Marketing Authorisation
Official permission granted by a regulatory authority allowing a drug to be marketed and sold within its jurisdiction. In the EU, marketing authorisations are granted by the European Commission based on EMA assessment. The US equivalent is FDA approval via NDA or BLA.
Technical Context
EU MA routes: centralised procedure (mandatory for biologics, orphan drugs, HIV/cancer/diabetes/neurodegenerative drugs — single application to EMA, assessment by CHMP, decision by European Commission — valid in all 27 EU member states + EEA); mutual recognition procedure (one member state assesses, others recognise); decentralised procedure (simultaneous application to multiple member states). MA holders must maintain pharmacovigilance systems, submit periodic safety update reports (PSURs/PBRERs), and comply with post-marketing obligations. MAs are initially valid for 5 years, then renewable for unlimited periods. Variations (changes to the MA) range from minor administrative changes to major modifications requiring new clinical data. Withdrawal of MA can occur voluntarily or by regulatory action for safety reasons.