01.21 G.S.R. 54(E)_Draft Notification for amendment in Schedule H1 for inclusion of…
  628. cdsco-ly3537982LY3537982
  629. EMEA-003215-PIP01-22 - paediatric investigation plan
  630. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) adopts…
  631. European Medicines Agency recommends restricted use of nimesulide-containing medicinal…
  632. Combination: Species digestivae - herbal medicinal product
  633. FDA Issues Final Notice on Breakthrough Devices: What’s Next for Industry, Medicare…
  634. Drug Safety Update: monthly PDF newsletter: Drug Safety Update May 2020
  635. September 23, 2026: Molecular and Clinical Genetics Panel of the Medical Devices Advisory…
  636. Brexit: the United Kingdom's withdrawal from the European Union
  637. Assessment templates and guidance - Ancillary medicinal substances incorporated in a…
  638. DR_G.S.R. 780(E) dt_10.11.2008_Amendment Rule 74,78,150E_Implimentation of Sch-L1
  639. Import Human Drug Operations
  640. February 13, 2024: Circulatory System Devices Panel of the Medical Devices Advisory…
  641. Fourth listen-and-learn focus group meeting of the Quality Innovation Group
  642. EMEA-003374-PIP01-22 - paediatric investigation plan
  643. PSUSA/00000598/202101 - periodic safety update report single assessment
  644. EU/3/04/243 - orphan designation for treatment of cystic fibrosis
  645. EMEA-001555-PIP01-13-M04 - paediatric investigation plan
  646. Will You Prepare for a Shifting Cybersecurity Landscape?
  647. 21 CFR 10.206: Procedures for electronic media coverage of agency public administrative…
  648. Patients and consumers: Key documents
  649. Multidisciplinary: vaccines
  650. European Medicines Agency Management Board holds its 50th meeting:Annual report 2005 shows…
  651. 2012 European Medicines Agency/International Federation for Animal Health Europe info day
  652. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 25…
  653. EU/3/06/372 - orphan designation for treatment of adrenal insufficiency
  654. 21 CFR 886.4170: Cryophthalmic unit.
  655. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  656. PSUSA/00010308/201512 - periodic safety update report single assessment
  657. EU/3/21/2569 - orphan designation for treatment of acute myeloid leukaemia
  658. EMEA-001288-PIP01-12 - paediatric investigation plan
  659. 21 CFR 99.501: Recordkeeping and reports.
  660. EMEA-001353-PIP01-12 - paediatric investigation plan
  661. EU/3/17/1840 - orphan designation for treatment of gastric cancer
  662. EMA supports regulatory harmonisation in East Africa
  663. PSUSA/00010613/202110 - periodic safety update report single assessment
  664. Gazette Notification S.O. 4672 (E) dated 27 December 2019
  665. Risk-Adapted Approach to clinical trials and Risk Assessments: Example 2: Type A Risk…
  666. 21 CFR 886.1435: Maxwell spot.
  667. EU/3/16/1716 - orphan designation for treatment of Duchenne muscular dystrophy
  668. Paediatric rheumatology expert group meeting
  669. Committee for Proprietary Medicinal Products (CPMP): meeting of 16 to 18 October 2001
  670. ema-aflunovAflunov
  671. Authorised uses of cancer medicine Yondelis unchanged following review of new data
  672. EU/3/20/2279 - orphan designation for treatment of non-traumatic subarachnoid haemorrhage
  673. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28…
  674. Committee for Herbal Medicinal Products (HMPC): 21-23 September 2020
  675. cfr-21-cfr-73-2329-guanine21 CFR 73.2329: Guanine.
  676. Surrender of lmport Registration Certificate under Cos-4A vide IRN/COS- 4N20221 000001…
  677. ema-bonvivaBonviva
  678. PSUSA/00010415/201707 - periodic safety update report single assessment
  679. 21 CFR 882.5960: Skull tongs for traction.
  680. 21 CFR 73.3119: 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
  681. 21 CFR 878.3: Effective dates of requirement for premarket approval.
  682. Drug Safety Update: monthly PDF newsletter: Drug Safety Update November 2021
  683. ema-novoeightNovoEight
  684. EMEA-001943-PIP04-20 - paediatric investigation plan
  685. cdsco-ly3471851LY3471851
  686. EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of…
  687. Medicine Shortages SPOC Working Party meetings
  688. Fate of veterinary medicinal products in manure Focus Group Meeting
  689. EMEA-002152-PIP01-17-M03 - paediatric investigation plan
  690. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 June 2014
  691. 21 CFR 864.9205: Blood and plasma warming device.
  692. Committee for Orphan Medicinal Products (COMP): 13-15 February 2024
  693. One Health: a joint framework for action published by five EU agencies
  694. cdsco-brazikumabBrazikumab
  695. EU/3/23/2852 - orphan designation for treatment of pancreatic cancer
  696. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations…
  697. ema-ebvalloEbvallo
  698. EMEA-000487-PIP01-08 - paediatric investigation plan
  699. Voices of HTM: JoJo Gonzales
  700. ema-aquiptaAquipta
  701. EMEA-000411-PIP01-08 - paediatric investigation plan
  702. 21 CFR 882.5060: Conditioning tool for eating disorders.
  703. Further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
  704. EMEA-001334-PIP01-12 - paediatric investigation plan
  705. European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 February…
  706. 21 CFR 814.17: Service of orders.
  707. Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
  708. FDA warns about the risk of hepatitis B reactivating in some patients treated with…
  709. Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2015
  710. EU/3/22/2745 - orphan designation for treatment of invasive aspergillosis
  711. Medical Device and Radiological Health Use Control and Policy Implementation
  712. EMEA-000470-PIP01-08-M11 - paediatric investigation plan
  713. cdsco-insulin-degludec-mayInsulin degludec may
  714. Committee for Orphan Medicinal Products (COMP): 9-11 July 2013
  715. Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024
  716. PSUSA/00002780/201803 - periodic safety update report single assessment
  717. cdsco-bi-685509BI 685509
  718. NOTICE to all Drugs Manufacturers and Pharmaceuticals Association
  719. EMEA-003120-PIP01-21 - paediatric investigation plan
  720. Prohibition of 80 fixed Dose combinations by the Central Government vide Gazette…
  721. EU/3/08/553 - orphan designation for treatment of glioma
  722. 21 CFR 1.377: What definitions apply to this subpart?
  723. EMEA-002038-PIP01-16 - paediatric investigation plan
  724. Impact of lung and heart immaturity when investigating medicinal products intended for…
  725. ema-vihumaVihuma
  726. February 14-15, 2018: Meeting of the Anesthetic and Analgesic Drug Products Advisory…
  727. Venetoclax Tablets 10/50/100 mg
  728. Fragariae folium - herbal medicinal product
  729. PSUSA/00010239/201502 - periodic safety update report single assessment
  730. Meeting Regulatory Requirements Through CMMS Design
  731. ICH Q4B Annex 13 Bulk density and tapped density of powders - Scientific guideline
  732. 21 CFR 803.3: How does FDA define the terms used in this part?
  733. PSUSA/00010209/202002 - periodic safety update report single assessment
  734. 2026.01.28 G.S.R. 65(E)_Draft notification of Chaudhary Charan Singh National Institute of…
  735. ema-plegridyPlegridy
  736. Brimonidine IP + Brinzolamide IP + Timolol eq. to Timolol Maleate IP + Benzalkonium…
  737. Guideline for the Development of Liposome Drug Products
  738. cdsco-research-park-lnp7457(Research Park)LNP7457
  739. ASEAN Variation Guideline Rev 2 (2021)
  740. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration
  741. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30…
  742. PSUSA/00003013/201511 - periodic safety update report single assessment
  743. Special Access Scheme (SAS) online system guidance
  744. ema-ganirelix-gedeon-richterGanirelix Gedeon Richter
  745. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24…
  746. Committee for Advanced Therapies (CAT): 2-4 December 2020
  747. ema-trulicityTrulicity
  748. PSUSA/00010067/202110 - periodic safety update report single assessment
  749. SPOR data services: questions and answers webinar with industry
  750. Regulatory information – adjusted fees for applications to EMA from 1 April 2020
  751. Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses…
  752. 21 CFR 1.692: How do I request internal agency review of a denial of an application or…
  753. Clinical Trials Information System (CTIS): Walk-in clinic
  754. Picrorhizae kurroae rhizoma et radix - herbal medicinal product
  755. First HDAC inhibitor for treatment of multiple myeloma recommended for approval in EU
  756. Drug Alert list for month of May 2013
  757. ema-arepanrixArepanrix
  758. Guidance for the use of medicinal cannabis in the treatment of palliative care patients in…
  759. Desidustat Tablets 25mg, 50mg, 100mgCT/SND/27/2023
  760. EU/3/14/1236 - orphan designation for treatment of epidermolysis bullosa
  761. Civil society representatives wanted for EMA's Management Board and Pharmacovigilance…
  762. Guidance for the publication of clinical data
  763. 21 CFR 890.1175: Electrode cable.
  764. Elranatamab solution for injection 44mg/1.1 mL (40mg/mL) and 76mg/1.9mL (40mg/mL) (r-DNA…
  765. EU recommendations for 2020/2021 seasonal flu vaccine composition
  766. PSUSA/00002229/201804 - periodic safety update report single assessment
  767. EMEA-002065-PIP01-16-M03 - paediatric investigation plan
  768. September 11, 2017: Pediatric Advisory Committee Meeting Announcement - 09/10/2017
  769. EMEA-002687-PIP01-19 - paediatric investigation plan
  770. PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk…
  771. cdsco-bedaquilineBedaquiline
  772. Career Center: The Secret of Success? It's Enthusiasm
  773. 21 CFR 876.5030: Continent ileostomy catheter.
  774. ema-qinlockQinlock
  775. PSUSA/00000494/201506 - periodic safety update report single assessment
  776. tga-ectd-baseline-sequenceseCTD baseline sequences
  777. ema-fungitraxxFungitraxx
  778. Handling of the Optimal Clinical Use Guidelines
  779. ema-duoplavinDuoPlavin
  780. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
  781. Provisions for Unannounced Inspection of Drugs and Medical Devices (Decree No.14 of China…
  782. Medical Device De Novo Requests: FDA Issues E-Submission Template Guidance
  783. Advertising and Promotion following agreement of the Windsor Framework
  784. EU/3/20/2252 - orphan designation for treatment of multiple myeloma
  785. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5…
  786. Ivosidenib 250 mg film-coated tablets
  787. Amfepramone-containing medicinal products - referral
  788. IT systems unavailable from 27 to 30 July 2018
  789. Wholesalers & manufacturers guidance following agreement of the Windsor Framework
  790. ema-lenalidomide-mylanLenalidomide Mylan
  791. PSUSA/00001416/202105 - periodic safety update report single assessment
  792. Field safety notice (FSN): what it is and why it's important
  793. Insulin human - direct healthcare professional communication (DHPC)
  794. European Medicines Agency bids farewell to CHMP Pharmacovigilance Working Party
  795. Committee for Medicinal Products for Veterinary Use (CVMP): 15-17 June 2021
  796. 21 CFR 882.5810: External functional neuromuscular stimulator.
  797. Refusal of orphan designation for treatment of malignant melanoma
  798. Agency sets out work priorities for 2011
  799. Drug Alert list for month of October 2022
  800. ema-eu-institutionsEU Institutions
  801. Thirty-first meeting of the Management Board
  802. Regulatory update - EMA encourages companies to submit quality type I variations for 2014…
  803. Palbociclib product-specific bioequivalence guidance
  804. PSUSA/00000608/201510 - periodic safety update report single assessment
  805. Completing a determination or designation application form in TGA Business Services
  806. PSUSA/00002076/201606 - periodic safety update report single assessment
  807. EU/3/14/1319 - orphan designation for treatment of haemophilia B
  808. Reporting adverse incidents: intraocular lenses: Adverse incidents with intraocular lenses
  809. QMS F0015.1.003 Structure of AO Files
  810. cdsco-itolizumabItolizumab
  811. Committee for Herbal Medicinal Products (HMPC): 13-14 May 2013
  812. Cilnidipine IP 10mg + Bisoprolol Fumarate IP 5mg film coated tablet.
  813. EU/3/15/1489 - orphan designation for treatment of myasthenia gravis
  814. CYCLOPHOSPHAMIDE POWDER FOR ORAL SOLUTION 30MG/MCT/SND/08/2024
  815. Refusal of orphan designation for treatment of pancreatic cancer
  816. EU/3/14/1384 - orphan designation for treatment of WHIM syndrome
  817. Guide to Incident Reporting for General Medical Devices and Active Implantable Medical…
  818. EU/3/14/1424 - orphan designation for treatment of diffuse large B-cell lymphoma
  819. April 16,2008 (G.S.R.207)
  820. Decentralised Manufacture: Labelling
  821. EU/3/17/1960 - orphan designation for treatment of congenital erythropoietic porphyria
  822. How tests and testing kits for coronavirus (COVID-19) work: Target Product Profile: enzyme…
  823. HTM Professionals’ Role in Organizational Culture and Risk Management
  824. NMPA Announcement on the Issuance of 13 Guidelines for Technical Review of the…
  825. EU/3/16/1739 - orphan designation for treatment of soft tissue sarcoma
  826. Handling of Designation of Drugs for Specific Use
  827. Ongoing safety review of Parkinson's drug Mirapex (pramipexole) and possible risk of heart…
  828. Flupirtine-containing medicinal products - referral
  829. EU/3/05/286 - orphan designation for treatment of multiple myeloma
  830. Valebo and associated names - referral
  831. Microbiological aspects of herbal medicinal products and traditional herbal medicinal…
  832. 21 CFR 890.5950: Powered heating unit.
  833. TEAM-NB Report Meeting PermRep NL
  834. ema-novomixNovoMix
  835. PSUSA/00002129/201803 - periodic safety update report single assessment
  836. Towards improved safety monitoring of veterinary medicines
  837. Regulatory update - EMA encourages companies to submit type I variations for 2017 by end…
  838. ema-equibactin-vet-referralEquibactin vet. - referral
  839. Multifocal Intraocular Lens Approved for Marketing
  840. EudraVigilance access policy for medicines for veterinary use
  841. ema-efficibEfficib
  842. New treatment for obesity caused by rare genetic disorders
  843. Details of clinical trial Permissions of Year 2020
  844. ema-aripiprazole-accordAripiprazole Accord
  845. 21 CFR 884.2685: Fetal scalp clip electrode and applicator.
  846. Rizatriptan Benzoate IP eq. to Rizatriptan 10mg + Meloxicam IP 20mg uncoated orally…
  847. Committee for Medicinal Products for Human Use (CHMP): 15-18 May 2017
  848. EMA re-elected as chair of ICMRA from October 2022
  849. Committee for Advanced Therapies (CAT): 20-22 March 2019
  850. Form MD-12 Specimen proforma for Medical Devices
  851. Committee for Medicinal Products for Human Use (CHMP): 20-23 April 2026
  852. cdsco-evixapodlinEvixapodlin
  853. Product Management Service (PMS) Application Programming Interface (API) training session
  854. EMEA-001694-PIP01-14 - paediatric investigation plan
  855. Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data…
  856. PSUSA/00002409/201707 - periodic safety update report single assessment
  857. Reliance GeneMedix Plc. withdraws its marketing authorisation application for Epostim…
  858. Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 March 2016
  859. ema-eperzanEperzan
  860. Medicines regulators on both sides of the Atlantic confirm commitment to cooperation on…
  861. Olumiant - withdrawal of application for variation to marketing authorisation
  862. ema-econorEconor
  863. Handling of the Two-step Approval Based on the Characteristics of Software as a Medical…
  864. UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: June 4, 2024: Meeting of the…
  865. Committee for Medicinal Products for Veterinary Use (CVMP): 5-7 September 2023
  866. cdsco-alglucosidase-alfaAlglucosidase Alfa
  867. Corrective action plan template
  868. ema-xofigo-referralXofigo - referral
  869. Mark Swanson: Here It Comes! Are You Ready for Updated Standard for Quality Management…
  870. Paediatric medicines: applications and procedures
  871. 21 CFR 892.1620: Cine or spot fluorographic x-ray camera.
  872. SAR443765 solution for injection 165mg/1.1 mL (150mg/mL)
  873. Foeniculi amari fructus - herbal medicinal product
  874. New EudraVigilance system is live
  875. EU/3/24/2930 - orphan designation for treatment of hyperphenylalaninaemia
  876. 21 CFR 864.2280: Cultured animal and human cells.
  877. Veterinary medicines: highlights of 2018
  878. Guidance on the format of the Risk Management Plan (RMP) in the EU - in integrated format
  879. EMEA-001303-PIP01-12-M04 - paediatric investigation plan
  880. 21 CFR 870.1660: Indicator injector.
  881. ema-spor-status-updateSPOR status update
  882. Committee for Advanced Therapies (CAT): 10-12 September 2025
  883. ema-porcilis-prrs-referralPorcilis PRRS - referral
  884. cdsco-rfb002RFB002
  885. PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing…
  886. opivacaine Hydrochloride USP eq. to anhydrous Ropivacaine hydrochloride Dextrose IP per ml…
  887. Twentieth Meeting of the Management Board
  888. ema-kinzalkombKinzalkomb
  889. Rare diseases: natural history studies for drug development – guidance for industry
  890. Management Board meeting: 12-13 June 2019
  891. Anifrolumab (MEDI-546) Solution for injection
  892. ema-reasanzReasanz
  893. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28…
  894. October 27th 2017 GSR 1337(E)
  895. Imbruvica - direct healthcare professional communication (DHPC)
  896. Sacituzumab tirumotecan
  897. EU/3/12/987 - orphan designation for treatment of myelodysplastic syndromes
  898. Committee for Orphan Medicinal Products (COMP): 10-12 September 2019
  899. PSUSA/00001532/201602 - periodic safety update report single assessment
  900. Nominate Today for the ACCE Hall of Fame!
  901. EMEA-001437-PIP01-13 - paediatric investigation plan
  902. Details of IEC/GSTN Code of all the beneficiaries Stakeholder/Importer/Exporters, Customs…
  903. PSUSA/00001174/201704 - periodic safety update report single assessment
  904. EU/3/23/2880 - orphan designation for treatment of epidermolysis bullosa
  905. Pioglitazone Hydrochloride IP eq. to Pioglitazone + Dapagliflozin Propanediol Monohydrate…
  906. Vitis viniferae folium - herbal medicinal product
  907. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 August 2020
  908. EMEA-000222-PIP01-08-M09 - paediatric investigation plan
  909. Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017
  910. cdsco-tocilizumabtocilizumab
  911. ema-prevexxion-rn-hvt-ibdPrevexxion RN+HVT+IBD
  912. EMEA-002923-PIP01-20 - paediatric investigation plan
  913. Ondansetron Extended Relese Injectable Supension 100mg/ml
  914. EMEA-000674-PIP02-11-M01 - paediatric investigation plan
  915. EMEA implementation of electronic submissions: statements of intent - Scientific guideline
  916. cdsco-adalimumab-40-mg-0-4mlAdalimumab, 40 mg/0.4ml
  917. EMEA-002284-PIP01-17 - paediatric investigation plan
  918. EU/3/05/269 - orphan designation for treatment of acute myeloid leukaemia
  919. 21 CFR 880.6970: Liquid crystal vein locator.
  920. EMEA-001808-PIP03-17 - paediatric investigation plan
  921. cdsco-hrf-10071-ripivirineHRF-10071, Ripivirine
  922. Curcumae xanthorrhizae rhizoma - herbal medicinal product
  923. EMEA-000573-PIP01-09-M05 - paediatric investigation plan
  924. EMEA-001489-PIP01-13-M02 - paediatric investigation plan
  925. cfr-21-cfr-26-60-definitions21 CFR 26.60: Definitions.
  926. 2021.08.17_S.O. 3364(E NIAB Hyderabad
  927. EU/3/21/2480 - orphan designation for treatment of autosomal dominant polycystic kidney…
  928. 21 CFR 866.3336: John Cunningham Virus serological reagents.
  929. European Medicines Agency Management Board strengthens conflicts of interest policies and…
  930. European Medicines Agency invites feedback on plans to revise existing guidelines on…
  931. EMEA-002597-PIP03-20 - paediatric investigation plan
  932. 21 CFR 73.170: Grape skin extract (enocianina).
  933. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  934. EMEA-001185-PIP01-11-M08 - paediatric investigation plan
  935. Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other…
  936. EMEA-003276-PIP01-22 - paediatric investigation plan
  937. Changing the labelling and package leaflet (Article 61(3) notifications)
  938. Meeting highlights from the Paediatric Committee: 22 - 24 July 2009
  939. 21 CFR 892.1600: Angiographic x-ray system.
  940. 21 CFR 58.47: Facilities for handling test and control articles.
  941. ema-rasilezRasilez
  942. Radioactive Drugs (PDF - 180KB)
  943. 21 CFR 60.36: Standard of due diligence.
  944. PSUSA/00002076/201906 - periodic safety update report single assessment
  945. 21 CFR 800.55: Administrative detention.
  946. EMEA-002987-PIP01-21 - paediatric investigation plan
  947. 21 CFR 3.4: Designated agency component.
  948. EU/3/17/1829 - orphan designation for treatment of Dravet syndrome
  949. PSUSA/00000185/201706 - periodic safety update report single assessment
  950. Announcement of NMPA, GAC, and SAMR on Implementing the Measures for the Administration of…
  951. EMEA-001993-PIP01-16 - paediatric investigation plan
  952. Clopidogrel Teva Pharma B.V.
  953. Vigil on the activities of distribution & sale of suspected spurious Tocilizumab 400 mg/20…
  954. Novagali Pharma S.A. withdraws its marketing authorisation application for Vekacia…
  955. Risk Communication - Protecting Canadians through Information
  956. 21 CFR 1.1445: Under what circumstances may FDA modify or revoke a waiver?
  957. cdsco-cardiovascular-orderCARDIOVASCULAR ORDER
  958. EU/3/23/2805 - orphan designation for treatment of inclusion body myositis
  959. Summary of Product Characteristics Advisory Group
  960. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Pioglitazone Hydrochloride IP…
  961. ema-bicaluplex-referralBicaluplex - referral
  962. cdsco-sep-29-2014-gsr-701-eSep 29 2014 GSR 701(E)
  963. Paediatric Committee (PDCO): 24-26 February 2016
  964. Committee for Orphan Medicinal Products (COMP): 17-19 March 2020
  965. PSUSA/00001507/202004 - periodic safety update report single assessment
  966. 21 CFR 886.1050: Adaptometer (biophotometer).
  967. CTD Module 1.5 - Assessed listed medicines - Restricted information certification form
  968. ema-israelIsrael
  969. We Have Met the Enemy, and He Is Us
  970. European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
  971. E-learning modules: medicines: Quick-start guide to using the MHRA learning system
  972. Team-NB Position Paper Article117 NB-Opinion Template V1
  973. 27th meeting of the committee for veterinary medicinal products
  974. QMS F0002.2.003 New Document Proposal (NDP) Template and Guidelines
  975. Custom-made medical devices in Great Britain
  976. cfr-21-cfr-73-2496-mica21 CFR 73.2496: Mica.
  977. External guidance on the implementation of the European Medicines Agency policy on the…
  978. Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic…
  979. cdsco-sait101-vs-rituximabSAIT101 vs Rituximab
  980. Call for civil society members of EMA Management Board
  981. PSUSA/00002079/202204 - periodic safety update report single assessment
  982. Council of Europe's European Directorate for the Quality of Medicines and Healthcare…
  983. 21 CFR 886.1290: Fixation device.
  984. Committee for Orphan Medicinal Products (COMP): 8-10 September 2026
  985. Import of duplicate product Siso Hair Color Shampoo regarding
  986. AAMI Explores Artificial Intelligence and Dentistry with New Standards Initiatives
  987. Key MedTech Subjects Highlighted at 2021 International Standards Conference
  988. Committee for Proprietary Medicinal Products (CPMP) 65th plenary meeting
  989. Committee for Medicinal Products for Human Use (CHMP): 15-18 August 2011
  990. European Network of Paediatric Research at the European Medicines Agency introduced to…
  991. 21 CFR 882.4400: Radiofrequency lesion generator.
  992. GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB [PDF, 267 KB]
  993. Sinks? Yes! Let’s Talk About Sinks - an endoscope processing FAQ
  994. EMEA-001397-PIP01-12 - paediatric investigation plan
  995. EMA update on metformin diabetes medicines
  996. 21 CFR 880.6085: Hot/cold water bottle.
  997. ema-tesavelTesavel

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