CHMP (Committee for Medicinal Products for Human Use)
The EMA's scientific committee responsible for evaluating human medicines and issuing opinions on marketing authorisation applications. The CHMP's positive or negative opinion forms the basis for the European Commission's final approval decision.
Technical Context
The CHMP is the EMA committee responsible for human medicines. It provides: scientific opinions on marketing authorisation applications (centralised procedure), referrals (safety reviews triggered by member states or the Commission), and scientific advice to sponsors during development. CHMP composition: one member and one alternate from each EU/EEA member state, plus up to 5 co-opted members with specific expertise. The assessment process assigns a rapporteur and co-rapporteur for each application, who lead the scientific evaluation and prepare assessment reports. CHMP opinions are adopted by consensus or qualified majority voting. A positive opinion is forwarded to the European Commission for the legally binding marketing authorisation decision (typically within 67 days). CHMP scientific guidelines (efficacy, safety, quality) provide detailed expectations for clinical development programmes.