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8 october 2025, 10:00 (cest) They are regulated at eu member state level, but the european medicines agency (ema) is involved in the regulatory process. Evaluation, supervision and safety monitoring of medicines in the eu.
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Information on the regulation of medicines for human use in the european union (eu), with a focus on the centralised procedure In the european union (eu) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended The european medicines agency (ema) plays a key role in this procedure.
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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. Check ema's annual reports for insights into our regulatory procedures, activities, and achievements The reports include an interactive timeline and figures and statistics for easy comprehension.
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) member states, to help applicants prepare marketing authorisation applications for human medicines Guidelines reflect a harmonised approach of the eu member states and the agency on how to interpret and apply the. The european medicines agency (ema) publishes detailed information on the medicines assessed by the committee for medicinal products for human use (chmp) and committee for medicinal products for veterinary use (cvmp).
