Orca1

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Global regulations and guidance

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Every Regulatory document record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. EU/3/03/169 - orphan designation for treatment of dermatomyositis
  2. PSUSA/00002235/201608 - periodic safety update report single assessment
  3. EMEA-000059-PIP01-07 - paediatric investigation plan
  4. Joint TAIEX/EMEA Central Eastern European Countries Forum on the regulation of veterinary…
  5. ema-zulvac-8-bovisZulvac 8 Bovis
  6. cdsco-covaxinCOVAXIN
  7. FDA Drug Safety Communication: Serious medication errors from intravenous administration…
  8. Team-NB Position Paper Off Label Use V1
  9. Mary K. Logan Research Grant Supports Continuous Monitoring Research
  10. Details of Manufacturer whose licenses have been suspended /cancelled
  11. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Sitagliptin Phosphate…
  12. ema-elidel-referralElidel - referral
  13. ema-kuvanKuvan
  14. PSUSA/00002063/202104 - periodic safety update report single assessment
  15. EU/3/04/258 - orphan designation for treatment of acute lymphoblastic leukaemia
  16. Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical…
  17. ema-solacyl-referralSolacyl - referral
  18. European Medicines Agency adopts first positive opinion for a similar biological medicinal…
  19. EMEA-001964-PIP03-21 - paediatric investigation plan
  20. EU/3/16/1719 - orphan designation for treatment of malignant mesothelioma
  21. Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri
  22. EMEA-000914-PIP01-10-M05 - paediatric investigation plan
  23. EMEA-002474-PIP02-18-M01 - paediatric investigation plan
  24. cdsco-july-17-2015-gsr-558-eJuly 17 2015 GSR 558(E)
  25. EMEA-002643-PIP01-19-M01 - paediatric investigation plan
  26. Paediatric Epilepsy Experts Group Meeting
  27. EMA business hours over Whit Monday holiday, 6 June
  28. European Medicines Agency recommends further measures to minimise risk of blood vessel…
  29. EMEA/H/N/PSR/S/0017 - periodic safety update report single assessment
  30. EU/3/21/2515 - orphan designation for treatment of primary biliary cholangitis
  31. 21 CFR 878.4350: Cryosurgical unit and accessories.
  32. Committee for Advanced Therapies (CAT): 6-8 September 2017
  33. European Medicines Agency recommends the suspension of the marketing authorisation of…
  34. 21 CFR 866.4830: Rocket immunoelectrophoresis equipment.
  35. IMI ADAPT SMART, IMI GetReal and MIT NEW Drug Development ParadIGmS (NEWDIGS) “Adaptive…
  36. World Organisation for Animal Health (OIE)
  37. Paediatric Committee (PDCO): 7-9 March 2012
  38. 21 CFR 888.4230: Cement ventilation tube.
  39. Questions and answers (Q&A) on Drug-agnostic Companion Diagnostics
  40. ema-rubraca-referralRubraca - referral
  41. First EudraVigilance Information Day
  42. 21 CFR 1.402: What are the requirements for submitting an appeal?
  43. Second veterinary e-submission workshop
  44. EU/3/14/1358 - orphan designation for treatment of post-essential thrombocythaemia…
  45. ema-vireadViread
  46. ema-folcepriFolcepri
  47. Procedure on management of proposals from interested parties for Community list entries or…
  48. Elite Biomedical Solutions Seeks BMET Apprentices with AAMI RAP
  49. AAMI eXchange 2024 – What You Need to Know
  50. Committee for Advanced Therapies (CAT): 11-13 April 2022
  51. ema-kineretKineret
  52. Yellow Fever Vaccine (Live) (I.P)
  53. SB27 (proposed pembrolizumab biosimilar) and Keytruda
  54. EU/3/23/2787 - orphan designation for treatment of gastric cancer
  55. ema-femara-referralFemara - referral
  56. 21 CFR 808.25: Procedures for processing an application.
  57. Simultaneous National Scientific Advice - information and training webinar
  58. Committee for Orphan Medicinal Products (COMP): 7-9 January 2014
  59. Daratumumab SC and Lenalidomide (Tec-DR)
  60. cdsco-noticeNotice
  61. ema-eryseng-parvoEryseng Parvo
  62. cdsco-pregabalin-erPregabalin ER
  63. cdsco-ll-bmt1LL-BMT1
  64. EU/3/07/469 - orphan designation for treatment of cystic fibrosis
  65. European Agency for the Evaluation of Medicinal Products: Committee for Proprietary…
  66. ema-quality-guidelinesQuality guidelines
  67. VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active…
  68. EU/3/12/1008 - orphan designation for treatment of sickle cell disease
  69. Genotoxic and carcinogenic potential of phenolphthalein - Scientific guideline
  70. 21 CFR 2.110: Definition of ammonia under Federal Caustic Poison Act.
  71. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Glimepiride IP + Metformin…
  72. PSUSA/00002908/201512 - periodic safety update report single assessment
  73. FAQs on Drugs and Cosmetics (Compounding of Offences) Rules, 2025
  74. Notified Body TÜV SÜD Warns of ‘Bottleneck’ if IVDR Compliance Dates are Extended; BSI…
  75. EMEA-001952-PIP01-16 - paediatric investigation plan
  76. PSUSA/00002359/202001 - periodic safety update report single assessment
  77. EU/3/06/400 - orphan designation for diagnosis of medullary thyroid carcinoma
  78. PMDA’s Activities Leading to Medical Device Innovation
  79. EU/3/05/327 - orphan designation for treatment of glioma
  80. Cybersecurity 101 with the ‘Dynamic Duo’
  81. Regulation of borderline disinfectant and related products with antiviral claims including…
  82. cetirizine ophthalmic solution 0.24% w/vct/snd/01/2024
  83. Notice regarding Uploading data of drug manufacturing facilities and approved drug…
  84. Public notice related to ASR Hip Implants
  85. Principles on Development of Combination Ophthalmic Solutions for Glaucoma (Early…
  86. Drug Alert list for month of December 2015
  87. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF MARCH-2019
  88. Insulin Human 4units, 8units and 12units single-use cartridge Inhalation Powder…
  89. Comments invited on draft revised guideline on medicines for the treatment of hypertension
  90. Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine)…
  91. Environmental risk assessment of medicinal products for human use - Scientific guideline
  92. 21 CFR 16.119: Reconsideration and stay of action.
  93. Oral Semaglutide versus
  94. EMEA-000332-PIP01-08-M16 - paediatric investigation plan
  95. ema-legislative-issuesLegislative issues
  96. Draft Guidance on Electronic Labelling for Non-prescription (P and GSL)Therapeutic…
  97. 21 CFR 864.7010: Flow cytometric test system for hematopoietic neoplasms.
  98. EMEA-001861-PIP01-15 - paediatric investigation plan
  99. EU/3/22/2687 - orphan designation for treatment of nontuberculous mycobacterial lung…
  100. Regulatory information – Update of EMA recommendations for 2015/2016 seasonal flu vaccine…
  101. Multimodal Tumor Treatment System Approved for Marketing
  102. 21 CFR 882.5805: Repetitive transcranial magnetic stimulation system.
  103. Australia Cadetship Program Brings New Professionals to HTM
  104. Purified Vero Cell Rabies Vaccine (PVRV) (Human) (R-VAC-002)
  105. 21 CFR 864.7750: Prothrombin time test.
  106. Quality data requirements for applications for veterinary medicinal products other than…
  107. EMA provides guidance on development of medicines to prevent stroke in patients with…
  108. Team-NB Statement MDR DoA postponement 20200428
  109. PSUSA/00000375/201810 - periodic safety update report single assessment
  110. Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2015
  111. ema-rxultiRxulti
  112. ema-nexgardNexGard
  113. PSUSA/00002909/201708 - periodic safety update report single assessment
  114. NutropinAq - withdrawal of application for variation to marketing authorisation
  115. Statistical methodology for the comparative assessment of quality attributes in drug…
  116. EU/3/16/1635 - orphan designation for treatment of GNE myopathy
  117. Regulatory information - Electronic application becomes mandatory today
  118. Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
  119. (Appendix 13) The Standards for Marketing Approval of Antihemorrhoids (External…
  120. EU/3/22/2579 - orphan designation for treatment of Dravet syndrome
  121. Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety…
  122. Medical Devices alert 21.10.2016
  123. EMEA-001732-PIP02-15 - paediatric investigation plan
  124. ema-kisqaliKisqali
  125. Above and Beyond: How One Department is Advancing the HTM Profession
  126. Two Industry Surveys for HTM Professionals Await Your Response
  127. New treatment to enable kidney transplant in highly sensitised patients
  128. European Medicines Agency finalises set of guidelines on similar biological medicines and…
  129. EU/3/12/965 - orphan designation for treatment of Cushing's syndrome
  130. European Medicines Agency announces regulatory action on COX-2 inhibitors
  131. Bacterial Endotoxins/Pyrogens
  132. 2024.08.12__DR_S.O. 3266(E) to 3267(E)_ Restriction of FDC (Naproxen + Esomeprazole and…
  133. EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
  134. EU/3/15/1516 - orphan designation for treatment of pancreatic cancer
  135. List of Approved BA/BE Centers
  136. PSUSA/00010579/201803 - periodic safety update report single assessment
  137. Committee for Advanced Therapies (CAT): 6-7 December 2012
  138. EMEA-002344-PIP02-18-M01 - paediatric investigation plan
  139. PSUSA/00001263/202007 - periodic safety update report single assessment
  140. ema-vibativVibativ
  141. Device specific vigilance guidance: Artificial Heart Valves
  142. cdsco-exenatideExenatide
  143. New version of EudraGMP allows access to information from all Member States
  144. cdsco-brilaroxazine-rp5063Brilaroxazine (RP5063)
  145. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16…
  146. Azurity Cabozantinib Tablets
  147. EU/3/10/837 - orphan designation for treatment of primary myelofibrosis
  148. PSUSA/00002974/201605 - periodic safety update report single assessment
  149. EU NTC ten year anniversary event
  150. EuroGen Pharmaceuticals withdraws its application for Orathecin
  151. UPDATED INFORMATION: February 9, 2023: Meeting of the Oncologic Drugs Advisory Committee…
  152. Committee for Advanced Therapies (CAT): 19-21 March 2025
  153. PSUSA/00001507/202304 - periodic safety update report single assessment
  154. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May…
  155. ema-escitalopram-referralEscitalopram - referral
  156. ema-tabrectaTabrecta
  157. 21 CFR 20.65: National defense and foreign policy.
  158. ema-daptomycin-hospiraDaptomycin Hospira
  159. Briefing meetings of the EMA Innovation Task Force now open to veterinary medicines
  160. 21 CFR 890.5975: Therapeutic vibrator.
  161. ema-fortekor-plusFortekor Plus
  162. EMEA-002255-PIP01-17 - paediatric investigation plan
  163. 21 CFR 892.3: Effective dates of requirement for premarket approval.
  164. 21 CFR 13.15: Separation of functions; ex parte communications; administrative support.
  165. European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): 2009 - 2023
  166. ema-ramvocidRamvocid
  167. ema-prac-membersPRAC members
  168. ema-cereproCerepro
  169. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 March…
  170. EMEA-003166-PIP01-21 - paediatric investigation plan
  171. EU/3/15/1464 - orphan designation for treatment of systemic sclerosis
  172. Notice for Import of Radiopharmaceutical Products dated 03.01.2017
  173. ema-modafinil-referralModafinil - referral
  174. Regulations for Management of Medical Device Safety Surveillance
  175. How Health Canada inspects medical device establishments (GUI-0064) [2016-11-17]
  176. ema-galliapharmGalliaPharm
  177. 2025.07.29_G.S.R. 513(E)_Certain amendments in Cosmetics Rule 2020
  178. Certification procedures for advanced therapies under development by micro-, small- and…
  179. Partial Revision of “Handling of Conditional Approval of Drugs”
  180. ema-inpremziaInpremzia
  181. Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats…
  182. Harmonisation and update of the clinical aspects in the authorised conditions of use for…
  183. AAMI’s Amanda Benedict to Represent U.S. Engagement in ISO Global Standards Development
  184. Rules for Medical Device Nomenclature (Decree No. 19 of China Food and Drug…
  185. PSUSA/00010382/201704 - periodic safety update report single assessment
  186. Paediatric Committee (PDCO): 20-23 March 2018
  187. Pharmacovigilance obligations of medicine sponsors - frequently asked questions
  188. 21 CFR 888.3480: Knee joint femorotibial metallic constrained cemented prosthesis.
  189. AAMI/UL 2800 Series Brings Flexibility, Usability to Medical Device Interoperability…
  190. Submitting results of paediatric studies
  191. ema-optrumaOptruma
  192. Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2010
  193. Variations: guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012
  194. Tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder…
  195. EMEA-002331-PIP01-18 - paediatric investigation plan
  196. Stakeholders and Communication
  197. AAMI President Arora Named as 'Woman Power Player' by Health IT Industry Listing
  198. 21 CFR 870.2450: Medical cathode-ray tube display.
  199. Guidance on releasing information from adverse reaction and medical device incident…
  200. EMEA-000056-PIP01-07-M02 - paediatric investigation plan
  201. cfr-21-cfr-82-2050-general21 CFR 82.2050: General.
  202. List of registrars recognized by Health Canada under section 32.1 of the Medical Devices…
  203. Public Notice regarding DCGI meeting with Stakeholders Dated 26.03.2024 for 28 march 2024…
  204. ema-kisplyxKisplyx
  205. IMDRF Table of Contents pilot: TGA regional assembly and technical guide
  206. EU/3/23/2887 - orphan designation for treatment of recurrent respiratory papillomatosis
  207. List of Drugs, Medical Devices and Cosmetics declared as Not of Standard…
  208. Committee for Advanced Therapies (CAT): 11-13 September 2019
  209. cdsco-nivolumabNivolumab
  210. EMEA-000720-PIP01-09-M02 - paediatric investigation plan
  211. PSUSA/00001996/202401 - periodic safety update report single assessment
  212. EMEA-002651-PIP01-19 - paediatric investigation plan
  213. TEAM-NB-MD Survey 2015.pptx
  214. EU/3/17/1884 - orphan designation for treatment of haemophilia B
  215. EMEA-002492-PIP01-18-M02 - paediatric investigation plan
  216. 21 CFR 864.3250: Specimen transport and storage container.
  217. cdsco-lenvatinibLenvatinib
  218. Committee for Medicinal Products for Veterinary Use (CVMP): 14 -16 May 2013
  219. PSUSA/00001370/202304 - periodic safety update report single assessment
  220. EMEA-003100-PIP01-21 - paediatric investigation plan
  221. Global UDIs are Closer Than You Think: An ISC 2022 Conversation
  222. Enpr-EMA Coordinating Group and networks meeting
  223. ISC21: Responding to Regulatory Challenges of Cloud Computing, Artificial Intelligence
  224. PSUSA/00000170/201501 - periodic safety update report single assessment
  225. Principles for the Evaluation of Vaccines Against the Novel Coronavirus…
  226. July 19, 2016: Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee Meeting…
  227. Inactivated Poliomyelitis Vaccine (Adsorbed)
  228. Form MD-26 Specimen proforma for Medical Devices
  229. 28th meeting of the committee for veterinary medicinal products
  230. 21 CFR 1.328: What definitions apply to this subpart?
  231. Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines - Drugs…
  232. EMEA-001635-PIP03-17 - paediatric investigation plan
  233. PSUSA/00000914/202101 - periodic safety update report single assessment
  234. EMEA-002427-PIP01-18-M02 - paediatric investigation plan
  235. Third EMA-EFPIA annual bilateral meeting
  236. 21 CFR 872.6670: Silicate protector.
  237. 21 CFR 868.2550: Pneumotachometer.
  238. Clinical development of medicinal products intended for the treatment of pain - Scientific…
  239. Accelerated Testing to Prove Long-Term Material Biostability
  240. EMEA-002322-PIP01-17 - paediatric investigation plan
  241. 21 CFR 868.2377: Apnea monitor.
  242. Development of medicines to treat tuberculosis
  243. PSUSA/00001458/201707 - periodic safety update report single assessment
  244. Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
  245. Medical devices: software applications (apps): Appendix 1 - symptom checkers
  246. 21 CFR 14.127: Membership of TEPRSSC.
  247. EMEA-002559-PIP04-21 - paediatric investigation plan
  248. ema-lescol-referralLescol - referral
  249. European Medicines Agency provides update on electronic submission of information on…
  250. EU/3/20/2352 - orphan designation for treatment of fibrodysplasia ossificans progressiva
  251. ema-nobivac-dp-plusNobivac DP Plus
  252. Risk-Adapted Approach to clinical trials and Risk Assessments: Example 1: Type A Risk…
  253. EU/3/10/821 - orphan designation for treatment of carbamoyl-phosphate synthase-1…
  254. PIC/S Audit Checklist - Interpretation Guide
  255. PSUSA00010291202106 - periodic safety update report single assessment
  256. Clinical Trials Information System (CTIS): Walk-in clinic - January 2024
  257. 21 CFR 868.5630: Nebulizer.
  258. 21 CFR 884.5380: Contraceptive tubal occlusion device (TOD) and introducer.
  259. 21 CFR 60.28: Time frame for determining regulatory review periods.
  260. ema-cimalgexCimalgex
  261. ema-nuzyraNuzyra
  262. UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
  263. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31…
  264. Ustekinumab 45mg/0.5 ml Injection, Autoinjector
  265. Recombinant Hepatitis E Vaccine (E. Coli)
  266. cfr-21-cfr-17-47-appeals21 CFR 17.47: Appeals.
  267. Policy: Principles for Claims Relating to Comparison of Non-therapeutic Aspects of…
  268. FDA strengthens warnings and changes prescribing instructions to decrease the risk of…
  269. ema-esignature-webinareSignature webinar
  270. NOTICE - regardingLaunch of export NOC module under SUGAM Portal
  271. Bisoprolol Fumarate IP + Telmisartan IP + Chlorthalidone IP (2.5mg + 20mg + 6.25mg & 5mg +…
  272. ema-meloxivetMeloxivet
  273. EU/3/14/1258 - orphan designation for treatment of soft tissue sarcoma
  274. EU/3/14/1332 - orphan designation for prevention of ischaemia/reperfusion injury…
  275. 16th meeting of the Committee for Orphan Medicinal Products
  276. 21 CFR 866.2360: Selective culture medium.
  277. Consultation on updated guideline on clinical development of medicines for treatment of…
  278. January 22, 2026: Tobacco Products Scientific Advisory Committee Meeting - 01/22/2026
  279. Enabling Innovation—Through Regulation? An ISC Conversation
  280. PSUSA/00001834/201704 - periodic safety update report single assessment
  281. Nobilis Multriva RT+IBm+ND+Gm+REOm
  282. 21 CFR 1.231: How and where do you register or renew your registration?
  283. Overview of the current regulatory testing requirements for veterinary medicinal products…
  284. ema-onglyzaOnglyza
  285. ema-byoovizByooviz
  286. Public Statement on Viagra and Patrex
  287. 21 CFR 878.4840: Absorbable polydioxanone surgical suture.
  288. Ninth industry stakeholder platform on research and development support
  289. 21 CFR 74.3106: D&C Blue No. 6.
  290. ema-tribrissen-referralTribrissen - referral
  291. Appendix 8 Guideline on the Registration of Human Plasma-derived Therapeutic Products
  292. Clinical efficacy and safety: dermatologicals
  293. Suplatast Tosilate 100mg Capsule
  294. Good Manufacturing Practices - Audit Report Form (FRM-0211)
  295. Committee for Medicinal Products for Veterinary Use (CVMP): 7-9 June 2011
  296. ema-pioglitazone-actavisPioglitazone Actavis
  297. cdsco-trastuzumabTrastuzumab
  298. HSPA's New President Monique Jelks on the Future of the Sterile Processing Profession
  299. PSUSA/00010582/201909 - periodic safety update report single assessment
  300. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 August 2012
  301. Pharmacovigilance fees – Information for companies on fees for safety monitoring of…
  302. EMEA-001768-PIP02-15-M03 - paediatric investigation plan
  303. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
  304. February 14, 2020: Tobacco Products Scientific Advisory Committee Meeting - 02/14/2020
  305. The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  306. 21 CFR 888.3015: Bone heterograft.
  307. cdsco-saroglitazar-magnesiumSaroglitazar Magnesium
  308. 21 CFR 864.9550: Lectins and protectins.
  309. 21 CFR 10.100: Public calendar.
  310. Drug Safety Update: monthly PDF newsletter: Drug Safety Update January 2022
  311. Research Focus: Surgical Masks, COVID-19, and Endoscope Outbreaks
  312. EMEA-003246-PIP01-22 - paediatric investigation plan
  313. ema-ovitrelleOvitrelle
  314. ema-aquildaAquilda
  315. EU/3/05/340 - orphan designation for treatment of myelodysplastic / myeloproliferative…
  316. Resmetirom tablet 60,80 & 100mg
  317. Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
  318. cdsco-etanercept-lupinEtanercept Lupin
  319. Notice regarding documents required for the Import
  320. ema-ledagaLedaga
  321. Medicine shortages: EU network takes steps to improve reporting and communication
  322. Sean Loughlin: The ‘So Cool’ Story of a Teen, a 3D Printer, Medical Technology, and One…
  323. European Medicines Agency recommends suspension of Hexavac
  324. 21 CFR 874.4720: Mediastinoscope and accessories.
  325. Review of testosterone-containing medicines started
  326. Committee for Medicinal Products for Veterinary Use (CVMP): 08-10 October 2019
  327. 2024.02.05 S.O. 476(E) Revoke of notification GSR 144(E) dated 17.02.2017 Oseltamivir and…
  328. 21 CFR 74.2208: D&C Green No. 8.
  329. Vildagliptin (as sustained release form) + Metformin Hydrochloride (as sustained release…
  330. Validation of immunoassay for the detection of antibody to human immunodeficiency virus in…
  331. European conference on rare diseases and orphan products (ECRD 2014)
  332. Refusal of orphan designation for treatment of acute uncomplicated plasmodium falciparum…
  333. Guidance for completing SFDA On-line MDMA Application Form: CANADIAN Jurisdiction
  334. Registration opens for workshop on dose finding at the European Medicines Agency
  335. ema-sabervelSabervel
  336. Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 June 2016
  337. Data on medicines (ISO IDMP standards): research and development
  338. European Medicines Agency/International Federation for Animal Health-Europe info day 2015
  339. 21 CFR 880.6850: Sterilization wrap.
  340. Key principles for the use of electronic product information for EU medicines
  341. Increased fees coming into effect on 1 April 2013
  342. Chapter 4 - Nicotine Dose Guidance Northern Ireland: Chapter 4 - Nicotine Dose Guidance…
  343. ema-velcadeVelcade
  344. 21 CFR 864.9300: Automated Coombs test systems.
  345. Committee for veterinary medicinal products: 44th meeting
  346. 21 CFR 866.3400: Parainfluenza virus serological reagents.
  347. EMEA-000968-PIP02-11-M05 - paediatric investigation plan
  348. ema-spor-status-updateSPOR Status Update
  349. CMDh confirms that methylprednisolone injections containing lactose must not be given to…
  350. EU/3/21/2540 - orphan designation for treatment of SCN8A developmental and epileptic…
  351. ESAs - New dosing recommendations to improve the safe use of Erythropoiesis-Stimulating…
  352. 21 CFR 56.103: Circumstances in which IRB review is required.
  353. Importing investigational medicinal products into Great Britain from approved countries…
  354. cdsco-eftilagimod-alfaEftilagimod alfa
  355. ema-zuprevoZuprevo
  356. Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines - referral
  357. FDA investigating possible increased risk of death with lymphoma medicine Ukoniq…
  358. Leadless cardiac pacemaker therapy : new guidance from an MHRA Expert Advisory Group
  359. 21 CFR 74.3230: D&C Red No. 17.
  360. Biphasic Insulin Aspart Injection I.P. 30/70
  361. EU/3/04/241 - orphan designation for treatment of idiopathic pulmonary fibrosis
  362. 21 CFR 870.2786: Hardware and software for optical camera-based measurement of pulse rate…
  363. EMEA-001161-PIP02-11-M03 - paediatric investigation plan
  364. DARWIN EU Advisory Board meeting: 3 May 2024
  365. DR_G.S.R. 395(E) dt_19.05.1999_26A_reg FDC of Metoclopramide and Aspirin, Paracetamol
  366. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10…
  367. PSUSA/00001720/201611 - periodic safety update report single assessment
  368. Committee for Medicinal Products for Human Use (CHMP): 13-16 February 2012
  369. ema-union-product-databaseUnion Product Database
  370. GMP Conformity Assessment of an Overseas Manufacturer (GUIDE-MQA-020)
  371. 21 CFR 890.5660: Therapeutic massager.
  372. EU/3/15/1545 - orphan designation for treatment of acute myeloid leukaemia
  373. Xaluprine (previously Mercaptopurine Nova Laboratories)
  374. 21 CFR 880.5150: Nonpowered flotation therapy mattress.
  375. Reproduce or re-use MHRA information: Application form for published material
  376. 21 CFR 20.100: Applicability; cross-reference to other regulations.
  377. 21 CFR 872.3100: Dental amalgamator.
  378. Calendulae flos - herbal medicinal product
  379. UK Launches New Association for Medical Device Approved Bodies
  380. EMEA-000573-PIP02-13-M03 - paediatric investigation plan
  381. Committee for veterinary medicinal products: Meeting of 13 to 14 May 2003
  382. Drug Alert list for month of April 2014
  383. Committee for Herbal Medicinal Products (HMPC): 2-4 March 2020
  384. Reconstitution of Central Expert Committee to determine the quantum of compensation in…
  385. Bedaquiline Tablets 100mg
  386. EMEA-002420-PIP01-18 - paediatric investigation plan
  387. Sodium Zirconium Cyclosilicatec
  388. EU/3/06/360 - orphan designation for treatment of vernal keratoconjunctivitis
  389. Action in pursuance to the investigation_Denvax Clinic
  390. Progress made in the operation of EU pharmacovigilance legislation
  391. Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA…
  392. ema-canakinumab-novartisCanakinumab Novartis
  393. Drug Alert list for month of January 2020
  394. 21 CFR 878.4660: Skin marker.
  395. ICH Q10 Pharmaceutical quality system - Scientific guideline
  396. Basiron AC and associated names - referral
  397. 2020 AAMI Bright Ideas Winner Looks to the Future
  398. Azelastine Hydrohloride 1 mg/ml Nasal Spray
  399. ema-evicelEvicel
  400. 21 CFR 80.31: Certification.
  401. PSUSA/00002345/201812 - periodic safety update report single assessment
  402. EU/3/09/645 - orphan designation for treatment of acromegaly
  403. EMEA-001506-PIP02-14-M01 - paediatric investigation plan
  404. Interested Parties to the HMPC
  405. European Medicines Agency closed 13-17 April 2017
  406. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2019 (SI…
  407. cdsco-trastuzumabbioTrastuzumabbio
  408. 21 CFR 874.4250: Ear, nose, and throat electric or pneumatic surgical drill.
  409. 21 CFR 872.3770: Temporary crown and bridge resin.
  410. Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in…
  411. EU/3/12/988 - orphan designation for treatment of Duchenne muscular dystrophy
  412. European Medicines Agency, European Commission and Health Canada agree implementation plan…
  413. PSUSA/00002001/201804 - periodic safety update report single assessment
  414. ema-nilemdoNilemdo
  415. Novel Corona Virus Vaccine -2019-nCov Vaccine (3mg dose- 28 days Schedule)
  416. Domperidone-containing medicines - referral
  417. PSUSA/00000788/202304 - periodic safety update report single assessment
  418. Reporting the results of population pharmacokinetic analyses - Scientific guideline
  419. Bepotastine besilate JP Montelukast Sodium IP tablets (Phase III)
  420. EU/3/16/1813 - orphan designation for treatment of haemophilia A
  421. Veterinary medicinal products containing toltrazuril to be administered orally to chickens…
  422. Assessment and procurement of coronavirus (COVID-19) tests: National standardised test…
  423. EMEA-003016-PIP01-21 - paediatric investigation plan
  424. Suramox 15 % LA and its associated name Stabox 15 % LA - referral
  425. PSUSA/00002025/201803 - periodic safety update report single assessment
  426. Committee for Medicinal Products for Human Use (CHMP): 12-15 November 2012
  427. ema-hexacimaHexacima
  428. Donna Swenson: At the Intersection of Science and Perception
  429. EU/3/16/1643 - orphan designation for treatment of systemic sclerosis
  430. EMEA-002218-PIP01-17 - paediatric investigation plan
  431. Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2019
  432. Efficacy Working Party documents
  433. Medical Device Good Manufacturing Practice (GMP) Regulations
  434. ema-contaceraContacera
  435. Compliance Monitor (CM) Overview and Application Process: Compliance Monitor application…
  436. EMA Management Board: highlights of October 2019 meeting
  437. DR_G.S.R. 733(E) dt_29.09.2012_Corregendum of GSR 270(E) dt 30.03.2012
  438. NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE-2022
  439. Seminar on recent developments in European Pharmacovigilance and Risk Management
  440. Hybrid Closed Loop Insulin Delivery System approved for marketing
  441. PSUSA/00010570/202302 - periodic safety update report single assessment
  442. Workshop on Paediatric pain
  443. European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare…
  444. PSUSA/00010561/201706 - periodic safety update report single assessment
  445. Tissue Mimicking Material (TMM) for Preclinical Acoustic Performance Characterization of…
  446. EU/3/23/2832 - orphan designation for treatment of Smith-Magenis syndrome
  447. cdsco-beclomethasoneBeclomethasone
  448. PSUSA/00010377/202204 - periodic safety update report single assessment
  449. Educational materials and associated distribution plans
  450. Regulatory requirements for new application and subsequent submissions
  451. EMEA-001110-PIP01-10-M01 - paediatric investigation plan
  452. Core summary of product characteristics (SmPC) and package leaflet for (99Mo/99mTc)…
  453. PSUSA/00009076/201506 - periodic safety update report single assessment
  454. Committee for Herbal Medicinal Products (HMPC): 22-24 September 2025
  455. Esmya / Ulipristal Acetate Gedeon Richter - direct healthcare professional communication…
  456. Innovative Healthcare Shifts Toward "Hospital at Home" Model
  457. EMEA-000733-PIP02-12 - paediatric investigation plan
  458. GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2025…
  459. Paediatric Committee (PDCO): 28-30 April 2020
  460. ema-support-to-researchSupport to research
  461. ema-increlexIncrelex
  462. Product defects and recalls
  463. Guidance for the use of medicinal cannabis in Australia: Overview
  464. Necessity of initiatives to stimulate the conduct of clinical studies with herbal…
  465. Revision of Q & A for "Planning of the Pediatric Drug Development Program during…
  466. EU/3/05/295 - orphan designation for prevention of recurrent hepatitis C virus induced…
  467. ema-mabcampathMabCampath
  468. Does India’s ICMED Plus Scheme Defy Standards Harmonization?
  469. Template for a public statement when no European Union herbal monograph is established
  470. cfr-21-cfr-809-3-definitions21 CFR 809.3: Definitions.
  471. EMEA-000452-PIP02-10-M06 - paediatric investigation plan
  472. PSUSA/00002598/202111 - periodic safety update report single assessment
  473. EU/3/24/2949 - orphan designation for treatment of peripheral T-cell lymphoma
  474. Drug Alert list for month of October 2022 (Revised)
  475. Trospium chloride+Xanomeline tartrate
  476. Voices of HTM: Heidi Horn
  477. Paediatric rheumatology expert group meeting
  478. Comments invited on draft reflection paper on data requirements for iron-based…
  479. EU/3/07/507 - orphan designation for treatment of glioma
  480. Committee for Advanced Therapies issues first recommendation for certification of…
  481. EMEA-002239-PIP01-17 - paediatric investigation plan
  482. Keytruda - opinion on variation to marketing authorisation
  483. 21 CFR 864.9165: Blood establishment computer software and accessories.
  484. FDA Advises on Cybersecurity Concerns in Annual Forum
  485. EMEA-002647-PIP01-19 - paediatric investigation plan
  486. European Medicines Agency's Management Board nominates Guido Rasi as Executive Director
  487. PSUSA/00010145/201708 - periodic safety update report single assessment
  488. FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML)…
  489. Committee for Orphan Medicinal Products (COMP): 17-19 March 2026
  490. 21 CFR 864.9285: Automated cell-washing centrifuge for immuno-hematology.
  491. EMEA-001573-PIP01-13 - paediatric investigation plan
  492. Team-NB sector survey in 2016
  493. Chemistry of active substances for veterinary medicinal products - Scientific guideline
  494. ema-credelioCredelio
  495. Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products…
  496. Topical Drug Products (7/94)
  497. Datopotamab Deruxtecan (Dato-DXd)
  498. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29…
  499. 1st EMEA/CPMP Workshop for Patients' Organisations – Information and Participation
  500. EMEA-001483-PIP01-13 - paediatric investigation plan
  501. EMEA-002527-PIP01-18 - paediatric investigation plan
  502. FDA Issues Draft Guidance on use of 'Real-World Data'
  503. EMEA-001006-PIP03-16 - paediatric investigation plan
  504. Expert meeting on neonatal and paediatric sepsis
  505. ICH guideline E17 on general principles for planning and design of multi-regional clinical…
  506. EU/3/07/430 - orphan designation for treatment of malaria
  507. EMEA-002934-PIP01-20 - paediatric investigation plan
  508. Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous…
  509. Update on review of valsartan medicines due to detection of NDMA: EMA reviewing valsartan…
  510. EU/3/07/475 - orphan designation for treatment of cystic fibrosis
  511. ema-singulair-referralSingulair - referral
  512. European Medicines Agency (EMA) Human Scientific Committees' Working Parties with…
  513. Clinical trials for medicines: non-investigational medicinal products
  514. Change Notification applications arising from the EU MDR/IVDR related changes to…
  515. After 30 Years in AAMI Standards, Cliff Bernier Takes a Bow
  516. Epinephrine plus Vasopressin
  517. Ibuprofen Kabi 400 mg Infusionslösung and associated names - referral
  518. PSUSA/00010287/201511 - periodic safety update report single assessment
  519. European Medicines Agency starts review of Gilenya (fingolimod)
  520. 21 CFR 19.10: Food and Drug Administration Conflict of Interest Review Board.
  521. cdsco-lumateperoneLumateperone
  522. 21 CFR 10.80: Dissemination of draft Federal Register notices and regulations.
  523. 21 CFR 862.1190: Copper test system.
  524. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 April 2015
  525. EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA…
  526. Committee for Orphan Medicinal Products (COMP): 8-10 October 2013
  527. Considerations for the General Toxicity Evaluation of Monoclonal Antibodies (Early…
  528. Inspection/Audits of Pharmacovigilane(PV) system of importers and manufactures of human…
  529. EU/3/18/2047 - orphan designation for treatment of phosphomannomutase 2-congenital…
  530. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.13) Regulations…
  531. Regulation of advanced therapy medicines
  532. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22…
  533. ema-fanaptumFanaptum
  534. Menotropin - direct healthcare professional communication (DHPC)
  535. Leveraging Medical Device Architectures for Better Alignment of Risk Mitigation Approaches
  536. European Medicines Agency closed 5-9 April 2012
  537. Notice - Opportunity to be Heard in the Suspension of a Medical Device Licence
  538. EMEA-003306-PIP01-22 - paediatric investigation plan
  539. MDR_G.S.R.224(E) dt_18.03.2019_Amendment in Environmental requirements for mfg. of Medical…
  540. iRhythm and Verily Receive FDA Clearance for Zio Watch to Detect AFib
  541. Paediatric strategy forum for medicinal product development of checkpoint inhibitors for…
  542. EU/3/23/2874 - orphan designation for treatment of systemic sclerosis
  543. EU cooperation on rare diseases honoured with new EU Ombudsman prize
  544. To Regulate or Not to Regulate Medical Device Servicing? eXchange Speakers Debate
  545. 21 CFR 872.3765: Pit and fissure sealant and conditioner.
  546. ema-procedural-announcementsProcedural announcements
  547. VICH GL51 Quality: statistical evaluation of stability data - Scientific guideline
  548. cdsco-office-memorandumOffice Memorandum
  549. NMPA Issues Technical Review Guidance for the Registration of Dengue Virus Nucleic Acid…
  550. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 April 2017
  551. EMEA-000993-PIP01-10 - paediatric investigation plan
  552. PSUSA/00001812/202206 - periodic safety update report single assessment
  553. EMEA-002438-PIP01-18 - paediatric investigation plan
  554. Advance notice of importation process for cosmetics and drugs
  555. New treatment for patients with soft tissue sarcoma
  556. EMEA-000813-PIP01-09 - paediatric investigation plan
  557. EU/3/16/1789 - orphan designation for treatment of sickle cell disease
  558. Meeting of the EMEA working party on herbal medicinal products 28 and 29 October 1999
  559. 21 CFR 872.3730: Pantograph.
  560. 21 CFR 11.10: Controls for closed systems.
  561. Management Board meeting: 13 June 2013
  562. Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration…
  563. EMA reviewing cancer medicine docetaxel
  564. HMA/EMA multi-stakeholder workshop on shortages
  565. Uncariae tomentosae cortex - herbal medicinal product
  566. 21 CFR 870.4230: Cardiopulmonary bypass defoamer.
  567. Requirement of fees for change in address of authorized agent without change in…
  568. cdsco-etavopivatEtavopivat
  569. ema-ritemviaRitemvia
  570. 21 CFR 866.3040: Aspergillus spp. serological reagents.
  571. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
  572. ema-okrido-referralOkrido - referral
  573. 21 CFR 58.113: Mixtures of articles with carriers.
  574. EU/3/18/2098 - orphan designation for treatment of papillary thyroid cancer
  575. Compilation of Union procedures on inspections and exchange of information
  576. 21 CFR 1.379: How long may FDA detain an article of food?
  577. Veterinary medicines: highlights of 2017
  578. ema-adartrel-referralAdartrel - referral
  579. EMEA-000239-PIP01-08-M03 - paediatric investigation plan
  580. Regulation impact statement: Proposed regulatory scheme for personalised medical devices…
  581. EMEA-001039-PIP03-17 - paediatric investigation plan
  582. 21 CFR 16.85: Examination of administrative record.
  583. 21 CFR 866.6010: Tumor-associated antigen immunological test system.
  584. 21 CFR 20.108: Agreements between the Food and Drug Administration and other departments…
  585. PSUSA/00001827/201612 - periodic safety update report single assessment
  586. 21 CFR 886.4300: Intraocular lens guide.
  587. Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation
  588. PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks
  589. EU/3/06/349 - orphan designation for treatment of off-periods in Parkinson's disease not…
  590. 21 CFR 12.75: Disqualification of presiding officer.
  591. EU/3/17/1899 - orphan designation for treatment of retinitis pigmentosa
  592. Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin + Glimepiride IP + Metformin…
  593. 21 CFR 872.3130: Preformed anchor.
  594. Template for information exchange for the preparation of the assessment report supporting…
  595. Benefits of Diane 35 and generics outweigh risks in specific patient group
  596. 21 CFR 864.9275: Blood bank centrifuge for in vitro diagnostic use.
  597. EMEA-002109-PIP01-16 - paediatric investigation plan
  598. Guidance on Therapeutic Product Registration in Singapore
  599. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 19…
  600. cdsco-pegozafermin-49422Pegozafermin 49422
  601. EMEA-002005-PIP01-16 - paediatric investigation plan
  602. 21 CFR 892.2020: Medical image communications device.
  603. Transatlantic workshop: drug-related progressive multifocal leukoencephalopathy
  604. Standards Spotlight: AAMI Standards Department Restructured to Meet Dynamic Needs
  605. Emergency Use Authorizations for the Decontamination of N95 Respirators
  606. 21 CFR 898.12: Performance standard.
  607. Extraordinary Management Board meeting on CTIS audit
  608. cdsco-ivd-office-orderIVD Office Order
  609. Drug Alert list for month of March 2023
  610. EMEA-000351-PIP01-08 - paediatric investigation plan
  611. EMEA-002845-PIP01-20 - paediatric investigation plan
  612. EU/3/02/131 - orphan designation for treatment of narcolepsy
  613. Increased Risk of Corneal Haze Associated with the Raindrop Near Vision Inlay: FDA Safety…
  614. 21 CFR 888.3650: Shoulder joint metal/polymer non-constrained cemented prosthesis.
  615. cdsco-umifenovir-tabletUmifenovir Tablet
  616. 21 CFR 884.1425: Perineometer.
  617. Virtual live hands-on training course for clinical trials sponsors using EudraVigilance…
  618. 21 CFR 812.40: General responsibilities of sponsors.
  619. Zika Virus Vaccine (Adsorbed), Zika Virus Vaccine (Adsorbed)
  620. Jcovden (previously COVID-19 Vaccine Janssen) - direct healthcare professional…
  621. ema-regranexRegranex
  622. Use of big data to improve human and animal health
  623. Labelling and packaging of medicinal products for human use following agreement of the…
  624. PSUSA/00010913/202306 - periodic safety update report single assessment
  625. 21 CFR 862.3030: Acetaminophen test system.
  626. Atazanavir Viatris (previously Atazanavir Mylan)
  627. NovoSeven - direct healthcare professional communication (DHPC)
  628. Cranial Perforators with an Automatic Clutch Mechanism, Failure to Disengage: FDA Safety…
  629. Tormentillae rhizoma - herbal medicinal product
  630. PSUSA/00010345/201702 - periodic safety update report single assessment
  631. Committee for Medicinal Products for Veterinary Use (CVMP): 12-14 January 2010
  632. Regulatory changes to importing, supplying and advertising nicotine vaping products
  633. EMEA-003125-PIP02-21 - paediatric investigation plan
  634. ICH Considerations: oncolytic viruses - Scientific guideline
  635. Update on human variations web-based electronic application form implementation on product…
  636. Mavenclad - direct healthcare professional communication (DHPC)
  637. EU/3/22/2624 - orphan designation for treatment of soft tissue sarcoma
  638. PSUSA/00003023/201707 - periodic safety update report single assessment
  639. Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for…
  640. November 4, 2016: Meeting of the Antimicrobial Drugs Advisory Committee - 11/03/2016
  641. Clinical evaluation of direct acting antiviral agents intended for treatment of chronic…
  642. EMEA-002232-PIP02-19-M02 - paediatric investigation plan
  643. cdsco-tenalisib-400mg-tabletTenalisib 400mg Tablet
  644. ema-multaqMultaq
  645. European Medicines Agency recommends precautionary recall of batches of…
  646. Clinical Trials Information System (CTIS): Walk-in clinic - April 2023
  647. Risk management plan information day
  648. GN-21-R4.5 Guidance on Change Notification for Registered Medical Devices [ARCHIVED on 30…
  649. PSUSA/00001639/201704 - periodic safety update report single assessment
  650. PSUSA/00001491/201801 - periodic safety update report single assessment
  651. ICH E4 Dose response information to support drug registration - Scientific guideline
  652. EU/3/16/1657 - orphan designation for treatment of biliary tract cancer
  653. ema-piqrayPiqray
  654. ema-real-world-evidenceReal-world evidence
  655. EMEA-002654-PIP02-19 - paediatric investigation plan
  656. Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women…
  657. EU/3/22/2719 - orphan designation for treatment of adrenoleukodystrophy
  658. EMEA-002646-PIP01-19 - paediatric investigation plan
  659. cdsco-tigilanol-tiglateTigilanol Tiglate
  660. Committee for Proprietary Medicinal Products (CPMP) 20th plenary meeting
  661. Stability testing: requirements for new dosage forms (ICH Q1C)
  662. Guide to Clinical Investigations carried out in Ireland
  663. AZD0780 30mg Tablet or PlaceboAZ
  664. PSUSA/00010489/202105 - periodic safety update report single assessment
  665. European Medicines Agency seeking participants for website user-experience research
  666. 21 CFR 14.100: List of standing advisory committees.
  667. 2006 EMEA/IFAH-Europe Info Day: 'Stimulating innovation and managing risk in market access…
  668. 21 CFR 862.1260: Estradiol test system.
  669. Notice for Online Clinical Trial Application and Monitoring System (OCTAMS)
  670. Veterinary medicines: highlights of 2015
  671. PSUSA/00000461/202112 - periodic safety update report single assessment
  672. EU/3/23/2861 - orphan designation for treatment of soft-tissue sarcoma
  673. EU/3/18/1993 - orphan designation for treatment of neuronal ceroid lipofuscinosis
  674. EudraVigilance training on electronic reporting of individual case safety reports in the…
  675. Lapatinib ditosylate monohydrate - paediatric investigation plan
  676. Medical devices that need a clinical investigation
  677. Calculation of dose factor to be submitted to the Union Product Database (UPD)…
  678. EU/3/15/1513 - orphan designation for treatment of hepatoblastoma
  679. Committee for Herbal Medicinal Products (HMPC): 7-9 July 2025
  680. 21 CFR 892.5750: Radionuclide radiation therapy system.
  681. Paediatric Committee (PDCO): 23-25 April 2014
  682. EMEA-000847-PIP01-10-M01 - paediatric investigation plan
  683. Committee for Orphan Medicinal Products (COMP): 5-6 February 2013
  684. EMEA Public Statement on the Recommendation to suspend the marketing authorisation for…
  685. 21 CFR 866.5270: C-reactive protein immunological test system.
  686. EU/3/15/1490 - orphan designation for treatment of non-infectious uveitis
  687. Essential Principles checklist
  688. EMEA-003098-PIP01-21 - paediatric investigation plan
  689. EMEA-001941-PIP01-16 - paediatric investigation plan
  690. First survey on patients' involvement in the European Medicines Agency's work reveals high…
  691. FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for…
  692. PSUSA/00002150/202005 - periodic safety update report single assessment
  693. Cancellation of Registration Certificates and lmport Registration Numbers for lmport of…
  694. Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting…
  695. ema-nobivac-leufelNobivac LeuFel
  696. PSUSA/0001026/201512 - periodic safety update report single assessment
  697. 2021 AAMI Business Meeting to Take Place on June 5
  698. FDA determines 2013 labeling adequate to manage risk of retinal abnormalities, potential…
  699. Notice: Transition to the Revised Version of ISO 13485 and its impact on the Compliance to…
  700. EU/3/23/2784 - orphan designation for treatment of chronic inflammatory demyelinating…
  701. nbcg-team-nb-member-list-28TEAM-NB Member-List-28
  702. EMEA-000742-PIP01-09 - paediatric investigation plan
  703. EU/3/02/112 - orphan designation for treatment of hepatocellular carcinoma
  704. IVD companion diagnostics
  705. EMEA-000898-PIP01-10-M02 - paediatric investigation plan
  706. ema-mizollen-referralMizollen - referral
  707. cdsco-aprodustataprodustat
  708. ema-canadaCanada
  709. ema-zynlontaZynlonta
  710. EMEA-001200-PIP01-11 - paediatric investigation plan
  711. ACMD meeting statement, Meeting 34, 22 June 2017
  712. EMEA-000841-PIP01-10 - paediatric investigation plan
  713. Demonstration of efficacy for veterinary medicinal products containing anticoccidial…
  714. 21 CFR 807.81: When a premarket notification submission is required.
  715. Guide to Placing Medical Device Standalone Software on the Market
  716. ema-vargatefVargatef
  717. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March…
  718. DR_G.S.R. 552(E) dt_04.12.1996_Amendment to Rule 49_Proviso included
  719. Literature-based submissions for listed medicines and registered complementary medicines
  720. ema-vascace-plus-referralVascace Plus - referral
  721. PSUSA/00000923/201812 - periodic safety update report single assessment
  722. EMEA-000956-PIP01-10 - paediatric investigation plan
  723. Core summary of product characteristics for human plasma derived antithrombin - Scientific…
  724. Nivolumab Concentrate for solution for infusion, 100 mg/10 mL (10 mg/mL)
  725. EU/3/05/299 - orphan designation for treatment of pancreatic cancer
  726. ema-tecentriqTecentriq
  727. Updation of exisiting risk based classification list_draft_dated 06 01 2025 for…
  728. 2026.08.14 G.S.R. 744(E)_Amendment in MD Rules, 2017 for inclusion of EU countries in Rule…
  729. Zubrin - withdrawal of application for variation to marketing authorisation
  730. ema-sitagliptin-accordSitagliptin Accord
  731. AU F0033.001 REPs User Access Request Form
  732. Introduction to Organisation Management Service (OMS) and Referentials Management Service…
  733. PSUSA/00010466/201610 - periodic safety update report single assessment
  734. EU/3/16/1688 - orphan designation for treatment of Prader-Willi syndrome
  735. 21 CFR 886.1840: Simulatan (including crossed cylinder).
  736. Thiomersal in vaccines for human use - recent evidence supports safety of…
  737. Committee for medicinal products for veterinary use: Meeting of 15-17 July 2008
  738. Supplier assessment, approval and qualification for listed and complementary medicines
  739. PSUSA/00000130/201909 - periodic safety update report single assessment
  740. Guidance on applying human factors to medical devices
  741. EMA regular press briefing on COVID-19 and monkeypox
  742. Training for the Future with VR
  743. 21 CFR 73.1298: Ferric ammonium ferrocyanide.
  744. Drug Alert list for month of July 2019
  745. ema-xalkoriXalkori
  746. Vaccines and Related Biological Products Advisory Committee September 22, 2022 Meeting…
  747. Committee for Herbal Medicinal Products (HMPC): 18-19 September 2017
  748. Committee for Herbal Medicinal Products (HMPC): 4-5 April 2016
  749. ema-mirceraMircera
  750. EMEA-000834-PIP01-10 - paediatric investigation plan
  751. 21 CFR 876.5982: Ingested, transient, space occupying device for weight management and/or…
  752. Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment…
  753. EU/3/12/1046 - orphan designation for treatment of fragile X syndrome
  754. Team-NB PositionPaper MDR Transition Timelines Notified Body Capacity V1
  755. 21 CFR 866.5580: Alpha-1-lipoprotein immunological test system.
  756. EMEA announces new Head of Unit for Communications and Networking
  757. UPDATED PUBLIC PARTICIPATION INFORMATION: June 10, 2024: Meeting of the Peripheral and…
  758. 21 CFR 864.9575: Environmental chamber for storage of platelet concentrate.
  759. European Medicine Agency: Committee for Medicinal Products for Human Use, 27-29 July 2004
  760. PSUSA/00000471/202102 - periodic safety update report single assessment
  761. NMPA Notice on Conducting a Pilot Program for Electronic Labeling of Cosmetics GYJZ [2025]…
  762. EMA mourns passing of Noël Wathion
  763. FDA Expected to Publish Final QMSR Rule Soon
  764. Drug Safety Update: monthly PDF newsletter: Drug Safety Update January 2023
  765. EU/3/11/876 - orphan designation for treatment of 5q spinal muscular atrophy
  766. EU/3/19/2189 - orphan designation for treatment of cystic fibrosis
  767. EU/3/05/325 - orphan designation for treatment of cystic fibrosis
  768. Paediatric Committee (PDCO): 15-17 August 2012
  769. EMEA-001323-PIP02-12 - paediatric investigation plan
  770. 21 CFR 3.6: Product jurisdiction officer.
  771. EU/3/24/2951 - orphan designation for treatment of spinocerebellar ataxia
  772. EU/3/21/2534 - orphan designation for treatment of osteogenesis imperfecta
  773. Pneumococcal polysaccharide conjugate vaccine (Adsorbed) (14 Valent)
  774. P/22/2011 - paediatric investigation plan
  775. Partial Revision of “Questions and Answers (Q&A) on the Operation of the Standards for…
  776. Establishment of maximum residue limits for milk considering the daily intake by children…
  777. ema-lenvimaLenvima
  778. DR_G.S.R. 203(E) dt_18.03.2015_Amendment Sch S, SchQ
  779. cdsco-ovidone-iodineovidone -Iodine
  780. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9…
  781. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - June 2015
  782. Active ingredient categories for medicinal cannabis products
  783. 2022.11.02_S.O. 5090(E)_Notification of eligible officers at CDTL Chennai as Govt Analyst…
  784. 21 CFR 862.3150: Barbiturate test system.
  785. DR_G.S.R. 317(E) dt_18.04.2019_Amendment in Form 45 and Form 46 under Schedule-A of D&C…
  786. Committee for Orphan Medicinal Products (COMP): 30-31 October 2017
  787. 21 CFR 874.4760: Nasopharyngoscope (flexible or rigid) and accessories.
  788. Reporting adverse incidents: biological and mechanical surgical heart valves: Artificial…
  789. EU/3/16/1609 - orphan designation for treatment of autoimmune haemolytic anaemia
  790. 21 CFR 20.54: Request for review without copying.
  791. Withdrawal of marketing authorisations for fenspiride medicines
  792. EU/3/22/2616 - orphan designation for treatment of limb-girdle muscular dystrophy
  793. PSUSA/00010439/201607 - periodic safety update report single assessment
  794. ema-florgane-referralFlorgane - referral
  795. Meetings management procedures
  796. EU/3/21/2431 - orphan designation for treatment of multiple system atrophy
  797. Etanercept - paediatric investigation plan
  798. Pioglitazone Teva Generics
  799. 'Hire Our Students!' How a Canadian HTM Pipeline Combats U.S. Hiring Woes
  800. aami-in-memoriam-sean-h-genIn Memoriam: Sean Hägen
  801. Committee for Orphan Medicinal Products (COMP): 8-9 June 2011
  802. NMPA Issued the Administrative Measures for Drug Quality Sampling Inspection
  803. EMEA-002133-PIP01-17-M03 - paediatric investigation plan
  804. Updated recommendations to decrease risk of spinal column bleeding and paralysis in…
  805. cdsco-tp-102TP-102
  806. EU/3/12/1002 - orphan designation for treatment of glioma
  807. Quadrivalent Influenza vaccine (Split Virion, Inactivated)
  808. ema-teriflunomide-accordTeriflunomide Accord
  809. 21 CFR 862.1225: Creatinine test system.
  810. 21 CFR 1.1390: When will modified requirements that we adopt or an exemption that we grant…
  811. Favipiravir Tablet 200/400/800 mg
  812. Requirements for the quality (production and control), safety and efficacy of allergen…
  813. EMEA-002457-PIP01-18 - paediatric investigation plan
  814. Workshop on Paediatric Regulation – stakeholders to discuss how to boost development of…
  815. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019
  816. PSUSA/00002921/202206 - periodic safety update report single assessment
  817. 21 CFR 830.10: Incorporation by reference.
  818. Online training course for bioequivalence inspectors
  819. Withdrawn applications and products
  820. European Medicines Agency website unavailable Sunday 1 December 2013
  821. ISC21: Standards and Regulations Meet Increasingly Complex Cyberthreats
  822. William ‘Bill’ Hyman, Dedicated Educator, Dies
  823. ema-soludox-referralSoludox - referral
  824. EMA to encourage use of scientific advice for post-authorisation safety studies
  825. Social Media Proves Useful for Training in Healthcare
  826. Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020
  827. ema-ninlaroNinlaro
  828. cdsco-remdesivir-100-mghRemdesivir 100 mgh
  829. 21 CFR 878.4670: Internal tissue marker.
  830. Paediatric Committee (PDCO): 21-24 June 2022
  831. Glycopyrrolate IP + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate Inhalation…
  832. Updated rules for clinical development of vaccines
  833. European Medicines Agency recommends changes to the use of metoclopramide
  834. PSUSA/00009231/202305 - periodic safety update report single assessment
  835. EU/3/19/2143 - orphan designation for treatment of small cell lung cancer
  836. Call for experts in anonymisation of clinical data
  837. PRAC review does not confirm increase in heart problems with testosterone medicines
  838. cdsco-nov-12-2010-g-s-r-910eNov 12, 2010 (G.S.R 910E)
  839. cfr-21-cfr-7-1-scope21 CFR 7.1: Scope.
  840. EU/3/01/081 - orphan designation for treatment of diarrhoea associated with intestinal…
  841. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2013
  842. Nyxthracis (previously Obiltoxaximab SFL)
  843. Dimethyl fumarate product-specific bioequivalence guidance
  844. ema-bimzelxBimzelx
  845. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 4…
  846. Twenty-sixth meeting of the Management Board
  847. PSUSA/00010417/201901 - periodic safety update report single assessment
  848. EMEA-001702-PIP01-14 - paediatric investigation plan
  849. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (11-valent)
  850. Inclusion of antioxidants and antimicrobial preservatives in medicinal products…
  851. EU/3/09/674 - orphan designation for prevention of scarring post glaucoma filtration…
  852. 2024.02.05_DR_G.S.R. 95(E)_Inclusion of Oseltamivir and Zanamivir in Schedule H1
  853. FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
  854. Tocilizumabconcentrate for solution for IV infusion
  855. Announcement of NMPA and General Administration of Customs on the Establishment of Aidian…
  856. Committee for Medicinal Products for Human Use (CHMP): 19-22 July 2010
  857. PSUSA/00002669/202112 - periodic safety update report single assessment
  858. Orphan medicines development in Europe and Japan
  859. ema-pixuvriPixuvri
  860. Gliolan - direct healthcare professional communication (DHPC)
  861. Sales of antibiotics for animal use have almost halved between 2011-2021
  862. 21 CFR 4.1: What is the scope of this subpart?
  863. Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney…
  864. Orphan drug designation eligibility criteria
  865. First DNA vaccine in the EU recommended for use in salmon
  866. Public consultation opens on draft guideline on biosimilars containing…
  867. Pre-screening checklist3
  868. PSUSA/0464/201907 - periodic safety update report single assessment
  869. Committee for Advanced Therapies (CAT): 16-18 June 2021
  870. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5…
  871. PSUSA/00000437/201609 - periodic safety update report single assessment
  872. Refusal of orphan designation for treatment of uraemic pruritus
  873. EMEA-000189-PIP01-08 - paediatric investigation plan
  874. 21 CFR 874.5370: Tongs antichoke device.
  875. EMEA-000534-PIP03-17 - paediatric investigation plan
  876. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - February 2016
  877. EU/3/09/636 - orphan designation for treatment of corneal graft rejection
  878. Carboplatin and Paclitaxel
  879. Preventing medication errors in the European Union
  880. Inactivated Salk Polio Vaccine
  881. ema-biktarvyBiktarvy
  882. cdsco-pregabalin-adjunctivePregabalin Adjunctive
  883. Importing investigational medicinal products into Great Britain from approved countries
  884. European Medicines Agency encourages companies to use electronic application tools
  885. EMEA-001716-PIP04-19 - paediatric investigation plan
  886. Healthcare Professionals' Organisations Working Party (HCPWP) workshop with academia
  887. First vaccine to protect against Ebola
  888. cdsco-molnupiravir-moderateMolnupiravir Moderate
  889. NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition…
  890. ema-sitoiganapSitoiganap
  891. PSUSA/00010751/202003 - periodic safety update report single assessment
  892. Syner-Kinase and associated names - referral
  893. Medical Device Unique Identification Database Goes Online
  894. EMEA-001909-PIP01-15 - paediatric investigation plan
  895. EU/3/19/2220 - orphan designation for treatment of mantle cell lymphoma
  896. CircoMax Myco - opinion on variation to marketing authorisation
  897. PSUSA/00000495/201501 - periodic safety update report single assessment
  898. EMEA-002941-PIP01-20-M02 - paediatric investigation plan
  899. ema-prubanPruban
  900. Axel Wirth & Vidya Murthy: The Next Imperative in Medical Device Cybersecurity
  901. ema-melosolute-referralMelosolute - referral
  902. cdsco-feb-5-2015-gsr-74-eFeb 5 2015 GSR 74(E)
  903. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 April 2013
  904. PSUSA/00010543/201912 - periodic safety update report single assessment
  905. Paediatric Committee (PDCO): 13-15 July 2011
  906. 21 CFR 50.52: Clinical investigations involving greater than minimal risk but presenting…
  907. Are Anemic Notified Body Numbers the Cause of Recent EU IVDR & MDR Delays for Industry?
  908. CVMP Interested Parties’ meeting
  909. 21 CFR 874.4100: Epistaxis balloon.
  910. Q&A on Implementation of BA/BE Guideline [PDF, 64.04 KB]
  911. EMEA-002247-PIP02-17 - paediatric investigation plan
  912. 2026.06.11 S.O. 3068(E) to S.O. 3083(E)_ Prohibition of 16 FDC's
  913. 21 CFR 876.5330: Transcutaneous electrical continence device.
  914. 21 CFR 862.1840: Total 25-hydroxyvitamin D mass spectrometry test system.
  915. EMEA-002633-PIP01-19 - paediatric investigation plan
  916. EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
  917. EMEA-002028-PIP01-16-M03 - paediatric investigation plan
  918. EMEA-002907-PIP01-20-M02 - paediatric investigation plan
  919. EMEA-001183-PIP02-13 - paediatric investigation plan
  920. Chimeric murine-human anti Interleukin 6 monoclonal antibody - paediatric investigation…
  921. The European Medicines Agency mourns the passing of Jordi Llinares Garcia
  922. EMEA-000189-PIP01-08-M01 - paediatric investigation plan
  923. PSUSA/00010339/201707 - periodic safety update report single assessment
  924. Office Memorandum permission to affix the sticker indicating date of manufacture and Date…
  925. cdsco-ceritinibCeritinib
  926. P/16/2011 - paediatric investigation plan
  927. EU/3/05/270 - orphan designation for treatment of renal-cell carcinoma
  928. 21 CFR 814.114: Timeframes for reviewing an HDE.
  929. cdsco-darunavir-tablet-800mgDarunavir Tablet 800mg
  930. cdsco-baricitinibBaricitinib
  931. Dave Osborn: Sounding the Alarm at Standards Week
  932. cdsco-mirikizumabMirikizumab
  933. EU/3/23/2788 - orphan designation for treatment of inherited retinal dystrophies
  934. PSUSA/00002355/201707 - periodic safety update report single assessment
  935. EU/3/19/2202 - orphan designation for treatment of glioma
  936. Rosae flos - herbal medicinal product
  937. Guideline on adjustment for baseline covariates in clinical trials
  938. 21 CFR 892.1570: Diagnostic ultrasonic transducer.
  939. DR_G.S.R. 290(E) dt_16.04.2008_26A_reg FDCs of Salbutamol or any other drug
  940. Team-NB-MD-Sector-Survey-PressRelease-20230411
  941. EU/3/12/1085 - orphan designation for treatment of non-infectious uveitis
  942. cdsco-dydrogesteroneDydrogesterone
  943. FDA Considering a Radiation Sterilization Change Master File Pilot Program
  944. Announcement of the National Medical Products Administration and National Health…
  945. Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
  946. PSUSA/00000181/201803 - periodic safety update report single assessment
  947. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14…
  948. Drug Alert list for month of May 2022
  949. Approved bodies for medical devices
  950. Guidance on investigation of reported medical device problems (GUI-0065)
  951. EMEA-000933-PIP01-10 - paediatric investigation plan
  952. 21 CFR 872.3900: Posterior artificial tooth with a metal insert.
  953. Comparator products in Bioequivalence/Therapeutic Equivalence studies
  954. Danielle McGeary: Don't Let Fear Stand in the Way of Certification
  955. Liraglutide injection(r-DNA)
  956. EMEA-000236-PIP03-11 - paediatric investigation plan
  957. Voices of Cybersecurity: Axel Wirth
  958. Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical…
  959. ema-clopidogrel-tadClopidogrel TAD
  960. EMEA-003199-PIP01-22 - paediatric investigation plan
  961. EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19…
  962. EMEA-001900-PIP02-17-M07 - paediatric investigation plan
  963. ema-upliznaUplizna
  964. Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 15-17 June 2010
  965. Training session for patients, consumers and healthcare professionals involved in medicine…
  966. 21 CFR 801.45: Devices that must be directly marked with a unique device identifier.
  967. mhra-advice-for-consumersAdvice for consumers
  968. Tecentriq - withdrawal of application for variation to marketing authorisation
  969. Cosmetics or therapeutic goods
  970. Indacaterol Maleate eq. to Indacaterol + Budesonide IP (75mcg + 200mcg & 150mcg + 400mcg)…
  971. 21 CFR 870.2600: Signal isolation system.
  972. EMEA-003097-PIP01-21 - paediatric investigation plan
  973. Committee for Medicinal Products for Human Use (CHMP): 16-19 June 2025
  974. Replacement of cell lines used for the production of immunological veterinary medicinal…
  975. European network of paediatric research at the European Medicines Agency (Enpr-EMA)…
  976. Availability of veterinary medicines
  977. Updated information on drug interactions between Victrelis (boceprevir) and certain…
  978. EU/3/07/431 - orphan designation for treatment of glioma
  979. Transparency: Regulatory and procedural guidance
  980. REGN3500 (Itepekimab) 300 mg (150 mg/mL) Solution
  981. Global regulators work towards alignment on policy approaches and regulatory flexibility…
  982. 21 CFR 862.3080: Breath nitric oxide test system.
  983. Drug Alert list for month of August 2022
  984. Multi-stakeholder workshop on the guideline on clinical investigation of medicinal…
  985. PSUSA/00000794/201909 - periodic safety update report single assessment
  986. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16…
  987. Committee for Medicinal Products for Veterinary Use (CVMP): 8-10 September 2015
  988. eXtended EudraVigilance Medicinal Product Dictionary training course
  989. PSUSA/00002977/201412 - periodic safety update report single assessment
  990. Drug Safety Update: monthly PDF newsletter: Drug Safety Update November 2022
  991. FDA requires warning about rare but severe itching after stopping long-term use of oral…
  992. September 20, 2018: Pediatric Advisory Committee Meeting Announcement - 09/20/2018
  993. 21 CFR 1.908: What requirements apply to transportation operations?
  994. 21 CFR 868.1075: Argon gas analyzer.
  995. IEC 60601’s Fourth Edition: Here’s What to Expect
  996. The High Cost of Poor Quality
  997. PSUSA/00001529/201711 - periodic safety update report single assessment

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