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Global regulations and guidance

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

  1. 21 CFR 73.2400: Pyrophyllite.
  2. Drugs Alert for the month of February 2014
  3. 2021.10.27_Draft GSR 767(E) to amend rule 2 to substitute cell or stem cell derived…
  4. Committee for Advanced Therapies (CAT): 15-16 September 2011
  5. Appendix 18 Confirmation of Quality Dossiers with Reference Agency's Approval
  6. Committee for Advanced Therapies – focus on incentives for SMEs and strengthened…
  7. EU/3/18/2095 - orphan designation for treatment of multiple system atrophy
  8. EMEA-003217-PIP01-22 - paediatric investigation plan
  9. EMEA-001329-PIP02-13 - paediatric investigation plan
  10. Plant testing strategy in the risk assessment for veterinary medicinal products…
  11. Consultation: Draft Documents for Post-Market Reporting Compliance (PMRC) Inspection…
  12. ema-raltegravir-viatrisRaltegravir Viatris
  13. Authorised Prescriber Scheme online system guidance
  14. European Medicines Agency finds no signal for decreased effectiveness of HBVAXPRO and…
  15. INFAI withdraws its marketing authorisation application for Gastromotal
  16. Update on Information on Convalescent Plasma in COVID-19
  17. Accelerated assessment fast-tracks Lenvima to benefit patients with thyroid cancer
  18. PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
  19. Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety…
  20. Pirfenidone - paediatric investigation plan
  21. ICH Q2(R2) Validation of analytical procedures - Scientific guideline
  22. 21 CFR 874.5800: External nasal splint.
  23. European Medicines Agency: Committee for Medicinal Products for Human Use, 22-23 June 2004
  24. EMEA-001032-PIP03-19 - paediatric investigation plan
  25. EU Ombudsman confirms EMA's correct handling of declared interests
  26. EU/3/24/2912 - orphan designation for treatment of congenital pseudarthrosis of long bones
  27. EU/3/23/2834 - orphan designation for treatment of pancreatic cancer
  28. Pharmacokinetics of Remdesivir
  29. Drug Alert list for month of September 2016
  30. ema-insulin-human-winthropInsulin Human Winthrop
  31. Grant of manufacturing licences for human vaccines sera Form 28D Form 28DA and endorsement…
  32. 21 CFR 880.6885: Liquid chemical sterilants/high level disinfectants.
  33. PSUSA/00001469/201705 - periodic safety update report single assessment
  34. EU/3/11/889 - orphan designation for treatment of acute lymphoblastic leukaemia
  35. EMA survey on initial marketing authorisation application 2016
  36. ema-imatinib-tevaImatinib Teva
  37. EU/3/20/2267 - orphan designation for treatment of progressive familial intrahepatic…
  38. EU/3/21/2521 - orphan designation for treatment in solid organ transplantation
  39. Advertising guidance for providers of disease education activities
  40. ema-norditropin-referralNorditropin - referral
  41. Monitoring of COVID-19 medicines
  42. ema-cevazuril-referralCevazuril - referral
  43. EMEA-001902-PIP01-15-M04 - paediatric investigation plan
  44. Ulipristal Acetate Gedeon Richter
  45. 21 CFR 822.37: Under what circumstances would you inspect records identifying subjects?
  46. EU/3/12/1005 - orphan designation for treatment of autosomal recessive congenital…
  47. cfr-21-cfr-874-1-scope21 CFR 874.1: Scope.
  48. 2009 EMEA-IFAH-Europe info day
  49. ema-eksunbiEksunbi
  50. Public consultation on key principles for the electronic product information of EU…
  51. First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
  52. Cyberattack on EMA - update 3
  53. 21 CFR 886.1330: Amsler grid.
  54. ema-emerfluEmerflu
  55. ema-olanzapine-glenmarkOlanzapine Glenmark
  56. EU/3/21/2492 - orphan designation for treatment of NGLY1 deficiency
  57. AU P0028.003 Threat to Impartiality
  58. 21 CFR 868.5710: Electrically powered oxygen tent.
  59. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - August 2016
  60. FDA adds warning about rare occurrence of serious liver injury with use of Veozah…
  61. PSUSA/00000414/201901 - periodic safety update report single assessment
  62. 21 CFR 890.3450: Upper extremity prosthesis including a simultaneously powered elbow…
  63. EMA issues advice on use of regdanvimab for treating COVID-19
  64. Orphan drug and paediatric clinical trials - EMEA workshop on methodological aspects of…
  65. DARWIN EU Advisory Board meeting: 16 February 2022
  66. GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the…
  67. COVID-19 test approval: how to apply
  68. Abacavir - Safety Review update of Abacavir and possible increased risk of heart attack
  69. EMA marks European Antibiotic Awareness Day
  70. EMEA-002554-PIP02-19 - paediatric investigation plan
  71. 21 CFR 820.60: Identification.
  72. EudraVigilance training on electronic reporting of Individual Case Safety Reports in the…
  73. Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents
  74. ema-tritace-referralTritace - referral
  75. Regulatory Science to 2025 – launch of six-month public consultation
  76. European Medicines Agency veterinary medicines innovation day
  77. European Medicines Agency recommends approval of first-in-class treatment for metastatic…
  78. Committee for Advanced Therapies (CAT): 18-20 January 2023
  79. PSUSA/00000008/201805 - periodic safety update report single assessment
  80. Paediatric Committee (PDCO): 14-16 September 2016
  81. Risk and regulatory assessment of lactose and other products prepared using calf rennet…
  82. Webinar presentation: Clean room requirements for biologicals
  83. EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside…
  84. Increasing the availability of veterinary medicines
  85. July Revised Drugs Alert List 2023
  86. ema-octegra-referralOctegra - referral
  87. 21 CFR 890.3910: Wheelchair accessory.
  88. EMEA-000846-PIP01-10-M01 - paediatric investigation plan
  89. Committee for paediatric medicinal products - towards more and better information on the…
  90. Iclusig - withdrawal of application for variation to marketing authorisation
  91. 21 CFR 882.5950: Neurovascular embolization device.
  92. 21 CFR 872.6855: Manual toothbrush.
  93. Priority access for children during Myozyme supply shortage
  94. cdsco-20152015
  95. ema-docetaxel-tevaDocetaxel Teva
  96. Confidentiality arrangement between the EU and the Republic of Korea
  97. PSUSA/00010385/201807 - periodic safety update report single assessment
  98. EU/3/19/2161 - orphan designation for treatment of epidermolysis bullosa
  99. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14…
  100. Being an Expert Witness for Medical Device Cases
  101. Agency internal and external IT systems offline from 26 November 1800 UK time to 29…
  102. Anastrozole - paediatric investigation plan
  103. EMEA-000829-PIP01-09 - paediatric investigation plan
  104. EU/3/12/960 - orphan designation for treatment of congenital hyperinsulinism
  105. Valsartan: review of impurities extended to other sartan medicines
  106. ema-rituximab-mabionRituximab Mabion
  107. 21 CFR 876.1520: Gastrointestinal lesion software detection system.
  108. EMEA-000665-PIP01-09 - paediatric investigation plan
  109. EMEA-000496-PIP01-08-M08 - paediatric investigation plan
  110. Updated measures for pregnancy prevention during retinoid use
  111. 21 CFR 1.1108: When and how will FDA issue a directed food laboratory order?
  112. 2011 European Medicines Agency/IFAH-Europe Info Day
  113. EMEA-002900-PIP01-20-M01 - paediatric investigation plan
  114. EU/3/17/1965 - orphan designation for treatment of Duchenne muscular dystrophy
  115. Committee for Medicinal Products for Veterinary Use re-elects Dr Anja Holm as chair
  116. EU/3/02/095 - orphan designation for treatment of renal-cell carcinoma
  117. ema-chanholdChanhold
  118. ema-nN
  119. 21 CFR 73.185: Haematococcus algae meal.
  120. INOmax - direct healthcare professional communication (DHPC)
  121. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27…
  122. EMEA-002873-PIP01-20 - paediatric investigation plan
  123. Assessment templates and guidance
  124. ema-biologics-working-partyBiologics Working Party
  125. PSUSA/00000431/202109 - periodic safety update report single assessment
  126. cdsco-hd204-to-avastinHD204 to Avastin®
  127. Explanatory note on the withdrawal of the note for guidance on harmonisation of…
  128. Guideline on quality, non-clinical and clinical requirements for investigational advanced…
  129. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 July 2015
  130. EU/3/10/789 - orphan designation for treatment of medulloblastoma
  131. ema-masitinib-ab-scienceMasitinib AB Science
  132. Bed-related Entrapment and Fall Report Form
  133. cdsco-marzeptacog-alfaeMarzeptacog alfae
  134. Retail Food Protection - State
  135. Estradiol valerate / Dienogest - paediatric investigation plan
  136. Revision and Release of the Good Manufacturing Practice for Medical Devices
  137. cdsco-octafibrin-gct-64-14Octafibrin GCT/64/14
  138. 21 CFR 890.5100: Immersion hydrobath.
  139. EU/3/12/953 - orphan designation for treatment of West syndrome
  140. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 December 2014
  141. Guide for Online Registration System for Medical Devices
  142. Data privacy in the age of big data
  143. EMEA-002011-PIP01-16 - paediatric investigation plan
  144. How tests and testing kits for coronavirus (COVID-19) work: Target Product Profile: Rapid…
  145. EU/3/10/815 - orphan designation for treatment of postcardiotomy right ventricular failure
  146. Ken Fuchs: Tackling the Wireless Challenge
  147. cdsco-grc-17536GRC 17536
  148. 21 CFR 1.1335: What records must I keep when I am the first land-based receiver of a food…
  149. ema-safety-working-partySafety Working Party
  150. FDA Releases Draft Guidance on Expanded Use of Remote Regulatory Assessments
  151. fda-safety-summaries-nitinolNitinol
  152. MEDICAL DEVICES RULES, 2017
  153. World Hepatitis Day: 28 July 2013
  154. EMEA-001996-PIP02-16-M01 - paediatric investigation plan
  155. ema-remicadeRemicade
  156. Buvidal - withdrawal of application for variation to marketing authorisation
  157. EMEA-000905-PIP01-10 - paediatric investigation plan
  158. EMA recommends suspension of medicines over flawed studies at Semler Research Centre
  159. EU/3/18/2129 - orphan designation for treatment of glycogen storage disease type II…
  160. Candesartan/Hydrochlorothiazide - paediatric investigation plan
  161. EU/3/14/1364 - orphan designation for treatment of glioma
  162. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  163. Thank you for submitting your request
  164. Summary of product characteristics for antiparasitic veterinary medicinal products…
  165. Committee for medicinal products for veterinary use: Meeting of 15 to 17 June 2004
  166. mhra-ai-airlock-backgroundAI Airlock Background
  167. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018
  168. EMEA-000986-PIP01-10 - paediatric investigation plan
  169. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance scientific…
  170. Concept paper on medicines to prevent HIV infection released for public consultation
  171. PSUSA/00000018/201712 - periodic safety update report single assessment
  172. cdsco-nrc-1111NRC-1111
  173. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using…
  174. PSUSA/00002780/202103 - periodic safety update report single assessment
  175. EU/3/10/740 - orphan designation for treatment of multiple myeloma
  176. Chapter 4 - Nicotine Dose Guidance - Great Britain: Chapter 4 - Nicotine Dose Guidance…
  177. Office Memorandum regarding Rotational Transfer of CDSCO
  178. Committee for Herbal Medicinal Products (HMPC): 23-25 January 2023
  179. ema-nexpovioNexpovio
  180. ema-vyduraVydura
  181. Clinical development of medicinal products for the treatment of autism spectrum disorder…
  182. EMA recommends avoidance of certain hepatitis C medicines and amiodarone together
  183. EU/3/08/566 - orphan designation for treatment of cystic fibrosis
  184. Progress in science, medicine and health
  185. Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for…
  186. ema-xiliarxXiliarx
  187. EMEA-002519-PIP02-18 - paediatric investigation plan
  188. EMEA-002264-PIP01-17 - paediatric investigation plan
  189. Hyaluronic Acid (HA)
  190. EMEA-002696-PIP02-21 - paediatric investigation plan
  191. EMEA-002904-PIP01-20 - paediatric investigation plan
  192. ema-tulavenTulaven
  193. cdsco-secukinumab-cosentyxsecukinumab (Cosentyx)
  194. EMEA-002713-PIP02-21 - paediatric investigation plan
  195. Guidance for Declaration of Conformity Procedures
  196. EMEA-000576-PIP03-12-M06 - paediatric investigation plan
  197. Implantable Left Ventricular Assist System Approved for Marketing
  198. PSUSA/00002157/201512 - periodic safety update report single assessment
  199. Clinical trials for medicines: collection, verification and reporting of safety events
  200. Erdafitinib 3 mg, 4 mg and 5 mg tablets
  201. cdsco-gsk2831781GSK2831781
  202. cdsco-ljn452LJN452
  203. PSUSA/00003043/202308 - periodic safety update report single assessment
  204. Paediatric Committee (PDCO): 20-22 May 2015
  205. PSUSA/00010771/202012 - periodic safety update report single assessment
  206. EU/3/09/701 - orphan designation for treatment of perinatal asphyxia
  207. Notice regarding not attending SEC Meeting
  208. Thank You to Our 2023 BI&T Reviewers
  209. EMEA-001462-PIP01-13 - paediatric investigation plan
  210. EMEA-000019-PIP11-14 - paediatric investigation plan
  211. 21 CFR 868.1500: Enflurane gas analyzer.
  212. PRAC updates on the risks of serious vascular occlusive events associated with cancer…
  213. Webinar presentation: Remote Inspections from TGA Manufacturing Quality Perspective
  214. ema-tarcevaTarceva
  215. PSUSA/00010012/201504 - periodic safety update report single assessment
  216. 3D printing (additive manufacturing) of medical devices or component parts during the…
  217. Reflection paper on use of real-world data in non-interventional studies to generate…
  218. Authorisation of veterinary medicinal products containing (potential) persistent…
  219. EMEA-002997-PIP01-21 - paediatric investigation plan
  220. DR_G.S.R. 418(E) dt_30.05.2011_26A_reh Human Placental Extracts (HPE)
  221. Meeting conducted by Indian Society for Clinical Research at FDA Bhawan, CDSCO, Kotla…
  222. Drug Safety Update: monthly PDF newsletter: Drug Safety Update September 2021
  223. EU/3/15/1508 - orphan designation for treatment of very long-chain acyl-CoA dehydrogenase…
  224. Admissibility to travel by Tejas Express, Vande Bharat Express & Humsafar Express trains…
  225. ema-uzpruvoUzpruvo
  226. cdsco-zybk2ZYBK2
  227. EMEA-002359-PIP01-18-M05 - paediatric investigation plan
  228. In vitro diagnostic medical devices: guidance on legislation
  229. EU/3/05/339 - orphan designation for treatment of chronic myeloid leukaemia
  230. Good manufacturing practice and good distribution practice
  231. EU/3/15/1571 - orphan designation for treatment of acute lymphoblastic leukaemia
  232. Sideritis herba - herbal medicinal product
  233. 21 CFR 870.3260: Vena cava clip.
  234. EMEA-000942-PIP01-10 - paediatric investigation plan
  235. Procedural information – EMA goes electronic for PDCO opinions and subsequent EMA…
  236. Pediatric Advisory Committee Meeting Announcement - 07/09/2025
  237. cfr-21-cfr-892-1-scope21 CFR 892.1: Scope.
  238. EU recommendations for 2022-2023 seasonal flu vaccine composition
  239. EU/3/10/835 - orphan designation for treatment of multiple myeloma
  240. Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices
  241. Selection of test materials for genotoxicity testing for traditional herbal medicinal…
  242. PSUSA/00010814/202202 - periodic safety update report single assessment
  243. 21 CFR 862.1430: 17-Ketosteroids test system.
  244. Second tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches…
  245. EMEA-000015-PIP01-07-M04 - paediatric investigation plan
  246. Revised PIC/S Scheme
  247. 21 CFR 890.3880: Special grade wheelchair.
  248. PCR Kits approved for testing of Covid-19 as on 25.01.2023
  249. cdsco-levonadifloxacinnLevonadifloxacinn
  250. EU/3/18/2127 - orphan designation for treatment of perinatal asphyxia
  251. Declaration of storage conditions: 1. in the product information of pharmaceutical…
  252. Clinical data for two more medicines now available online
  253. 21 CFR 866.5420: Alpha-1-glycoproteins immunological test system.
  254. PSUSA/00002905/201504 - periodic safety update report single assessment
  255. 21 CFR 4.4: How can I comply with these current good manufacturing practice requirements…
  256. PSUSA/00010005/201702 - periodic safety update report single assessment
  257. European Medicines Agency provides plan to help deal with manufacturing-related medicine…
  258. EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6…
  259. PSUSA/00000911/202303 - periodic safety update report single assessment
  260. 21 CFR 60.32: Applicant response to petition.
  261. ema-levetiracetam-hospiraLevetiracetam Hospira
  262. Human variations electronic application form (eAF) Q&A clinics – session 6
  263. Recombinant Human Albumin 20% (r-DNA origin)
  264. EU/3/20/2305 - orphan designation for treatment of myelodysplastic syndromes
  265. EU/3/13/1219 - orphan designation for treatment of Dravet syndrome
  266. Brochure for Korean Medical Device(English Version)
  267. 21 CFR 14.65: Public inquiries and requests for advisory committee records.
  268. Oenotherae oleum - herbal medicinal product
  269. Committee for Advanced Therapies (CAT): 17-19 April 2024
  270. EMEA-002681-PIP01-19-M01 - paediatric investigation plan
  271. Progress update on pilot for academic and non-profit developers of advanced therapy…
  272. ema-zycortalZycortal
  273. EU/3/08/610 - orphan designation for treatment of medullary thyroid carcinoma
  274. European Medicines Agency to review the safety of somatropin-containing medicines
  275. Flebogamma DIF (previously Flebogammadif)
  276. Committee on Advanced Therapies (CAT) celebrates its first birthday
  277. cdsco-myl-1701p-and-eyleaMYL-1701P and Eylea
  278. ema-rare-disease-day-2015Rare Disease Day 2015
  279. 21 CFR 878.9: Limitations of exemptions from section 510(k) of the Federal Food, Drug, and…
  280. 21 CFR 864.8150: Calibrator for cell indices.
  281. 21 CFR 862.1118: Biotinidase test system.
  282. European Medicines Agency/International Federation for Animal Health Europe info day 2016
  283. ema-oO
  284. ema-fingolimod-accordFingolimod Accord
  285. Goodbye 2023: when optimism came back
  286. Clindamycin Phosphate IP 1.2%w/w eq. to Clindamycin 1%w/w + Hydrous Benzoyl Peroxide IP…
  287. PSUSA/00010443/201606 - periodic safety update report single assessment
  288. Sixth Nitrosamine Implementation Oversight Group (NIOG) meeting
  289. New recommendations for terlipressin-containing medicines in the treatment of hepatorenal…
  290. Insulin Glargine Injection
  291. Guidance on the Implementation of the Ministerial Ordinance on the Good Laboratory…
  292. ema-xoterna-breezhalerXoterna Breezhaler
  293. EU/3/20/2266 - orphan designation for treatment of ovarian cancer
  294. Committee for Advanced Therapies (CAT): 10-11 November 2011
  295. Committee for Orphan Medicinal Products (COMP): 19-21 April 2016
  296. Examples of hand sanitisers/surgical hand disinfectant approved by CDSCO including the WHO…
  297. 21 CFR 812.2: Applicability.
  298. EU/3/17/1963 - orphan designation for treatment of LIPIN1 disease
  299. PSUSA/00003023/202207 - periodic safety update report single assessment
  300. Rabitec - opinion on variation to marketing authorisation
  301. Workshop on development pathways for advanced-therapy medicinal products
  302. PSUSA/00001826/202305 - periodic safety update report single assessment
  303. EMEA-000687-PIP01-09-M02 - paediatric investigation plan
  304. Equine Covid-19 Antiserum
  305. 2026.02.18 S.O. 912(E)_Notification of Medical Device Testing Officers (MDTO) for…
  306. Committee for Medicinal Products for Human Use (CHMP): 21-24 May 2012
  307. EU/3/07/461 - orphan designation for treatment of ligneous conjunctivitis
  308. cdsco-imm-101IMM-101
  309. AMENDMENT OF NOTICE: March 1, 2018 - Neurological Devices Panel of the Medical Devices…
  310. cdsco-sar443122SAR443122
  311. Statement on the outcome of the UK referendum
  312. EMEA-001384-PIP02-17 - paediatric investigation plan
  313. Committee for Herbal Medicinal Products (HMPC): 06-08 July 2020
  314. EMEA-001238-PIP02-20 - paediatric investigation plan
  315. cdsco-bi-1291583BI 1291583
  316. Sisymbrii officinalis herba - herbal medicinal product
  317. Summary Report of the Post-Market Reporting Compliance Inspections Conducted from…
  318. Similar biological medicinal products - Scientific guideline
  319. ema-eE
  320. EU/3/14/1376 - orphan designation for treatment of Niemann-Pick's disease, type C
  321. EU/3/07/457 - orphan designation for treatment of aspiration pneumonitis requiring…
  322. aami-in-memoriam-pat-lynchIn Memoriam: Pat Lynch
  323. EU/3/04/255 - orphan designation for treatment of small cell lung cancer
  324. Bisoprolol Fumarate IP + Telmisartan IP film coated bilayered tablet (Phase III)
  325. First cases of BSE in USA and Canada: risk assessment of ruminant materials originating…
  326. EU/3/22/2617 - orphan designation for treatment of hyper IgM syndromes
  327. ema-linguistic-review-humanLinguistic review - Human
  328. Joint EMA / European Directorate for the Quality of Medicines and Healthcare (EDQM) event…
  329. 21 CFR 862.1255: 2,3-Diphosphoglyceric acid test system.
  330. Committee for Orphan Medicinal Products (COMP): 6-7 November 2012
  331. ARGB Appendix 7 - Guidance on TGO 84
  332. European Medicines Agency increases public information on conflicts of interest of experts…
  333. EMEA-001884-PIP02-15 - paediatric investigation plan
  334. cdsco-hp-hmg-and-menopurHP-hMG and Menopur®
  335. Paediatric Committee (PDCO): 18-21 May 2021
  336. Committee for Orphan Medicinal Products (COMP): 11-13 May 2026
  337. 21 CFR 884.1630: Colposcope.
  338. ema-voncentoVoncento
  339. Xigris [drotrecogin alfa (activated)] - Voluntary market withdrawal of Xigris [drotrecogin…
  340. 21 CFR 892.1200: Emission computed tomography system.
  341. Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT)…
  342. EMEA-001170-PIP01-11 - paediatric investigation plan
  343. EU/3/20/2313 - orphan designation for diagnosis of progressive supranuclear palsy
  344. 2024.08.12__DR_S.O. 3285(E) to 3440(E)_ Prohibition of 156 FDCs
  345. cdsco-dapagliflozinDapagliflozin
  346. Drug Safety Update: monthly PDF newsletter: Drug Safety Update October 2019
  347. Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing…
  348. FDA investigating rare brain infection in patient taking Gilenya (fingolimod)
  349. Committee for Advanced Therapies (CAT): 11-13 May 2022
  350. cfr-21-cfr-810-1-scope21 CFR 810.1: Scope.
  351. Dengue Chkngunya IgM Elisa
  352. IT systems temporarily unavailable from 31 December 2020 to 1 January 2021
  353. ema-pradaxaPradaxa
  354. EU/3/22/2722 - orphan designation for treatment of hereditary angioedema
  355. Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2021
  356. PSUSA/00002024/201510 - periodic safety update report single assessment
  357. EMEA-002022-PIP01-16 - paediatric investigation plan
  358. EU/3/21/2502 - orphan designation for treatment of small cell lung cancer
  359. EU/3/13/1207 - orphan designation for treatment of ovarian cancer
  360. Precautionary marketing suspension of thalassaemia medicine Zynteglo
  361. PSUSA/00010392/201605 - periodic safety update report single assessment
  362. European Medicines Agency invites expressions of interest for ophthalmology workshop
  363. PSUSA/00010484/201811 - periodic safety update report single assessment
  364. 21 CFR 878.4750: Implantable staple.
  365. 21 CFR 20.31: Retention schedule of requests for Food and Drug Administration records.
  366. Conversations on Cancer presents “Living with Metastatic Breast Cancer”
  367. EU/3/16/1785 - orphan designation for treatment of sudden sensorineural hearing loss
  368. Management Board meeting: 16 December 2010
  369. Lidocain/Prilocain Idetec and associated names - referral
  370. PSUSA/00010290/201801 - periodic safety update report single assessment
  371. 2018 Annual Report for Medical Device Registration Released
  372. 21 CFR 862.1356: Interoperable automated glycemic controller.
  373. Everolimus product-specific bioequivalence guidance
  374. Insmed withdraws its marketing authorisation application for IPLEX
  375. Innovation to Market — Insights from Developing a Class 1 Med Device
  376. ema-rocephin-referralRocephin - referral
  377. cdsco-aro-apoc3ARO-APOC3
  378. Focus group meeting on the revision of the CVMP guideline for the demonstration of…
  379. EMEA-002819-PIP01-20-M01 - paediatric investigation plan
  380. EU/3/21/2454 - orphan designation for treatment of achondroplasia
  381. AAMI Honors Standards Developers, Committees, and Sterilization Professionals
  382. EMEA-001148-PIP01-11 - paediatric investigation plan
  383. NMPA Announcement on Issuing the Classification Rules and Classification Catalogue of…
  384. Committee for Proprietary Medicinal Products (CPMP) 38th plenary meeting
  385. Rambis and associated names - referral
  386. Adenovirus-mediated Herpes simplex virus-thymidine kinase gene - paediatric investigation…
  387. Committee for medicinal products for veterinary use: Meeting of 8 to 10 February 2005
  388. Classification of Medical Device pertaining to Oncology under the provisions of Medical…
  389. Concept paper on the revision of the COVID-19 vaccines guidance documents
  390. EU/3/18/2132 - orphan designation for treatment of beta thalassaemia intermedia and major
  391. World Mental Health Day: 10 October 2012
  392. EU/3/13/1100 - orphan designation for treatment of amyloid light-chain amyloidosis
  393. New treatment option for rare inflammatory disease
  394. Use of Clinical Trials Information System becomes mandatory for new clinical trial…
  395. EU/3/17/1868 - orphan designation for treatment of fragile X syndrome
  396. Updated list of laboratories for conducting Performance evaluation of IVD reagents kits…
  397. EMEA-001397-PIP04-17-M01 - paediatric investigation plan
  398. cdsco-dupilumab-150-mg-mlDupilumab 150 mg/mL
  399. European Medicines Agency's Management Board endorses revised EMA code of conduct
  400. EMA recommends new safety measures for Zydelig
  401. Notice Evaluation of Certain pre 1988 permitted FDC de novo for manufacture of Sale in the…
  402. 21 CFR 886.5850: Sunglasses (nonprescription).
  403. PSUSA/00001744/202303 - periodic safety update report single assessment
  404. 21 CFR 876.5220: Colonic irrigation system.
  405. EMEA-000463-PIP01-08-M03 - paediatric investigation plan
  406. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 12-14 June 2012
  407. ema-pregabalin-sandoz-gmbhPregabalin Sandoz GmbH
  408. Revised guideline on clinical studies for Alzheimer's disease medicines
  409. ema-eudravigilanceEudraVigilance
  410. POSTPONED - Vaccines and Related Biological Products Advisory Committee May 16, 2024…
  411. PSUSA/00001629/201905 - periodic safety update report single assessment
  412. ICH Q4B Annex 6 Uniformity of dosage unites general chapter - Scientific guideline
  413. PSUSA/00010475/201907 - periodic safety update report single assessment
  414. Sales of antibiotics for use in food-producing animals drop across the EU
  415. EMEA-003160-PIP01-21 - paediatric investigation plan
  416. European Medicines Agency closed 23 December 2013 to 2 January 2014
  417. EMEA-002679-PIP01-19 - paediatric investigation plan
  418. Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid…
  419. Training and resources for patients and consumers
  420. EMEA-000410-PIP01-08-M04 - paediatric investigation plan
  421. EU/3/07/477 - orphan designation for treatment of hepatocellular carcinoma
  422. PSUSA/00010291/201706 - periodic safety update report single assessment
  423. Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the…
  424. Visci albi herba - herbal medicinal product
  425. STATE NSQ ALERT FOR THE MONTH OF June 2025
  426. ema-canileishCaniLeish
  427. 21 CFR 868.5090: Emergency airway needle.
  428. 21 CFR 878.5080: Air-handling apparatus accessory.
  429. ema-zactranZactran
  430. EMEA-002709-PIP01-19-M01 - paediatric investigation plan
  431. 21 CFR 874.5350: Suction antichoke device.
  432. Building a Rural Community Pipeline for HTM, Michigan 'Made it Work'
  433. cdsco-abemaciclibAbemaciclib
  434. cfr-21-cfr-878-4440-eye-pad21 CFR 878.4440: Eye pad.
  435. PSUSA/00003141/202201 - periodic safety update report single assessment
  436. EMEA/H/N/PSR/J/0015 - periodic safety update report single assessment
  437. EMEA-003353-PIP01-22 - paediatric investigation plan
  438. PSUSA/00000477/201503 - periodic safety update report single assessment
  439. Pandemic influenza: news archive
  440. EU/3/15/1439 - orphan designation for treatment of cytomegalovirus infection following…
  441. AAMI News, March 2022, Vol.57, No.3
  442. Bibrocathol 2% Eye ointment
  443. Focus on Service and Repairs: Device Servicing Collaborative Community Moves Forward
  444. cdsco-semaglutide-2-4-mgSemaglutide 2.4 mg
  445. EMA Management Board: highlights of March 2016 meeting
  446. 21 CFR 862.1440: Lactate dehydrogenase test system.
  447. Good Laboratory Practice Program (Nonclinical Laboratories) EPA Data Audit Inspections
  448. ema-ovugelOvuGel
  449. FDA requires label changes to warn of risk for possibly permanent nerve damage from…
  450. EMEA-003191-PIP01-22 - paediatric investigation plan
  451. EU/3/12/1036 - orphan designation for treatment of familial chylomicronaemia syndrome…
  452. European Medicines Agency (EMA) Human Scientific Committees' Working Parties with…
  453. EU actions to support availability of medicines during COVID-19 pandemic – update #3
  454. Guidelines relevant for advanced therapy medicinal products
  455. ema-livtencityLivtencity
  456. 2018.07.30_Draft_GSR 720(E)_Inclusion of Form 39A_Report of test or analysis by approved…
  457. Medicines: register to manufacture, import or distribute active substances
  458. EMEA-001377-PIP01-12 - paediatric investigation plan
  459. Prohibits to manufacture, sale and distribution and use of drug Nimesulide and its…
  460. Pneumococcal Polysaccharide Conjugate Vaccine I.P. (PCV13-TT
  461. EMA and Australian regulator strengthen collaboration in the area of orphan medicines
  462. Ondexxya - direct healthcare professional communication (DHPC)
  463. ema-verkaziaVerkazia
  464. EMEA-001523-PIP05-19-M01 - paediatric investigation plan
  465. Update on review of recalled valsartan medicines: preliminary assessment of possible risk…
  466. ema-luniviaLunivia
  467. Third international awareness session on science and regulation for animal health and…
  468. Committee for Advanced Therapies (CAT): 9-11 January 2013
  469. Retinoid-containing medicinal products - referral
  470. Focus on Human Factors: For Medical Devices, Human Factors Matter
  471. Notice to Stakeholders - Amended Food and Drugs Regulations for Active Ingredients…
  472. cdsco-adalimumabAdalimumab
  473. cdsco-noticeNotice
  474. ema-orbax-referralOrbax - referral
  475. EU/3/12/1011 - orphan designation for treatment of sickle cell disease
  476. Risk management plans for medicines and biologicals
  477. PSUSA/00010525/201710 - periodic safety update report single assessment
  478. Inosine Pranobex 500mg/1000 mg Tablets
  479. EU/3/21/2474 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  480. Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety…
  481. Problems with Surgical Tables? Try These Troubleshooting Tips
  482. Provisional registration extension and transition to full registration
  483. European Medicines Agency publishes active substance list with lead Member State…
  484. 2026.03.02 G.S.R. 165(E)_Inclusion of Qualifications of Inspector Medical Devices and…
  485. EMEA-003157-PIP01-21 - paediatric investigation plan
  486. Committee for Orphan Medicinal Products (COMP): 16-18 June 2015
  487. Clinical investigation of medicinal products for treatment of migraine - Scientific…
  488. EMEA-000910-PIP01-10 - paediatric investigation plan
  489. cdsco-lorlatinib-pf-06463922Lorlatinib (PF-06463922)
  490. FDA Clearance for Device that Can Help Detect Autism in Babies and Toddlers
  491. Raising awareness of the perils of antimicrobial resistance
  492. Head of International Affairs, Emer Cooke, to leave European Medicines Agency
  493. Molnupiravir Moderatepure
  494. Kenneth Maddock: Managing Your Perspective
  495. European Medicines Agency website unavailable Saturday 4 May
  496. EMEA-000439-PIP02-11 - paediatric investigation plan
  497. EU/3/10/729 - orphan designation for treatment of acute myeloid leukaemia
  498. cdsco-selexipagnselexipagn
  499. PSUSA/00000313/202011 - periodic safety update report single assessment
  500. Regulatory information – adjusted fees for applications to EMA from 1 April 2018
  501. 21 CFR 895.101: Prosthetic hair fibers.
  502. （In Japanese）Ministerial Ordinance on Good Clinical Practice for Medical Devices
  503. EudraVigilance training on the electronic reporting of individual case safety reports…
  504. ema-calquenceCalquence
  505. EU/3/20/2295 - orphan designation for diagnosis of insulinoma
  506. PSUSA/00001970/201602 - periodic safety update report single assessment
  507. EMEA-003090-PIP02-22 - paediatric investigation plan
  508. Committee for Medicinal Products for Veterinary Use (CVMP): 19-20 January 2021
  509. Risk-Adapted Approach to clinical trials and Risk Assessments: Example 2: Type A Protocol…
  510. European Medicines Agency reminds companies about arrangements before and during Olympic…
  511. Oral almitrine to be withdrawn by EU Member States
  512. Vaccines and Related Biological Products Advisory Committee September 30, 2021 Meeting…
  513. EMEA-000110-PIP01-07 - paediatric investigation plan
  514. Metformin Hydrochloride IP (as extended release) + Dapagliflozin + Teneligliptin…
  515. Notice- Inviting, any objections / suggestion on the Draft Rules as New Drugs and Clinical…
  516. EMEA-002981-PIP01-21 - paediatric investigation plan
  517. PRAC recommends that fusafungine nose and mouth sprays are no longer marketed
  518. ema-imagifyImagify
  519. First European Medicines Agency (EMA) and IPFA – PPTA bilateral meeting
  520. EMA establishes task force to take quick and coordinated regulatory action related to…
  521. David Murphy elected new Chair of EMA Committee for Medicinal Products for Veterinary Use…
  522. Advice for Retailers and Producers: Advice for retailers of e-cigarettes and…
  523. Fluocinolone acetonide intravitreal
  524. 21 CFR 26.33: Product coverage.
  525. March 2, 2022: Device Good Manufacturing Practice Advisory Committee Meeting Announcement…
  526. PSUSA/00002425/201709 - periodic safety update report single assessment
  527. 21 CFR 1.241: What are the consequences of failing to register, update, renew, or cancel…
  528. European Medicines Agency recommends approval of first higher-strength insulin for…
  529. PSUSA/00002102/202105 - periodic safety update report single assessment
  530. Paediatric Committee (PDCO): 25-28 June 2024
  531. NSQ ALERT FOR THE MONTH OF JUlY-2024
  532. Pesticides and Industrial Chemicals in Domestic and Imported Foods
  533. ema-recocamRecocam
  534. EMEA/H/N/PSR/0001 - periodic safety update report single assessment
  535. Pharmacovigilance Risk Assessment Committee (PRAC): 19-20 July 2012
  536. Zanidatamab (ZW25 and JZP598)
  537. EU/3/22/2739 - orphan designation for treatment of Duchenne muscular dystrophy
  538. ema-zoledronic-acid-actavisZoledronic acid Actavis
  539. PSUSA/00001151/201503 - periodic safety update report single assessment
  540. EMEA-001217-PIP01-11-M08 - paediatric investigation plan
  541. Union Product Database – Product grouping and 3rd country product names Webinar for UPD…
  542. 21 CFR 882.1200: Two-point discriminator.
  543. Blue Guide: advertising and promoting medicines: Appendix 3 - Blue Guide
  544. NSQ May 2024 CDSCO Labs
  545. EMEA-001090-PIP01-11 - paediatric investigation plan
  546. cdsco-fluocinoloneFluocinolone
  547. EMEA-000454-PIP01-08-M07 - paediatric investigation plan
  548. 21 CFR 878.4490: Absorbable hemostatic agent and dressing.
  549. European Medicines Agency veterinary medicines info day
  550. Imported Electronic Product
  551. ema-bovelaBovela
  552. cdsco-vis649VIS649
  553. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.4) Regulations…
  554. PSUSA/00001777/201802 - periodic safety update report single assessment
  555. Exempt autologous human cells and tissues
  556. 21 CFR 800.20: Patient examination gloves and surgeons' gloves; sample plans and test…
  557. Feed Contaminants Program (withdrawn, pending revision)
  558. Notice regarding Approval of FDCs Containing new drugs
  559. 21 CFR 872.3910: Backing and facing for an artificial tooth.
  560. 21 CFR 872.3310: Coating material for resin fillings.
  561. Linezolid (Zyvox) - Updated information about the drug interaction between linezolid…
  562. PSUSA/00001694/202003 - periodic safety update report single assessment
  563. EU/3/07/462 - orphan designation for treatment of idiopathic thrombocytopenic purpura
  564. 21 CFR 878.4430: Microneedling device for aesthetic use.
  565. First oncolytic immunotherapy medicine recommended for approval
  566. 21 CFR 866.5570: Lactoferrin immunological test system.
  567. 18th meeting of the committee for veterinary medicinal products
  568. EMEA-001032-PIP01-10-M05 - paediatric investigation plan
  569. Fifth industry stakeholder platform on research and development support
  570. tga-evidence-guidelinesEvidence guidelines
  571. cfr-21-cfr-868-1-scope21 CFR 868.1: Scope.
  572. PCR Kits approved for testing of Covid-19 as on 09.12.2021
  573. Procurement activities 2021
  574. 21 CFR 878.4025: Silicone sheeting.
  575. Insulin Degludec versus insulin glargine
  576. EU/3/11/887 - orphan designation for treatment of post-essential thrombocythaemia…
  577. EMEA-001270-PIP01-12-M06 - paediatric investigation plan
  578. EMA's Head of Human Medicines Development and Evaluation Patrick Le Courtois retires after…
  579. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  580. EMEA-000482-PIP01-08-M06 - paediatric investigation plan
  581. Regulations on Unique Device Identification Management, Etc.
  582. Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS #37 ACCS…
  583. PSUSA/00001696/202311 - periodic safety update report single assessment
  584. 21 CFR 878.4020: Occlusive wound dressing.
  585. Data on medicines (ISO IDMP standards): post-authorisation
  586. cdsco-azelnidipine-tab-16-mgAzelnidipine tab 16 mg
  587. Priyanka Upendra: Incident Response and Forensics for Connected Medical Devices
  588. cdsco-epx-100EPX-100
  589. DR_G.S.R. 651(E) dt_09.09.2009_Amendment Rule 3A_CDTL, chennai notified for Condoms
  590. EMEA-002124-PIP01-17 - paediatric investigation plan
  591. PSUSA/00001321/201710 - periodic safety update report single assessment
  592. In vitro diagnostic medical devices: procurement, safety, quality and performance…
  593. EMEA-001964-PIP02-19 - paediatric investigation plan
  594. ema-metacamMetacam
  595. 21 CFR 862.1605: Pregnanediol test system.
  596. Pharmacovigilance fees payable to the European Medicines Agency
  597. Refusal of orphan designation for treatment of intracerebral haemorrhage
  598. cdsco-bi-1015550BI 1015550
  599. Trastuzumab Deruxtecan (T-DXd; DS-8201a) Lyophilized Powder for concentrate for solution…
  600. Empagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin…
  601. Product-specific bioequivalence guidance
  602. Over 1000 SMEs now registered with European Medicines Agency SME office
  603. European Immunization Week 2022: Statement by Executive Director Emer Cooke - Why vaccines…
  604. Involvement of children and young people at the Paediatric Committee - Scientific…
  605. What’s this “Chevron Decision?” An HTM Perspective
  606. EU/3/09/656 - orphan designation for treatment of diffuse large B-cell lymphoma
  607. cdsco-liraglutideLiraglutide
  608. 21 CFR 73.70: Calcium carbonate.
  609. cfr-21-cfr-1-73-food21 CFR 1.73: Food.
  610. ema-vistideVistide
  611. ema-lojuxtaLojuxta
  612. cdsco-aur108AUR108
  613. cfr-21-cfr-1-3-definitions21 CFR 1.3: Definitions.
  614. Ground Fault Circuit Interrupter
  615. Committee for Advanced Therapies (CAT): 19-21 June 2013
  616. New guidance to speed up development of antibiotics
  617. EMEA-001944-PIP01-16-M03 - paediatric investigation plan
  618. Use of pleuromutilins in food-producing animals in the European Union: development of…
  619. ema-sliwensSliwens
  620. ema-vivanzaVivanza
  621. PSUSA/00010390/201607 - periodic safety update report single assessment
  622. ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic…
  623. With Healthcare 'Under Constant Cyberattack,' HHS Releases Guidance
  624. Classification of active medical devices (including software-based medical devices)
  625. 21 CFR 862.1610: Pregnanetriol test system.
  626. EU/3/19/2192 - orphan designation for treatment of Bardet-Biedl syndrome
  627. FAQS ON IMPLEMENTATION OF GSR 823(E) DATED 17TH NOVEMBER, 2022 WITH RESPECT TO BAR CODE OR…
  628. August 20 2015 GSR 648(E)
  629. AAMI Standards Monitor Digest: February 2020
  630. ema-theryttrexTheryttrex
  631. FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam…
  632. cdsco-sisunatovirSisunatovir
  633. ema-helixate-nexgenHelixate NexGen
  634. Sodium zirconium cyclosilicate (SZC)
  635. Coronary Artery CT Fractional Flow Reserve Calculation Software approved for marketing
  636. EU/3/16/1737 - orphan designation for treatment of osteomyelitis
  637. EU/3/16/1683 - orphan designation for treatment of neonatal sepsis
  638. EMEA-001234-PIP01-11 - paediatric investigation plan
  639. ema-vuewayVueway
  640. Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19…
  641. Stryker Neptune Waste Management Systems: Updated FDA Safety Communication
  642. Medical Device Quality Management System Regulations
  643. EU/3/22/2574 - orphan designation for treatment of pyridoxamine 5'-phosphate oxidase…
  644. cfr-21-cfr-54-2-definitions21 CFR 54.2: Definitions.
  645. PSUSA/00001821/201605 - periodic safety update report single assessment
  646. Notice dated 7.07.2014 Hearing for redressal of Public Grievance
  647. AAMI Releases Guide for HTM Department Financials
  648. EU/3/18/1988 - orphan designation for treatment of cystic fibrosis
  649. ema-zikaZika
  650. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  651. EU/3/12/1066 - orphan designation for treatment of senile systemic amyloidosis
  652. 21 CFR 872.5570: Intraoral devices for snoring and intraoral devices for snoring and…
  653. Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018
  654. 21 CFR 862.1530: Plasma oncometry test system.
  655. EMEA-000559-PIP01-09-M04 - paediatric investigation plan
  656. 21 CFR 868.1760: Volume plethysmograph.
  657. cdsco-july-17-2012-gsr-574-eJuly 17, 2012 (GSR 574(E))
  658. Handling of Medical Device Software
  659. 21 CFR 866.5890: Inter-alpha trypsin inhibitor immunological test system.
  660. EMEA-001561-PIP01-13-M02 - paediatric investigation plan
  661. 21 CFR 80.34: Authority to refuse certification service.
  662. PSUSA/00002125/202008 - periodic safety update report single assessment
  663. Dydrogesterone Extended Release Tablet 20 mgM
  664. EU/3/00/013 - orphan designation for treatment of Huntington’s disease
  665. 21 CFR 814.40: Time frames for reviewing a PMA.
  666. Clinical Trials Regulations webinar recordings
  667. PSUSA/00001362/202307 - periodic safety update report single assessment
  668. EU/3/15/1509 - orphan designation for treatment of spinal muscular atrophy
  669. National Annual Report for Medical Device Adverse Event Monitoring (2020)
  670. EU/3/05/264 - orphan designation for treatment of 5q spinal muscular atrophy
  671. Prevenar 20 (previously Apexxnar)
  672. EMEA-001167-PIP02-11-M01 - paediatric investigation plan
  673. Committee for medicinal products for veterinary use: Meeting of 13-15 October 2009
  674. 21 CFR 26.19: Information relating to quality aspects.
  675. Toolbox guidance on scientific elements and regulatory tools to support quality data…
  676. March 6, 2017: Pediatric Advisory Committee Meeting Announcement - 03/06/2017
  677. ema-budesonide-sun-referralBudesonide SUN - referral
  678. EU/3/16/1663 - orphan designation for treatment of interstitial cystitis
  679. ema-pomalidomide-zentivaPomalidomide Zentiva
  680. EMEA-002735-PIP01-19-M01 - paediatric investigation plan
  681. EU/3/11/946 - orphan designation for prevention of ischaemia/reperfusion injury associated…
  682. Scientific guidelines for limited market products deemed not eligible for authorisation…
  683. Not of standard quality alert for the month of April – 2024
  684. NMPA Issued 3 Guidelines for Technical Review of the Registration of Synthetic Resin Teeth…
  685. NMPA Announcement on Issuing the List of Medical and Pharmaceutical Journals Approved to…
  686. PSUSA/00001213/202301 - periodic safety update report single assessment
  687. DR_G.S.R. 408 (E) dt_26.04.2018_amendment of Rule 96, Rule 97 , Sch H & Sch K
  688. 21 CFR 866.6050: Ovarian adnexal mass assessment score test system.
  689. ema-zarzioZarzio
  690. Fifth EMA workshop for SMEs "Regulatory considerations in initiating clinical trials"
  691. EU/3/18/2009 - orphan designation for treatment of ovarian cancer
  692. Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc…
  693. Verbasci flos - herbal medicinal product
  694. Post market review compliance dashboard
  695. 21 CFR 82.203: FD&C Green No. 3.
  696. Insulin Human 30/70 Mix Marvel
  697. FDA, VHA Team Up to Make Public ‘Recipes’ for Devices in Short Supply When Emergencies…
  698. cdsco-baricitinib-sleBaricitinib SLE
  699. Schering-Plough Europe withdraws its marketing authorisation applicationfor Garenoxacin…
  700. cdsco-dienogest-ph-ivDienogest (Ph IV)
  701. Adjustment for cross-over in estimating effects in oncology trials - Scientific guideline
  702. ema-efmodyEfmody
  703. ema-coversyl-referralCoversyl - referral
  704. Centrally Authorised Products (CAPs) Bridging Mechanism
  705. Adjusol trimethoprim sulfa liquide and its associated names - referral
  706. Reducing the use of antimicrobial agents in animal husbandry
  707. European Medicines Agency launches new e-learning course for Article 57(2) requirements on…
  708. November 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee…
  709. Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)
  710. 21 CFR 60.22: Regulatory review period determinations.
  711. Introduction to the Poisons Standard
  712. A practical approach to effective lifecycle implementation of systems and processes for…
  713. cdsco-norditropinNorditropin®
  714. European Parliament Votes to Extend Medical Device Regulation
  715. EU/3/22/2734 - orphan designation for treatment of adrenoleukodystrophy
  716. GN-21-R6 Guidance on Change Notification for Registered MD (2025 Jul) PUB
  717. PSUSA/00010288/202105 - periodic safety update report single assessment
  718. Committee for Advanced Therapies (CAT): 18-20 February 2026
  719. Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue…
  720. 21 CFR 862.1130: Blood volume test system.
  721. Candesartan cilexetil - paediatric investigation plan
  722. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August…
  723. EMA restricts use of Keytruda and Tecentriq in bladder cancer
  724. European Communities (Medical Devices) (Amendment) Regulations 2002 (SI 576/2002) [IVDs]
  725. Paediatric Committee (PDCO): 11-14 November 2025
  726. 21 CFR 878.4011: Tissue adhesive with adjunct wound closure device for topical…
  727. (DOC Version - 150 K)
  728. EMEA-002571-PIP01-19 - paediatric investigation plan
  729. Regulatory information - eSubmission Gateway or web client mandatory for all eCTD…
  730. EMEA-000959-PIP01-10 - paediatric investigation plan
  731. 21 CFR 866.2540: Microbiological incubator.
  732. February 6, 2024: General Hospital and Personal Use Devices Panel of the Medical Devices…
  733. Circular- Testing and evaluaion of Medical Devices/ In-Vitro Diagnostics by Medical…
  734. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14…
  735. PSUSA/00001041/202001 - periodic safety update report single assessment
  736. PSUSA/00010332/202304 - periodic safety update report single assessment
  737. EU/3/09/704 - orphan designation for treatment of systemic-onset juvenile idiopathic…
  738. 21 CFR 862.1065: Ammonia test system.
  739. EMEA-003316-PIP01-22 - paediatric investigation plan
  740. Committee for Advanced Therapies (CAT): 7-9 November 2018
  741. 21 CFR 886.5838: Nasolacrimal compression device.
  742. Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 February 2024
  743. Committee for Medicinal Products for Veterinary Use (CVMP): 10-12 May 2021
  744. Regulation on EMA’s extended mandate becomes applicable
  745. 21 CFR 73.2725: Ultramarines.
  746. cdsco-trastuzumab-deruxtecanTrastuzumab Deruxtecan
  747. 21 CFR 866.5760: Tryptase test system.
  748. The Health Canada eSTAR pilot program
  749. 21 CFR 892.5710: Radiation therapy beam-shaping block.
  750. EMEA-002077-PIP01-16-M05 - paediatric investigation plan
  751. Clopidogrel - paediatric investigation plan
  752. EMEA-000827-PIP01-09-M05 - paediatric investigation plan
  753. Chair of EMA's committee for orphan medicines receives award for outstanding patient…
  754. PSUSA/00001437/201711 - periodic safety update report single assessment
  755. Update to guidance on regulatory expectations in the context of COVID-19 pandemic
  756. EMEA-000510-PIP02-10-M02 - paediatric investigation plan
  757. PSUSA/00009272/201909 - periodic safety update report single assessment
  758. 21 CFR 862.1120: Blood gases (PCO2, PO2) and blood pH test system.
  759. Paediatric Committee (PDCO): 23-26 July 2024
  760. Innovation in Ventilation for Healthcare
  761. EU/3/11/926 - orphan designation for treatment of primary membranoproliferative…
  762. cfr-21-cfr-1-1-general21 CFR 1.1: General.
  763. EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma
  764. NMPA Announcement on Issuing the Working Procedures for Dynamic Adjustment of…
  765. European Medicines Agency updates procedural guidance in line with new pharmacovigilance…
  766. Management Board meeting: 8 June 2011
  767. Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group - referral
  768. cdsco-aslan004ASLAN004
  769. 2021.11.29_ Draft GSR 840(E)_Amendment of rule 127 of the Drugs Rules 1945 for adding…
  770. EMEA-000511-PIP01-08-M04 - paediatric investigation plan
  771. Tookad - withdrawal of application for variation to marketing authorisation
  772. William Hyman: The FDA’s Self-Imposed Deadlines (Part II)
  773. EMEA-002547-PIP01-19 - paediatric investigation plan
  774. EMA's procedural handling of safety review was complete and independent
  775. European Medicines Agency gives interim recommendations to deal with shortcomings in…
  776. Second EMEA - EGA Info Day - Generic and Biosimilar Medicines in the Centralised Procedure
  777. ema-respivac-trtRespivac TRT
  778. March 18 2015 GSR 203(E)
  779. Abbott Laboratories Limited withdraws its marketing authorisation application for Ozespa…
  780. ema-chmp-membersCHMP members
  781. Rosuvastatin (calcium) - paediatric investigation plan
  782. Bylvay - withdrawal of application for variation to marketing authorisation
  783. PSUSA/00001783/202005 - periodic safety update report single assessment
  784. EMEA-002468-PIP02-18 - paediatric investigation plan
  785. DR_G.S.R 304 (E) dt_07.06.1991_26A_Prohibition of Mfr of (i) FDC ergot preps and (ii)…
  786. cdsco-bevacizumab-25-mg-mlBevacizumab 25 mg/mL
  787. Quercetin Nutraceutical bar
  788. Completed Paediatric Studies - submission, processing and assessment
  789. ema-emadineEmadine
  790. ema-ultratardUltratard
  791. Mandatory use of international standard for the reporting of side effects to improve…
  792. Meliloti herba - herbal medicinal product
  793. Launching of National Single Window System (NSWS) Portal
  794. October 7, 2024, Meeting of the Science Board to the Food and Drug Administration…
  795. National Drug Residue Milk Monitoring Program
  796. cagrilintide s.c. 2.4 mg
  797. 21 CFR 73.1410: Logwood extract.
  798. EMEA-001929-PIP01-16 - paediatric investigation plan
  799. PSUSA/00001009/202111 - periodic safety update report single assessment
  800. Guideline on non-clinical and clinical development of similar biological medicinal…
  801. ema-quviviqQuviviq
  802. (DOC Version - 131 K)
  803. EMEA-003081-PIP01-21-M02 - paediatric investigation plan
  804. ema-competactCompetact
  805. PSUSA/00010269/201507 - periodic safety update report single assessment
  806. Olmesartan - Safety Review Update of Benicar (olmesartan) and cardiovascular events
  807. ema-pravachol-referralPravachol - referral
  808. Drug Safety Update: monthly PDF newsletter: Drug Safety Update January 2021
  809. Remdesivir for Injection 100mg/ml
  810. NMPA Issues Requirements for Registration Classification and Application Dossiers of…
  811. ACB meeting statement, Meeting 2, 18 April 2013
  812. ema-qternQtern
  813. Infant Formula Program - Inspection, Sample Collection, and Examination
  814. Dapagliflozin Propanedilol Monohydrate eq. to Dapagliflozin + Teneligliptin Hydrobromide…
  815. Celgene Europe Limited withdraws its application for an extension of the indication for…
  816. PSUSA/00010551/202201 - periodic safety update report single assessment
  817. EMA advises continued use of medicines for hypertension, heart or kidney disease during…
  818. Software and Artificial Intelligence (AI) as a Medical Device
  819. Committee for Medicinal Products for Veterinary Use (CVMP) publishes new draft strategy on…
  820. Clinical investigation of medicinal products in the treatment of chronic obstructive…
  821. Leaflet Software Training 2
  822. Picato - direct healthcare professional communication (DHPC)
  823. PSUSA/00003150/201703 - periodic safety update report single assessment
  824. EU actions to support availability of medicines during COVID-19 pandemic – update #5
  825. EMEA-002862-PIP01-20-M02 - paediatric investigation plan
  826. Committee for Herbal Medicinal Products (HMPC): 16-18 November 2020
  827. ema-pandemrixPandemrix
  828. EMEA-003422-PIP01-23 - paediatric investigation plan
  829. Romiplostim Injection (r-DNA origin) 250 mcg/vial
  830. Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in…
  831. Addendum 01 to FAQ on Medical Devices Rules 2017
  832. Biphasic Isophane Insulin Injection IP 100IU/ml (30% soluble insulin/ 70% isophane…
  833. EMEA-002725-PIP01-19 - paediatric investigation plan
  834. European Medicines Agency recommends conditional approval of Pixuvri (pixantrone) for…
  835. EMEA-000949-PIP01-10 - paediatric investigation plan
  836. PSUSA/00010436/202005 - periodic safety update report single assessment
  837. Stem cell -based products for veterinary use: Specific questions on extraneous agents to…
  838. Clinical Trials Conducted on Ethical Grounds-Japanese Compassionate Use System-
  839. cdsco-lcz696-nyhaLCZ696 NYHA
  840. 21 CFR 890.3825: Mechanical walker.
  841. PSUSA/00010190/201812 - periodic safety update report single assessment
  842. 21 CFR 25.32: Foods, food additives, and color additives.
  843. Azelnidipine + Telmisartan IP tablets (Phase III)
  844. Prescription medicines and biologicals: TGA annual summary 2017
  845. EU/3/09/624 - orphan designation for treatment of glioma
  846. Ononidis radix - herbal medicinal product
  847. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017
  848. 21 CFR 866.3920: Assayed quality control material for clinical microbiology assays.
  849. Risks associated with the use of herbal products containing Aristolochia species…
  850. Nominees Sought for AAMI Board of Directors
  851. European Medicines Agency closed 2-3 June 2011
  852. Notice regarding meeting 12 july 2016 CDSCO
  853. SMF(Site Master File) template
  854. ACMD meeting statement, Meeting 38, 5 December 2017
  855. E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data…
  856. Quality Management System Inspection of Medical Devices and in-vitro Diagnostics in Japan
  857. Metformin Hydrochloride IP (as ER) + Glimepiride IP + Sitagliptin Phosphate Monohydrate IP…
  858. New guidelines on good manufacturing practices for advanced therapies
  859. Collecting high-quality data on antibiotic use in animals in support of the fight against…
  860. Committee for Orphan Medicinal Products (COMP): 8-10 July 2014
  861. In Their Words: Diversity in HTM
  862. NMPA Announcement on Issuing the Provisions for the Administration of Adverse Reaction…
  863. Quality for listed medicines
  864. PSUSA/00002199/201701 - periodic safety update report single assessment
  865. EMEA-002051-PIP02-16 - paediatric investigation plan
  866. EMEA-002597-PIP08-22 - paediatric investigation plan
  867. Phenobarbital Sodium Injection
  868. List of the Certified Medical Device Testing Laboratory under MDR, 2017
  869. No change is needed in use of direct oral anticoagulants following EMA-funded study
  870. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for…
  871. EU/3/09/689 - orphan designation for treatment of myasthenia gravis
  872. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  873. COVID-19: EMA meetings with delegates and experts will be held virtually until end April…
  874. ema-talzennaTalzenna
  875. VICH GL5 Stability testing: photostability testing of new veterinary drug substances and…
  876. Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 April 2016
  877. Recommendation on Sterility Testing
  878. Leadership Allows Barrett Franklin to Create Positive Change on a Broader Scale
  879. Fingolimod product-specific bioequivalence guidance
  880. EU/3/17/1856 - orphan designation for treatment of neuromyelitis optica spectrum disorders
  881. ema-qsivaQsiva
  882. 21 CFR 862.1090: Angiotensin converting enzyme (A.C.E.) test system.
  883. Drug Alert list for month of December 2013
  884. In Memoriam: Philip Schneider
  885. cdsco-morf-057m-s-psi-croMORF-057M/s PSI CRO
  886. cdsco-dostarlimab-500mg-10mlDostarlimab, 500mg/10mL
  887. ema-laurina-referralLaurina - referral
  888. CHMP opinions on consultation procedures
  889. PSUSA/00001744/201903 - periodic safety update report single assessment
  890. European Medicines Agency maintains fee reduction for SMEs developing orphan medicines in…
  891. EMEA-002367-PIP01-18 - paediatric investigation plan
  892. ema-globorixGloborix
  893. Polariscope
  894. Paediatric medicines procedures
  895. NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification…
  896. ema-nuedextaNuedexta
  897. 13th meeting of the Committee for Orphan Medicinal Products
  898. Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of…
  899. Committee for Orphan Medicinal Products (COMP): 6-8 November 2018
  900. European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FVE) webinar on…
  901. EU/3/00/011 - orphan designation for conditioning treatment prior to…
  902. EMEA-002452-PIP01-18 - paediatric investigation plan
  903. Balinatunfib 100 mg Tablets
  904. Recombinant Rabies G protein Vaccine
  905. Current approaches to product marking
  906. ema-padcevPadcev
  907. First paediatric medicine to treat rare hormonal disorder
  908. ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual live hands-on training…
  909. EMEA-002867-PIP01-20 - paediatric investigation plan
  910. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - January 2017
  911. European Medicines Agency closed 25 May 2015
  912. July 25, 2019: Meeting of the Arthritis Advisory Committee Meeting Announcement…
  913. 21 CFR 26.39: Equivalence assessment.
  914. EMA and EATRIS webinar on support for academic and non-profit ATMP developers
  915. ema-qtrilmetQtrilmet
  916. EMEA-003372-PIP01-22 - paediatric investigation plan
  917. SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and…
  918. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 September 2016
  919. FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verz2019:enio…
  920. ema-yesafiliYesafili
  921. cdsco-mkp-10241MKP-10241
  922. Using AI on Big Data to Create Succinct Clinical Summaries
  923. ema-trecondiTrecondi
  924. PSUSA/00000016/202207 - periodic safety update report single assessment
  925. PSUSA/00000277/201412 - periodic safety update report single assessment
  926. ema-mysimbaMysimba
  927. EU/3/12/1055 - orphan designation for treatment of peripheral T-cell lymphoma (nodal…
  928. Guidance on Good Clinical Practice compliance inspection framework
  929. Bioresearch Monitoring Inspections of In Vitro Diagnostics Devices
  930. European Union (EU) International Organisation for Standardization (ISO) for…
  931. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  932. FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous…
  933. Tear Sheet - Cough and Cold Medicine for Children
  934. ema-colistin-referralColistin - referral
  935. TEMOZOLOMIDE POWDER FOR ORAL SUSPENSION 20MG/ML (300MG/15ML)CT/SND/10/2024
  936. PSUSA/00010442/201607 - periodic safety update report single assessment
  937. Vaxzevria (previously COVID-19 Vaccine AstraZeneca) - direct healthcare professional…
  938. EU/3/14/1402 - orphan designation for treatment of beta thalassaemia intermedia and major
  939. EMEA-002708-PIP01-19 - paediatric investigation plan
  940. zelnidipine 8 mg plus Telmisartan 40 mg and Azelnidipine 16 mg plus Telmisartan 40mg tab…
  941. Committee on Herbal Medicinal Products (HMPC)
  942. EU/3/20/2273 - orphan designation for prevention of fetal and neonatal alloimmune…
  943. Rucaparib camsylate - direct healthcare professional communication (DHPC)
  944. EU/3/14/1239 - orphan designation for treatment of cystic fibrosis
  945. October 4, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  946. 21 CFR 872.6770: Cartridge syringe.
  947. 21 CFR 862.1410: Iron (non-heme) test system.
  948. Public data from Article 57 database
  949. EMEA-001839-PIP01-15 - paediatric investigation plan
  950. EU/3/18/2071 - orphan designation for treatment of medullary thyroid carcinoma
  951. Clinical trials for medicines: modifying a clinical trial approval
  952. List of Medical devices testing Laboratory for carry out test or evaluation of Medical…
  953. Submission of an updated RMP
  954. Site Master File (SMF) for Source Plasma Establishments
  955. Voices of Cybersecurity: Chris Falkner
  956. DR_G.S.R. 93(E) dt_25.02.1997_26A_Reg FDC of Streptomycin and Penicillins
  957. PSUSA/00000059/201409 - periodic safety update report single assessment
  958. ema-elfabrioElfabrio
  959. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  960. 21 CFR 73.2575: Titanium dioxide.
  961. 2022.08.10_S.O. 3757(E)_Notification of Director Incharge of CDL Kolkata
  962. ema-united-statesUnited States
  963. EMEA-000837-PIP01-10-M02 - paediatric investigation plan
  964. Evaluation of anticancer medicinal products in man - addendum on paediatric oncology…
  965. EU/3/03/184 - orphan designation for treatment of glioma
  966. Committee for Advanced Therapies (CAT): 13-16 August 2024
  967. ema-letifendLetifend
  968. PSUSA/00000548/201610 - periodic safety update report single assessment
  969. September 20-21, 2016: General and Plastic Surgery Devices Panel of the Medical Devices…
  970. PSUSA/00000477/201803 - periodic safety update report single assessment
  971. European Medicines Agency publishes revised Code of Conduct
  972. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March…
  973. Verbenae citriodorae folium - herbal medicinal product
  974. Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward…
  975. Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use - Scientific…
  976. 21 CFR 74.1710: D&C Yellow No. 10.
  977. Dapagliflozin propanediol Monohydrate eq. to Dapagliflozin 10mg + Telmisartan 80mg film…
  978. Sitagliptin product-specific bioequivalence guidance
  979. ema-clopidogrel-1a-pharmaClopidogrel 1A Pharma
  980. Pharmacovigilance Risk Assessment Committee (PRAC): 10-12 May 2023
  981. January 25,2016 S.O 237(E)
  982. Electronic application form pilot to be extended to initial veterinary applications
  983. Repurposing of authorised medicines: pilot to support not-for-profit organisations and…
  984. 21 CFR 888.3500: Knee joint femorotibial metal/composite semi-constrained cemented…
  985. Clinical Trials Regulation
  986. NMPA Issues the Revised Draft of the Blood Products Appendix in the Good Manufacturing…
  987. Guideline on development, production, characterisation and specification for monoclonal…
  988. EU/3/14/1246 - orphan designation for diagnosis of gastro-entero-pancreatic neuroendocrine…
  989. 21 CFR 1.1171: How does an accreditation body request reconsideration by FDA of a decision…
  990. 21 CFR 870.4250: Cardiopulmonary bypass temperature controller.
  991. PSUSA/00001620/201411 - periodic safety update report single assessment
  992. 21 CFR 882.5970: Cranial orthosis.
  993. Update on EMA’s Brexit preparedness
  994. ema-besremiBesremi
  995. 21 CFR 880.6887: Spore test strip.
  996. ema-roaccutane-referralRoaccutane - referral
  997. Webinar on requesting access to and using EMA's substance, product, organisation and…

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