| 07/06/2024 | PIP: EMEA-003184-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | Document: Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
| 07/06/2024 | PIP: EMEA-003080-PIP03-22 - paediatric investigation plan | New |
| 07/06/2024 | Event: Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods | Updated |
| 07/06/2024 | Document: Workplan 2023-2025: HMA-EMA joint Big Data Steering Group | Updated |
| 07/06/2024 | PIP: EMEA-002612-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003079-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | Orphan: EU/3/13/1200 - orphan designation for treatment of papillary thyroid cancer | Updated |
| 07/06/2024 | Orphan: EU/3/13/1199 - orphan designation for treatment of follicular thyroid cancer | Updated |
| 07/06/2024 | Medicine: Nexavar | Updated |
| 07/06/2024 | Medicine: Sylvant | Updated |
| 07/06/2024 | Orphan: EU/3/07/508 - orphan designation for treatment of Castleman's disease | Updated |
| 07/06/2024 | Medicine: Lamivudine Teva | Updated |
| 07/06/2024 | Medicine: Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
| 07/06/2024 | PIP: EMEA-000032-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | Medicine: Irbesartan/Hydrochlorothiazide Teva | Updated |
| 07/06/2024 | PIP: EMEA-003370-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003364-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003339-PIP02-23 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003302-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003279-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003251-PIP01-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-003208-PIP02-22 - paediatric investigation plan | New |
| 07/06/2024 | PIP: EMEA-001231-PIP02-13-M10 - paediatric investigation plan | Updated |
| 07/06/2024 | PIP: EMEA-001523-PIP04-19-M02 - paediatric investigation plan | Updated |
| 07/06/2024 | PIP: EMEA-001490-PIP01-13-M04 - paediatric investigation plan | Updated |
| 07/06/2024 | PIP: EMEA-001238-PIP03-21-M01 - paediatric investigation plan | Updated |
| 07/06/2024 | Medicine: Parsabiv | Updated |
| 06/06/2024 | Event: Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | Updated |
| 06/06/2024 | PIP: EMEA-001214-PIP09-21-M01 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-001194-PIP01-11-M06 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-001075-PIP04-15-M06 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-000973-PIP01-10-M04 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-000353-PIP02-16-M03 - paediatric investigation plan | Updated |
| 06/06/2024 | PIP: EMEA-000115-PIP01-07-M13 - paediatric investigation plan | Updated |
| 06/06/2024 | Medicine: Skyclarys | Updated |
| 06/06/2024 | Medicine: Litfulo | Updated |
| 06/06/2024 | Medicine: Rizmoic | Updated |
| 06/06/2024 | Medicine: Hizentra | Updated |
| 06/06/2024 | Medicine: Sitagliptin / Metformin hydrochloride Sun | Updated |
| 06/06/2024 | Medicine: Byfavo | Updated |
| 06/06/2024 | Medicine: Tysabri | Updated |
| 06/06/2024 | Medicine: Mimpara | Updated |
| 06/06/2024 | Medicine: Jubbonti | Updated |
| 06/06/2024 | Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs) | Updated |
| 06/06/2024 | Medicine: Qdenga | Updated |
| 06/06/2024 | Page: Pharmacovigilance: Overview | Updated |
| 06/06/2024 | PSUSA: PSUSA/00003043/202308 - periodic safety update report single assessment | New |
| 06/06/2024 | Medicine: Enbrel | Updated |
| 06/06/2024 | Event: Product Management Service (PMS) Product UI training (access & navigation) | Updated |
| 06/06/2024 | Medicine: Trodelvy | Updated |
| 06/06/2024 | Medicine: Myocet liposomal (previously Myocet) | Updated |
| 06/06/2024 | Medicine: Giapreza | Updated |
| 06/06/2024 | Page: Plasma master file certificates | Updated |
| 05/06/2024 | Page: Vaccine Monitoring Platform | Updated |
| 05/06/2024 | PSUSA: PSUSA/00003121/202308 - periodic safety update report single assessment | New |
| 05/06/2024 | Medicine: Reyataz | Updated |
| 05/06/2024 | Medicine: Erbitux | Updated |
| 05/06/2024 | Medicine: Beyfortus | Updated |
| 05/06/2024 | Medicine: PecFent | Updated |
| 05/06/2024 | Document: Salbutamol inhalation products suppy shortage | New |
| 05/06/2024 | Referral: Synapse - referral | Updated |
| 05/06/2024 | Referral: Ibuprofen NVT - referral | Updated |
| 05/06/2024 | Medicine: Alprolix | Updated |
| 05/06/2024 | Page: EudraVigilance training and support | Updated |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 05/06/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system | New |
| 05/06/2024 | Event: Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system | New |
| 05/06/2024 | Medicine: Camcevi | Updated |
| 05/06/2024 | Medicine: Abilify Maintena | Updated |
| 05/06/2024 | Page: PRIME: priority medicines | Updated |
| 05/06/2024 | Document: List of medicines currently in PRIME scheme | Updated |
| 05/06/2024 | Document: Application form for European Medicines Agency certificates of medicinal products | Updated |
| 04/06/2024 | Medicine: Xromi | Updated |
| 04/06/2024 | Document: Procedural advice on paediatric applications | Updated |
| 04/06/2024 | Medicine: Oxbryta | Updated |
| 04/06/2024 | Medicine: Onpattro | Updated |
| 04/06/2024 | Medicine: Suliqua | Updated |
| 04/06/2024 | Medicine: Xultophy | Updated |
| 04/06/2024 | PSUSA: PSUSA/00002114/202308 - periodic safety update report single assessment | New |
| 04/06/2024 | Document: Application form to request Simultaneous National Scientific Advice (SNSA) or a pre-CTA Advice | New |
| 03/06/2024 | News: EU recommendations for 2024/2025 seasonal flu vaccine composition | Updated |
| 03/06/2024 | Document: 2023 annual report of the European Medicines Agency | Updated |
| 03/06/2024 | Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized process | New |
| 03/06/2024 | Document: SNSA procedural flowchart | New |
| 03/06/2024 | Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and content | New |
| 03/06/2024 | Document: SNSA – Involvement of NCAs | New |
| 03/06/2024 | Document: SNSA meeting minutes template for applicants | New |
| 03/06/2024 | Document: SNSA final advice report template | New |
| 03/06/2024 | Referral: Ocaliva - referral | Updated |
| 03/06/2024 | Medicine: Comirnaty | Updated |
| 03/06/2024 | Page: Class waivers | Updated |
| 03/06/2024 | Page: Annual report on deferrals | Updated |
| 03/06/2024 | Page: Paediatric investigation plans | Updated |
| 03/06/2024 | Page: Paediatric investigation plans: questions and answers | Updated |
| 03/06/2024 | Page: Paediatric investigation plans: Templates and forms | Updated |
| 03/06/2024 | Page: Paediatric medicines: Overview | Updated |
| 03/06/2024 | Page: Paediatric medicines: Research and development | Updated |
| 03/06/2024 | Page: Paediatric medicines: applications and procedures | New |
| 03/06/2024 | Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants | Updated |
| 03/06/2024 | Medicine: Xarelto | Updated |
| 03/06/2024 | Page: Information Management | Updated |
| 03/06/2024 | Medicine: Dacogen | Updated |
| 03/06/2024 | PIP: EMEA-003371-PIP01-22 - paediatric investigation plan | New |
| 03/06/2024 | Document: Template for scientific document | Updated |
| 03/06/2024 | Document: Paediatric investigation plan (PIP) - Key elements guidance | Updated |
| 03/06/2024 | Medicine: SomaKit TOC | Updated |
| 03/06/2024 | Medicine: Sunitinib Accord | Updated |
| 03/06/2024 | Medicine: Suboxone | Updated |
| 03/06/2024 | Medicine: Filspari | Updated |
| 03/06/2024 | Medicine: Awiqli | Updated |
| 03/06/2024 | Medicine: Xtandi | Updated |
| 03/06/2024 | Page: Recommendations on medication errors | Updated |
| 03/06/2024 | Medicine: Imfinzi | Updated |
| 03/06/2024 | Medicine: Imjudo | Updated |
| 03/06/2024 | Medicine: Bimervax | Updated |
| 03/06/2024 | Medicine: Cufence | Updated |
| 03/06/2024 | Medicine: Zilbrysq | Updated |
| 03/06/2024 | Medicine: Rozlytrek | Updated |
| 03/06/2024 | Medicine: Omlyclo | Updated |
| 03/06/2024 | Document: CTIS newsflash - 31 May 2024 | New |
| 03/06/2024 | Document: Shortage of human normal immunoglobulins | New |
| 03/06/2024 | Page: Removing an orphan designation | Updated |
