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Dec 18, 2023 · The AI workplan, prepared under the joint HMA-EMA Big Data Steering Group (BDSG), ensures the EMRN remains at the forefront in benefiting from AI in medicines regulation. The workplan was adopted by EMA’s Management Board at its December meeting. The field of AI is developing swiftly.
Jan 6, 2021 · Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The originally authorised Spikevax contains elasomeran, a molecule called messenger RNA (mRNA) with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.
Jun 21, 2024 · EMA, the Heads of Medicines Agencies and the European Commission are inviting interested parties to comment on the revised draft guidelines on variations categories and procedures. This proposal aims to make the lifecycle management of human medicines more efficient and future-proof. Provide your comments by 23 August 2024.
Human. The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass through the centralised procedure. They also supply thousands of European experts who serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members.
Mar 12, 2023 · Pre-authorisation guidance. These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase. This guidance should be read in conjunction with the rules governing medicinal ...
Regulatory science strategy. The European Medicines Agency's (EMA) 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy aims to build a more adaptive regulatory system that will encourage innovation in ...
The External Organisation Administrator is a special role in the EMA Account Management portal. This Administrator, once validated by EMA, can approve or reject requests to become an administrator for other EMA-run systems[ 1] for their organisation. EudraVigilance: When requesting access as a Responsible Person or EU QPPV/Additional QPPV ...
