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The European Medicines Agency (EMA) is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines. The EMA serves the EU and three countries from the EEAIceland, Norway, and Liechtenstein.
National authorisation procedures mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries; decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.
What is scientific advice? Scientific advice is about advising medicine developers on the most appropriate way to generate robust evidence on a medicines benefits and risks. For a medicine to be authorised, medicine developers have to demonstrate that it is effective, safe and of good quality.
EMA has seven scientific committees that evaluate medicines along their lifecycle from early stages of development, through marketing authorisation to safety monitoring once they are on the market.
EMA gives scientific advice by responding to specific questions posed by the medicine developer on the development of a particular medicine. The developer of a medicine presents the way it plans to develop its medicine and identifies questions and possible solutions. EMA then gives advice on the developers proposals.
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The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
How long does it take? Upon submission of a valid application, the evaluation takes up to 210 days, at the end of which the Committee for Medicinal Products for Human Use (CHMP) must issue a scientific opinion on whether the medicine may be authorised or not.
EMAs committees Committee for Medicinal Products for Human Use (CHMP) Pharmacovigilance Risk Assessment Committee (PRAC) Committee for Veterinary Medicinal Products (CVMP) Committee for Orphan Medicinal Products (COMP) Committee on Herbal Medicinal Products (HMPC) Committee for Advanced Therapies (CAT)

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