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Global regulations and guidance

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

  1. EMEA-001403-PIP01-12 - paediatric investigation plan
  2. Committee for Advanced Therapies (CAT): 13-15 November 2013
  3. ECDC and EMA highlight considerations for additional and booster doses of COVID-19…
  4. Urticae radix - herbal medicinal product
  5. EU/3/08/575 - orphan designation for treatment of isovaleric acidaemia
  6. Emtricitabine/Tenofovir disoproxil Krka
  7. 21 CFR 1.1159: How will FDA oversee LAAF-accredited laboratories?
  8. Setting the Stage for the Next Generation of Medical Devices
  9. Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to…
  10. ema-academia-info-dayAcademia Info Day
  11. Workshop on the implementation of ISO standard for individual case safety reports (ICSRs)
  12. Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 May 2019
  13. PSUSA/00000774/202011 - periodic safety update report single assessment
  14. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16…
  15. EU/3/17/1876 - orphan designation for treatment of acute myeloid leukaemia
  16. 21 CFR 1.902: How do the criteria and definitions in this subpart apply under the Federal…
  17. Consideration of Directions of Hon'ble Supreme Court of India in the case of 294…
  18. Connor Walsh: Grow in Your Career with a Mentor
  19. SPURIOUS ALERT FOR THE MONTH OF APRIL 2024
  20. EMEA-002994-PIP01-21 - paediatric investigation plan
  21. First COVID-19 vaccine safety update published
  22. Quarterly system demo - Q3 2022
  23. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
  24. Use of heat treatment to inactivate endogenous retroviruses in live immunological…
  25. 21 CFR 884.6120: Assisted reproduction accessories.
  26. Prospective dialogue between developers and regulators makes for better evidence…
  27. Evaluation of anticancer medicinal products in man - Scientific guideline
  28. 2015 Pharmacovigilance Inspectors Working Group training course
  29. Request a MHRA speaker at an event or conference
  30. Exceptional Use Authorisation
  31. 21 CFR 866.3170: Nucleic acid-based hepatitis C virus ribonucleic acid tests.
  32. EMEA-002310-PIP01-17 - paediatric investigation plan
  33. EU/3/17/1935 - orphan designation for treatment of non-traumatic subarachnoid haemorrhage
  34. EMEA-002784-PIP01-20 - paediatric investigation plan
  35. EU/3/03/137 - orphan designation for treatment of follicular lymphoma
  36. IVD_classifiction_updated 25.10.2023
  37. Committee for Advanced Therapies (CAT): 11-13 May 2026
  38. cdsco-herpes-zosterHerpes Zoster
  39. On the Main Stage: How an Entrepreneurial Spark—and a Lot of Soap—Is Saving Lives Around…
  40. Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal…
  41. Meeting highlights from the Committee for Medicinal Products for Human Use,11-14 December…
  42. 21 CFR 890.1450: Powered reflex hammer.
  43. ema-jinarcJinarc
  44. EU/3/13/1136 - orphan designation for treatment of 5q spinal muscular atrophy
  45. cfr-21-cfr-99-1-scope21 CFR 99.1: Scope.
  46. Insulin glargine - paediatric investigation plan
  47. European Communities (Medical Devices) Regulations 1994 (SI 252/1994) [General]
  48. Pyrogens, Still a Danger
  49. cdsco-tranexamic-acidTranexamic acid
  50. EMEA-001581-PIP02-16 - paediatric investigation plan
  51. ema-further-resourcesFurther resources
  52. CDSCO updated list of laboratories to conduct Performance evaluation of IVDs dated…
  53. Follow up information session on the TransCelerate initiative
  54. EMEA-001876-PIP01-15 - paediatric investigation plan
  55. Meeting report of the Seventh EMEA/FEDESA Joint Info Day at the European Agency in London
  56. Xalkori - opinion on variation to marketing authorisation
  57. Guideline on clinical investigation of medicinal products for the treatment of venous…
  58. Joint HMA/EMA multi-stakeholder workshop on submission predictability
  59. Tapentadol Hydrochloride Nasal Spray 225 mg/ml
  60. Team-NB-PositionPaper-AI-Designation-V1-20221216
  61. PSUSA/00010491/202304 - periodic safety update report single assessment
  62. Indacaterol (as acetate) eq. to Indacaterol + Glycopyrrolate IP eq. to Glycopyrronium +…
  63. cdsco-rsv-maternal-vaccineRSV Maternal Vaccine
  64. EU/3/16/1709 - orphan designation for treatment of partial deep dermal and full-thickness…
  65. Variations requiring assessment (veterinary medicines)
  66. Oreventive measure to contain spread of COVID-19 in CDSCO HQ attendance of Central…
  67. Novartis withdraws its application to extend the marketing authorisation for Zometa
  68. ema-dimethyl-fumarate-mylanDimethyl fumarate Mylan
  69. cdsco-at-752AT-752
  70. New EMA guidance on development of antibacterials to help in the fight against…
  71. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin + Metoprolol Succinate IP eq…
  72. EU/3/00/012 - orphan designation for treatment of tyrosinaemia type 1
  73. Fluticasone Furoate + Oxymetazoline hydrochloride IP nasal spray (Phase III)
  74. 21 CFR 890.5850: Powered muscle stimulator.
  75. EMEA-003367-PIP01-22 - paediatric investigation plan
  76. European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP)…
  77. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26…
  78. Ambroxol and bromhexine-containing medicines - referral
  79. Management Board meeting: 9 June 2011
  80. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 November 2011
  81. GN-16-R2 Guidance on Essential Principles for Safety and Performance of Medical Devices…
  82. Evaluation of medicinal products for cardiovascular disease prevention - Scientific…
  83. Guidance document on disposal of expired/ unused drugs
  84. EMEA-002522-PIP01-18 - paediatric investigation plan
  85. EU/3/10/770 - orphan designation for treatment of acute myeloid leukaemia
  86. cdsco-verekitug-upb-101Verekitug (UPB-101)
  87. cdsco-randomizedRandomized
  88. 21 CFR 884.4100: Endoscopic electrocautery and accessories.
  89. EudraVigilance: electronic reporting
  90. cdsco-nivolumab-relatlimabNivolumab+Relatlimab
  91. Immunologicals guidelines
  92. Japanese Encephalitis Vaccine
  93. Top 10 tips on benchtop steam sterilizers
  94. 21 CFR 809.30: Restrictions on the sale, distribution and use of analyte specific…
  95. Annual report 2020 published
  96. Regulatory Pathway to be followed for Medical Devices under MDR-2017
  97. PSUSA/00002068/202308 - periodic safety update report single assessment
  98. 21 CFR 862.1405: Immunoreactive insulin test system.
  99. Meeting of the EMEA working party on herbal medicinal products 30 June - 1 July 2003
  100. Paediatric Committee (PDCO): 28-31 January 2025
  101. EU/3/07/492 - orphan designation for treatment of glioma
  102. EU/3/13/1131 - orphan designation for treatment of cystic fibrosis
  103. Committee for medicinal products for veterinary use: Meeting of 11-13 November 2008
  104. Committee for Medicinal Products for Human Use (CHMP): 25-28 June 2018
  105. European Medicines Agency issues reminder on PIP deferral obligations
  106. Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential…
  107. cdsco-as012AS012
  108. ema-vV
  109. EMEA-001776-PIP04-17 - paediatric investigation plan
  110. cfr-21-cfr-60-2-purpose21 CFR 60.2: Purpose.
  111. 21 CFR 882.5560: Cerebrospinal fluid shunt system.
  112. Ethical use of animals in medicine testing
  113. Q&A: Good clinical practice (GCP)
  114. Advice for health procurement teams about therapeutic goods and medical devices
  115. PSUSA/00002052/201410 - periodic safety update report single assessment
  116. EMEA-002443-PIP02-18 - paediatric investigation plan
  117. eXtended EudraVigilance Medicinal Product Dictionary Training Course
  118. ema-daivobet-referralDaivobet - referral
  119. PSUSA/00000776/201801 - periodic safety update report single assessment
  120. cdsco-agalsidase-alfaAgalsidase alfa
  121. Addressing Diversity Gaps in Healthcare Technology Management
  122. ema-byettaByetta
  123. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25…
  124. PSUSA/00003065/202008 - periodic safety update report single assessment
  125. Diamorphine - paediatric investigation plan
  126. 21 CFR 884.4520: Obstetric-gynecologic general manual instrument.
  127. PSUSA/00010883/202204 - periodic safety update report single assessment
  128. EU/3/13/1107 - orphan designation for treatment of X-linked juvenile retinoschisis
  129. 21 CFR 1.666: How do I request reaccreditation?
  130. PSUSA/00002057/202209 - periodic safety update report single assessment
  131. EU Clinical Trials Register information now available through WHO's International Clinical…
  132. ema-evotopinEvotopin
  133. 21 CFR 20.105: Testing and research conducted by or with funds provided by the Food and…
  134. cdsco-gsk3196165GSK3196165
  135. hsa-electronic-consentElectronic consent
  136. Human Factors Experts Seek Trust and Safety for AI/ML Medical Devices
  137. FAQ on Medical Device Rule,2017
  138. EMEA-002913-PIP01-20 - paediatric investigation plan
  139. Non-clinical assessment of the carcinogenic potential of human insulin analogues…
  140. Announcement of the National Medical Products Administration on Issuing the Administrative…
  141. Pneumococcal Conjugate Vaccine (2+1 schedule)
  142. Transparency in drug regulation
  143. Use of antiretroviral treatment in HIV-patients with hepatic impairment and/or HBV/HCV…
  144. FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
  145. Gabapentin USP 6.0%w/w + Lidocaine HCl IP eq. to Lidocaine 5.0%w/w gel
  146. NMPA Issued the Announcement on Effective Implementation of Unique Identification for the…
  147. PSUSA/00002408/201607 - periodic safety update report single assessment
  148. 21 CFR 12.100: Administrative record of a hearing.
  149. Ibuprofen product-specific bioequivalence guidance
  150. House Calls for HTM? Seeking to Survey Home Healthcare Equipment Management Practices
  151. DR_G.S.R. 678(E) dt_31.10.2006_Schedule M-I
  152. PSUSA/00010068/201907 - periodic safety update report single assessment
  153. PSUSA/00002060/202005 - periodic safety update report single assessment
  154. cdsco-ranibizumab-r-dnaRanibizumab r-dna
  155. EU/3/19/2236 - orphan designation for treatment of adrenoleukodystrophy
  156. EMEA-002407-PIP01-18 - paediatric investigation plan
  157. ema-enteroporc-coliEnteroporc Coli
  158. 21 CFR 868.5830: Autotransfusion apparatus.
  159. Use of bovine serum in the manufacture of human biological medicinal products - Scientific…
  160. ema-paglitazPaglitaz
  161. PSUSA/00002254/202104 - periodic safety update report single assessment
  162. Information about BIA-ALCL for people with breast implants
  163. EMEA-001127-PIP02-11-M02 - paediatric investigation plan
  164. DR_G.S.R. 69(E) dt_11.02.1991_26A_reg certain FDCs
  165. Clinical trials for medicines: guidance on quality and risk proportionality
  166. Saroglitazar tablet 4mg II
  167. EMEA-001720-PIP01-14-M03 - paediatric investigation plan
  168. cdsco-july-21-2011-gsr-557-eJuly 21, 2011, (GSR 557 (E)
  169. 2018.12.07_Draft_GSR 1185(E)_Date of implementation of GSR 408(E) dated 26.04.2018
  170. ema-steglatroSteglatro
  171. Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting…
  172. Biosimilar medicines regulation
  173. ema-esbrietEsbriet
  174. New medicine for rare inflammatory condition of the oesophagus
  175. 21 CFR 868.1200: Indwelling blood oxygen partial pressure (PO2) analyzer.
  176. 21 CFR 878.4370: Surgical drape and drape accessories.
  177. 21 CFR 890.3940: Wheelchair platform scale.
  178. cdsco-rusfertide-ptg-300Rusfertide (PTG-300)
  179. 21 CFR 882.5801: Computerized behavioral therapy device for psychiatric disorders.
  180. Colae semen - herbal medicinal product
  181. Restricted representation application checklist
  182. EMEA-000425-PIP02-10-M04 - paediatric investigation plan
  183. 21 CFR 866.1645: Fully automated short-term incubation cycle antimicrobial susceptibility…
  184. AAMI All-Star: Arif Subhan
  185. EMEA-001028-PIP01-10 - paediatric investigation plan
  186. Fentanyl-ratiopharm Matrixpflaster - referral
  187. ema-bovilis-cryptiumBovilis Cryptium
  188. Tiliae tomentosae flos - herbal medicinal product
  189. European Medicines Agency-EuropaBio information day
  190. EU/3/12/1088 - orphan designation for treatment of 5q spinal muscular atrophy
  191. Two modules of guideline on good pharmacovigilance practices released for public…
  192. PSUSA/00001532/202102 - periodic safety update report single assessment
  193. Committee for Medicinal Products for Veterinary Use (CVMP): 4-6 October 2022
  194. Office Memorandum: Timeline for CDL Kasauli to review and processing of applications…
  195. Meet the 2024 AAMI Award Winners!
  196. Public consultation opens on draft guideline on clinical investigation of medicinal…
  197. EMEA-000339-PIP02-09-M03 - paediatric investigation plan
  198. cdsco-afliberceptAflibercept
  199. Air Velocity Meters
  200. ema-luxturnaLuxturna
  201. International Council on Harmonisation of Technical Requirements for Registration of…
  202. Study: Implanted Defibrillators Less Likely for Women, Minorities
  203. EU/3/11/910 - orphan designation for treatment of traumatic spinal cord injury
  204. Safety signals: recommendations now available in all EU languages
  205. Potential Eye Damage From Alcon CyPass Micro-Stent Used to Treat Open-Angle Glaucoma: FDA…
  206. ema-qalsodyQalsody
  207. ema-optisonOptison
  208. Drug Alert list for month of October 2017
  209. Union Product Database: webinar for marketing authorisation holders
  210. Bepirovirsen in HBeAg-negative
  211. 21 CFR 880.5550: Alternating pressure air flotation mattress.
  212. Rare Disease Day 2014 – twelve new orphan medicines available to patients over the past…
  213. Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
  214. ema-newflend-nd-h9Newflend ND H9
  215. Abatacept biosimilar (DRL_AB) with Orencia
  216. Mary Ann Drosnock: The Importance of Drying Flexible Endoscopes
  217. Grency® Iliac Vein Stent System Approved for Marketing
  218. ema-sepioglinSepioglin
  219. AI Airlock Phase 2 Cohort
  220. 21 CFR 12.21: Initiation of a hearing involving the issuance, amendment, or revocation of…
  221. AAMI, ISO Publish Sterilization Standards for Packaging
  222. Indacaterol (as Indacaterol acetate) 150mcg + Glycopyrronium (As Glycopyrrolate IP) 50mcg…
  223. EU/3/18/2133 - orphan designation for treatment of soft tissue sarcoma
  224. EU/3/14/1242 - orphan designation for treatment of Rett syndrome
  225. ema-skyriziSkyrizi
  226. UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety…
  227. 21 CFR 880.6870: Dry-heat sterilizer.
  228. EMEA-002157-PIP01-17 - paediatric investigation plan
  229. 21 CFR 872.1820: Dental x-ray exposure alignment device.
  230. Committee for Advanced Therapies (CAT): 19-21 February 2025
  231. EMA and EUnetHTA step up interaction to align data requirements
  232. EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta
  233. EU/3/13/1143 - orphan designation for treatment of acute liver failure
  234. 21 CFR 1.630: How do I apply to FDA for recognition or renewal of recognition?
  235. Consumer Packaging and Labelling Regulations (C.R.C., c. 417)
  236. cdsco-aur101AUR101
  237. Medical devices manufactured at the point-of-care - Analysis of survey results by sector
  238. ema-memantine-merzMemantine Merz
  239. Core summary of product characteristics (SmPC) and package leaflet for sodium fluoride…
  240. EU/3/08/551 - orphan designation for treatment of haemophilia A
  241. eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November…
  242. PSUSA/00010298/201603 - periodic safety update report single assessment
  243. Introducing the 2022 Nominees for the AAMI Board of Directors & Nominating Committee
  244. EU/3/09/623 - orphan designation for treatment of beta thalassaemia intermedia and major
  245. ema-kovaltryKovaltry
  246. Twelfth meeting of the industry stakeholder platform on the operation of the centralised…
  247. PSUSA/00000051/201910 - periodic safety update report single assessment
  248. ema-rss-feedsRSS feeds
  249. NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification…
  250. EU/3/04/200 - orphan designation for treatment of functional gastro-entero-pancreatic…
  251. Committee for medicinal products for veterinary use: Meeting of 10-12 March 2009
  252. EU/3/16/1685 - orphan designation for treatment of acute respiratory distress syndrome…
  253. EU/3/16/1732 - orphan designation for treatment of amyotrophic lateral sclerosis
  254. Changing sponsor details in Product Information (PI) and labels of prescription medicines
  255. Committee for Advanced Therapies (CAT): 23-25 May 2018
  256. PSUSA/00009182/202212 - periodic safety update report single assessment
  257. EU/3/22/2610 - orphan designation for treatment of blastic plasmacytoid dendritic cell…
  258. ema-delstrigoDelstrigo
  259. 2022.01.18_Final GSR 20(E)_QR code for active pharmaceutical ingredients
  260. Borderline products: how to tell if your product is a medical device and which risk class…
  261. EU/3/22/2661 - orphan designation for treatment of glioma
  262. DR_G.S.R. 160(E) dt_16.03.2006_Schedule H inclusion of drugs sr. no 1 to 536
  263. Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical…
  264. ema-pheburanePheburane
  265. Stability testing of existing active ingredients and related finished products…
  266. 21 CFR 884.1700: Hysteroscopic insufflator.
  267. EMEA Public Statement on herbal medicinal products containing cimicifugae racemosae…
  268. PSUSA/00000227/201911 - periodic safety update report single assessment
  269. Novel veterinary medicines – how to make use of stem cells and monoclonal antibodies
  270. CHMP meeting on Paroxetine and other SSRIs
  271. SBO-154 for injection (40mg/vial)
  272. Chlorthalidone IP + Fimasartan Potassium Trihydrate eq. to Fimasartan Potassium film…
  273. ema-floxyfral-referralFloxyfral - referral
  274. Guideline on non-clinical and clinical development of similar biological medicinal…
  275. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 18-20 May 2010
  276. Notice regarding Monitoring the end use of drugs which are meant for dual use
  277. EMEA-003314-PIP01-22 - paediatric investigation plan
  278. Organisational Matters Drafting Group
  279. CPMP elects new chair and vice-chair at its 100th meeting
  280. Team-NB PositionPaper Voluntary Transfer Agreement V1 20221005
  281. Ipsen Ltd withdraws its application for an extension of indication for NutropinAq
  282. Performance evaluation of In-Vitro Diagnostic to the In Vitro Diagnostic Medical Device…
  283. PSUSA/00010864/202101 - periodic safety update report single assessment
  284. 21 CFR 814.118: Denial of approval or withdrawal of approval of an HDE.
  285. EMEA-002200-PIP01-17 - paediatric investigation plan
  286. cdsco-insulin-degludecInsulin Degludec
  287. PSUSA/00000034/201809 - periodic safety update report single assessment
  288. EU/3/14/1301 - orphan designation for treatment of idiopathic pulmonary fibrosis
  289. 21 CFR 872.6070: Ultraviolet activator for polymerization.
  290. cdsco-saruparib-azd5305Saruparib (AZD5305)
  291. FDA Drug Safety Communication: Ongoing Safety Review of Stalevo…
  292. CHMP meeting to discuss Multaq on Friday 2 September
  293. PSUSA/00000922/201508 - periodic safety update report single assessment
  294. PSUSA/00002601/201510 - periodic safety update report single assessment
  295. Committee for Herbal Medicinal Products (HMPC): 17-19 March 2025
  296. EMEA-000377-PIP01-08 - paediatric investigation plan
  297. FDA requires warnings about increased risk of serious heart-related events, cancer, blood…
  298. cdsco-olsalazineOlsalazine
  299. Sourcing medicines for the UK Market
  300. Cell culture inactivated influenza vaccines - annex to note for guidance on harmonisation…
  301. CVMP interested parties' meeting
  302. Cancellation of products under RC/COS-003827, for import of Cosmetics under Cosmetics…
  303. EU/3/18/2082 - orphan designation for treatment of Kabuki syndrome
  304. EMEA-003406-PIP01-23 - paediatric investigation plan
  305. 21 CFR 864.7060: Antithrombin III assay.
  306. Committee for Herbal Medicinal Products (HMPC): 5-6 May 2010
  307. Introduction to pharmacovigilance and rules for expedited reporting of individual case…
  308. Payment of Challan through Bharatkosh 15.02.2018
  309. Mohamed Basiony: What If Medical Devices Had Brains?
  310. ema-miplyffaMiplyffa
  311. European Medicines Agency closed 29-30 May 2014
  312. Canagliflozin + Metformin HCl Film coated tablets (Phase IV)
  313. Electronic Relays
  314. EMEA-001672-PIP01-14 - paediatric investigation plan
  315. cdsco-lcz696-paradigmLCZ696 Paradigm
  316. EMA starts rolling review of remdesivir for COVID-19
  317. ema-xyremXyrem
  318. Echinaceae purpureae radix - herbal medicinal product
  319. Notice regarding Creation of Speical Assistance Booth for addressing issues of submission…
  320. EU/3/13/1211 - orphan designation for treatment of glioma
  321. cdsco-tocilizumab-20mg-mlTocilizumab, 20mg/mL
  322. ema-bovilis-bvd-referralBovilis BVD - referral
  323. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - November 2018
  324. PSUSA/00001734/202107 - periodic safety update report single assessment
  325. Regulatory information - EMA clarifies interpretation of new variation classification…
  326. EMEA-002559-PIP06-22 - paediatric investigation plan
  327. 21 CFR 886.1090: Haidinger brush.
  328. Guidance on Evaluation of the Devices for Physical Function Recovery [102.85 KB]
  329. Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2016
  330. AAMI Announces Next President and CEO
  331. cdsco-semaglutideSemaglutide
  332. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July…
  333. Committee for medicinal products for veterinary use: Meeting of 14 to 15 April 2004
  334. GMP information for manufacturers of compounded medicines and DAAs
  335. Data quality framework for medicines regulation
  336. EU/3/18/1976 - orphan designation for treatment in haematopoietic stem cell…
  337. Notice regarding Permission to conduct BA/BE study and clinical trial
  338. ema-jetreaJetrea
  339. EU/3/09/620 - orphan designation for treatment of myelofibrosis secondary to polycythaemia…
  340. ema-repathaRepatha
  341. Field safety notice (FSN): what it is and why it's important: Flyer on field safety…
  342. IcoSema and daily insulin glargine 100 units/mL
  343. Checklist for Form MD-8 IVD (Application for grant of Loan Licence to manufacture for sale…
  344. EU/3/02/096 - orphan designation for treatment of alkaptonuria
  345. Clinical Trials Regulation: progress on implementation
  346. EU/3/12/985 - orphan designation for treatment of retinitis pigmentosa
  347. EMEA-EFPIA 'Quality by Design' application workshop
  348. EU/3/11/934 - orphan designation for treatment of idiopathic pulmonary fibrosis
  349. Questions and answers: Article 31 pharmacovigilance referrals
  350. EMEA-003324-PIP01-22 - paediatric investigation plan
  351. Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular…
  352. DR_G.S.R. 385(E) dt_19.04.2018_Amendment of Sch-K to exempt Oxygen 93% IP
  353. Prasugrel product-specific bioequivalence guidance
  354. 21 CFR 880.6920: Syringe needle introducer.
  355. Notice regarding human vacine appliation through SUGAM online Portal of CDSCO
  356. December 10, 2021: Neurological Devices Panel of the Medical Devices Advisory Committee…
  357. 21 CFR 812.18: Import and export requirements.
  358. Clinical investigation of medicinal products for treatment of rheumatoid arthritis…
  359. cdsco-public-noticePublic Notice
  360. 2010 annual workshop of the European Network of Paediatric Research at the European…
  361. Ozempic / Victoza - direct healthcare professional communication (DHPC)
  362. Online Application for Free Sale certificate Market standing certificate and…
  363. EU/3/09/615 - orphan designation for treatment of mucopolysaccharidosis, type IVA (Morquio…
  364. EMEA-002317-PIP02-21 - paediatric investigation plan
  365. EU/3/10/843 - orphan designation for prevention of arteriovenous access failure in…
  366. DR_G.S.R. 219(E) dt_26.03.2020_Sale of Hydroxychloroquine as per Schedule H1_Section 26B
  367. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin…
  368. cdsco-srp-4045-and-srp-4053SRP-4045 and SRP-4053
  369. EU/3/18/2118 - orphan designation for treatment of Hutchinson-Gilford progeria
  370. PSUSA/00002207/202110 - periodic safety update report single assessment
  371. cdsco-cetrelimabCetrelimab
  372. 2012.08.28_S.O. 1983(E)_Dr. Gyanendra Nath Singh, Sec. Cum Scietificd Directior,_ As LA…
  373. Find product information about medicines
  374. Perflubutane - paediatric investigation plan
  375. EMEA-003066-PIP01-21 - paediatric investigation plan
  376. ema-isotretinoin-referralIsotretinoin - referral
  377. EU/3/01/047 - orphan designation for treatment of multiple myeloma
  378. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - January 2018
  379. Barbara Christe: Educators, Is this 'Survivor'? HELP Us!
  380. PSUSA/00002662/201709 - periodic safety update report single assessment
  381. Milnacipran Pierre Fabre Medicament
  382. Caryophylli floris aetheroleum - herbal medicinal product
  383. Committee for Orphan Medicinal Products: February 2004 meeting
  384. EU/3/16/1629 - orphan designation for treatment of idiopathic intracranial hypertension
  385. PSUSA/00000101/202006 - periodic safety update report single assessment
  386. EU/3/21/2425 - orphan designation for treatment of cutaneous T-cell lymphoma
  387. 21 CFR 1.672: What is the duration of direct accreditation?
  388. 21 CFR 862.1070: Amylase test system.
  389. Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and…
  390. Paediatric Committee (PDCO): 16-18 March 2011
  391. 21 CFR 870.5925: Automatic rotating tourniquet.
  392. Clinical Trials Information System (CTIS) sponsor end user training programme - September…
  393. PSUSA/00010560/201904 - periodic safety update report single assessment
  394. EU/3/19/2172 - orphan designation for treatment of Angelman syndrome
  395. Update on infringement procedure against Roche Registration Ltd.
  396. How Technology & Finances Are Fostering Remote Health Reimagination
  397. Regulatory information – adjusted fees for pharmacovigilance applications to EMA from…
  398. Respiratory Syncytial Virus Vaccine -PF-06928316
  399. VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in…
  400. Modelling and simulation in the development of medicines
  401. Tech World: Wet Packs! How Did We Get These Stinking Wet Packs?
  402. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  403. Guideline on Utilization of Master File for Drug Substances, etc. PFSB / ELD Notification…
  404. EMEA-001151-PIP02-17 - paediatric investigation plan
  405. Erlotinib product-specific bioequivalence guidance
  406. Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device…
  407. Questions & answers: EU actions to prevent medicine shortages due to Brexit
  408. 21 CFR 1.1119: What are the conflict of interest requirements for a recognized…
  409. EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on…
  410. Report and videos available from Enpr-EMA launch
  411. European Medicines Agency publishes report on patient recruitment and geographical…
  412. Urosodiol Injection 625 mg/25ml 925mg/ml)
  413. Nucala - direct healthcare professional communication (DHPC)
  414. Partial Revision of “Approval Applications for Drugs”
  415. Clinical trials for medicines: Good clinical practice inspections
  416. Cybersecurity at the AAMI eXchange: Highlights from Several Key Sessions
  417. 2026.06.22 G.S.R. 504(E)_Draft notification regarding submission of Periodic Safety Update…
  418. ACT EU: creating a better environment for clinical trials through collaboration
  419. 21 CFR 14.7: Administrative remedies.
  420. PSUSA/00003104/202305 - periodic safety update report single assessment
  421. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: Hands-on…
  422. EMEA-002274-PIP01-17 - paediatric investigation plan
  423. EMEA-003122-PIP01-21-M01 - paediatric investigation plan
  424. AI Airlock Sandbox Pilot Programme Report
  425. EU/3/15/1499 - orphan designation for treatment of thromboangiitis obliterans (Buerger's…
  426. cdsco-lumateperoneLumateperone
  427. European Medicines Agency and US Food and Drug Administration release first conclusions of…
  428. ICH M2 Electronic common technical document (eCTD) - file format criteria - Scientific…
  429. cdsco-camizestrant-azd9833Camizestrant (AZD9833
  430. Implantable Cardiac Pacing Lead Approved for Marketing
  431. 21 CFR 868.5800: Tracheostomy tube and tube cuff.
  432. EMEA-001131-PIP02-12 - paediatric investigation plan
  433. 21 CFR 810.4: Service of orders.
  434. The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
  435. Committee for Medicinal Products for Veterinary Use: Meeting of 10-12 November 2009
  436. Actelion withdraws its application for an extension of indication for Zavesca
  437. PSUSA/00010566/202106 - periodic safety update report single assessment
  438. Standards for Medicament Factory Establishments
  439. EMEA-003036-PIP01-21 - paediatric investigation plan
  440. ema-evarrestEvarrest
  441. European Medicines Agency seeks views on involvement of children and young people in…
  442. Eli Lilly withdraws its marketing authorisation application for ARXXANT
  443. Special Access Scheme (SAS) online system guidance
  444. PSUSA/00002201/202006 - periodic safety update report single assessment
  445. Committee for Proprietary Medicinal Products (CPMP) 34th plenary meeting
  446. EU/3/17/1831 - orphan designation for treatment of limb-girdle muscular dystrophy
  447. Validation of immunoassay for the detection of hepatitis B virus surface antigen in plasma…
  448. Fraxini folium - herbal medicinal product
  449. Committee for Medicinal Products for Human Use (CHMP): 19-22 July 2021
  450. Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the…
  451. 21 CFR 1.276: What definitions apply to this subpart?
  452. PSUSA/00001402/202003 - periodic safety update report single assessment
  453. 21 CFR 862.1490: Lysozyme (muramidase) test system.
  454. With U.S. Med Device Cybersecurity Policy in Flux, Today's Resources Can Help
  455. Guideline on human cell-based medicinal products
  456. cdsco-neutral-code-labellingNeutral Code - labelling
  457. ema-verasealVeraSeal
  458. PZN-128 powder for solution
  459. Translarna - withdrawal of application for variation to marketing authorisation
  460. Resmetirom Tablets 60mg,80mg and 100mg
  461. Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure
  462. PSUSA/00010283/201701 - periodic safety update report single assessment
  463. 21 CFR 73.260: Vegetable juice.
  464. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June…
  465. EU/3/10/743 - orphan designation for prevention of sepsis caused by Gram-positive…
  466. Opportunities for patients and the public to be involved in the work of the MHRA
  467. Will Generative AI Take the Paperwork Out of Healthcare?
  468. Vildagliptin +Dapagliflozin tablets (Phase III)
  469. 21 CFR 882.5855: Brain stimulation programming planning software.
  470. Recombinant Human Filgrastim Injectable for Solution 300 mcg/ 0.5 mL Pre-filled syringe…
  471. EU/3/19/2180 - orphan designation for treatment of myelodysplastic syndromes
  472. European Medicines Agency starts review of rosiglitazone-containing medicines
  473. DR_G.S.R. 57(E) dt_07.02.1995_26A_Reg ORS solution
  474. Tin Whiskers - Problems, Causes, and Solutions
  475. ema-zydelig-referralZydelig - referral
  476. Seasonal Influenza Rapid Antigen and Combination tests
  477. PSUSA/00001932/201506 - periodic safety update report single assessment
  478. Use of genomics in cardiovascular clinical trials
  479. Is AI Rehumanizing Healthcare? AAMI Expert Panel Explores
  480. Emergency Task Force (ETF) documents
  481. EudraVigilance training on electronic reporting of Individual Case Safety Reports in the…
  482. Public consultation open on concept paper on pharmacogenomics in evaluation of authorised…
  483. Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical…
  484. EMEA-003344-PIP02-22 - paediatric investigation plan
  485. UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin…
  486. Atezolizumab Injection 1200mg/20ml Vial
  487. cdsco-qva149QVA149
  488. Committee for Advanced Therapies (CAT): 14-15 October 2010
  489. EU/3/10/832 - orphan designation for treatment of sickle cell disease
  490. Committee for Advanced Therapies (CAT): 13-14 September 2012
  491. EMA launches pilot project on analysis of raw data from clinical trials
  492. cdsco-carbetocin-rtsCarbetocin RTS
  493. EMEA public statement on Refludan (Lepirudin) - Fatal anaphylactic reactions
  494. Australian manufacturing licences and overseas GMP certification
  495. FAQ in Vitro Diagnostic IVD Devices revised 2022
  496. EU/3/12/1048 - orphan designation for treatment of pancreatic cancer
  497. How to improve product lifecycle management
  498. Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal…
  499. Sixth EMEA/FEDESA Joint Info Day at the European Agency in London
  500. Get to Know the AAMI Standards Team’s New Senior Directors
  501. EU/3/12/1078 - orphan designation for treatment of Duchenne muscular dystrophy
  502. Ten years of orphan medicines legislation in Europe – European Medicines Agency reviews…
  503. European Antibiotic Awareness Day 2013: 'Everyone is responsible'
  504. Dasatinib product-specific bioequivalence guidance
  505. Myrrha - herbal medicinal product
  506. EMA-HTA workshop on parallel scientific advice in drug development to take place tomorrow
  507. 21 CFR 73.169: Grape color extract.
  508. cdsco-jnj-42756493JNJ-42756493
  509. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23…
  510. Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting…
  511. EMEA-003264-PIP01-22 - paediatric investigation plan
  512. EMEA-002402-PIP02-18 - paediatric investigation plan
  513. Ethanol content in herbal medicinal products and traditional herbal medicinal products…
  514. EU/3/24/2928 - orphan designation for treatment of pulmonary alveolar proteinosis
  515. 34th meeting of the Committee for Orphan Medicinal Products
  516. EU/3/18/2005 - orphan designation for treatment of follicular lymphoma
  517. Core summary of product characteristics (SmPC) and package leaflet for iopamidol 300…
  518. 21 CFR 868.6225: Nose clip.
  519. EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
  520. Committee for medicinal products for veterinary use: Meeting of 12 - 14 December 2006
  521. A common data model in Europe? – Why? Which? How?
  522. European Medicines Agency confirms positive benefit-risk balance for Champix
  523. PSUSA/00001738/202007 - periodic safety update report single assessment
  524. 21 CFR 862.3120: Arsenic test system.
  525. EMEA-000882-PIP03-11-M05 - paediatric investigation plan
  526. cdsco-dimethyl-fumaratedimethyl Fumarate
  527. NMPA Issued the Announcement on Issues Pertaining to the Current Administration on Drug…
  528. National Patient Safety Alert Supporting Information. Patient hoists and slings: incidents…
  529. Eligible healthcare professionals' organisations
  530. EU/3/14/1257 - orphan designation for treatment of recombination-activating gene 1…
  531. March 15, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  532. EMEA-001438-PIP01-13-M01 - paediatric investigation plan
  533. EMEA-001905-PIP01-15 - paediatric investigation plan
  534. Mirabegron (as extended release form) + Tamsulosin Hydrochloride IP (as modified release…
  535. 21 CFR 868.5675: Rebreathing device.
  536. 21 CFR 21.50: Procedures for submitting requests for amendment of records.
  537. Oversight and monitoring of investigational medical product trials: Oversight and…
  538. Additional monitoring - information materials
  539. Refusal of orphan designation for treatment of pancreatic cancer
  540. Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, Florida: FDA…
  541. Exporting active substances manufactured in Great Britain for use in EEA and Northern…
  542. Gliclazide IP (As sustained release) + Sitagliptin Phosphate Monohydrate IP eq. to…
  543. EMA virtual workshop on myocarditis post COVID-19 vaccination
  544. Guideline on clinical evaluation of new vaccines
  545. EU/3/11/868 - orphan designation for treatment of diffuse large B-cell lymphoma
  546. Public consultation on reflection paper on prophylactic use of antimicrobials in animals
  547. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16…
  548. Data Monitoring Committees issues - Scientific guideline
  549. cdsco-rsvRSV
  550. Vaccines and Related Biological Products Advisory Committee Meeting May 28, 2026…
  551. Committee for Orphan Medicinal Products (COMP): 14-16 February 2023
  552. AS F0016.1.001: On-Site Assessment-Audit Process Flowchart
  553. Is your advertising for therapeutic goods compliant?
  554. Eprinex pour-on and its associated names - referral
  555. SPARC121 Topical Foam 1%, 2%, 3%
  556. New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory…
  557. Drugs alert for the month of October 2014
  558. Organisations Management Services (OMS) data quality standards: webinar with OMS users
  559. EMEA-000917-PIP01-10-M04 - paediatric investigation plan
  560. 2021.03.12_S.O. 1170(E)_Notifying Amar jyoti, Dilip Kr, Rinku & Arun Kr at RDTL Guwahati…
  561. Regulatory Alert regarding Cancellation of Registration Certificates of Ethics Committees…
  562. Bl 456906 solution for injection 0.5 ml
  563. EMEA-001473-PIP01-13 - paediatric investigation plan
  564. EU/3/09/652 - orphan designation for treatment of cystic fibrosis
  565. UPDATED INFORMATION: April 17, 2023: Meeting of the Antimicrobial Drugs Advisory Committee…
  566. Guidance for Pre-manufacturing and Pre-exportation Notifications (C.07.011) under Canada's…
  567. Antipsychotic medicines: licensed products, uses and side effects
  568. Surrender of Cosmetic Registration Certificate No RC/COS-002497 daled 08-Jul- 2021
  569. 21 CFR 74.1260: D&C Orange No. 10.
  570. EU/3/19/2210 - orphan designation for treatment of beta thalassaemia intermedia and major
  571. Vaccines and Related Biological Products Advisory Committee January 26, 2023 Meeting…
  572. P/82/2010 - paediatric investigation plan
  573. EU/3/01/050 - orphan designation for treatment of Wilson's disease
  574. PY test Kit Carbon 14 Urea Capsule
  575. Get to Know the AAMI Standards Team: Thomas Kim, Director of Standards
  576. EMEA-001825-PIP01-15 - paediatric investigation plan
  577. Health (Pricing and Supply of Medical Goods) Act 2013 [Establishment of the HPRA]
  578. AU P0033.003 REPs User Account Management
  579. Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS)
  580. 21 CFR 862.2320: Beta or gamma counter for clinical use.
  581. ema-intanzaIntanza
  582. cfr-21-cfr-73-340-paprika21 CFR 73.340: Paprika.
  583. PSUSA/00000062/201708 - periodic safety update report single assessment
  584. 21 CFR 1.634: When will FDA revoke recognition?
  585. Environmental Risk Assessment European Specialised Expert Community
  586. 21 CFR 14.55: Termination of advisory committees.
  587. 21 CFR 864.6675: Platelet aggregometer.
  588. PSUSA/00001833/201706 - periodic safety update report single assessment
  589. Global regulators call for international collaboration to integrate real-world evidence…
  590. ema-twinrix-paediatricTwinrix Paediatric
  591. EMEA-002488-PIP01-18 - paediatric investigation plan
  592. EMEA-000802-PIP02-11-M01 - paediatric investigation plan
  593. ema-paccal-vetPaccal Vet
  594. Lamivudine/Zidovudine Teva
  595. EMEA-003104-PIP01-21 - paediatric investigation plan
  596. PSUSA/00001308/202103 - periodic safety update report single assessment
  597. PSUSA/00000008/201505 - periodic safety update report single assessment
  598. EMEA-002144-PIP01-17 - paediatric investigation plan
  599. PSUSA/00002338/202206 - periodic safety update report single assessment
  600. Onivyde pegylated liposomal (previously known as Onivyde)
  601. Quality: pharmaceutical development
  602. Committee for veterinary medicinal products: 53rd meeting
  603. Risk minimisation measures for medicines
  604. Human Variations eAF (DADI) go-live Q&A session
  605. EU/3/15/1587 - orphan designation for treatment of acute myeloid leukaemia
  606. Alcon Laboratories withdraws its application for RETAANE
  607. GD211 Training, Summary
  608. Data anonymisation workshop
  609. Leuprorelin - direct healthcare professional communication (DHPC)
  610. cdsco-cccccccc
  611. Ch. 7 - Recall Procedures
  612. EMEA-001195-PIP01-11-M05 - paediatric investigation plan
  613. Pending EC decisions on maximum residue limits
  614. AAMI Adds EO, VHP to Sterilization Materials Compatibility Guidance
  615. EMEA-001995-PIP01-16-M03 - paediatric investigation plan
  616. Reflection paper on the use of measurable residual disease as a clinical endpoint in…
  617. EMEA-001039-PIP01-10-M02 - paediatric investigation plan
  618. cdsco-pmz-1620PMZ-1620
  619. European Medicines Agency maintains recommendation not to grant a marketing authorisation…
  620. cfr-21-cfr-58-200-purpose21 CFR 58.200: Purpose.
  621. mhra-how-to-use-ramaxlHow to use RamaXL
  622. 21 CFR 17.15: Parties to the hearing.
  623. ema-synflorixSynflorix
  624. PSUSA/00001458/202207 - periodic safety update report single assessment
  625. Committee for Herbal Medicinal Products (HMPC): 24-25 March 2014
  626. EU/3/18/2085 - orphan designation for treatment of pancreatic cancer
  627. Durvalumab versus Sunitinib
  628. The New EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3)…
  629. Committee for veterinary medicinal products: 57th meeting
  630. DR_G.S.R. 510(E) dt_25.07.2005_26A_reg Valdecoxib and its formulations
  631. ema-nustendiNustendi
  632. External whistleblowing policy
  633. PSUSA/00000378/201901 - periodic safety update report single assessment
  634. nbcg-team-nb-leaflet-pdfTeam-NB-Leaflet.pdf
  635. ema-zinplavaZinplava
  636. EMEA-002096-PIP01-16-M03 - paediatric investigation plan
  637. EU/3/08/609 - orphan designation for treatment of Stargardt's disease
  638. PSUSA/00001584/202302 - periodic safety update report single assessment
  639. PSUSA/00010288/201611 - periodic safety update report single assessment
  640. EU/3/20/2363 - orphan designation for treatment of primary ciliary dyskinesia
  641. Committee for Advanced Therapies (CAT): 13-14 February 2014
  642. EMEA-001823-PIP01-15-M02 - paediatric investigation plan
  643. 21 CFR 73.1299: Ferric ferrocyanide.
  644. 21 CFR 872.1720: Pulp tester.
  645. ema-ema-closed-1-mayEMA closed 1 May
  646. EU/3/22/2731 - orphan designation for treatment of small cell lung cancer
  647. RESOLUTION RDC NO. 665, 30 MARCH 2022
  648. 21 CFR 74.706: FD&C Yellow No. 6.
  649. Notice regarding SUGAM for New Drugs FDC and SND
  650. Focus group meeting of CVMP experts, interested parties and member states - reflection…
  651. 27th August 2002 GSR 601 (E)
  652. ema-equimectin-referralEquimectin - referral
  653. Reporting a quality defect to EMA
  654. CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
  655. Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Insulin…
  656. EMEA-001441-PIP02-15-M02 - paediatric investigation plan
  657. EMEA-003019-PIP01-21 - paediatric investigation plan
  658. Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches…
  659. 21 CFR 866.3860: Trichomonas vaginalis nucleic acid assay.
  660. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23…
  661. PSUSA/00001502/202304 - periodic safety update report single assessment
  662. HTMA-OH Honors HTM’s Legacy and Future at 2025 Expo
  663. 21 CFR 14.35: Written submissions to an advisory committee.
  664. Similar medicinal products containing somatropin (Annex to guideline on similar biological…
  665. 21 CFR 822.5: How will I know if I must conduct postmarket surveillance?
  666. 21 CFR 21.74: Providing notice that a record is disputed.
  667. 21 CFR 1.327: Who is excluded from all or part of the regulations in this subpart?
  668. EU-wide recall of Raptiva (efalizumab) to be initiated
  669. PSUSA/00000108/201412 - periodic safety update report single assessment
  670. Committee for medicinal products for veterinary use: Meeting of 14 to 16 February 2006
  671. New recommendations to manage risk of allergic reactions with intravenous iron-containing…
  672. PSUSA/00002661/201607 - periodic safety update report single assessment
  673. PSUSA/00000435/201708 - periodic safety update report single assessment
  674. 21 CFR 866.3220: Entamoeba histolytica serological reagents.
  675. 21 CFR 862.2250: Gas liquid chromatography system for clinical use.
  676. EMEA strengthens handling of safety concerns for human medicines
  677. EU/3/20/2394 - orphan designation for treatment of Phelan-McDermid syndrome
  678. The 1st GHWP Innovation Medical Device Symposium Held Grandly
  679. VPM1002(recombinant BCG) vaccine
  680. PSUSA/00000199/201906 - periodic safety update report single assessment
  681. EU/3/23/2786 - orphan designation for treatment of sickle cell disease
  682. Medical Device Alert date 14 June 2022
  683. ema-somakit-tocSomaKit TOC
  684. PSUSA/00000616/201412 - periodic safety update report single assessment
  685. EMEA-000963-PIP01-10 - paediatric investigation plan
  686. Clopidogrel ratiopharm GmbH
  687. EMEA-002841-PIP01-20 - paediatric investigation plan
  688. NMPA Issues Announcement on Revising Package Insert of Posterior Pituitary Injection
  689. EU/3/20/2286 - orphan designation for treatment of soft tissue sarcoma
  690. EU/3/16/1650 - orphan designation for treatment of beta thalassaemia intermedia and major
  691. Dacarbazine Faulding - referral
  692. ema-defitelioDefitelio
  693. Guideline on clinical investigation of medicinal products, including depot preparations in…
  694. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
  695. Dexamethasone Alapis - referral
  696. ICH E7 Studies in support of special populations: geriatrics - questions and answers…
  697. EMEA-001312-PIP02-19 - paediatric investigation plan
  698. 21 CFR 82.1334: D&C Red No. 34.
  699. Gefapixant Tablets 45mg
  700. Saccharomyces cerevisiae CBS 5926 - herbal medicinal product
  701. EMEA-002491-PIP02-19 - paediatric investigation plan
  702. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - July 2019
  703. EMEA-000366-PIP04-12 - paediatric investigation plan
  704. FDA approves label changes for anti-seizure drug Potiga (ezogabine) describing risk of…
  705. PSUSA/00002002/201506 - periodic safety update report single assessment
  706. cdsco-oav101OAV101
  707. PSUSA/00001396/201706 - periodic safety update report single assessment
  708. Mycobacterium w (Heat Killed) Injection
  709. Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products - Scientific…
  710. Relugolix Tablets 120 mg
  711. EMEA-000995-PIP01-10 - paediatric investigation plan
  712. EU/3/17/1847 - orphan designation for treatment of soft tissue sarcoma
  713. FDA warns about increased risk of ruptures or tears in the aorta blood vessel with…
  714. PSUSA/00001614/201503 - periodic safety update report single assessment
  715. Team-NB-List-PositionPapers-20241218
  716. PSUSA/00010051/201607 - periodic safety update report single assessment
  717. 21 CFR 862.1195: Corticoids test system.
  718. EMEA-001196-PIP02-17 - paediatric investigation plan
  719. Durvalumab plus Domvanalimab (AB154
  720. EMEA-001614-PIP01-13 - paediatric investigation plan
  721. 21 CFR 882.5910: Dura substitute.
  722. 21 CFR 26.80: Entry into force, amendment, and termination.
  723. UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is…
  724. ema-rhinisengRhiniseng
  725. 21 CFR 886.1670: Ophthalmic isotope uptake probe.
  726. Public Statement on Fee Reductions for Designated Orphan Medicinal Products
  727. ema-lenalidomide-krka-d-dLenalidomide Krka d.d.
  728. EU/3/18/2110 - orphan designation for treatment of Fanconi anaemia
  729. Insulin Aspart Injection 100IU/mL, 3 mL Prefilled Pen of 3 mL Cartridge.
  730. PSUSA/00001174/202304 - periodic safety update report single assessment
  731. Zavesca - withdrawal of application for variation to marketing authorisation
  732. EMEA-001168-PIP01-11-M03 - paediatric investigation plan
  733. Committee for Medicinal Products for Veterinary Use (CVMP): 6-8 September 2022
  734. PSUSA/00010289/201902 - periodic safety update report single assessment
  735. DARWIN EU Advisory Board meeting - 24 May 2023
  736. Notice Order regarding Oseltamivir and Zanamivir
  737. Small and medium-sized enterprises: driving innovation in medicines
  738. ICH E2D Post-approval safety data management - Scientific guideline
  739. 21 CFR 862.1320: Gastric acidity test system.
  740. Tamiflu - Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate)…
  741. 21 CFR 882.5894: Limited output transcutaneous piezoelectric stimulator for skin reactions…
  742. Changes affecting TGA-issued conformity assessment certificates
  743. ema-ocrevusOcrevus
  744. EMEA-002306-PIP02-18 - paediatric investigation plan
  745. ema-ristempaRistempa
  746. Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2022
  747. EU/3/09/712 - orphan designation for treatment of Netherton syndrome
  748. Guidance for 'specials' manufacturers: Appendix: updates to the document
  749. Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety…
  750. ema-suiseng-diff-aSuiseng Diff/A
  751. Committee on Herbal Medicinal Products assessors training on quality for herbal medicinal…
  752. Public Statement on Trovan IV and Turvel IV
  753. WHO collaborative procedure for registering medicines through reliance
  754. Committee for Orphan Medicinal Products (COMP): 2-3 March 2010
  755. Infringement procedure against Roche – EMA update
  756. EMEA-002962-PIP01-21 - paediatric investigation plan
  757. Comments from the ‘No Peanut’ Gallery: SBOM Usefulness and Limits
  758. November 08,2012 ( G.S.R 816 (E) )
  759. ema-raloxifene-tevaRaloxifene Teva
  760. cdsco-crn04894CRN04894
  761. 21 CFR 870.3: Effective dates of requirement for premarket approval.
  762. EMEA-001503-PIP01-13 - paediatric investigation plan
  763. EU/3/22/2704 - orphan designation for treatment of vanishing white matter disease
  764. ema-ziagenZiagen
  765. Human Variations electronic application forms Q&A Clinics – Session 1
  766. 21 CFR 882.1470: Computerized cognitive assessment aid.
  767. ema-hemangiolHemangiol
  768. PSUSA/00001638/201604 - periodic safety update report single assessment
  769. Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is…
  770. 21 CFR 872.3890: Endodontic stabilizing splint.
  771. EU/3/07/525 - orphan designation for treatment of neuroblastoma
  772. PSUSA/00001596/201901 - periodic safety update report single assessment
  773. EU/3/21/2467 - orphan designation for treatment of perivascular epithelioid cell tumours
  774. FDA Issues Final Guidance for Electronic Submission Template for 510(k) Submissions
  775. 21 CFR 807.35: Notification of registrant.
  776. EMEA-001311-PIP01-12-M01 - paediatric investigation plan
  777. First Global Animal Health Conference to enhance positive environment for veterinary…
  778. ZyCoV-D SmPc and Factsheet
  779. European Medicines Agency publishes final 'Road map to 2015'
  780. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August…
  781. Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin…
  782. cdsco-blu-5937BLU-5937
  783. Revise list drug alert November-2024
  784. ema-easoticEasotic
  785. Committee for Advanced Therapies (CAT): 18-19 January 2023
  786. 21 CFR 814.20: Application.
  787. cdsco-phase-3-relamorelinPhase 3 Relamorelin
  788. ema-blitzimaBlitzima
  789. EU/3/24/2946 - orphan designation for treatment of thrombotic thrombocytopenic purpura
  790. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration…
  791. 21 CFR 886.4390: Ophthalmic laser.
  792. EMEA-002691-PIP02-20 - paediatric investigation plan
  793. Quadrivalent Human Papillomavirus (HPV) Vaccine
  794. ema-kimmtrakKimmtrak
  795. EU/3/21/2535 - orphan designation for treatment of acute lymphoblastic leukaemia
  796. Doravirine Tablets 100 mg
  797. Pertuzumab 420 mg/14mL Injection
  798. COVID-19 medicines that received EMA advice
  799. HIMSS21: What Do You Do When Ransomware Strikes?
  800. NMPA Notice on Issuing the Guidelines for On-Site Inspection of the Quality Management…
  801. EU/3/16/1677 - orphan designation for treatment of periodic paralysis
  802. 21 CFR 890.3920: Wheelchair component.
  803. EU/3/19/2228 - orphan designation for treatment of multiple system atrophy
  804. EU/3/21/2511 - orphan designation for treatment of Krabbe disease
  805. ema-equilis-west-nileEquilis West Nile
  806. cdsco-cocculus-hirsutusCocculus hirsutus
  807. FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and possible…
  808. World Diabetes Day: 14 November 2011
  809. Ablavar (previously Vasovist)
  810. PSUSA/00003082/201703 - periodic safety update report single assessment
  811. Human medicines: highlights of 2020
  812. ema-lumykrasLumykras
  813. Drug Alert list for month of January 2023
  814. cdsco-ut-15c-phase-iiiUT-15C Phase III
  815. PSUSA/00009162/201803 - periodic safety update report single assessment
  816. PSUSA/00000210/201708 - periodic safety update report single assessment
  817. 21 CFR 4.101: How does the FDA define key terms and phrases in this subpart?
  818. 21 CFR 870.2890: Vessel occlusion transducer.
  819. PSUSA/00002589/202006 - periodic safety update report single assessment
  820. Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment…
  821. Lumipulse® G HBsAg-Quant Approved for Marketing
  822. Dr. Xu Jinghe Attended the 2nd GHWP (Guangzhou) Academy Training
  823. Milvexian, an Oral Factor XIa
  824. ema-gazyvaroGazyvaro
  825. Avoiding duplication of clinical trials in children
  826. Suspension of the Teva marketing authorisation for Levothyroxine 100 microgram tablets
  827. EMEA-003030-PIP02-21 - paediatric investigation plan
  828. EU/3/16/1763 - orphan designation for treatment of haemophagocytic lymphohistiocytosis
  829. cdsco-alpelisibAlpelisib
  830. Electronic Instructions for Use - eIFU
  831. PSUSA/00000170/202101 - periodic safety update report single assessment
  832. Clinical evaluation of medicinal products used in weight control - addendum on weight…
  833. Cancer Medicines Forum: March 2023
  834. Pre-clearance application for animal-derived ingredients
  835. EMEA-003112-PIP01-21 - paediatric investigation plan
  836. PSUSA/00010190/201712 - periodic safety update report single assessment
  837. EU/3/12/1052 - orphan designation for treatment of haemophilia A
  838. EU/3/09/682 - orphan designation for treatment of ovarian cancer
  839. 21 CFR 890.3800: Motorized three-wheeled vehicle.
  840. EMEA-000192-PIP01-08 - paediatric investigation plan
  841. ema-sortis-referralSortis - referral
  842. Brexit preparedness: EMA to further temporarily scale back and suspend activities
  843. 21 CFR 866.3328: Influenza virus antigen detection test system.
  844. March 15 2017 GSR 250(E)
  845. PSUSA/00001455/201410 - periodic safety update report single assessment
  846. elmisartan IP + Amlodipine Besilate IP eq .to Amlodipine + Bisoprolol Fumarate IP (40mg +…
  847. Asian Medical Device Markets: The 2024 Outlook
  848. PSUSA/00000095/201512 - periodic safety update report single assessment
  849. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
  850. EU/3/09/650 - orphan designation for treatment of acute lymphoblastic leukaemia
  851. AAMI Foundation: Kilmer Scholarship & Grant Program Launched
  852. Taliglucerase alfa - paediatric investigation plan
  853. The Power of Laughter, the Language of Business: an eXchange Keynote Presentation
  854. PSUSA/00001370/201804 - periodic safety update report single assessment
  855. Regulatory information - Revised dossier-submission requirements for active-substance…
  856. Committee for Medicinal Products for Human Use (CHMP): 18-21 August 2025
  857. 21 CFR 814.120: Temporary suspension of approval of an HDE.
  858. 21 CFR 803.52: If I am a manufacturer, what information must I submit in my individual…
  859. Committee for Advanced Therapies (CAT): 21-23 January 2026
  860. Progress report: Australian Government response to the Senate Community Affairs References…
  861. ema-calcichew-d3-referralCalcichew D3 - referral
  862. 21 CFR 810.10: Cease distribution and notification order.
  863. EMEA-002942-PIP01-20 - paediatric investigation plan
  864. European Union (EU) International Organisation for Standardization (ISO) for…
  865. Lumateperone as Adjunctive Therapy
  866. EMEA-001164-PIP01-11-M07 - paediatric investigation plan
  867. Role of pharmacokinetics in the development of medicinal products in the paediatric…
  868. European Medicines Agency notified of recall of swine fever vaccine (Porcilis Pesti) by…
  869. EMEA-002921-PIP01-20 - paediatric investigation plan
  870. 21 CFR 1.1199: Are electronic records created under this subpart subject to the electronic…
  871. March 14, 2024: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  872. Core summary of product characteristics (SmPC) and package leaflet for…
  873. EU/3/17/1881 - orphan designation for treatment of sickle cell disease
  874. ema-roctavianRoctavian
  875. EMEA-001267-PIP01-12 - paediatric investigation plan
  876. PSUSA/00010433/201811 - periodic safety update report single assessment
  877. Checklist for Form MD-26 MD
  878. PSUSA/00010236/202001 - periodic safety update report single assessment
  879. ema-columviColumvi
  880. Paediatric Committee (PDCO): 8-11 December 2020
  881. cdsco-s-o-2237-eS.O. 2237(E)
  882. Belumosudil Tablets 200mg
  883. Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide - paediatric…
  884. 21 CFR 882.4310: Powered simple cranial drills, burrs, trephines, and their accessories.
  885. PSUSA/00000185/202206 - periodic safety update report single assessment
  886. Superseded pharmacovigilance guidance documents
  887. Committee for Orphan Medicinal Products (COMP): 15-16 April 2013
  888. EU/3/16/1787 - orphan designation for treatment of argininosuccinic aciduria
  889. ema-poulvac-e-coliPoulvac E. coli
  890. Addendum to the note for guidance on evaluation of medicinal products indicated for…
  891. EMA regular press briefing on public health emergencies
  892. Sabrina L. Reilly: Rethinking Resolutions
  893. Codeine-containing medicines - referral
  894. CVMP: meeting archive 2016-2018
  895. EU/3/18/2066 - orphan designation for treatment of biliary tract cancer
  896. 13th industry stakeholder platform - operation of European Union (EU) pharmacovigilance
  897. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30…
  898. 21 CFR 50.25: Elements of informed consent.
  899. Meeting of the CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients and…
  900. Committee for Advanced Therapies (CAT): 8-10 October 2025
  901. ICH E9 statistical principles for clinical trials - Scientific guideline
  902. Guidance on substantial amendments to a clinical trial
  903. EMEA-002690-PIP01-19 - paediatric investigation plan
  904. 21 CFR 82.1261: D&C Orange No. 11.
  905. ema-pantoloc-controlPantoloc Control
  906. EU/3/14/1252 - orphan designation for treatment of pancreatic cancer
  907. European Medicines Agency recommends first marketing authorisation for an advanced therapy…
  908. EU/3/14/1303 - orphan designation for treatment of ovarian cancer
  909. EU/3/16/1659 - orphan designation for treatment of inclusion body myositis
  910. cdsco-marstacimab-prophylaxiMarstacimab Prophylaxi
  911. ema-dasseltaDasselta
  912. EMEA-002243-PIP02-20 - paediatric investigation plan
  913. Brimonidine Tartrate 0.1% Ophthalmic Solution
  914. 21 CFR 26.11: Start of operational period.
  915. DR_G.S.R. 1074(E) dt_30.10.2018_Prohibition of import of Rapid Diagnostic Tests for…
  916. ema-reprocyc-parvoflexReproCyc ParvoFLEX
  917. The EMEA and the CMD(h) review Europe-wide experience with user consultation in the…
  918. EU/3/07/436 - orphan designation for treatment of post-neonatal intracerebral haemorrhage
  919. PSUSA/00001815/201610 - periodic safety update report single assessment
  920. 21 CFR 870.1345: Intravascular bleed monitor.
  921. 21 CFR 868.2340: Compensated thorpe tube flowmeter.
  922. Who are the originators of innovative medicines in the EU?
  923. ema-gefitinib-mylanGefitinib Mylan
  924. EU/3/17/1889 - orphan designation for treatment of gastrointestinal stromal tumours
  925. Flosfluridine tidoxil - paediatric investigation plan
  926. PSUSA/00002861/201511 - periodic safety update report single assessment
  927. RESOLUTION RDC NO. 67, 21 DECEMBER 2009
  928. Clinical Trials Information System Webinar: Last Year of Transition
  929. EU/3/15/1457 - orphan designation for treatment of tenosynovial giant cell tumour…
  930. EU/3/15/1496 - orphan designation for treatment of oculopharyngeal muscular dystrophy
  931. EMEA-002789-PIP01-20 - paediatric investigation plan
  932. Supporting better use of medicines
  933. Notice dated 26.03.2016 regarding the proposed revised guidelines on Similar Biologics…
  934. EMEA-000790-PIP01-09 - paediatric investigation plan
  935. EU/3/12/1095 - orphan designation for treatment of mucopolysaccharidosis type IIIB…
  936. 21 CFR 15.25: Written submissions.
  937. Procedure on Notification of Foreign Inspections
  938. EMA restricts use of multiple sclerosis medicine Zinbryta
  939. EMEA-001718-PIP01-14 - paediatric investigation plan
  940. AAMI Foundation Seeks Applicants for 2022 Logan Grants
  941. EU/3/06/386 - orphan designation for diagnosis of glioma
  942. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
  943. Epoetin theta - paediatric investigation plan
  944. Thymosin Alpha 1 for injection 1.6 mg
  945. Meeting highlights from the Paediatric Committee: 16 - 18 January 2008
  946. March 29-30, 2018: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical…
  947. Benzocaine gels and liquids - Reports of serious and potentially fatal adverse effects…
  948. Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2011
  949. EU/3/24/2891 - orphan designation for treatment of glioma
  950. 21 CFR 890.1615: Miniature pressure transducer.
  951. HTM Efforts to Promote Cyber Hygiene of Ultrasound Devices
  952. ema-riprazo-hctRiprazo HCT
  953. SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organisation and…
  954. Rubi idaei folium - herbal medicinal product
  955. Manufacture and market FDC of Atenolol+Losartan+Hydrochlorthaizide
  956. EMEA-000780-PIP01-09-M06 - paediatric investigation plan
  957. EMEA/IFAH-Europe Info Day, 'Balancing the benefits and risks of veterinary medicinal…
  958. Aide-Memoire on the Inspection of Active Pharmaceutial Ingredients (APIs)
  959. PSUSA/00001619/201610 - periodic safety update report single assessment
  960. Committee for medicinal products for veterinary use: Meeting of 12 - 14 June 2007
  961. FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone…
  962. May 18-19, 2022: Science Advisory Board to the National Center for Toxicological Research…
  963. Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing…
  964. EU/3/08/552 - orphan designation for treatment of haemophilia B
  965. PSUSA/00002925/201505 - periodic safety update report single assessment
  966. EMEA-001776-PIP03-17 - paediatric investigation plan
  967. ema-jorvezaJorveza
  968. S.O. 1928(E)_25.04.2023_Notification for testing Covid kit NIB Noida
  969. Clinical investigation of medicinal products for the treatment of multiple sclerosis…
  970. PSUSA/00002911/202010 - periodic safety update report single assessment
  971. cdsco-ceftazidime-caz-aviCeftazidime CAZ AVI
  972. March 10 2016 S.O 705(E) TO 1048(E)
  973. EMEA-002600-PIP04-22 - paediatric investigation plan
  974. Committee for Medicinal Products for Human Use (CHMP): 24-27 June 2013
  975. Legal requirements for children's medicines: Where paediatric data is assessed
  976. Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
  977. EMEA-001942-PIP01-16 - paediatric investigation plan
  978. Kansas City Cardiomyopathy Questionnaire (KCCQ)
  979. April 28, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement…
  980. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  981. Pruni africanae cortex - herbal medicinal product
  982. Use of herbal medicinal products containing methyleugenol - Scientific guideline
  983. Nomegestrol and chlormadinone - referral
  984. EMA recommends approval for use of Kineret in adults with COVID-19
  985. Supplementary information for pharmacists and medicines procurers on the Windsor Framework
  986. PSUSA/00000097/201505 - periodic safety update report single assessment
  987. Consultation meeting with stakeholders: Request from the European Commission for advice on…
  988. 21 CFR 801.415: Maximum acceptable level of ozone.
  989. 21 CFR 862.2400: Densitometer/scanner (integrating, reflectance, TLC, or…
  990. Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working…
  991. EMEA-001812-PIP01-15-M01 - paediatric investigation plan
  992. List of Approved Products
  993. 21 CFR 892.1760: Diagnostic x-ray tube housing assembly.
  994. Cybersecurity Expert Kevin Fu Joins AAMI Editorial Board
  995. Guidance Document: Preparation of Premarket Medical Device Licence and Licence Amendment…
  996. The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience…

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