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Evaluation, supervision and safety monitoring of medicines in the eu. The national medicine registers in the different member states of the european union (eu) and european economic area (eea) contain information on medicines authorised in those countries,. Information on the regulation of medicines for human use in the european union (eu), with a focus on the centralised procedure
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The european medicines agency (ema) plays a key role in this. While the majority of new, innovative medicines are evaluated by ema and authorised by the european commission in order to be marketed in the eu, most generic medicines and medicines. A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the european medicines agency.
The european medicines agency's committee for medicinal products for human use prepares scientific guidelines in consultation with regulatory authorities in the european union (eu).
The european medicines agency (ema) makes guidance and templates available to provide marketing authorisation applicants with practical advice on how to draw up the product.
