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Global regulations and guidance

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

  1. Implementation Opinions on "Artificial Intelligence + Drug Regulation" issued by NMPA
  2. EMEA-001389-PIP01-12 - paediatric investigation plan
  3. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10…
  4. EU/3/07/476 - orphan designation for treatment of acute myeloid leukaemia
  5. PSUSA/00001472/201803 - periodic safety update report single assessment
  6. Notifying EMA of changes to contact persons (veterinary medicines)
  7. Stability testing for applications for variations to marketing authorisation - Scientific…
  8. Team-NB Position Paper Certificates under conditions-V1
  9. May 23, 2024: Molecular and Clinical Genetics Panel of the Medical Devices Advisory…
  10. ema-evkeezaEvkeeza
  11. Tamsulosin Hydrochloride IP (As extended release tablet) + Dutasteride IP (as film coated…
  12. ema-mylotargMylotarg
  13. PSUSA/00010000/201712 - periodic safety update report single assessment
  14. State Drug Alert for the Month of September 2024
  15. What Are the Top HTM Initiatives at the Veterans Health Administration? New Director…
  16. Committee for Advanced Therapies (CAT): 20-22 January 2021
  17. cdsco-lorlatinibLorlatinib
  18. EMEA-001117-PIP01-10 - paediatric investigation plan
  19. Suvaxyn PRRS MLV - opinion on variation to marketing authorisation
  20. cdsco-bilastine-tabBilastine tab
  21. ema-avonexAvonex
  22. Quality of water for pharmaceutical use - Scientific guideline
  23. EU/3/15/1449 - orphan designation for treatment of retinitis pigmentosa
  24. 21 CFR 872.1810: Intraoral source x-ray system.
  25. Office Memorandum regarding Clarification of Comprehensive permission for products…
  26. 21 CFR 882.4525: Microsurgical instrument.
  27. Trimetadizine ratiopharm - referral
  28. EMEA-001656-PIP01-14 - paediatric investigation plan
  29. cdsco-afatinib-bibw-2992Afatinib BiBW 2992
  30. Tenofovir disoproxil Zentiva
  31. EMA’s governance during the COVID-19 public health emergency
  32. Pradaxa - opinion on variation to marketing authorisation
  33. Guidance on medical device establishment licensing and medical device establishment…
  34. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 June 2016
  35. EU/3/13/1203 - orphan designation for treatment of diffuse large B-cell lymphoma
  36. Guide to Clinical Investigations carried out in Ireland
  37. EU/3/16/1730 - orphan designation for treatment of ornithine translocase deficiency
  38. Committee for Medicinal Products for Human Use (CHMP): 22-25 April 2013
  39. Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the…
  40. May 18, 2017: Pediatric Advisory Committee and Pediatric Ethics Subcommittee Meeting…
  41. cdsco-qaw039QAW039
  42. Medical Device Grouping Guideline with FAQ
  43. EMEA-001502-PIP01-13 - paediatric investigation plan
  44. In Memoriam: Jo-Ann Maltais
  45. Investigation into GLP-1-based diabetes therapies concluded
  46. ema-trajentaTrajenta
  47. cdsco-galcanezumabGalcanezumab
  48. PSUSA/00001453/201810 - periodic safety update report single assessment
  49. EU/3/12/982 - orphan designation for respiratory distress syndrome in premature neonates…
  50. Call for expressions of interest for civil society representatives to participate in work…
  51. FDA Drug Safety Communication: FDA approves label changes for use of general anesthetic…
  52. Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-9…
  53. 21 CFR 868.1670: Neon gas analyzer.
  54. ema-axuminAxumin
  55. ema-evoltraEvoltra
  56. AU P0029 006 Communication by AOs with RA on Organizations Participating in MDSAP
  57. Providing a separate shelf/rack for generic medicines in retail shops visible to the…
  58. European Medicines Agency website updated with new pages
  59. 21 CFR 866.5350: Fibrinopeptide A immunological test system.
  60. cdsco-brazikumabBrazikumab
  61. Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety…
  62. EMEA-002850-PIP02-21 - paediatric investigation plan
  63. ema-entecavir-accordEntecavir Accord
  64. Training on electronic reporting of individual case safety reports (ICSRs) to…
  65. 21 CFR 888.4220: Cement monomer vapor evacuator.
  66. cdsco-imu-838-versus-placeboIMU-838 versus Placebo
  67. Guideline on medicinal products for the treatment of insomnia
  68. Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 July 2018
  69. Regulatory information – Updates to product information templates for all medicines for…
  70. Team-NB-Position Paper ClassD V4.4
  71. European Commission - European Medicines Agency - China Food and Drugs Administration…
  72. Guidance Notes on Preparation of a Site Master File for Good Distribution Practice…
  73. European Medicines Agency IT systems unavailable from 16 April to 17 April 2016
  74. Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada
  75. 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented…
  76. FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya…
  77. EU/3/23/2749 - orphan designation for treatment of mucormycosis
  78. EMEA-002525-PIP01-18 - paediatric investigation plan
  79. E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3…
  80. Higher-tier testing of veterinary medicinal products to dung fauna - Scientific guideline
  81. Miglustat product-specific bioequivalence guidance
  82. ema-memantine-ratiopharmMemantine ratiopharm
  83. mhra-more-implementationMORE implementation
  84. ema-venclyxtoVenclyxto
  85. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 11…
  86. EU/3/13/1150 - orphan designation for treatment of B-lymphoblastic leukaemia/lymphoma
  87. EMEA-001776-PIP01-15-M01 - paediatric investigation plan
  88. NMPA Issues the Announcement on Three Documents Including the Working Procedures for…
  89. cdsco-sars-cov-2vSARS-CoV-2V
  90. Paediatric Committee (PDCO): 21-24 February 2017
  91. 21 CFR 872.6010: Abrasive device and accessories.
  92. 21 CFR 878.4635: Sunlamp products and ultraviolet lamps intended for use in sunlamp…
  93. QMS F0004.1.001: Risk Management Flowchart
  94. EMEA-002741-PIP01-20-M01 - paediatric investigation plan
  95. ema-what-we-doWhat we do
  96. 21 CFR 862.3110: Antimony test system.
  97. EU/3/12/961 - orphan designation for treatment of systemic amyloidosis caused by beta-2…
  98. 21 CFR 862.2700: Nephelometer for clinical use.
  99. ema-inlytaInlyta
  100. Medicinal Products (Safety Features on Packaging) Regulations 2022 (SI 270/2022)…
  101. Medicines shortages: regulatory processes to manage supply disruptions
  102. Mock-up of Application Form for Confirmation of Change Management Protocol, etc. Related…
  103. ema-infergenInfergen
  104. cdsco-molnupiravir-mildhMolnupiravir Mildh
  105. EU/3/23/2818 - orphan designation for treatment in haematopoietic stem cell…
  106. cdsco-coversinCoversin
  107. EMEA-000582-PIP01-09-M03 - paediatric investigation plan
  108. Committee for Advanced Therapies (CAT): 23-25 January 2019
  109. EU/3/06/396 - orphan designation for prevention of the ischemia/reperfusion injury…
  110. EMEA-001440-PIP01-13-M03 - paediatric investigation plan
  111. Action in pursuance to the investigation carried out at facility (M/s Wellness Solution)…
  112. What's on the Horizon for HDO Sterilization Guidance? WG 40 Co-chairs Weigh In
  113. Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 23…
  114. cdsco-ly3502970lilyLY3502970lily
  115. ema-tecartusTecartus
  116. EMEA-000727-PIP01-09-M07 - paediatric investigation plan
  117. Nilotinib Hydrochloride Monohydrate, Varespladib Methyl, Marimastat
  118. EMEA-003211-PIP01-22 - paediatric investigation plan
  119. Asthma long-acting ß2 agonists: use and safety: Asthma Long-acting ß2 agonists: use and…
  120. Vedolizumab Solution for Injection, 108 mg/0.68 mL in pre-filled syringe
  121. EMEA-003135-PIP01-21 - paediatric investigation plan
  122. BIIB141 or RTA-408 (Omaveloxolone)
  123. EU/3/14/1269 - orphan designation for treatment of gastro-entero-pancreatic neuroendocrine…
  124. Artificial intelligence workplan to guide use of AI in medicines regulation
  125. Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on…
  126. Committee for medicinal products for veterinary use: Meeting of 6 to 7 September 2004
  127. EMEA-000042-PIP01-07 - paediatric investigation plan
  128. EU/3/05/302 - orphan designation for treatment of sickle cell disease
  129. EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in…
  130. Team-NB-List-PositionPapers-20231218
  131. EMEA-001755-PIP01-15 - paediatric investigation plan
  132. ema-dexdomitorDexdomitor
  133. cdsco-csj117CSJ117
  134. PSUSA/00003178/201606 - periodic safety update report single assessment
  135. Pregabalin IP (As Prolonged Release) 75mg + Etoricoxib IP 60mg uncoated bilayered tablets…
  136. cfr-21-cfr-808-3-definitions21 CFR 808.3: Definitions.
  137. Meeting highlights from the Paediatric Committee: 7 - 9 January 2009
  138. ema-awiqliAwiqli
  139. cdsco-cls-taCLS-TA
  140. 2019.12.27 S.O.4671(E)_Extention of Effective date of S.O. 5980 (E) dated 03.12.2018
  141. EMEA-001517-PIP01-13-M01 - paediatric investigation plan
  142. eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
  143. BMS-986489 FDC (BMS-986012+Nivolumab)
  144. European Medicines Agency (EMA) / Drug Information Association (DIA) signal management…
  145. ema-imjudoImjudo
  146. ema-evrysdiEvrysdi
  147. EU/3/23/2886 - orphan designation for treatment of acquired factor X deficiency
  148. Blue Guide: advertising and promoting medicines: Appendix 5 - Blue Guide
  149. EMEA-002986-PIP01-21 - paediatric investigation plan
  150. Start of rolling review for adapted Spikevax COVID-19 vaccine
  151. CAT: meeting archive 2017-2019
  152. 21 CFR 868.6100: Anesthetic cabinet, table, or tray.
  153. EU/3/05/291 - orphan designation for treatment of Hodgkin's lymphoma
  154. EMEA-002717-PIP02-20 - paediatric investigation plan
  155. EU/3/18/2123 - orphan designation for treatment of acute myeloid leukaemia
  156. EMEA-002696-PIP01-19 - paediatric investigation plan
  157. PSUSA/00000095/201712 - periodic safety update report single assessment
  158. Guidance on Medical Device Compliance and Enforcement (GUI-0073)
  159. EU/3/16/1617 - orphan designation for treatment of acute myeloid leukaemia
  160. Determination checklist: for sponsor seeking provisional determination
  161. HIMSS21: Is a ‘Hybrid Healthcare’ System on the Horizon?
  162. ema-symtuzaSymtuza
  163. FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple…
  164. Biannual Big Data Steering Group and industry stakeholders meeting 2023
  165. cdsco-abx464-once-dailyABX464 once daily
  166. Drug Quality Reporting System (DQRS) (MedWatch Reports) NDA Field Alert Reporting (FARs)
  167. 21 CFR 20.66: Internal personnel rules and practices.
  168. EMEA-000934-PIP01-10 - paediatric investigation plan
  169. Combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted…
  170. Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 February 2014
  171. NMPA Announcement on Adding the Medication Information for Children to the Package Insert…
  172. Why Japan for drug development Vol.1 (presentation for ENDPOINTS Events)
  173. ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and…
  174. Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due…
  175. ema-ionsysIonsys
  176. Type A Medicated Articles
  177. Mammography Facility Inspections
  178. Benidipine Hydrochloride IP Telmisartan IP Film coated tablets (Phase III)
  179. Amlodipin Woerwag - referral
  180. Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the…
  181. Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
  182. Revised Capital Refresh Saves Banner Health Millions
  183. ema-registrationRegistration
  184. Conformity assessment procedures for immunohaematology reagents
  185. EMEA-002174-PIP01-17 - paediatric investigation plan
  186. PSUSA/00010224/202308 - periodic safety update report single assessment
  187. 21 CFR 1.651: How must an accredited third-party certification body conduct a food safety…
  188. Changes to submission and assessment of maximum residue limits of veterinary medicines in…
  189. ema-beyfortusBeyfortus
  190. Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology…
  191. Committee for Herbal Medicinal Products (HMPC): 27-28 March 2017
  192. EU/3/02/121 - orphan designation for intra-operative photodynamic diagnosis of residual…
  193. Type-IB variations: questions and answers
  194. Rifapentine plus Isoniazid
  195. ema-waylivraWaylivra
  196. Elagolix Tablets 200 mg
  197. EMEA-001368-PIP01-12 - paediatric investigation plan
  198. ema-oprymeaOprymea
  199. EMEA-002890-PIP01-20 - paediatric investigation plan
  200. Clinical investigation of medicinal products in the treatment of lipid disorders…
  201. Committee for Advanced Therapies (CAT): 16-18 July 2025
  202. DR_G.S.R. 502(E) dt_30.06.2022_Proviso to Sr.no 39 in Sch K for Liquid Antiseptics in…
  203. EU/3/18/1994 - orphan designation for treatment of biliary tract cancer
  204. 21 CFR 862.1695: Free thyroxine test system.
  205. Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in…
  206. 21 CFR 82.5: General specifications for straight colors.
  207. EU/3/12/989 - orphan designation for treatment of ovarian cancer
  208. Robert Sayle: Attention Biomeds! Your IT Colleague Would Like to Chat
  209. Parental Leave policy and procedures
  210. cfr-21-cfr-73-600-turmeric21 CFR 73.600: Turmeric.
  211. AP214 Acetate (Αcetyl-(Lys)6-α-MSH, acetate salt) - paediatric investigation plan
  212. EU/3/14/1244 - orphan designation for treatment of polycythaemia vera
  213. PIC/S Guidance on Remote Assessments
  214. Balloon Cryoablation Catheter Approved for Marketing
  215. ema-prozac-referralProzac - referral
  216. Summary Report: Stakeholder Consultations on the Good Manufacturing Practices (GMP)…
  217. cdsco-semaglutide-2016Semaglutide 2016
  218. EU/3/06/429 - orphan designation for treatment of renal-cell carcinoma
  219. EMEA-001487-PIP02-15 - paediatric investigation plan
  220. Good to Be Back! 2022 International Conference on Medical Device Standards and Regulation…
  221. ema-tecfideraTecfidera
  222. New Master’s in Clinical Engineering Program Launches at Miami University
  223. Medicinal Products (Prescription and Control of Supply) (Amendment) (No.10) Regulations…
  224. Rheumatology/Immunology Working Party
  225. BAY94-8862M/s George Clinical India Pvt Ltd
  226. EU/3/19/2222 - orphan designation for treatment of AL amyloidosis
  227. EMEA-001931-PIP02-19 - paediatric investigation plan
  228. ema-kyndrisaKyndrisa
  229. ema-isentressIsentress
  230. EMEA-002376-PIP01-18 - paediatric investigation plan
  231. How to use RamaXL: RamaXL
  232. ema-harvoniHarvoni
  233. EU/3/20/2276 - orphan designation for treatment of retinal detachment
  234. MEETING POSTPONED: March 23, 2018: Pediatric Advisory Committee Meeting Announcement…
  235. Committee for Herbal Medicinal Products (HMPC): 13-15 January 2020
  236. Committee for Medicinal Products for Veterinary Use (CVMP): 16-18 April 2024
  237. Points to consider for the discussion with PMDA using the ICH S1B (R1) guideline and in…
  238. PSUSA/00001509/201504 - periodic safety update report single assessment
  239. cdsco-bempedoic-acidBempedoic acid
  240. Dienogest/ethinylestradiol-containing medicinal products indicated in acne - referral
  241. EMEA-002893-PIP01-20-M03 - paediatric investigation plan
  242. Herbal medicines – strengthening assessment methodology and improved communication for the…
  243. Ministerial Ordinance on Good Clinical Practice for Medical Devices
  244. June Revised Drugs Alert List 2023
  245. EMEA-001697-PIP01-14 - paediatric investigation plan
  246. 21 CFR 862.3870: Cannabinoid test system.
  247. cdsco-mirikizumabMirikizumab
  248. Daugherty & Liebel: Classifying Medical Device Human Factors Issues for the MAUDE and…
  249. Regulatory information - adjusted fees for applications to EMA from 1 April 2017
  250. Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on…
  251. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30…
  252. Bausch & Lomb Ireland withdraws its marketing authorisation application for Retisert
  253. Reporting irregularities that may affect medicines
  254. Team-NB-Position paper on Dental Implants-20200311-V1
  255. 21 CFR 890.5275: Microwave diathermy.
  256. 21 CFR 801.417: Chlorofluorocarbon propellants.
  257. PSUSA/00010021/202107 - periodic safety update report single assessment
  258. 21 CFR 866.3720: Streptococcus spp. exoenzyme reagents.
  259. EMEA-002375-PIP02-18 - paediatric investigation plan
  260. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April…
  261. EU/3/12/954 - orphan designation for treatment of amyotrophic lateral sclerosis
  262. 2024.12.10_MDR_S.O. 5331(E)_reg Notification of Medical Device Testing Officers (MDTO) for…
  263. EMEA-000488-PIP01-08 - paediatric investigation plan
  264. PSUSA/00001780/202301 - periodic safety update report single assessment
  265. EU/3/16/1681 - orphan designation for treatment of eosinophilic oesophagitis
  266. Stakeholder participation in information management
  267. PSUSA/00000986/201909 - periodic safety update report single assessment
  268. Nitrosamines impurities in medicines
  269. 21 CFR 878.4590: Focused ultrasound stimulator system for aesthetic use.
  270. cdsco-fb2001FB2001
  271. ema-synordiaSynordia
  272. DepoCyte - withdrawal of application for variation to marketing authorisation
  273. ema-antimicrobial-resistanceAntimicrobial resistance
  274. Notice regarding exemption of drugs Sale License
  275. Lena Cordie: The Strength of UDI Is in Its Adoption
  276. Injection-site residues: considerations for risk assessment and residue surveillance…
  277. Micro Therapeutic Research - referral
  278. Neofordex - direct healthcare professional communication (DHPC)
  279. Notice-Meeting of the Pharmaceuticals Industry Associations
  280. PSUSA/00001912/201709 - periodic safety update report single assessment
  281. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - September 2018
  282. cdsco-may-5-2014-g-s-r-311-eMay 5 2014 G.S.R 311(E)
  283. EU/3/14/1372 - orphan designation for treatment of microscopic polyangiitis (avacopan)
  284. 21 CFR 878.4420: Electrosurgical device for over-the-counter aesthetic use.
  285. Clarification for regulatory pathway for Cocrystals
  286. EMEA-000628-PIP01-09-M04 - paediatric investigation plan
  287. EMEA-001281-PIP01-12 - paediatric investigation plan
  288. ema-clopidogrel-qualimedClopidogrel Qualimed
  289. ema-semintraSemintra
  290. PSUSA/00001813/201710 - periodic safety update report single assessment
  291. Webinar presentation: Considerations for the Australian UDI, 20 July 2021
  292. Drug Alert list for month of June 2023
  293. 21 CFR 892.1130: Nuclear whole body counter.
  294. Facilitating global access to diabetes treatments for non-EU patients
  295. 21 CFR 884.4550: Gynecologic surgical laser.
  296. EMEA-003412-PIP01-23 - paediatric investigation plan
  297. 21 CFR 868.5540: Rigid laryngoscope.
  298. Public consultation opens on the revised guideline on good distribution practice of…
  299. ema-qinprezoQinprezo
  300. Guide to Electronic Submissions - Medical Devices
  301. Tozorakimab (MEDI3506) Solution for injection 150mg/mL or Placebo
  302. 2021.04.07_GSR 258(E)_ Inclusion of Tapentadol in Sch H1 at S.No. 48
  303. European Medicines Agency welcomes new members and observers to its Management Board
  304. Kilmer Fund Accepting 2022 Grant and Scholarship Applications
  305. EMEA-001349-PIP01-12-M03 - paediatric investigation plan
  306. ema-tevagrastimTevagrastim
  307. NMPA Announcement on Issuing the Good Pharmacovigilance Practice
  308. Team-NB-List-PositionPapers-20250409
  309. Submission and assessment timetables for innovative medicines applications
  310. ema-roclandaRoclanda
  311. ema-vyloyVyloy
  312. EMEA-001667-PIP01-14 - paediatric investigation plan
  313. Medical devices: conformity assessment and the UKCA mark
  314. EU/3/17/1830 - orphan designation for treatment of diffuse large B-cell lymphoma
  315. ema-heparescHeparesc
  316. 21 CFR 882.1330: Depth electrode.
  317. FDA Elevates the Science of Patient Preference Information
  318. Pharmaceutical Affairs Act Enforcement Rules, Pharmaceutical Affairs Act Enforcement…
  319. Review concludes evidence does not support that HPV vaccines cause CRPS or POTS
  320. Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in…
  321. Better identification of medicinal products
  322. EU/3/06/369 - orphan designation for treatment of epidermolysis bullosa
  323. 21 CFR 26.6: Equivalence assessment.
  324. CVMP interested parties' meeting
  325. Paediatric addendum to the guideline on clinical investigation of medicinal products for…
  326. PSUSA/00002878/202111 - periodic safety update report single assessment
  327. HTM's Invisible Lead Time: Addressing Leadership Development
  328. How to Pay Fees to Health Products and Food Branch (HPFBI)
  329. PSUSA/00001711/201907 - periodic safety update report single assessment
  330. Standards of Review Fees for the Registration of Western Medicines, Standards of Review…
  331. cdsco-grc-54276GRC 54276
  332. cdsco-budesonideBudesonide
  333. EMEA-000527-PIP03-13 - paediatric investigation plan
  334. Carvi aetheroleum - herbal medicinal product
  335. Committee for Medicinal Products for Human Use (CHMP): 17-20 March 2014
  336. EU/3/12/1032 - orphan designation for treatment of haemophilia B
  337. M/s Biocon Biologics India LimitedItolizumab Injection
  338. Filgotinib Administered
  339. Telmisartan IP + Amlodipine Besilate IP eq. to Amlodipine + Bisoprolol Fumarate IP (40mg +…
  340. June 18.06.2013 G.S.R 377(E)
  341. 21 CFR 886.5910: Image intensification vision aid.
  342. PSUSA/00010355/201509 - periodic safety update report single assessment
  343. 21 CFR 870.2050: Biopotential amplifier and signal conditioner.
  344. Clinical Trials Information System (CTIS) sponsor end user training programme - December…
  345. Recombinant Hepatitis E Vaccine, Single Human Dose
  346. ema-zemdriZemdri
  347. Committee for Medicinal Products for Veterinary Use (CVMP): 16-17 February 2021
  348. Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19…
  349. EU/3/13/1154 - orphan designation for treatment of ovarian cancer
  350. 21 CFR 882.1430: Electroencephalograph test signal generator.
  351. Prohibition of Fixed Dose Combination of drugs for human use under Section 26A of Drugs &…
  352. 21 CFR 812.19: Address for IDE correspondence.
  353. Team-NB Position Paper Implant Card
  354. EMEA-001441-PIP01-13-M03 - paediatric investigation plan
  355. European Medicines Agency reminds marketing-authorisation holders about revised monographs…
  356. FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with…
  357. EU/3/17/1928 - orphan designation for treatment of Leber's congenital amaurosis
  358. PSUSA/00000812/201506 - periodic safety update report single assessment
  359. Multidisciplinary: pharmacogenomics
  360. Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation(Early…
  361. EMEA-001220-PIP03-16-M02 - paediatric investigation plan
  362. 2016.05.04_S.O. 1326(E)_Notification for Government Analyst_Dr. Raman Mohan Singh, Dir…
  363. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12…
  364. Risk-Adapted Approach to clinical trials and Risk Assessments: Example 3: Type A Risk…
  365. 21 CFR 14.125: Procedures of TEPRSSC.
  366. Third EMA and Association of the European Self-Medication Industry (AESGP) annual…
  367. EMA commissions independent research to prepare for real-world monitoring of COVID-19…
  368. PSUSA/00002210/202204 - periodic safety update report single assessment
  369. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018
  370. ema-dolovet-rifen-referralDolovet Rifen - referral
  371. Office Memo Issue of reports for testanalysis in form 13 on SUGAM Portal-regarding
  372. PSUSA/00001819/201509 - periodic safety update report single assessment
  373. Committee for Advanced Therapies (CAT): 16-18 February 2022
  374. Requirements for the Pilot Program of Electronic Labels for Cosmetics
  375. PSUSA/00010707/202110 - periodic safety update report single assessment
  376. Committee for Herbal Medicinal Products (HMPC): 11-12 July 2011
  377. Notice regarding SUGAM Online
  378. EMEA-000955-PIP01-10 - paediatric investigation plan
  379. Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting…
  380. cdsco-office-memorandumOffice Memorandum
  381. EMEA-001201-PIP01-11-M02 - paediatric investigation plan
  382. Checklist for Form MD-39 IVD (Application for grant of registration to Medical Device…
  383. EMEA-001849-PIP02-15-M04 - paediatric investigation plan
  384. European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric…
  385. 21 CFR 25.15: General procedures.
  386. PSUSA/00001347/201903 - periodic safety update report single assessment
  387. July 31.07.2013 GSR 520(E)
  388. EMEA-001437-PIP02-19 - paediatric investigation plan
  389. EMEA-001563-PIP02-15-M01 - paediatric investigation plan
  390. Lenalidomide product-specific bioequivalence guidance
  391. European Medicines Agency responds to criticism over transparency in British Medical…
  392. EMEA-003063-PIP02-22 - paediatric investigation plan
  393. Medical Device Sector Clinical Investigations for Medical Device (CIMD)
  394. EMEA-002846-PIP02-22 - paediatric investigation plan
  395. FDA warns about serious bleeding risk with over-the-counter antacid products containing…
  396. 21 CFR 872.3285: Preformed clasp.
  397. Quality, preclinical and clinical aspects of gene therapy medicinal products - Scientific…
  398. Assessing your compliance with the Medical Devices Regulations
  399. Aflibercept Injection 40 mg/ml, (0.278 ml/ vial)
  400. A vision for use of real-world evidence in EU medicines regulation
  401. 21 CFR 870.3460: Endovascular Suturing System.
  402. Announcement of the National Medical Products Administration on the Release of the Good…
  403. ema-infanrix-hexaInfanrix Hexa
  404. 21 CFR 809.20: General requirements for manufacturers and producers of in vitro diagnostic…
  405. Explanation of Application for Accreditation of Foreign Manufacturers
  406. EU/3/18/2045 - orphan designation for treatment of Duchenne muscular dystrophy
  407. Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2022 (SI…
  408. EMEA-001205-PIP02-19-M02 - paediatric investigation plan
  409. Meet Your 2024 AAMI Fellows!
  410. NM8074Recombinant humanized monoclonal antibody
  411. Medicinal Products (Control of Advertising) Regulations 2007 (SI 541/2007) [Establishment…
  412. Committee for Orphan Medicinal Products: February 2007 meeting
  413. FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium…
  414. Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 February…
  415. European Medicines Agency issues six key recommendations to tackle the issue of medication…
  416. ema-accelerated-assessmentAccelerated assessment
  417. Paediatric Committee (PDCO): 25-27 May 2016
  418. Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA…
  419. Global regulators highlight key role of healthcare professionals in fostering confidence…
  420. Clinical Trials Information System (CTIS): Walk-in clinic - December 2023
  421. ema-brazilBrazil
  422. ema-porcilis-coliclosPorcilis ColiClos
  423. Goserelin 10.8mg Injection
  424. Levistici radix - herbal medicinal product
  425. 21 CFR 872.6880: Preformed impression tray.
  426. 5-aminolevulinic acid, hydrochloride - paediatric investigation plan
  427. EMEA-001862-PIP02-19 - paediatric investigation plan
  428. Digital application dataset integration (DADI) Q&A webinar - variations form for human…
  429. Log Jam: Lesson Learned from the Log4Shell Vulnerability
  430. 21 CFR 878.4452: Nonabsorbable expandable hemostatic sponge for temporary internal use.
  431. ema-pylobactellPylobactell
  432. Drug Alert list for the month of September 2014
  433. Sprout Safety Inspections
  434. 21 CFR 862.1730: Free tyrosine test system.
  435. ema-edurantEdurant
  436. ema-implanon-referralImplanon - referral
  437. Coordination of GLP inspections
  438. FDA Embraces Vaporized Hydrogen Peroxide for Medical Device Sterilization
  439. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - February 2019
  440. EU/3/19/2157 - orphan designation for treatment of ornithine transcarbamylase deficiency
  441. Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
  442. ema-synapse-referralSynapse - referral
  443. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020
  444. PSUSA/00003167/201612 - periodic safety update report single assessment
  445. First treatment for acute hepatic porphyria
  446. EU/3/12/1035 - orphan designation for treatment of inclusion body myositis
  447. PSUSA/00001313/201610 - periodic safety update report single assessment
  448. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13…
  449. Details of Rejected clinical trial applications / permissions (Form CT-04 and CT-06) 2020
  450. EMEA-001530-PIP01-13 - paediatric investigation plan
  451. Lichen islandicus - herbal medicinal product
  452. Tofacitinib Gel 2% w/wCT/SND/07/2023
  453. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee - 07/23/2026
  454. European Medicines Agency information day on measuring the impact of pharmacovigilance…
  455. cdsco-1st-may-2002-gsr-311-e1st May 2002 (GSR 311(E))
  456. 21 CFR 20.33: Form or format of response.
  457. Management Board: Meetings 2009
  458. RO7790121/F05, 225 mg/1.5 ml (antibody) (RVT-3101, ANTI TL1A)r
  459. cdsco-inebilizumab2Inebilizumab2
  460. EU/3/23/2850 - orphan designation for treatment of Alport syndrome
  461. Regulatory science research
  462. cdsco-trenexamic-acidTrenexamic Acid
  463. 21 CFR 872.3940: Total temporomandibular joint prosthesis.
  464. Type-II variations: questions and answers
  465. cdsco-oral-nrc-2694-aOral NRC-2694-A
  466. Baxter dialysis solutions - referral
  467. EU/3/03/144 - orphan designation for treatment of congenital ichthyoses
  468. FDA Issues Updated Facility Inspection Report
  469. Conditional Early Approval System for Innovative Medical Device Products (Fast-Break…
  470. EU medicines agencies reflect on lessons learned from COVID-19
  471. DR_G.S.R. 731(E) dt_30.09.1994_26A_reg Kaolin, phenyl sulphadiazole, neomycin etc
  472. The new EudraVigilance system and electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  473. EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5
  474. PSUSA/00009153/201704 - periodic safety update report single assessment
  475. PSUSA/00002911/201410 - periodic safety update report single assessment
  476. cdsco-trc041266TRC041266
  477. Measles and Rubella Vaccine (Live)
  478. ema-ditelosDitelos
  479. EU/3/13/1130 - orphan designation for treatment of transglutaminase-1-deficient autosomal…
  480. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  481. ADHD - Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity…
  482. 21 CFR 870.3690: Pacemaker test magnet.
  483. New medicine for rare form of eye allergy in children and teenagers
  484. EMEA-002567-PIP01-19 - paediatric investigation plan
  485. Guidance on pharmacovigilance procedures
  486. Meeting of DTAB Sub Committee for examining the Fixed Dose Combinations (FDCs) considered…
  487. Herbal medicinal products: Regulatory and procedural guidance
  488. EU/3/17/1927 - orphan designation for treatment of acute myeloid leukaemia
  489. ema-priorix-referralPriorix - referral
  490. cdsco-nov-18-2011-gsr-821-eNov 18, 2011 (GSR 821(E))
  491. Approved panel of experts for the Subject Expert Committees
  492. Management Board meeting: 19 March 2020
  493. EMEA-001204-PIP02-14 - paediatric investigation plan
  494. EMEA-003047-PIP01-21 - paediatric investigation plan
  495. EMEA-001135-PIP01-11 - paediatric investigation plan
  496. EU actions to support availability of medicines during COVID-19 pandemic – update #4
  497. 21 CFR 56.124: Actions alternative or additional to disqualification.
  498. About the Guidance for Preparation of Application Forms for Registration of Drug Master…
  499. cfr-21-cfr-886-1-scope21 CFR 886.1: Scope.
  500. Committee for Orphan Medicinal Products (COMP): 3-5 October 2012
  501. Medical Devices Compliance Program Bulletin
  502. Typhoid Conjugate vaccineApril11
  503. EU/3/16/1816 - orphan designation for treatment of oculopharyngeal muscular dystrophy
  504. First stakeholder forum on the implementation of the new 2010 pharmacovigilance…
  505. ema-bisphosphonates-referralBisphosphonates - referral
  506. Committee for Orphan Medicinal Products: July 2005 meeting
  507. ema-cerivastatin-referralCerivastatin - referral
  508. Seventh Framework Programme (FP7) small-population research methods projects and…
  509. 21 CFR 890.5925: Traction accessory.
  510. La FDA advierte contra el uso de silicona inyectable para delinear la figura
  511. EMEA-001688-PIP03-16 - paediatric investigation plan
  512. Committee for Medicinal Products for Human Use (CHMP): 14-17 February 2011
  513. 21 CFR 1.1138: What are the eligibility requirements for a LAAF-accredited laboratory?
  514. Meeting with stakeholders on monitoring sales of veterinary antimicrobial agents in Europe
  515. ema-non-clinical-guidelinesNon-clinical guidelines
  516. ema-kevzaraKevzara
  517. 2026.02.16 G.S.R. 135(E)_Notification for amendment in certain Drugs Rules (Related to…
  518. 21 CFR 868.1030: Manual algesimeter.
  519. Tackling medication errors: European Medicines Agency workshop calls for coordinated EU…
  520. Surovatamig (AZD0486) concentrate for solution for infusion 16 mg/vial (2mg/mL) and powder…
  521. Ransomware Attack Serves as 'Wake-Up' Call to Healthcare's Vulnerabilities
  522. MORE platform API (Application Programming Interface) set up - user reference guide
  523. ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to…
  524. April 15 2015 GSR 289(E)
  525. ema-bevespi-aerosphereBevespi Aerosphere
  526. 21 CFR 886.1430: Ophthalmic contact lens radius measuring device.
  527. EMEA-003041-PIP01-21 - paediatric investigation plan
  528. Medical device problem report form for health care professionals
  529. EMEA-002546-PIP01-19 - paediatric investigation plan
  530. Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid…
  531. TNF Blockers - UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric…
  532. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-15 June…
  533. EMEA-002405-PIP01-18 - paediatric investigation plan
  534. Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for…
  535. cdsco-ll-bmt1LL-BMT1
  536. EMEA-001742-PIP01-14-M01 - paediatric investigation plan
  537. ema-erysengEryseng
  538. EU/3/16/1671 - orphan designation for treatment of acromegaly
  539. Committee for Orphan Medicinal Products: June 2005 meeting
  540. ema-world-arthritis-dayWorld Arthritis Day
  541. GQP Ministerial Ordinance (Ministerial Ordinance on Standards for Quality Assurance for…
  542. EMEA-002721-PIP02-20 - paediatric investigation plan
  543. ema-renutendRenuTend
  544. Public Notice regarding Restriction on Import manufacture, sale and distribution of…
  545. 21 CFR 878.4470: Surgeon's gloving cream.
  546. EMEA-001316-PIP01-12-M01 - paediatric investigation plan
  547. How Italy’s HTM Problems Reflect the World’s
  548. 21 CFR 17.19: Authority of the presiding officer.
  549. 21 CFR 872.4760: Bone plate.
  550. Where Is Extended Reality Going and How Is HTM Involved?
  551. cdsco-secukinumab-sunriseSecukinumab SUNRISE
  552. Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg + Sacubitril and Valsartan…
  553. Month wise Tentative Schedule of SEC (Vaccine) meetings of the Year 2024
  554. Preliminary and Final Report Form (FRM-0255)
  555. notification 19-2015-2020
  556. PSUSA/00002942/202106 - periodic safety update report single assessment
  557. Core summary of products characteristics for human anti-D immunoglobulin for intramuscular…
  558. Implementation of medical devices future regime: Implementation of the Future Regulations
  559. Requirement of Obtaining Approval from the Office of Drugs Controller General of India…
  560. Committee for Proprietary Medicinal Products (CPMP) 62nd plenary meeting
  561. PSUSA/00001894/201509 - periodic safety update report single assessment
  562. Regulation on Medical Device Groups and Class by Group
  563. cdsco-sugammadexSugammadex
  564. ema-aptivusAptivus
  565. PSUSA/00002094/201605 - periodic safety update report single assessment
  566. EU/3/14/1255 - orphan designation for treatment of acute myeloid leukaemia
  567. Asenapine product-specific bioequivalence guidance
  568. EMEA-002393-PIP01-18 - paediatric investigation plan
  569. David Stiles: HTM's Essential Role in Disaster Preparedness
  570. EU/3/11/922 - orphan designation for prevention of fetal and neonatal alloimmune…
  571. Infrared (IR) thermometers: caution in use
  572. Committee for Orphan Medicinal Products (COMP): 9-10 December 2014
  573. Committee for medicinal products for veterinary use: Meeting of 14 to 16 March 2006
  574. Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2019
  575. ema-spanidinSpanidin
  576. Webinar presentation: Remote GMP inspections: Current feedback and future considerations
  577. EU/3/07/517 - orphan designation for treatment of hepatocellular carcinoma
  578. EU/3/23/2878 - orphan designation for treatment of diffuse large B-cell lymphoma
  579. Pharmacokinetic studies in man - Scientific guideline
  580. List of RC Holders and RC issued in Offline mode From 2013 to 2017
  581. 21 CFR 812.64: IRB's continuing review.
  582. ema-yurvac-rhdYURVAC RHD
  583. EU/3/22/2692 - orphan designation for treatment of amyotrophic lateral sclerosis
  584. cdsco-erdafitinibErdafitinib
  585. EU/3/19/2178 - orphan designation for treatment of argininosuccinic aciduria
  586. ema-ontilyvOntilyv
  587. 21 CFR 884.1730: Laparoscopic insufflator.
  588. Use of market authorisation evidence from comparable overseas regulators and assessment…
  589. Can Hospitals Sterilize Their 3D Printed Equipment? Innovation Sets the Bar
  590. PSUSA/00002591/202104 - periodic safety update report single assessment
  591. PSUSA/00001125/201703 - periodic safety update report single assessment
  592. 21 CFR 803.21: Where can I find the reporting codes for adverse events that I use with…
  593. Inactivated Japanese Encephalitis Vaccine
  594. EU/3/21/2452 - orphan designation for prevention of bronchopulmonary dysplasia
  595. Public consultation open on phasing-in of 'black symbol' for medicines under additional…
  596. Committee for Medicinal Products for Veterinary Use (CVMP): 14-16 February 2023
  597. ema-dalirespDaliresp
  598. 21 CFR 882.4725: Radiofrequency lesion probe.
  599. International collaboration on good manufacturing practice inspections expanded
  600. Clinical Trials Information System (CTIS): Walk-in clinic - June 2023
  601. 21 CFR 58.195: Retention of records.
  602. ema-giaprezaGiapreza
  603. First medicine for rare blood cancer
  604. PSUSA/00002974/201905 - periodic safety update report single assessment
  605. EU/3/01/033 - orphan designation for treatment of malignant mesothelioma
  606. ema-methoxasol-t-referralMethoxasol-T - referral
  607. EU/3/17/1949 - orphan designation for treatment of GM2 gangliosidosis
  608. Medical Device Manufacturers
  609. Gelatin Polycaprolactone Layered Gingival Repair Membrane Approved for Marketing
  610. Update on EMA relocation preparedness
  611. European Medicines Agency public statement on valdecoxib and parecoxib sodium…
  612. ema-a-stronger-role-for-emaA stronger role for EMA
  613. EMEA-000019-PIP03-08 - paediatric investigation plan
  614. EU/3/06/364 - orphan designation for treatment of hepatocellular carcinoma
  615. EMA's proactive publication of clinical data a success
  616. Technical workshop on real-world metadata for regulatory purposes
  617. EU/3/03/176 - orphan designation for treatment of chronic lymphocytic leukaemia
  618. Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in…
  619. GN-18 R2 Guidance on Preparation of a Product Registration Submission for IVD MD using the…
  620. 21 CFR 862.1770: Urea nitrogen test system.
  621. Meeting highlights from EMA’s safety committee (PRAC) 29-31 October 2018
  622. Application audit (technical file review) of IVD medical device applications
  623. Medical device adverse event reports - statistics for 2013
  624. PSUSA/00002602/202003 - periodic safety update report single assessment
  625. Committee for Orphan Medicinal Products: January 2005 meeting
  626. PSUSA/00001476/202008 - periodic safety update report single assessment
  627. European Medicines Agency recommends first switch from prescription-only to…
  628. 21 CFR 830.50: Changes that require use of a new device identifier.
  629. Contract Sterilization Letter
  630. Drug Alert list for month of June 2016
  631. EU/3/20/2310 - orphan designation for treatment of retinitis pigmentosa
  632. Committee for Orphan Medicinal Products (COMP): 7-8 September 2010
  633. Dostarlimab, Belrestotug
  634. Seventh meeting of the EMEA Human Scientific Committees' Working Party with with Patients'…
  635. Glycopyrrolate IP + Formoterol Fumarate dehydrate IP eq. to Formoterol Fumarate +…
  636. 21 CFR 862.1785: Urinary urobilinogen (nonquantitative) test system.
  637. ema-enyglidEnyglid
  638. Launch of international pilot programme on inspection of manufacturers of sterile…
  639. EU/3/20/2343 - orphan designation for treatment of anal cancer
  640. ema-vantobraVantobra
  641. Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2007 (SI…
  642. 21 CFR 874.1090: Auditory impedance tester.
  643. Guidance on Evaluation of Customized Orthopedic Devices for Osteosynthesis [99.33 KB]
  644. Procedure for the review and revision of European Union herbal monographs and European…
  645. 21 CFR 890.5150: Powered patient transport.
  646. ema-jemperliJemperli
  647. Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA), Inactivated Poliomyelitis…
  648. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21…
  649. ARGB Appendix 8 - Guidance on TGO 86
  650. ema-myaleptaMyalepta
  651. EMEA-002521-PIP01-18 - paediatric investigation plan
  652. EMEA-000656-PIP01-09 - paediatric investigation plan
  653. Classification of Medical Device pertaining to Pain Management under the provisions of…
  654. EU/3/13/1200 - orphan designation for treatment of papillary thyroid cancer
  655. EU/3/14/1339 - orphan designation for treatment of Dravet syndrome
  656. Guideline on the use of the CTD format in the preparation of a registration application…
  657. EU/3/24/2898 - orphan designation for treatment of hereditary angioedema
  658. EMEA-002570-PIP01-19 - paediatric investigation plan
  659. European Union International Organization for Standardization (ISO) for the identification…
  660. EMEA-003295-PIP01-22 - paediatric investigation plan
  661. Paediatric Committee (PDCO): 16-18 February 2011
  662. Avotermin - paediatric investigation plan
  663. Appendix 1 to the guideline on clinical evaluation of diagnostic agents on imaging agents…
  664. Clinical investigation of medicinal products for prevention of stroke and systemic embolic…
  665. EU/3/07/453 - orphan designation for treatment of haemophilia B (congenital factor IX…
  666. 21 CFR 870.3700: Pacemaker programmers.
  667. EMEA-000492-PIP01-08-M01 - paediatric investigation plan
  668. ema-stamaril-referralStamaril - referral
  669. ema-miratazMirataz
  670. cfr-21-cfr-864-1-scope21 CFR 864.1: Scope.
  671. Public notice alerting about unlicensed kit of Bione for corona testing displayed on their…
  672. 21 CFR 26.69: Monitoring of conformity assessment bodies.
  673. Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Glimperide IP + Metformin…
  674. EMEA-001207-PIP02-19-M01 - paediatric investigation plan
  675. 21 CFR 868.5470: Hyperbaric chamber.
  676. Paediatric Committee (PDCO): 12-15 November 2019
  677. World Heart Day: 29 September 2012
  678. 2021.02.05_Draft GSR 99(E)_For inclusion of provisions related to the registration of…
  679. PSUSA/00001701/202301 - periodic safety update report single assessment
  680. ema-veltassaVeltassa
  681. EU/3/05/273 - orphan designation for treatment of pulmonary arterial hypertension and…
  682. 21 CFR 888.3780: Wrist joint polymer constrained prosthesis.
  683. NMPA Announcement on Approving the Registration of 139 Medical Devices
  684. Medical device cyber security guidance for industry
  685. ema-zulvac-1-bovisZulvac 1 Bovis
  686. ema-equilis-strepeEquilis StrepE
  687. AAMI’s Best of BI&T Awards Recognize Journal Authors
  688. QMS P0005.003: Management Responsibility and Management Review Procedure
  689. ema-ich-safetyICH: safety
  690. Monitoring the safety of medicines: European Medicines Agency presents first report on…
  691. ema-services-and-databasesServices and databases
  692. EMEA-000896-PIP01-10 - paediatric investigation plan
  693. PSUSA/00000167/202001 - periodic safety update report single assessment
  694. Questions and answers (Q&A) on administrative procedures for application for approval…
  695. ema-pyrukyndPyrukynd
  696. 21 CFR 862.3620: Methadone test system.
  697. European Medicines Agency starts review of aliskiren-containing medicines following…
  698. Management Board meeting: 3 October 2013
  699. 21 CFR 868.5925: Powered emergency ventilator.
  700. PSUSA/00000236/201610 - periodic safety update report single assessment
  701. 21 CFR 880.6785: Manual patient transfer device.
  702. PSUSA/00000174/201603 - periodic safety update report single assessment
  703. Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products…
  704. PSUSA/00010353/201905 - periodic safety update report single assessment
  705. EudraVigilance training on electronic reporting of individual case safety reports
  706. cdsco-medi4736MEDI4736
  707. New action plan to support SMEs as drivers of pharmaceutical innovation
  708. EU/3/09/634 - orphan designation for treatment of pancreatic cancer
  709. 21 CFR 876.5290: Implanted mechanical/hydraulic urinary continence device surgical…
  710. Sterile Drug Substance Manufacturers (7/94)
  711. FDA Grants 510(k) Clearance to Dexcom G7 Continuous Glucose Monitor
  712. 21 CFR 890.5170: Powered flotation therapy bed.
  713. PSUSA/00000059/202309 - periodic safety update report single assessment
  714. Drug Alert list for month of March 2020
  715. European Medicines Agency Human Scientific Committees' Working Party with Patients' and…
  716. HMA/EMA multi-stakeholder workshop on artificial intelligence (AI) - enabling the safe and…
  717. European Medicines Agency update on review of non-selective NSAIDs
  718. European Medicines Agency Human Scientific Committees' Working Parties with Patients' and…
  719. Office Memorandum dated 14.12.2018 (Ms. Galderma India)
  720. Efonidipine hydrochloride Ethanolate + Telmisartan IP Film coated bilayered tablet (Phase…
  721. Clinical investigation of medicinal products to prevent development/slow progression of…
  722. GME751 (pembrolizumab) concentrate for solution for infusion 25 mg/mL (100mg/vial)
  723. Deputy Executive Director Noël Wathion retires after 25 years of service
  724. The new EudraVigilance System and the electronic reporting of the individual case safety…
  725. cdsco-insulin-detemirInsulin Detemir
  726. Invirase (saquinavir) labels now contain updated risk information on abnormal heart…
  727. Ethical use of animals in medicine testing
  728. EU/3/19/2184 - orphan designation for treatment of neurofibromatosis type 1
  729. ema-memantine-fgkMemantine FGK
  730. EMEA-003202-PIP01-22 - paediatric investigation plan
  731. LY4268989 (MORF-057), LY3074828 (Mirikizumab)
  732. 21 CFR 866.1700: Culture medium for antimicrobial susceptibility tests.
  733. Workshop Teaches How to ?Do Smarter? Healthcare Technology Management
  734. EU/3/15/1515 - orphan designation for treatment of cutaneous T-cell lymphoma
  735. EU/3/07/495 - orphan designation for treatment of acute lymphoblastic leukaemia
  736. 21 CFR 74.2710: D&C Yellow No. 10.
  737. Office Memorandum: Issue of Clinical trial permission for r-DNA derived products Dated…
  738. cdsco-ct-umifenovir-hcl-capct Umifenovir Hcl cap
  739. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 October 2023
  740. 21 CFR 21.33: Medical records.
  741. EMEA-001684-PIP01-14 - paediatric investigation plan
  742. ema-protect-symposiumPROTECT symposium
  743. Pre-accession linguistic check for Croatian underway
  744. EU/3/04/239 - orphan designation for treatment of pancreatic cancer
  745. Refinements to the Personalised Medical Device Framework
  746. Sun Ranibizumab Solution for Injection, 10 mg/mL
  747. EU/3/12/1074 - orphan designation for treatment of peripheral T-cell lymphoma (nodal…
  748. Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes: FDA…
  749. 21 CFR 74.1331: D&C Red No. 31.
  750. Improving Patient Information
  751. Pharmacovigilance: marketing authorisation
  752. DR_G.S.R. 26(E) dt_19.01.2006_Amendment Rule 69, 75,76, 122B& Sch A_Additional Fee…
  753. Applications for medical device clinical trials under the Interim Order: Guidance document
  754. ema-pristiqsPristiqs
  755. cdsco-tirzepatideTirzepatide
  756. Ustekinumab Solution for Injection
  757. ema-isemidIsemid
  758. Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients…
  759. Bempedoic Acid 180mg + Ezetimibe 10mg film coated tablets
  760. What we publish on medicines and when
  761. 21 CFR 12.125: Appeal from or review of initial decision.
  762. EU/3/07/438 - orphan designation for treatment of peripheral T-cell lymphoma (nodal, other…
  763. EMEA-001864-PIP02-19 - paediatric investigation plan
  764. Marixino (previously Maruxa)
  765. EU/3/22/2630 - orphan designation for treatment of idiopathic pulmonary fibrosis
  766. ema-porcilis-ar-t-dfPorcilis AR-T DF
  767. Vonoprazan Tablets 10mg/20mg
  768. FDA Drug Safety Communication: Completed safety review of Xenical/Alli (orlistat) and…
  769. 21 CFR 73.575: Titanium dioxide.
  770. EU/3/19/2152 - orphan designation for treatment of Stargardt's disease
  771. EU/3/07/486 - orphan designation for treatment of retinitis pigmentosa
  772. Oral Eflornithine NSRT2020
  773. EU/3/08/572 - orphan designation for treatment of chronic idiopathic myelofibrosis
  774. The role of single-arm trials in the authorisation of new cancer medicines
  775. PSUSA/00010488/201905 - periodic safety update report single assessment
  776. Strengthening supply chain cyber security at the MHRA
  777. Products Classification Guidance
  778. Prizvalve® Transcatheter Aortic Valve System Approved for Marketing
  779. EU/3/06/392 - orphan designation for treatment of acute myeloid leukaemia
  780. Euro Nippon Kayaku GmbH withdraws its marketing authorisation application for Spanidin…
  781. PSUSA/00001694/201703 - periodic safety update report single assessment
  782. ema-adempasAdempas
  783. Will You Help Shape the FDA’s Medical Device Active Surveillance System?
  784. AAMI News Special Standards Issue
  785. European Medicines Agency publishes a video explaining the concept of medicines under…
  786. Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting…
  787. European Medicines Agency and European Monitoring Centre for Drugs and Drug Addiction…
  788. Drug Safety Update: monthly PDF newsletter: Drug Safety Update - July 2015
  789. Ranibizumab solution for injection 10 mg/ml (r-DNA origin)
  790. Oral Cholera Vaccine (Inactivated)
  791. 21 CFR 892.1820: Pneumoencephalographic chair.
  792. cdsco-nucalaNUCALA
  793. Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug…
  794. EU/3/05/324 - orphan designation for treatment of nephrotic syndrome
  795. EU/3/16/1631 - orphan designation for diagnosis of glioma
  796. Committee for Advanced Therapies (CAT): 7-9 September 2022
  797. EMEA-002285-PIP02-19-M02 - paediatric investigation plan
  798. Durvalumab plus Olaparib
  799. ema-elrexfioElrexfio
  800. EU/3/18/2033 - orphan designation for treatment of ornithine transcarbamylase deficiency
  801. European Medicines Agency website updated with new searching and sharing features
  802. European regulators propose way forward for publication of full clinical-trial data
  803. Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 December 2019
  804. EMEA-000597-PIP03-15-M05 - paediatric investigation plan
  805. Topical corticosteroids and withdrawal reactions
  806. cdsco-noticeNotice
  807. EU/3/13/1212 - orphan designation for treatment of follicular lymphoma
  808. 21 CFR 870.3250: Vascular clip.
  809. Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices
  810. EU/3/18/2126 - orphan designation for treatment of short bowel syndrome
  811. ema-takhzyroTakhzyro
  812. Clinical trials for medicines: ending a clinical trial
  813. 21 CFR 14.140: Establishment of a color additive advisory committee.
  814. ema-suvaxyn-circoSuvaxyn Circo
  815. PSUSA/00002709/201704 - periodic safety update report single assessment
  816. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
  817. Access to EudraVigilance data
  818. Guidance for 'specials' manufacturers
  819. ema-trimetazidine-referralTrimetazidine - referral
  820. EU/3/19/2171 - orphan designation for treatment of centronuclear myopathies
  821. EU/3/09/710 - orphan designation for treatment of oesophagus carcinoma
  822. FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid…
  823. EU/3/21/2509 - orphan designation for treatment of glioma
  824. Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott's (formerly…
  825. Cystic fibrosis workshop - Registries initiative
  826. Paediatric Committee (PDCO): 13-16 October 2026
  827. EU/3/21/2562 - orphan designation for treatment of glioma
  828. EU/3/04/203 - orphan designation for treatment of myasthenia gravis
  829. Methocarbamol / paracetamol-containing medicinal products - referral
  830. EMEA-000144-PIP01-07-M05 - paediatric investigation plan
  831. PSUSA/00002410/202108 - periodic safety update report single assessment
  832. Product development procedures
  833. Aseptic Processing and Packaging for the Food Industry
  834. PSUSA/00003065/201708 - periodic safety update report single assessment
  835. EU/3/02/120 - orphan designation for treatment of cystic fibrosis
  836. EMEA-002968-PIP01-21 - paediatric investigation plan
  837. Six-year review shows success of the EU signal management system in improving safe use of…
  838. cdsco-lorlatinib-tab-25-rmgLorlatinib tab 25 rmg
  839. Researchers Find Worrying Trend in Sterile Processing Departments
  840. EMEA-002275-PIP01-17 - paediatric investigation plan
  841. cdsco-ly2835219LY2835219
  842. European Network of Paediatric Research at EMA elects new chair
  843. Guidance on licensing biosimilars, ATMPs and PMFs
  844. CommonSpirit Health Specialist Recognized With 2022 AAMI Award
  845. 21 CFR 808.35: Revocation of an exemption.
  846. Carbamazepin Tillomed - referral
  847. Good agricultural and collection practice for starting materials of herbal origin…
  848. Good Manufacturing Practice (GMP)/Distribution Practice Practice (GDP) Inspectors Working…
  849. AAMI Foundation Names Six 2022 Scholarship Recipients
  850. cfr-21-cfr-872-6080-airbrush21 CFR 872.6080: Airbrush.
  851. Flomoxef (Flumarin) Fosfomycin (Fomicyt)
  852. cfr-21-cfr-895-25-labeling21 CFR 895.25: Labeling.
  853. EU/3/17/1946 - orphan designation for treatment of paroxysmal nocturnal haemoglobinuria
  854. Guideline on data requirements for authorisation of immunological veterinary medicinal…
  855. PSUSA/00010434/202107 - periodic safety update report single assessment
  856. Leaflet Technical Documentation Training 2022 2
  857. 21 CFR 866.5100: Antinuclear antibody immunological test system.
  858. Multiplicity issues in clinical trials - Scientific guideline
  859. Drug Alert for the Month of Revised Jan 2024
  860. Order regarding import of Radio-pharmaceuticals
  861. ema-cyklo-f-referralCyklo-f - referral
  862. PSUSA/00002170/201803 - periodic safety update report single assessment
  863. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17…
  864. ema-mersarexMersarex
  865. Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17…
  866. EMEA-000978-PIP01-10-M01 - paediatric investigation plan
  867. FDA investigating leukemia drug Iclusig (ponatinib) after increased reports of serious…
  868. European Medicines Agency recommends additional measures to better manage risk of…
  869. DR_G.S.R. 411(E) dt_27.04.2018_ Regulation and restriction of the manufacture, sale &…
  870. ema-rivaroxaban-accordRivaroxaban Accord
  871. EU/3/09/654 - orphan designation for treatment of cystic fibrosis
  872. ema-rubracaRubraca
  873. Portable Ultrasound Diagnostic System and Disposable Intracardiac Echocardiography…
  874. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (21- Valent)
  875. ASEAN Guideline on Process Validation Q&A
  876. Irbesartan Hydrochlorothiazide BMS
  877. EMEA-002152-PIP03-19 - paediatric investigation plan
  878. 21 CFR 880.2800: Sterilization process indicator.
  879. 21 CFR 20.112: Voluntary drug experience reports submitted by physicians and hospitals.
  880. Committee for Medicinal Products for Human Use (CHMP): 20-23 September 2010
  881. Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities - What…
  882. EMEA-002470-PIP01-18 - paediatric investigation plan
  883. VICH GL41 Target animal safety: examination of live veterinary vaccines in target animals…
  884. EudraVigilance training and support
  885. 21 CFR 1.277: What is the scope of this subpart?
  886. OM on Rapid Response Regulatory Framework for COVID-19
  887. ema-hyftorHyftor
  888. EU/3/08/611 - orphan designation for treatment of acute liver failure
  889. EU/3/17/1936 - orphan designation for treatment of gastrointestinal stromal tumours
  890. Committee for Herbal Medicinal Products (HMPC): 21-22 May 2012
  891. cdsco-cetuximab-100-mg-20-mlCetuximab 100 mg/20 ml
  892. Capsici fructus - herbal medicinal product
  893. EU/3/23/2772 - orphan designation for treatment of oesophageal atresia
  894. Clinical evaluation of medicinal products intended for treatment of hepatitis B…
  895. CardioGen-82 - FDA alerts healthcare professionals to stop performing heart scans with…
  896. 21 CFR 14.39: Additional rules for a particular advisory committee.
  897. Guideline on Management of Computerized Systems, Q & A
  898. Glycopyyronium Bromide Ph. Eur. eq.to Glycopyrronium 12.5mcg + Formoterol Fumarate…
  899. cfr-21-cfr-872-1-scope21 CFR 872.1: Scope.
  900. Medicinal Products (Prescription and Control of Supply) (Amendment) (No 5) Regulations…
  901. Vaccine availability survey
  902. Template and recommended format for list of references
  903. EMEA-002892-PIP01-20 - paediatric investigation plan
  904. Committee for Advanced Therapies (CAT): 13-14 October 2011
  905. cdsco-lifitegrastLifitegrast
  906. EMEA-001978-PIP01-16 - paediatric investigation plan
  907. Evaluation of Vitamin D Supplementation in affecting the outcome of newly Diagnosed…
  908. NMPA Announcement on Updating the Catalogue of Raw Materials Banned for Cosmetics
  909. FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with…
  910. 21 CFR 16.24: Regulatory hearing required by the act or a regulation.
  911. AAA817 - [225Ac]Ac-PSMA-617
  912. P/0325/2014 - paediatric investigation plan
  913. EU/3/04/244 - orphan designation for treatment of emphysema secondary to congenital…
  914. PSUSA/00001694/201903 - periodic safety update report single assessment
  915. EMEA-001974-PIP01-16-M02 - paediatric investigation plan
  916. Guidance for completing a notification form for lapses in medical device conformity…
  917. ema-porcilis-pcv-idPorcilis PCV ID
  918. Drug Quality Sampling and Testing - Human Drugs
  919. Recombinant Human Serum Albumin (rHSA) 20%
  920. EMEA-001619-PIP04-17-M02 - paediatric investigation plan
  921. NMPA Announcement on Revising the Package Insert of Misoprostol Tablets for Obstetrical…
  922. Quality Systems
  923. The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3)…
  924. EMEA-003226-PIP01-22 - paediatric investigation plan
  925. EMEA-000335-PIP01-08-M15 - paediatric investigation plan
  926. BMET Graduates Celebrate 2024 National Apprenticeship Week
  927. Windsor Framework explainer
  928. Embracing 'Digital Disruption' to Redesign Patient Experiences
  929. Prevymis - direct healthcare professional communication (DHPC)
  930. Committee for Medicinal Products for Veterinary Use (CVMP): 9-11 November 2010
  931. cdsco-lumateperoneLumateperone
  932. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2012
  933. EMEA-002376-PIP02-20 - paediatric investigation plan
  934. EU/3/20/2378 - orphan designation for treatment of Wilson's disease
  935. How will pharmacovigilance look in 2030?
  936. Domestic and Import Food Additives and Color Additives
  937. ema-hyalograft-c-autograftHyalograft C autograft
  938. PSUSA/00010525/201804 - periodic safety update report single assessment
  939. PSUSA/00001484/202203 - periodic safety update report single assessment
  940. aami-news-in-brief-july-2020News in Brief: July 2020
  941. 21 CFR 878.4456: Hemostatic device for intraluminal gastrointestinal use.
  942. EU/3/23/2845 - orphan designation for treatment of infantile neuroaxonal dystrophy
  943. EMA concludes safety review of Uptravi
  944. Maribavir - paediatric investigation plan
  945. Comments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report
  946. EU/3/21/2466 - orphan designation for treatment of medulloblastoma
  947. Preparing your biologicals application for inclusion in the ARTG
  948. 2021.12.10_S.O. 5139(E)_Renotification of NIB Noida as CDL for testing and lot release of…
  949. EMEA-002330-PIP01-18-M03 - paediatric investigation plan
  950. Committee for Advanced Therapies (CAT): 5-7 November 2025
  951. EU/3/16/1637 - orphan designation for treatment of primary hyperoxaluria
  952. EMEA-000366-PIP02-09-M06 - paediatric investigation plan
  953. EMEA-001238-PIP03-21-M01 - paediatric investigation plan
  954. Cancellation of Registration Certificate No. SVH-9 and Import License SVH-9-131
  955. Tick and flea control agent Bravecto continues to be acceptably safe to use
  956. Risk characterisation and assessment of maximum residue limits (MRL) for biocides…
  957. Committee for Orphan Medicinal Products (COMP): 19-21 June 2018
  958. EMEA-002471-PIP01-18 - paediatric investigation plan
  959. Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2013
  960. Committee for medicinal products for veterinary use: Meeting of 17-18 April 2007
  961. ema-ambirixAmbirix
  962. 21 CFR 868.5550: Anesthetic gas mask.
  963. EMEA releases recommendations for better information for patients
  964. Towards a single development programme for new antibiotics in EU, Japan and US
  965. European Medicines Agency recommends restricting the use of modafinil
  966. 21 CFR 868.5880: Anesthetic vaporizer.
  967. ema-oyavasOyavas
  968. POSTPONED: April 23-24, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical…
  969. New gene therapy to treat rare genetic disorder metachromatic leukodystrophy
  970. VICH GL27 Guidance on the pre-approval information for registration of new veterinary…
  971. cdsco-metrexassistMETREXASSISTâ„¢
  972. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14
  973. Small and medium-sized enterprises info day
  974. PSUSA/00001048/202109 - periodic safety update report single assessment
  975. ema-vumerityVumerity
  976. EU/3/05/341 - orphan designation for treatment of ovarian cancer
  977. EU/3/24/2932 - orphan designation for treatment of neonatal encephalopathy
  978. ema-doramectin-referralDoramectin - referral
  979. Direct healthcare professional communications
  980. ema-targretinTargretin
  981. Regulations for Reporting Serious Adverse Events of Medical Devices
  982. NMPA Announcement on Issuing 2 Guidance including the Technical Review Guidance for the…
  983. EMEA-002450-PIP01-18 - paediatric investigation plan
  984. Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder…
  985. Regulation on Medical Device Approval Report Review, Etc
  986. NMPA Announcement on Issues Pertaining to Online Application for Drug Registration Affairs
  987. 21 CFR 801.122: Medical devices for processing, repacking, or manufacturing.
  988. EMEA-001625-PIP02-21-M01 - paediatric investigation plan
  989. 21 CFR 806.20: Records of corrections and removals not required to be reported.
  990. EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
  991. Liothyronine Sodium Tablets 5mcg & 20 mcg
  992. October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee…
  993. ema-patients-and-consumersPatients and consumers
  994. 21 CFR 874.3302: Bone-conduction hearing aid.
  995. 21 CFR 2.5: Imminent hazard to the public health.

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