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Global regulations and guidance

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

  1. P/80/2010 - paediatric investigation plan
  2. Workshop for micro-, small- and medium-sized enterprises: statistical perspectives in…
  3. CagriSema s.c. in doses 2.4/2.4 mg
  4. Regulation of Human medicines - News
  5. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - September 2019
  6. PSUSA/00001849/201711 - periodic safety update report single assessment
  7. EMEA-003173-PIP01-21 - paediatric investigation plan
  8. Application for priority applicant determination - medical devices
  9. MDS-REQ 9: Requirements for Licensing of Medical Devices Establishments
  10. PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
  11. EMEA-003006-PIP01-21 - paediatric investigation plan
  12. AAMI News, March 2021, Vol.56, No.3
  13. Revestive - opinion on variation to marketing authorisation
  14. cdsco-tofacetinib-gel-2Tofacetinib Gel 2%
  15. EU/3/03/155 - orphan designation for treatment of ovarian cancer
  16. EMEA-002310-PIP02-17 - paediatric investigation plan
  17. Foreign risk notification for medical devices guidance document
  18. pmda-examination-feesExamination Fees
  19. 21 CFR 7.87: Records related to opportunities for presentation of views conducted before…
  20. New medicine to protect babies and infants from respiratory syncytial virus (RSV)…
  21. Missing data in confirmatory clinical trials - Scientific guideline
  22. 21 CFR 73.3110: Chlorophyllin-copper complex, oil soluble.
  23. Paediatric Committee (PDCO): 8-10 February 2012
  24. Electronic instructions for use of medical devices: guidance on regulations
  25. Ralph J. Basile: Guide for Standard Test Soils
  26. Guide to reporting medical device shortages and discontinuations (GUI-0137)
  27. Gefitinib product-specific bioequivalence guidance
  28. ema-alpheonAlpheon
  29. Valproate and related substances - referral
  30. Paediatric Committee (PDCO): 25-28 March 2025
  31. Out-of-specification investigations
  32. Your Child's Prescription: Important Questions to Ask
  33. PSUSA/00010299/201903 - periodic safety update report single assessment
  34. Exenatide product-specific bioequivalence guidance
  35. 21 CFR 12.70: Authority of presiding officer.
  36. EU/3/15/1589 - orphan designation for treatment of neonatal diabetes
  37. Regulation impact statement for reclassification of hip, knee and shoulder joint implants
  38. Committee for Advanced Therapies (CAT): 7-9 December 2016
  39. ema-complaintsComplaints
  40. 21 CFR 886.1140: Ophthalmic chair.
  41. Influenza vaccines – submission and procedural requirements - Scientific guideline
  42. Vilanterol Trifenatate equivalent to Vilanterol 25mcg + Umeclidinium Bromide equivalent to…
  43. Paediatric Committee (PDCO): 12-15 November 2024
  44. Form MD-22 Specimen proforma for Medical Devices
  45. EMEA-001023-PIP01-10 - paediatric investigation plan
  46. ADHOC working group meeting on herbal medicinal products: 6 - 7 July 1998
  47. AAMI Accepting 2024 Applications for TMC, HTLC
  48. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 February 2016
  49. EU/3/16/1679 - orphan designation for treatment of glioma
  50. Legal requirements for children's medicines: Implementation of changes to product…
  51. EMEA-003179-PIP01-22 - paediatric investigation plan
  52. EU/3/15/1500 - orphan designation for treatment of hepatitis delta virus infection
  53. Applications for registered complementary medicines
  54. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF July-2017
  55. EU/3/16/1655 - orphan designation for treatment of acute myeloid leukaemia
  56. EMA website briefly unavailable on 8 March 2021
  57. Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 11.02.2022
  58. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  59. TEAM-NB position paper on key areas of debate on MDD and IVDD
  60. EU/3/16/1639 - orphan designation for treatment of X-linked spinal and bulbar muscular…
  61. Paediatric Committee (PDCO): 1-4 September 2020
  62. AAMI Standards Debuts New Cloud-Based Committee Central Platform
  63. Pre-clearance application for animal-derived ingredients
  64. EMEA-002700-PIP01-19 - paediatric investigation plan
  65. Handling competing interests: revised rules for Management Board members
  66. Integration of EudraGMDP and OMS - Webinar for industry
  67. ema-coxevacCoxevac
  68. EMEA-000568-PIP01-09-M06 - paediatric investigation plan
  69. EU/3/22/2718 - orphan designation for treatment of 22q11.2 deletion syndrome
  70. Myrtilli fructus siccus - herbal medicinal product
  71. EMEA-002305-PIP01-17-M01 - paediatric investigation plan
  72. 21 CFR 872.3950: Glenoid fossa prosthesis.
  73. Therapeutic Goods Advertising Compliance Education Strategy
  74. ema-posatexPosatex
  75. cdsco-ocrelizumab-30mg-mlOcrelizumab, 30mg/mL
  76. Human medicines: highlights of 2021
  77. Recombinant Human Follicle Stimulating Hormone (Follitropin alfa)Solution for Injection…
  78. Eprotirome - paediatric investigation plan
  79. Benidipine Hydrochloride + Chlorthalidone IP Film coated tablets (Phase III)
  80. Tepadina - direct healthcare professional communication (DHPC)
  81. EU/3/12/1039 - orphan designation for treatment of cutaneous T-cell lymphoma
  82. 21 CFR 872.6650: Massaging pick or tip for oral hygiene.
  83. User guide: Evaluation of substances for use in listed medicines and assessed listed…
  84. 21 CFR 880.2200: Liquid crystal forehead temperature strip.
  85. RoActemra - direct healthcare professional communication (DHPC)
  86. cdsco-bosutinib-tabBosutinib tab
  87. EMEA-002148-PIP01-17 - paediatric investigation plan
  88. ema-omvohOmvoh
  89. 21 CFR 20.52: Availability of records at National Technical Information Service.
  90. European Medicines Agency gives first opinion on compassionate use
  91. Thirty-fifth meeting of the Management Board
  92. Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2026
  93. EMEA-002401-PIP01-18 - paediatric investigation plan
  94. EMEA-001600-PIP01-13-M02 - paediatric investigation plan
  95. EMEA-002739-PIP01-19 - paediatric investigation plan
  96. 2022.01.21_Draft_GSR 32(E)_Insertion of Provisions for deemed approvals in various rules…
  97. cdsco-semaglutide-soulSemaglutide (SOUL)
  98. Regulation on Management of Essential Documents of Clinical Trials on Medical Devices
  99. 21 CFR 886.1680: Ophthalmic projector.
  100. PSUSA/00010092/202104 - periodic safety update report single assessment
  101. 21 CFR 54.4: Certification and disclosure requirements.
  102. EudraVigilance training on electronic reporting of Individual Case Safety Reports in the…
  103. Shaping regulatory science to 2025
  104. Standard Operating Procedure Team Inspections
  105. Emer Cooke’s end-of-year message
  106. ema-pritorPritor
  107. EU/3/14/1345 - orphan designation for treatment of Cushing's syndrome
  108. EMEA-000514-PIP01-08 - paediatric investigation plan
  109. ema-post-assessment-guidancePost-assessment guidance
  110. ema-spor-user-registrationSPOR user registration
  111. cdsco-lnp023gcLNP023gc
  112. Sodium Copper Chlorophyllin
  113. PSUSA/00010288/202311 - periodic safety update report single assessment
  114. EU/3/16/1793 - orphan designation for treatment of facioscapulohumeral muscular dystrophy
  115. Workshop on the therapeutic use of bacteriophages
  116. cdsco-nw-3509aNW-3509A
  117. 2026.01.21 G.S.R. 51(E)_ Draft Notification regarding Blue line on Label of Antimicrobial
  118. ema-nobilis-or-inacNobilis OR Inac
  119. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28…
  120. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30…
  121. Core summary of product characteristics and package leaflet for gadopentetate dimeglumine…
  122. FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain…
  123. cdsco-nova22007NOVA22007
  124. 21 CFR 874.4490: Argon laser for otology, rhinology, and laryngology.
  125. Seresto and its associated name Foresto - referral
  126. 21 CFR 864.7470: Glycosylated hemoglobin assay.
  127. EU/3/16/1703 - orphan designation for treatment of pro-opiomelanocortin deficiency
  128. cdsco-pirfenidonePirfenidone
  129. EU/3/16/1648 - orphan designation for treatment of soft tissue sarcoma
  130. First EMA-Animal Health Europe annual bilateral meeting July 2024
  131. 21 CFR 814.106: HDE amendments and resubmitted HDE's.
  132. 67th meeting of the Committee for Proprietary Medicinal Products (CPMP)
  133. EMEA-002919-PIP02-21 - paediatric investigation plan
  134. ema-karveaKarvea
  135. FDA Officially Recognizes AAMI Sterilization Standards
  136. Notice regarding environmental conditions for equipments
  137. European Medicines Agency update on combined contraceptives
  138. Committee for veterinary medicinal products: Meeting of 12 to 14 November 2002
  139. Dapagliflozin Propanediol eq. to Dapagliflozin + Sitagliptin Phosphate monohydrate IP eq…
  140. 21 CFR 878.4850: Blood lancets.
  141. Risk management requirements for elemental impurities in veterinary medicinal products…
  142. EU/3/10/745 - orphan designation for treatment of multiple myeloma
  143. EU/3/14/1355 - orphan designation for treatment of plasma cell myeloma
  144. GLP-1 medicines for weight loss and diabetes: what you need to know
  145. PSUSA/00009174/201802 - periodic safety update report single assessment
  146. Esbriet - withdrawal of application for variation to marketing authorisation
  147. 21 CFR 872.6475: Heat source for bleaching teeth.
  148. New manufacturing sites and new formulation approved for COVID-19 vaccine from…
  149. Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 February 2020
  150. Revocation of authorisation for sickle cell disease medicine Adakveo
  151. EMEA-000877-PIP03-17-M04 - paediatric investigation plan
  152. EU/3/22/2695 - orphan designation for treatment of sickle cell disease
  153. Medicinal Products (Safety Features on Packaging) Regulations 2019 (SI 36/2019)…
  154. Public Notice regarding Strict regulatory control over manufacture, sale and distribution…
  155. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  156. PSUSA/00002368/202003 - periodic safety update report single assessment
  157. 21 CFR 870.1210: Continuous flush catheter.
  158. EMEA-003043-PIP01-21 - paediatric investigation plan
  159. EU/3/12/1049 - orphan designation for treatment of ovarian cancer
  160. AAMI News, August 2020, Vol.55, No.8
  161. June 16 2015 S.O 1597(E)
  162. The TGA's approach to delays in medical device conformity assessment recertification
  163. 21 CFR 892.1730: Photofluorographic x-ray system.
  164. 2022.09.28_S.O. 4574(E)_Designation of Government Analysts at RDTL Chandigarh as MDTO as…
  165. COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
  166. EU/3/22/2736 - orphan designation for treatment of ornithine transcarbamylase deficiency
  167. Committee for Orphan Medicinal Products (COMP): 7-9 October 2025
  168. 21 CFR 20.117: New drug information.
  169. Tramadol hydrochloride, Paracetamol - paediatric investigation plan
  170. PSUSA/00010209/201502 - periodic safety update report single assessment
  171. COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch…
  172. Life-Threatening Injuries Associated with the ShoulderFlex Massager: FDA Safety…
  173. ema-cat-documentsCAT Documents
  174. Antigenics Therapeutics Limited withdraws its marketing authorisation application for…
  175. EU/3/22/2585 - orphan designation for treatment of erythropoietic protoporphyria
  176. ema-javlorJavlor
  177. European Medicines Agency recommends authorisation of additional vaccine for influenza…
  178. EMEA-002184-PIP01-17-M01 - paediatric investigation plan
  179. ema-legal-noticeLegal notice
  180. ema-fevaxyn-pentofelFevaxyn Pentofel
  181. 21 CFR 892.1720: Mobile x-ray system.
  182. In Memoriam: Mike O’Rear, an ‘Outstanding’ HTM Leader
  183. ema-umbiproUmbipro
  184. EMEA-001862-PIP03-20 - paediatric investigation plan
  185. Linzagolix tablets 100 mg / 200 mg
  186. IPA programme - Introductory meeting
  187. Committee for Proprietary Medicinal Products (CPMP) 45th plenary meeting
  188. cdsco-atr-002ATR-002
  189. European Medicines Agency releases new additional guidance for development of…
  190. Press briefing on the conclusion of the investigation of COVID-19 Vaccine AstraZeneca and…
  191. EU/3/20/2288 - orphan designation for treatment of myelodysplastic syndromes
  192. Molnupiravir Moderateb2
  193. Details of rejected applications of Human Vaccine Manufacturers or Importers (Form…
  194. cdsco-paclitaxelPaclitaxel
  195. EMEA-000814-PIP01-09 - paediatric investigation plan
  196. Measuring blood pressure: top 10 tips
  197. Notices/Circular /Advisory regarding schedule H, H1 C & X
  198. EU/3/24/2958 - orphan designation for treatment of Creutzfeldt-Jakob disease
  199. Portugal to also benefit from EU-US mutual recognition agreement for inspections
  200. Workshop on revising the guideline on strategies to identify and mitigate risks for…
  201. GN-14-R3 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices…
  202. NMPA issued the Announcement on Implementing Electronic Application of Medical Device…
  203. Drug Safety Update: monthly PDF newsletter: Drug Safety Update January 2020
  204. ema-actira-referralActira - referral
  205. Checklist for Form MD-12 MD
  206. Questions and answers on the withdrawal of the note for guidance on single dose toxicity…
  207. EMEA-003269-PIP01-22 - paediatric investigation plan
  208. GMP/GDP Inspections Working Party
  209. EU/3/06/371 - orphan designation for treatment of cystic fibrosis
  210. Barrett Franklin: What’s Your Cornerstone to Success?
  211. Chapter 6 - Ingredient Guidance - Great Britain
  212. Parallel distribution (human medicines) procedures
  213. 2025.01.06_G.S.R. 11(E)_Corrigendum to G.S.R 10(E) dated 04.01.2025 reg Extension of…
  214. EU/3/19/2201 - orphan designation for treatment of C3 glomerulopathy
  215. EU/3/21/2549 - orphan designation for treatment of familial exudative vitreoretinopathy
  216. Non-remunerated and remunerated donors: safety and supply of plasma-derived medicinal…
  217. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9…
  218. April 9,2010(G.S.R_303 E)
  219. EU/3/07/470 - orphan designation for treatment of ornithine-transcarbamylase deficiency
  220. In Memoriam: Mario Castañeda
  221. EMEA-000278-PIP01-08-M01 - paediatric investigation plan
  222. 31st meeting of the committee for veterinary medicinal products
  223. EU/3/21/2542 - orphan designation for treatment of primary IgA nephropathy
  224. 21 CFR 892.1890: Radiographic film illuminator.
  225. Clinical Trials Information System (CTIS) bitesize talk: Requests for information
  226. 21 CFR 884.2660: Fetal ultrasonic monitor and accessories.
  227. ema-revascRevasc
  228. European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 March 2006
  229. NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New…
  230. EU/3/03/141 - orphan designation for treatment of acute myeloid leukaemia
  231. EMEA-001721-PIP01-14 - paediatric investigation plan
  232. Biovigilance responsibilities of sponsors of biologicals
  233. PSUSA/00001491/202301 - periodic safety update report single assessment
  234. Freely Available Sterilization Supplement Gets Second Installment
  235. AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood…
  236. PSUSA/00001104/202209 - periodic safety update report single assessment
  237. Linezolid in combination with Bedaquiline and Pretomanid
  238. ema-crysvitaCrysvita
  239. ema-lunsumioLunsumio
  240. Ultrasound in the Food, Drug, and Device Industries
  241. ema-belviqBelviq
  242. PSUSA/00010881/202106 - periodic safety update report single assessment
  243. Supply shortage of Fabrazyme – updated treatment recommendations required for adult male…
  244. 21 CFR 876.5955: Peritoneo-venous shunt.
  245. NM5072 (Recombinant humanized monoclonal antibody)
  246. Committee for medicinal products for veterinary use: Meeting of 6 to 8 September 2005
  247. mhra-innovation-acceleratorInnovation Accelerator
  248. Clinical investigation of medicinal products in the treatment of depression - Scientific…
  249. EMEA-001855-PIP01-15-M04 - paediatric investigation plan
  250. 21 CFR 1.345: What information must nontransporters establish and maintain to identify the…
  251. Vaccines and Related Biological Products Advisory Committee October 2, 2020 Meeting…
  252. European Medicines Agency workshop on antibacterials
  253. Committee for Medicinal Products for Human Use (CHMP): 16-19 December 2013
  254. Point of care testing: top 10 tips poster: Top 10 tips for point of care testing
  255. PSUSA/00002696/202203 - periodic safety update report single assessment
  256. EMA workshop on the challenges in drug development, regulation and clinical practice in…
  257. Update of AAMI HE75: A Comprehensive Resource Covering Human Factors Engineering for All…
  258. 21 CFR 862.3830: Salicylate test system.
  259. EMEA-002582-PIP02-21 - paediatric investigation plan
  260. EMEA-002933-PIP01-20 - paediatric investigation plan
  261. EMEA-002212-PIP01-17 - paediatric investigation plan
  262. ema-arimidex-referralArimidex - referral
  263. ema-partners-networksPartners & networks
  264. 21 CFR 14.40: Establishment and renewal of advisory committees.
  265. EU/3/05/271 - orphan designation for treatment of visceral leishmaniasis
  266. European Medicines Agency recommends suspension of marketing authorisations for…
  267. ema-rapinyl-referralRapinyl - referral
  268. Inactivated Kyasanur Forest Disease (KFD) Vaccine
  269. Regulatory information - EMA releases practical guidance on access-to-documents requests
  270. EMEA-002535-PIP04-21 - paediatric investigation plan
  271. CVMP strategy on antimicrobials 2021-2025
  272. cdsco-pf-07220060PF-07220060
  273. Paul Kelley: When Brains Collide
  274. ema-fortum-referralFortum - referral
  275. 9th meeting of the Committee for Orphan Medicinal Products
  276. Monitoring of the quality standards of hand sanitizer as per Drugs and Cosmetics Act, 1940…
  277. Vonoprazan Fumarate 20 mg Tablets
  278. NMPA Issues Charging Standards for Drug Registration and Rules for Implementing Drug…
  279. 21 CFR 870.4450: Vascular clamp.
  280. Drug Alert list for month of June 2022
  281. cdsco-scd411-and-eyleaSCD411 And Eylea
  282. EU/3/20/2265 - orphan designation for treatment of acute myeloid leukaemia
  283. PSUSA/00000589/201611 - periodic safety update report single assessment
  284. Management Board meeting: 16-17 March 2011
  285. 21 CFR 872.3850: Gutta percha.
  286. Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good…
  287. 21 CFR 1.1125: What are the internal audit requirements for a recognized accreditation…
  288. Guidance on the Review and Approval of Digital Therapeutics(DTx)(Revision)
  289. Impact of the war in Ukraine on methodological aspects of ongoing clinical trials…
  290. Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting…
  291. cdsco-bhv-7000BHV-7000
  292. PSUSA/00009205/201609 - periodic safety update report single assessment
  293. If a Microbiologically Controlled Product Is Changed Post-Approval, Is the Approval Still…
  294. 21 CFR 17.27: Hearing subpoenas.
  295. 23rd meeting of the committee for veterinary medicinal products
  296. Alendronic Acid / Colecalciferol Mylan
  297. Notice dated 10.12.2014
  298. Warfarin and other anticoagulants - monitoring of patients during the COVID-19 pandemic
  299. EMEA-000718-PIP01-09-M06 - paediatric investigation plan
  300. cdsco-ap063AP063
  301. 21 CFR 12.120: Initial decision.
  302. EMEA-003330-PIP01-22 - paediatric investigation plan
  303. EU/3/10/727 - orphan designation for treatment of retinitis pigmentosa in Usher syndrome…
  304. ema-quality-by-designQuality by design
  305. Annexure Sheet for submit the Application Form(For Stakeholders)
  306. Committee for Medicinal Products for Human Use (CHMP): 17-20 November 2014
  307. Giapreza - direct healthcare professional communication (DHPC)
  308. Mitre Updates Medical Device Cybersecurity Playbook
  309. cdsco-lnp023LNP023
  310. 21 CFR 868.5730: Tracheal tube.
  311. EU/3/20/2248 - orphan designation for treatment of Fabry disease
  312. 21 CFR 864.1850: Dye and chemical solution stains.
  313. EU/3/02/106 - orphan designation for treatment of active ulcerative colitis
  314. Simponi - withdrawal of application for variation to marketing authorisation
  315. EMEA-002826-PIP01-20-M03 - paediatric investigation plan
  316. PSUSA/00010390/201707 - periodic safety update report single assessment
  317. MHRA Windsor Framework Video Explainers
  318. EU/3/24/2910 - orphan designation for treatment of acute myeloid leukaemia
  319. ema-aeriusAerius
  320. 21 CFR 872.3830: Endodontic paper point.
  321. 21 CFR 870.4330: Cardiopulmonary bypass on-line blood gas monitor.
  322. ema-templates-for-assessorsTemplates for assessors
  323. Meeting Notice regarding Meeting of Stakeholders to discuss the matter related to Draft…
  324. ema-trimbowTrimbow
  325. PSUSA/00010007/202307 - periodic safety update report single assessment
  326. February 13.02.2014 G.S.R 86 (E)
  327. 21 CFR 870.3800: Annuloplasty ring.
  328. EU/3/20/2292 - orphan designation for treatment of blastic plasmacytoid dendritic cell…
  329. Voices of Cybersecurity: Shawn Jackman
  330. Latanoprost IP + Netarsudil Mesylate eq. to Netarsudil + Benzalkonium Chloride IP (As…
  331. EMEA-002480-PIP01-18 - paediatric investigation plan
  332. PSUSA/00010815/202307 - periodic safety update report single assessment
  333. Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 18 March…
  334. Q&A: For This Medical Asepsis Expert, It’s Not Just Sterile Product Packaging – It’s…
  335. EMEA-002559-PIP02-19 - paediatric investigation plan
  336. Health Products Regulatory Authority (Fees) Regulations 2023 (SI 697/2023) [Establishment…
  337. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 July 2013
  338. Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on…
  339. Enpr-EMA priority activities
  340. EMEA-002763-PIP01-20 - paediatric investigation plan
  341. 21 CFR 880.6430: Liquid medication dispenser.
  342. EU/3/14/1279 - orphan designation for prevention of scarring post glaucoma filtration…
  343. Direct animal healthcare professional communications
  344. 21 CFR 1.610: Who is eligible to seek recognition?
  345. 21 CFR 886.1425: Lens measuring instrument.
  346. EU/3/22/2709 - orphan designation for treatment of essential thrombocythaemia
  347. Guidance Notes on Retail Supply of Registered Therapeutic Products (Pharmacy Only…
  348. Wireless Smart Bandage Assists in Healing Mice
  349. PSUSA/00001686/201511 - periodic safety update report single assessment
  350. 21 CFR 874.1070: Short increment sensitivity index (SISI) adapter.
  351. 33rd meeting of the committee for veterinary medicinal products
  352. ema-compagel-referralCompagel - referral
  353. EU/3/19/2137 - orphan designation for treatment of severe combined immunodeficiency due to…
  354. European Medicines Agency confirms positive benefit-risk balance of RotaTeq
  355. cdsco-biasp-30BIASP-30
  356. Supplying authorised medicines to Northern Ireland
  357. EMEA-002927-PIP01-20 - paediatric investigation plan
  358. tga-gmp-clearance-guidanceGMP clearance guidance
  359. Developing Guidance for HTM, Then and Now
  360. PSUSA/00002610/202105 - periodic safety update report single assessment
  361. Ebola outbreak: EMA to review experimental medicines to support treatment decisions
  362. 21 CFR 13.30: Proceedings of a Board.
  363. Polmacoxib 2mg + Paracetamol IP 325 mg (Phase III)
  364. 21 CFR 895.102: Powdered surgeon's glove.
  365. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP)…
  366. FDA Updates Premarket Notification Submissions Guidance for Peripheral Atherectomy Devices
  367. EMEA-001444-PIP01-13 - paediatric investigation plan
  368. 21 CFR 807.39: Misbranding by reference to establishment registration or to registration…
  369. European Medicines Agency workshop on multiplicity issues in clinical trials
  370. Special Access Scheme (SAS): Guidance for Sponsors
  371. Medicines for human use under evaluation 2014–2012
  372. ema-spevigoSpevigo
  373. FluticasonePropionate HFA Pressurized Metered Dose Inhaler 110mcg ex-actuator dose…
  374. PSUSA/00000165/201610 - periodic safety update report single assessment
  375. Committee for Proprietary Medicinal Products (CPMP) 53rd plenary meeting
  376. EMEA/H/N/PSR/J/0003 - periodic safety update report single assessment
  377. ema-briliqueBrilique
  378. PSUSA/00000177/201601 - periodic safety update report single assessment
  379. Separate provision for subsequent Importer in Online system for Medical Devices
  380. European Medicines Agency introduces new fee incentives for SMEs for post-authorisation…
  381. Spironolactone Topical Cream 5%
  382. EMEA-002053-PIP01-16 - paediatric investigation plan
  383. Handling of Active Substance Master Files and Certificates of Suitability
  384. Timelines for activities requiring minor and major procedures for cargo clearances at port…
  385. 21 CFR 862.1187: Conjugated sulfolithocholic acid (SLCG) test system.
  386. EMEA-001143-PIP01-11-M04 - paediatric investigation plan
  387. Constitution of In Vitro Diagnostic Device Advisory Committee
  388. ICH Q3C (R9) Residual solvents - Scientific guideline
  389. EMEA-001277-PIP01-12 - paediatric investigation plan
  390. EMEA-000795-PIP01-09-M01 - paediatric investigation plan
  391. EU/3/16/1658 - orphan designation for treatment of retinitis pigmentosa
  392. ema-ramelteonRamelteon
  393. Calcichew D3 mite - referral
  394. Study Finds AI Coughing App May Help Diagnose TB and Monitor its Treatment
  395. ema-triacelluvaxTriacelluvax
  396. EMEA-001212-PIP01-11 - paediatric investigation plan
  397. PSUSA/00010342/202309 - periodic safety update report single assessment
  398. International Cardiac Occluder Standard Is First of Its Kind
  399. EMEA-002400-PIP01-18 - paediatric investigation plan
  400. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26…
  401. Committee for Orphan Medicinal Products (COMP): 22-24 May 2018
  402. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - February 2015
  403. Committee for Medicinal Products for Veterinary Use (CVMP): 17-18 January 2023
  404. EU/3/01/032 - orphan designation for treatment of multiple myeloma
  405. Devices made by Silimed: Latest update: 8 January 2016
  406. Clinical investigation of medicinal products for hormone replacement therapy of oestrogen…
  407. EMEA-001840-PIP01-15 - paediatric investigation plan
  408. cfr-21-cfr-882-1-scope21 CFR 882.1: Scope.
  409. PSUSA/00000262/202311 - periodic safety update report single assessment
  410. EU/3/22/2608 - orphan designation for treatment of inherited retinal dystrophies due to…
  411. cdsco-guselkmabGuselkmab
  412. Sponsor six monthly reporting form
  413. ema-kyntheumKyntheum
  414. ema-okediOkedi
  415. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  416. ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products…
  417. ofatumumab and siponimod versus fingolimod
  418. Office Corrigendum regarding Drugs Inspector's transfers in CDSCO
  419. Principles for the Evaluation of Vaccines Against the Novel Coronavirus…
  420. PSUSA/00000799/201502 - periodic safety update report single assessment
  421. 21 CFR 890.5880: Multi-function physical therapy table.
  422. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg + Lobeglitazone Sulfate…
  423. cdsco-ly3471851LY3471851
  424. MDR_G.S.R.652(E) dt_13.09.2019_Amendment in Form MD-10 to replace the SLA as issuing…
  425. ema-tezspireTezspire
  426. International Coalition of Medicines Regulatory Authorities (ICMRA)
  427. 2023.05.15_S.O. 2191(E)_NIB Government Analyst Notification
  428. ema-incivoIncivo
  429. Practical guidelines relating to non-eCTD electronic submissions - Scientific guideline
  430. FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough…
  431. PSUSA/00010283/201601 - periodic safety update report single assessment
  432. EMEA-002859-PIP01-20 - paediatric investigation plan
  433. Individual case safety report (ICSR) information day
  434. Pioglitazone Hydrochloride IP Eq. to Pioglitazone Dapagliflozin Propanediol Monohydrate…
  435. EMEA-001558-PIP01-13 - paediatric investigation plan
  436. GL-08-R1 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2023 Mar) PUB
  437. PSUSA/00010891/202310 - periodic safety update report single assessment
  438. cfr-21-cfr-17-9-answer21 CFR 17.9: Answer.
  439. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  440. Clinical trials for medicines: labelling
  441. EMEA public statement on Refacto (moroctocog alfa): Introduction of a change to Refacto…
  442. EMA working on COVID-19 during closure on 13 and 14 May 2021
  443. July 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting…
  444. ema-zaltrapZaltrap
  445. cdsco-ianalumab-vay736-gianalumab (VAY736)g
  446. Jinarc recommended for approval in rare kidney disease
  447. ema-fasturtecFasturtec
  448. Revised guideline aims to strengthen global approach to development of new antibacterial…
  449. The bacterial challenge - Time to react a call to narrow the gap between…
  450. Digital application dataset integration (DADI) webinar - common factors in the Fast…
  451. PSUSA/00010280/202002 - periodic safety update report single assessment
  452. Pharmacovigilance Risk Assessment Committee (PRAC): 30 August-2 September 2021
  453. EU/3/10/806 - orphan designation for treatment of progressive non-fluent aphasia
  454. EMEA-000611-PIP01-09 - paediatric investigation plan
  455. EMEA-002539-PIP01-18 - paediatric investigation plan
  456. ema-emendEmend
  457. PSUSA/00010224/202008 - periodic safety update report single assessment
  458. European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars
  459. ema-dukoralDukoral
  460. 21 CFR 890.3480: Powered lower extremity exoskeleton.
  461. Team-NB Position Paper Modifications Sampling Plan V1
  462. EMEA-002531-PIP01-18 - paediatric investigation plan
  463. EU/3/18/2015 - orphan designation for treatment of haemophilia A
  464. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 March 2018
  465. 21 CFR 26.18: Regulatory collaboration.
  466. EU/3/09/725 - orphan designation for treatment of Duchenne muscular dystrophy
  467. PSUSA/00002319/201712 - periodic safety update report single assessment
  468. Amoxicillin Trihydrate IP eq. to Amoxicillin USP 600mg + Potassium Clavulanate diluted IP…
  469. EMEA-000636-PIP01-09-M07 - paediatric investigation plan
  470. Ondexxya - direct healthcare professional communication (DHPC)
  471. 21 CFR 20.115: Product codes for manufacturing or sales dates.
  472. 21 CFR 876.5100: Suprapubic catheter accessories.
  473. cdsco-pembrolizumabPembrolizumab
  474. Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2023
  475. Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine)
  476. 21 CFR 876.5930: Rectal control system.
  477. NMPA Issued Announcement on Five Supplementary Test Methods Including Testing Items for…
  478. Resmetirom tablets 60mg,80mg,100mg
  479. EU/3/01/052 - orphan designation for treatment of hepatocellular carcinoma
  480. ema-suboxoneSuboxone
  481. Vaccines and Related Biological Products Advisory Committee October 5, 2023 Meeting…
  482. PSUSA/00001662/202101 - periodic safety update report single assessment
  483. FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal…
  484. cdsco-zy-19489ZY-19489
  485. The use and regulation of pulse oximeters (information for healthcare professionals)
  486. PSUSA/00010806/202210 - periodic safety update report single assessment
  487. The Top Five Cybersecurity Threats—The Future is Now
  488. EMEA-001538-PIP01-13 - paediatric investigation plan
  489. EU/3/18/2130 - orphan designation for treatment of pulmonary arterial hypertension
  490. Salviae miltiorrhizae radix et rhizoma - herbal medicinal product
  491. Post Approval changes for clinical trials (Form CT-06) for CGTP through SUGAM Online…
  492. EU/3/16/1710 - orphan designation for treatment of McArdle's disease
  493. 21 CFR 892.5840: Radiation therapy simulation system.
  494. Chapter 1.1 - Submission Type Guidance Northern Ireland
  495. 21 CFR 882.1845: Physiological signal conditioner.
  496. EU/3/22/2604 - orphan designation for treatment of primary sclerosing cholangitis
  497. EU/3/14/1304 - orphan designation for treatment myasthenia gravis
  498. EMEA-002097-PIP01-16 - paediatric investigation plan
  499. ema-vimpatVimpat
  500. PSUSA/00002866/201703 - periodic safety update report single assessment
  501. Regulation of tampons in Australia
  502. ema-sprimeoSprimeo
  503. Dydrogesterone Sustained Release Tablet 20mgCT/SND/10/2023
  504. ema-thymanaxThymanax
  505. EMEA-PDA Conference. European GMP: Current issues and future developments
  506. Tysabri - withdrawal of application for variation to marketing authorisation
  507. cdsco-desidustat-zyan1Desidustat ZYAN1
  508. Thymosin Alpha 1 for injection 1.6mg
  509. Regulation on Designation and Operation of Industry Standards Development Cooperation…
  510. Zolsketil pegylated liposomal
  511. ACB meeting statement, Meeting 5, 25 September 2014
  512. PSUSA/00001504/202108 - periodic safety update report single assessment
  513. PSUSA/00010192/201612 - periodic safety update report single assessment
  514. ema-catiolanzeCatiolanze
  515. Pulse Oximeter Accuracy and Limitations: FDA Safety Communication
  516. Committee for Proprietary Medicinal Products (CPMP) 11th plenary meeting
  517. Action in pursuance to the investigation carried out at M/s Nichi-In Centre for…
  518. FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much…
  519. ema-dimethyl-fumarate-mylanDimethyl fumarate Mylan
  520. EU/3/07/465 - orphan designation for treatment of orthostatic hypotension in patients with…
  521. Notice regarding Consideration of the directions of Hon'ble Supreme Court of India in case…
  522. cdsco-oral-galactoseOral Galactose
  523. EU/3/16/1619 - orphan designation for treatment of non-infectious uveitis
  524. Committee for Medicinal Products for Veterinary Use (CVMP): 23-25 May 2018
  525. EU/3/14/1404 - orphan designation for treatment of multiple system atrophy
  526. International Women’s Day 2023: #EmbraceEquity: Barbra Carter, Criminal Enforcement…
  527. Considerations for Non-Clinical Studies in the Development of Diagnostic…
  528. Updated information about the risk of blood clots in women taking birth control pills…
  529. Guideline on conduct of pharmacovigilance for medicines used by the paediatric population
  530. Workshop on demonstrating significant benefit of orphan medicines: concepts, methodology…
  531. ema-comirnatyComirnaty
  532. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
  533. ema-trazimeraTrazimera
  534. EU/3/14/1430 - orphan designation for treatment of congenital factor VII deficiency
  535. Safety communications concerning medicines, medical devices and other healthcare products
  536. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29…
  537. EMEA-000789-PIP01-09 - paediatric investigation plan
  538. ema-dafiroDafiro
  539. ema-imvanexImvanex
  540. PSUSA/00002396/202105 - periodic safety update report single assessment
  541. 21 CFR 872.4600: Intraoral ligature and wire lock.
  542. Template for submission of a request for scientific support and advice on a traditional…
  543. EU/3/08/539 - orphan designation for treatment of Wilson's disease
  544. 21 CFR 74.340: FD&C Red No. 40.
  545. EU/3/02/129 - orphan designation for treatment of pancreatic cancer
  546. 2018-08-27_Draft GSR 813(E)_Amendment of Form 45 & 46 for Package Insert
  547. EMEA-003243-PIP01-22 - paediatric investigation plan
  548. Manufacturers Reinvent Playbook for COVID-19
  549. ema-healthcare-professionalsHealthcare professionals
  550. EMEA-000725-PIP01-09-M03 - paediatric investigation plan
  551. ema-varubyVaruby
  552. NMPA Announcement on Approving the Registration of 139 Medical Devices
  553. Australian Dental Sector Working Group, Meeting statement, Meeting 2, 29 June 2021
  554. ema-qdengaQdenga
  555. Procedure to be followed for regularisation of FDCs declared as rational in respect of 249…
  556. Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02…
  557. 21 CFR 874.4710: Esophagoscope (flexible or rigid) and accessories.
  558. cdsco-spesolimab-i-vspesolimab i.v
  559. 21 CFR 890.5765: Pressure-applying device.
  560. cdsco-noticeNotice
  561. EMEA-002063-PIP01-16-M02 - paediatric investigation plan
  562. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  563. cfr-21-cfr-71-1-petitions21 CFR 71.1: Petitions.
  564. EU/3/01/068 - orphan designation for treatment of multiple myeloma
  565. Refusal of orphan designation for treatment of patent ductus arteriosus in premature…
  566. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10…
  567. PSUSA/00001804/202112 - periodic safety update report single assessment
  568. Advanced therapies: research and development
  569. MHRA fees: Current MHRA fees
  570. Post-Pandemic Telemedicine Use by Veterans Has Dropped in U.S. Rural Regions, Study…
  571. Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer…
  572. Tecentriq - withdrawal of application for variation to marketing authorisation
  573. Atorvastatin Calcium IP eq. to Atorvastatin 10mg/20mg/40mg + Bempedoic Acid…
  574. COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
  575. Survey: Open Positions and Untapped Diversity for HTM
  576. ema-onzealdOnzeald
  577. cdsco-imetelstat-grn163lImetelstat (GRN163L)
  578. PSUSA/00000715/201705 - periodic safety update report single assessment
  579. Development of the Clinical Trials Information System
  580. Guideline on clinical investigation of medicinal products for prevention of venous…
  581. EMEA-001435-PIP02-16-M02 - paediatric investigation plan
  582. Mercaptopurine monohydrate - paediatric investigation plan
  583. Recalls annual report 2019-20
  584. Azelnidipine Telmisartan tablets
  585. 21 CFR 12.78: Unavailability of presiding officer.
  586. NMPA Issued the Notice on Strengthening the Supervision and Inspection of Sterile and…
  587. 21 CFR 882.1580: Non-electroencephalogram (EEG) physiological signal based seizure…
  588. 21 CFR 82.1707: D&C Yellow No. 7.
  589. Committee for Advanced Therapies (CAT): 14-16 May 2025
  590. cdsco-lcz696-on-nt-pro-bnpLCZ696 on NT Pro BNP
  591. Workshop: measuring the impact of pharmacovigilance activities
  592. Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 4) Regulations…
  593. PSUSA/00001879/202008 - periodic safety update report single assessment
  594. PSUSA/00003013/201805 - periodic safety update report single assessment
  595. cdsco-pembrolizumab-bat3306Pembrolizumab (BAT3306)
  596. 21 CFR 884.6150: Assisted reproduction micromanipulators and microinjectors.
  597. New gene therapy for rare inherited disorder causing vision loss recommended for approval
  598. ZRC-NB-3224 (humanized monoclonal antibody (IgG4 k isotype)
  599. EMEA-001779-PIP01-15 - paediatric investigation plan
  600. 21 CFR 868.5655: Portable liquid oxygen unit.
  601. EU/3/00/017 - orphan designation for treatment of acute promyelocytic leukaemia
  602. European Medicines Agency closed 25-26 May 2017
  603. PSUSA/00000560/201601 - periodic safety update report single assessment
  604. In vitro diagnostic point-of-care test devices
  605. cdsco-proxalutamide-gt0918Proxalutamide (GT0918)
  606. cdsco-etrasimod-iqviaEtrasimod( IQVIA)
  607. ema-lamivudine-viivLamivudine ViiV
  608. EU/3/10/808 - orphan designation for treatment of graft-versus-host disease
  609. Committee for Medicinal Products for Human Use (CHMP): 11-14 October 2021
  610. ema-cerdelgaCerdelga
  611. 21 CFR 862.1310: Galactose test system.
  612. Manufacturing and marketing of FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg…
  613. A new role for EMA in monitoring and mitigating critical medical device shortages during…
  614. Publication of Gazette Notification of Drugs Inspectors in CDSCO under Section 21 of Drugs…
  615. Office Memorandum regarding clarification the receipt in G.R6 G.R 7 for payment made…
  616. EMEA-002669-PIP02-20 - paediatric investigation plan
  617. 21 CFR 860.260: Granting or declining a De Novo request.
  618. 21 CFR 872.3060: Noble metal alloy.
  619. Inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO
  620. 21 CFR 878.4780: Powered suction pump.
  621. Paediatric Committee (PDCO): 7-10 November 2023
  622. EMEA-001014-PIP01-10-M01 - paediatric investigation plan
  623. EU/3/16/1726 - orphan designation for treatment of glycogen storage disease type II…
  624. ema-yarvitanYarvitan
  625. ema-temozolomide-accordTemozolomide Accord
  626. EU/3/18/2063 - orphan designation for treatment in solid organ transplantation
  627. EMEA-001479-PIP01-13 - paediatric investigation plan
  628. EMEA-001343-PIP01-12 - paediatric investigation plan
  629. Checklist for Form MD-14 MD
  630. ema-winfuranWinfuran
  631. Emerging medicinal products: from laboratory to patient use
  632. 21 CFR 870.2840: Apex cardiographic transducer.
  633. EMEA-001213-PIP02-12-M02 - paediatric investigation plan
  634. EU/3/12/1092 - orphan designation for treatment of ovarian cancer
  635. Calls for civil society members for two EMA committees
  636. Fifteenth Meeting of the Management Board
  637. Typhoid Conjugate Vaccine (Bivalent)
  638. Kaftrio - opinion on variation to marketing authorisation
  639. ema-deferasirox-accordDeferasirox Accord
  640. Simvastatin Vale - referral
  641. Visit of the Danish Association of the Pharmaceutical Industry
  642. PSUSA-00001457-201708 - periodic safety update report single assessment
  643. Getting Postmarket Surveillance Done Right: A Conversation with Mark Swanson
  644. EU/3/18/2017 - orphan designation for treatment of amyotrophic lateral sclerosis
  645. EMEA-002552-PIP01-19 - paediatric investigation plan
  646. EU/3/12/970 - orphan designation for treatment of amyotrophic lateral sclerosis
  647. surrender RC letter dated 04.08.2025 (M/s. NKG Advisory Business and Consulting Services…
  648. EU/3/10/791 - orphan designation for treatment of moderate and severe closed traumatic…
  649. EU/3/17/1947 - orphan designation for treatment of mitochondrial encephalomyopathy, lactic…
  650. EU/3/21/2462 - orphan designation for treatment of propionic acidaemia
  651. 21 CFR 886.5120: Low-power binocular loupe.
  652. Meeting on redacting commercially confidential information (CCI) in clinical reports and…
  653. New EMEA human medicines units announced
  654. Clinical evidence guidelines: Medical devices
  655. Management Board meeting: 16 March 2017
  656. Medical devices: UK approved bodies: UL International (UK) Ltd In-vitro Diagnostics…
  657. Paediatric Committee (PDCO): 13-16 December 2016
  658. DARWIN EU Advisory Board meeting: 8 September 2022
  659. Compliance Testing of Electronic Products at WEAC (updated 01/01/23)
  660. AAMI Foundation Embarks on New Direction
  661. PSUSA/00001786/201610 - periodic safety update report single assessment
  662. AS F0020.1.001: Special On-Site Assessment Flowchart
  663. cdsco-june-3-2015-gsr-449-eJune 3 2015 GSR 449(E)
  664. PSUSA/00010376/201610 - periodic safety update report single assessment
  665. Biannual Big Data Steering Group and industry stakeholders meeting 2024
  666. Public Notice regarding DCGI meeting with Stakeholders Dated 06.03.2024
  667. European Medicines Agency publishes CVs of experts involved in its activities
  668. PSUSA/00010339/201507 - periodic safety update report single assessment
  669. European Medicines Agency confirms that presence of unexpected viral DNA in live…
  670. cdsco-lopinavir-ritonavirLopinavir/Ritonavir
  671. HTM Education Program Focuses on Device Design
  672. ema-repaglinide-krkaRepaglinide Krka
  673. Identifying research priorities for the study of drug-related progressive multifocal…
  674. PSUSA/00000095/202012 - periodic safety update report single assessment
  675. PSUSA/00009284/202002 - periodic safety update report single assessment
  676. EU/3/00/014 - orphan designation for treatment of primary and of the following forms of…
  677. EMEA-002703-PIP01-19 - paediatric investigation plan
  678. 2024.10.25_G.S.R. 666 (E)_Corrigendum to G.S.R 922(E) dated 28th December, 2023
  679. EU regulators develop recommendations to forecast demand of medicines
  680. P/5/2010 - paediatric investigation plan
  681. Mupirocin 2% w/w Ointment
  682. Requirements for plasma master file certification - Scientific guideline
  683. EMEA-002166-PIP01-17-M07 - paediatric investigation plan
  684. EMEA-001676-PIP01-14-M05 - paediatric investigation plan
  685. 2006 EMEA/EFPIA Workshop on Biomarkers
  686. Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 October 2010
  687. 21 CFR 866.5200: Carbonic anhydrase B and C immunological test system.
  688. PSUSA/00000919/201802 - periodic safety update report single assessment
  689. Guideline on the documentation to be submitted for inclusion into the 'community list of…
  690. EU/3/20/2300 - orphan designation for treatment of non-traumatic subarachnoid haemorrhage
  691. EMEA-003058-PIP01-21 - paediatric investigation plan
  692. European Communities (In Vitro Diagnostic Medical Devices) (Amendment) Regulations 2020…
  693. ARGB Appendix 12 - Guidance on TGO 108: Standard for Human Cell or Tissue Products - Donor…
  694. Infographic: How to access medicinal cannabis
  695. EU/3/17/1962 - orphan designation for treatment of IgG4-related disease
  696. 21 CFR 878.4200: Introduction/drainage catheter and accessories.
  697. Insulin icodec 700 U/ml
  698. AS F0015.1.001: AO Nonconformity Flowchart
  699. EMEA-000737-PIP02-11-M03 - paediatric investigation plan
  700. Interested in joining the Committee for Advanced Therapies (CAT) to represent patients'…
  701. William Hyman: Today’s Challenge? Keeping Track of Bills about Medical Device Regulation
  702. EU/3/07/522 - orphan designation for prevention of oral mucositis in head and neck cancer…
  703. ema-ketoconazole-aid-scfmKetoconazole AID-SCFM
  704. Anthelmintic resistance - Scientific guideline
  705. EU/3/13/1134 - orphan designation for treatment of adenosine-deaminase-deficient severe…
  706. ema-spironolactone-cevaSpironolactone Ceva
  707. Vaccines and Related Biological Products Advisory Committee December 12, 2024 Meeting…
  708. Advice for consumers: e-cigarette Analysis Print
  709. What is the BSI/AAMI International Standards & Regulation Conference About?
  710. EU/3/15/1567 - orphan designation for treatment of blastic plasmacytoid dendritic cell…
  711. EMA closed 15 August 2019
  712. ema-photobarrPhotoBarr
  713. ARGB Appendix 10: Guidance on TGO 105: Standards for faecal microbiota transplant (FMT)…
  714. 21 CFR 870.5175: Septostomy catheter.
  715. ema-pepaxtiPepaxti
  716. Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography: FDA…
  717. cdsco-sb3SB3
  718. AAMI News, June 2021, Vol.56, No.6
  719. DR_G.S.R. 29 (E) dt_17.01.2014_26A_Oxytocin supply to licensed Mfgrers and to Vet…
  720. FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious…
  721. EMA to work with stakeholders to improve the product information for EU medicines
  722. EU/3/14/1356 - orphan designation for treatment of acute myeloid leukaemia
  723. European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment)…
  724. ema-imatinib-actavisImatinib Actavis
  725. Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of…
  726. ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of…
  727. Committee for Advanced Therapies (CAT): 15-16 October 2015
  728. PSUSA/00000227/201505 - periodic safety update report single assessment
  729. Focus on Service and Repairs: CMS, FCC Push for Permanent Telehealth Expansions
  730. Committee for Orphan Medicinal Products (COMP): 13-15 February 2018
  731. EU/3/21/2405 - orphan designation for treatment of gastric cancer
  732. 21 CFR 872.5560: Electrical salivary stimulatory system.
  733. EU/3/16/1721 - orphan designation for prevention of graft loss in pancreatic islet…
  734. EMEA-002075-PIP01-16-M03 - paediatric investigation plan
  735. 21 CFR 1.352: What information must transporters establish and maintain?
  736. Guidance on Performance Evaluation on In Vitro Diagnostic Medical Devices
  737. Medical devices: ask for a regulatory advice meeting from the MHRA
  738. Guidance document on Medical Device Software under MDR-2017
  739. Supplementary Explanation on Points to Consider for Preparing Biological Diversity Risk…
  740. cfr-21-cfr-73-300-carrot-oil21 CFR 73.300: Carrot oil.
  741. PSUSA/00003168/201902 - periodic safety update report single assessment
  742. PSUSA/00001392/201708 - periodic safety update report single assessment
  743. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March…
  744. Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 March 2013
  745. Management Board meeting: 6 October 2011
  746. ema-dimethyl-fumarate-accordDimethyl fumarate Accord
  747. EU/3/15/1532 - orphan designation for treatment of short bowel syndrome
  748. EMEA-003358-PIP01-22 - paediatric investigation plan
  749. EMEA-002496-PIP01-18 - paediatric investigation plan
  750. 21 CFR 882.5360: Cranioplasty plate fastener.
  751. EU/3/16/1644 - orphan designation for prevention of cytomegalovirus disease
  752. PSUSA/00001505/202004 - periodic safety update report single assessment
  753. PSUSA/00001658/202311 - periodic safety update report single assessment
  754. Expansion of testing of IVDs for Clinical Chemistry reagents/Kits at NIB Noida under the…
  755. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  756. PRO feedback form Internal and Pro feedback form External
  757. FDA Drug Safety Communication: FDA limits packaging for anti-diarrhea medicine Loperamide…
  758. (Appendix 14) The Standards Marketing Approval of Athlete’s Foot and Ringworm Remedies
  759. PSUSA/00010396/201704 - periodic safety update report single assessment
  760. Insert - Adverse Reaction Reporting for Natural Health Products
  761. cdsco-bi-764198BI 764198
  762. Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021
  763. Regulations for Reporting Serious Adverse Events of Medical Devices
  764. EU/3/11/903 - orphan designation for prevention of oral mucositis in head and neck cancer…
  765. EMEA-001016-PIP01-10-M01 - paediatric investigation plan
  766. Opal HTM Selected for mHUB MedTech Accelerator Program
  767. EMEA-002935-PIP01-20-M03 - paediatric investigation plan
  768. 21 CFR 25.51: Environmental assessments and findings of no significant impact.
  769. Glimepiride IP + Metformin Hydrochloride IP (as extended release) + Sitagliptin Phosphate…
  770. PSUSA/00001259/201610 - periodic safety update report single assessment
  771. Four-week limit for use of high-strength estradiol creams
  772. Herbal medicinal products: questions and answers
  773. 21 CFR 3.5: Procedures for identifying the designated agency component.
  774. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 December 2014
  775. Annual report highlights progress in science, medicines and health in 2023
  776. EMEA-002583-PIP01-19 - paediatric investigation plan
  777. EU/3/19/2231 - orphan designation for treatment of amyotrophic lateral sclerosis
  778. ema-locametzLocametz
  779. EU/3/21/2522 - orphan designation for treatment of complex regional pain syndrome
  780. 21 CFR 862.1145: Calcium test system.
  781. PSUSA/00010502/201807 - periodic safety update report single assessment
  782. EU/3/08/607 - orphan designation for treatment of systemic sclerosis
  783. EU/3/23/2770 - orphan designation for treatment of fragile X syndrome
  784. Product Management Service (PMS) Product UI training (access & navigation)
  785. 2022.09.28_S.O. 4573(E)_Notification for designation of RDTL Chandigarh also as CMDTL as…
  786. Comments invited on good-pharmacovigilance-practice module on reporting of adverse…
  787. BE1040V INJECTION 400 MG / 16ML
  788. Quality assessors training
  789. EMEA-002526-PIP02-19 - paediatric investigation plan
  790. ema-libertekLibertek
  791. ICH M2 Electronic common technical document (eCTD) - Scientific guideline
  792. Committee for Herbal Medicinal Products (HMPC): 6-7 July 2015
  793. Unapproved New Drugs (Marketed, Human, Prescription Drugs only) (PDF - 52KB)
  794. PSUSA/00010361/201805 - periodic safety update report single assessment
  795. MDR_G.S.R. 318(E) dt_18.04.2019_Amendment in Rule 91 & Second Schedule for fees of free…
  796. EU/3/16/1772 - orphan designation for treatment of Crigler-Najjar syndrome
  797. Quality: specifications, analytical procedures and analytical validation
  798. EMEA-000368-PIP01-08 - paediatric investigation plan
  799. 2024.12.30_S.O. 5633(E)_Notification regarding Banning Nimesulide for animal use
  800. EMEA-001342-PIP01-12 - paediatric investigation plan
  801. Development and manufacture of human medicinal products specifically designed for phage…
  802. Fast track routes for medicines that address unmet medical needs
  803. EU/3/04/234 - orphan designation for treatment of pulmonary arterial hypertension and…
  804. Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices
  805. Speeding up development of Ebola treatments and vaccines
  806. EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
  807. EO Sterilization: FDA and Industry Weigh the Future
  808. Committee for Advanced Therapies (CAT): 14-16 July 2021
  809. Public Information Cell
  810. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  811. Cyberattack on EMA - update 5
  812. Tanaceti parthenii herba - herbal medicinal product
  813. AAMI News, April 2022, Vol.57, No.4
  814. ema-tafinlarTafinlar
  815. EMEA-003187-PIP01-22 - paediatric investigation plan
  816. 21 CFR 892.5650: Manual radionuclide applicator system.
  817. The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or…
  818. Students in Standards? A Valuable Contribution to Upcoming Cloud Computing Report
  819. Substance, product, organisation and referential (SPOR) master data
  820. AS F0014.1.001: Special Documentary Assessment Flowchart
  821. POZELIMAB AND CEMDISIRAN
  822. EMEA-002037-PIP01-16 - paediatric investigation plan
  823. POSTPONED: October 7, 2020 Circulatory System Devices Panel of the Medical Devices…
  824. EMEA-002707-PIP01-19-M01 - paediatric investigation plan
  825. cdsco-omalizumab-150-mg-mlOmalizumab 150 mg/ml
  826. EU/3/14/1336 - orphan designation for treatment of Leigh syndrome
  827. Notice dated 08.07.2013:- Revision of CDSCO Guidance for industry for biological products…
  828. EMEA-001428-PIP03-15-M02 - paediatric investigation plan
  829. EMEA-003149-PIP01-21-M01 - paediatric investigation plan
  830. 21 CFR 70.11: Related substances.
  831. Saxagliptin + Dapagliflozin Film coated tablets (Phase IV)
  832. EU-eIFU-NBMed-Position-Statement-NBMed-April-17-2013
  833. Zolvix - withdrawal of application for variation to marketing authorisation
  834. GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (18Sep-pub)
  835. cdsco-fitusiraFitusira
  836. 21 CFR 882.5891: Transcutaneous electrical nerve stimulator to treat headache.
  837. Guidance on Patient-matched Medical Devices manufactured using 3D printers
  838. Rare Disease Day: 28 February 2011
  839. Vildagliptin + Pioglitazone Hcl IP eq. Pioglitazone uncoated tablet (Phase III)
  840. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23…
  841. EU/3/21/2482 - orphan designation for treatment of GM2 gangliosidosis
  842. Clinical requirements for non replacement therapy in haemophilia A and B - Scientific…
  843. Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 June 2012
  844. ema-management-boardManagement Board
  845. Amendment to Provisions for In Vitro Diagnostic Reagent Registration (Decree No. 30 of…
  846. Medicine labels: Guidance on TGO 91 and TGO 92
  847. Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of…
  848. Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices…
  849. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  850. 21 CFR 882.4600: Leukotome.
  851. EU/3/19/2196 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  852. ema-cefuroximaxetil-referralCefuroximaxetil - referral
  853. EU/3/21/2512 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's…
  854. ema-celldemicCelldemic
  855. SAMR Issued the Provisions for Registration and Notification of Cosmetics
  856. 21 CFR 862.1200: Corticosterone test system.
  857. EU/3/15/1537 - orphan designation for treatment of congenital adrenal hyperplasia
  858. Combination Products: A Growing Trend in Health Technology
  859. EU/3/04/209 - orphan designation for prevention of graft rejection after lung…
  860. Qtern - withdrawal of application for variation to marketing authorisation
  861. ema-kapruviaKapruvia
  862. Action Plan for Medical Devices - Progress Report Card: June 2021
  863. PSUSA/00001780/201701 - periodic safety update report single assessment
  864. FDA Drug Safety Communication: FDA review finds additional data supports the potential for…
  865. DR_G.S.R. 499(E) dt_14.08.1998_26A_reg Mepacrine HCl and Fenfuramine & Dexfenfluramine
  866. ema-upkanzUpkanz
  867. ema-horstemHorStem
  868. PSUSA/00000625/202204 - periodic safety update report single assessment
  869. Notice dated 12.05.2016 regarding FDC Court cases pending before the Delhi High Court…
  870. EU/3/04/206 - orphan designation for treatment of osteosarcoma
  871. ema-information-systemsInformation systems
  872. Innovators Sought for Technologies to Improve Pediatric Mental Health
  873. 21 CFR 862.2850: Atomic absorption spectrophotometer for clinical use.
  874. PSUSA/00001781/202301 - periodic safety update report single assessment
  875. Public statement on Parecoxib Sodium (Dynastat/Rayzon/Xapit) on the risk of serious…
  876. Development of a guideline on preparation of herbal teas - Scientific guideline
  877. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  878. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  879. cdsco-hrf-10071-tabHRF-10071 tab
  880. EMEA-003251-PIP01-22 - paediatric investigation plan
  881. Managing medical devices
  882. EU/3/15/1512 - orphan designation for treatment of avian influenza
  883. European Medicines Agency publishes minutes of CHMP, CVMP and CAT meetings for the first…
  884. ema-lipitor-referralLipitor - referral
  885. November 8 2016 GSR 1050(E)
  886. cdsco-pf-07321332PF-07321332
  887. Committee for Medicinal Products for Human Use (CHMP): 21-24 September 2015
  888. 28th meeting of the Committee for Orphan Medicinal Products
  889. 2022.05.23_Draft GSR 383(E)_Proviso to Sr.no 39 in Sch K for Liquid Antiseptics in Drugs…
  890. 21 CFR 876.5250: Urine collector and accessories.
  891. Efficiency in Field Repair with Live Video Support
  892. 21 CFR 868.5760: Cuff spreader.
  893. EU/3/02/097 - orphan designation for treatment of renal-cell carcinoma
  894. Management Board meeting: 7 October 2010
  895. DR_G.S.R. 76(E) dt_08.02.2012_Amendment in Rule 127_Addition of Titanium Dioxide coated…
  896. EU/3/16/1728 - orphan designation for treatment of graft-versus-host disease
  897. Sitagliptin phosphate monohydrate, metformin hydrochloride - paediatric investigation plan
  898. 12th pharmacovigilance stakeholder forum
  899. EMEA-003049-PIP01-21 - paediatric investigation plan
  900. Isotretinoin: an expert review of suspected psychiatric and sexual side effects
  901. 2015 Forum on bioequivalence inspections
  902. EU/3/11/911 - orphan designation for treatment of globoid cell leukodystrophy (Krabbe…
  903. June 8, 2023: Meeting of the Antimicrobial Drugs Advisory Committee Meeting Announcement…
  904. Mock-ups for veterinary medicines
  905. Press briefing on EU recommendation for COVID-19 Vaccine AstraZeneca
  906. European Medicines Agency simplifies processing of fee reductions for orphan medicines
  907. Pimavenserin Capsules 34 mg
  908. Krka, d.d., Novo mesto withdraws its marketing authorisation application for Desloratadine…
  909. PSUSA/00000062/202208 - periodic safety update report single assessment
  910. Management Board meeting: 13 March 2025
  911. EU/3/22/2645 - orphan designation for treatment of invasive aspergillosis
  912. 21 CFR 866.6020: Immunomagnetic circulating cancer cell selection and enumeration system.
  913. Mammography Quality Standards Act Auditor's Guide
  914. ema-eliquisEliquis
  915. EU/3/11/857 - orphan designation for treatment of transthyretin-mediated amyloidosis
  916. PSUSA/00010333/201911 - periodic safety update report single assessment
  917. European Union (EU) International Organisation for Standardization (ISO) for…
  918. 25th meeting of the Committee for Orphan Medicinal Products
  919. 21 CFR 2.10: Examination and investigation samples.
  920. Notice regarding List of medical devices testing Laboratory
  921. 21 CFR 807.95: Confidentiality of information.
  922. EU/3/15/1503 - orphan designation for prevention of bronchopulmonary dysplasia
  923. eCTD AU module 1 and regional information
  924. Oportuzumab monatox DLRC Pharma Services
  925. PSUSA/00002392/202308 - periodic safety update report single assessment
  926. Terbutaline - New warnings against use of terbutaline to treat preterm labor
  927. ema-ibranceIbrance
  928. Committee for Proprietary Medicinal Products (CPMP): meeting of 13 to 15 November 2001
  929. EMEA-001450-PIP01-13-M01 - paediatric investigation plan
  930. Workshop on endpoints for cystic fibrosis clinical trials
  931. Medical Device Quality Management System Regulations, Annex.pdf
  932. HTM Pros, Help Us Perfect Your Documentation
  933. Webinar presentation: GMP overview and an update on PIC/S guide to GMP for medicinal…
  934. cdsco-ifetroban-injectionIfetroban Injection
  935. ema-leponex-referralLeponex - referral
  936. 21 CFR 890.5900: Power traction equipment.
  937. Guidance for manufacturer's declaration of conformity for system or procedure packs
  938. Guidance on Drug-Agnostic Companion Diagnostics
  939. Tribuli terrestris herba - herbal medicinal product
  940. ema-xtandiXtandi
  941. EU/3/10/818 - orphan designation for treatment of citrullinaemia type 1
  942. Drug Alert list for month of April 2019
  943. ema-oxyglobinOxyglobin
  944. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  945. AAMI Seeks 2022 Nominations for Awards Programs
  946. EMEA releases guidelines on development of medicines for Alzheimer's disease and…
  947. EU/3/07/450 - orphan designation for treatment of osteosarcoma
  948. Release of consignments of Vaccine and critical IVDs-certain instructions issued
  949. Rilvegostomig (AZD2936)n
  950. Types of application (legal basis)
  951. EMEA-002564-PIP01-19 - paediatric investigation plan
  952. EMEA-002940-PIP01-20 - paediatric investigation plan
  953. Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs…
  954. Committee for Orphan Medicinal Products (COMP): 11-12 March 2014
  955. EMEA-001078-PIP01-10 - paediatric investigation plan
  956. EMEA-001821-PIP01-15-M07 - paediatric investigation plan
  957. Promoting high quality scientific research in paediatric medicines
  958. PSUSA/00010364/201703 - periodic safety update report single assessment
  959. AAMI COVID-19 Resources and Updates
  960. Meeting of the EMEA working party on herbal medicinal products 3 - 4 November 2003
  961. Drugs Alert for the Month of May 2014
  962. EU/3/15/1580 - orphan designation for treatment of neuroblastoma
  963. Call for all sponsors to publish clinical trial results in EU database
  964. mhra-regulatoryconnectRegulatoryConnect
  965. New recommendations to strengthen supply chains of critical medicines
  966. EU/3/20/2323 - orphan designation for treatment of mucopolysaccharidosis type III…
  967. Notice Consideration of the direction of Hon'ble Supreme Court of India in the case of 294…
  968. FDA warns about serious problems with high doses of the allergy medicine diphenhydramine…
  969. PSUSA/00010289/201802 - periodic safety update report single assessment
  970. ema-ituxrediItuxredi
  971. New Standard for Alternate Equipment Management (AEM)
  972. EU/3/12/1013 - orphan designation for treatment of progressive multifocal…
  973. EU/3/11/914 - orphan designation for treatment of amyotrophic lateral sclerosis
  974. PSUSA/00009277/201603 - periodic safety update report single assessment
  975. EMEA-003071-PIP01-21 - paediatric investigation plan
  976. EU/3/07/483 - orphan designation for treatment of acute myeloid leukaemia
  977. PSUSA/00002695/201507 - periodic safety update report single assessment
  978. PSUSA/00002026/201711 - periodic safety update report single assessment
  979. EU/3/02/104 - orphan designation for treatment of visceral leishmaniasis
  980. 2018.11.29_ Draft G.S.R. 1152(E)_Amendment in Part X B Part XII B pertains to Blood centre…
  981. Combination: Species diureticae - herbal medicinal product
  982. 21 CFR 1.1455: How must records required by this subpart be maintained and made available?
  983. ema-avinew-referralAvinew - referral
  984. ema-trilocurTrilocur
  985. 11th meeting of the Committee for Orphan Medicinal Products
  986. PSUSA/00001584/202002 - periodic safety update report single assessment
  987. EU/3/15/1530 - orphan designation for treatment of craniopharyngioma
  988. cdsco-insulinglargineInsulinGlargine
  989. Merck KGaA withdraws its application for an extension of the indication for Erbitux…
  990. Public Health alert against the use of unauthorised Cosmetics Products
  991. European Union International Organization for Standardization (ISO) for the identification…
  992. 21 CFR 21.72: Individual consent to disclosure of records to other persons.
  993. EU/3/16/1662 - orphan designation for treatment of amyotrophic lateral sclerosis

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