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Evaluation, supervision and safety monitoring of medicines in the eu. The european medicines agency (ema) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in europe. Follow the journey of a medicine for human use assessed by ema in this interactive timeline
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It explains all stages from initial research to patient access, including how ema supports. 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. 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).
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.
