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More informationDraft guidance, Feb 2024.
Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK
28 February 2024
Phase I period for public consultation now open.
EMA will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. EMA has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional level in Africa, and in particular for the setting up of the African Medicines Agency (AMA), in collaboration with African, European and international actors.
EMA has just launched the new Antimicrobial Sales and Use (ASU) Platform to support the collection of data by Member States on the sales and use of antimicrobials in animals.
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025.
On 24 January 2024 EMA published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products Draft released and open for comments.
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