DateContentStatus
07/06/2024 Document: Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methodsUpdated
07/06/2024 Document: Workplan 2023-2025: HMA-EMA joint Big Data Steering GroupUpdated
06/06/2024 Document: List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)Updated
06/06/2024 Document: Research projects conducted under the remit of the PRAC impact strategyNew
05/06/2024 Document: Salbutamol inhalation products suppy shortageNew
05/06/2024 Document: List of medicines currently in PRIME schemeUpdated
05/06/2024 Document: Application form for European Medicines Agency certificates of medicinal productsUpdated
04/06/2024 Document: Procedural advice on paediatric applicationsUpdated
04/06/2024 Document: Application form to request Simultaneous National Scientific Advice (SNSA) or a pre-CTA AdviceNew
03/06/2024 Document: 2023 annual report of the European Medicines AgencyUpdated
03/06/2024 Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized processNew
03/06/2024 Document: SNSA procedural flowchartNew
03/06/2024 Document: Guidance for applicants on Simultaneous National Scientific Advice (SNSA) Briefing book format and contentNew
03/06/2024 Document: SNSA – Involvement of NCAsNew
03/06/2024 Document: SNSA meeting minutes template for applicantsNew
03/06/2024 Document: SNSA final advice report templateNew
03/06/2024 Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicantsUpdated
03/06/2024 Document: Template - Request for compliance check on an agreed paediatric investigation plan (PIP)Updated
03/06/2024 Document: Template for scientific documentUpdated
03/06/2024 Document: Paediatric investigation plan (PIP) - Key elements guidanceUpdated
03/06/2024 Document: CTIS newsflash - 31 May 2024New
03/06/2024 Document: Shortage of human normal immunoglobulinsNew