EMA (European Medicines Agency)
The EU agency responsible for scientific evaluation, supervision, and safety monitoring of medicines. The EMA's centralised procedure (mandatory for biological products including peptides) provides a single marketing authorisation valid across all EU member states. EMA approval is tracked by PeptideTrace.
Technical Context
EMA structure: CHMP (evaluates human medicines), PRAC (Pharmacovigilance Risk Assessment Committee — safety monitoring), PDCO (Paediatric Committee — paediatric investigation plans), COMP (Committee for Orphan Medicinal Products — orphan designation), and CAT (Committee for Advanced Therapies). The centralised procedure timeline: Day 0 (application validation) → Day 80 (first assessment round) → Day 120 (CHMP questions to applicant) → clock stop (applicant prepares responses) → Day 180 (second assessment) → Day 210 (CHMP opinion) → European Commission decision (typically within 67 days of CHMP opinion). Total timeline: approximately 12-15 months. The EMA also manages the EU pharmacovigilance system (EudraVigilance), the EU Clinical Trials Register, and the European Public Assessment Report (EPAR — publicly available detailed assessment of each approved medicine).