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This page lists the European Medicines Agency's general guidance documents relating to veterinary medicines
The European Medicines Agency's scientific guidelines on the safety and residues of veterinary medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy...
The European Medicines Agency's scientific guidelines on the biological substances other than immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...
Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.
The European Medicines Agency's scientific guidelines on the clinical efficacy and safety of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and...
The European Medicine Agency's (EMA) scientific guidelines on real-world evidence aim support the use of real-world data in regulatory decision-making.
The European Medicines Agency (EMA) makes available resource materials including videos and links to workshops for healthcare professionals interested in learning more about EMA activities.