Conditional marketing authorisation (EU)
The European (and Chinese) counterpart of accelerated approval: a drug for an unmet need is authorised on less complete data with specific obligations to deliver confirmatory results, renewed yearly until converted to standard approval.
The EMA grants conditional marketing authorisation when benefit to public health outweighs the risk of incomplete data, typically on phase 2 or interim phase 3 results; it is valid for one year, renewable, and converts to standard authorisation once obligations are met (median about 4 years). Around 30 oncology drugs hold or held CMAs, including CAR-T products and several ADCs. China's NMPA grants conditional approvals extensively for domestic PD-1 antibodies and other drugs, often on single-arm data, with confirmatory trials required. Approval under exceptional circumstances is for diseases where full data can never be collected.
Pages like this
not linked directly; found by shared links- TermComplete response letter (CRL)
Shares Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Confirmatory trial.
- TermIndication withdrawal
Shares Full (traditional, regular) approval, Confirmatory trial, Accelerated approval.
- TermSurrogate endpoint
Shares Confirmatory trial, Accelerated approval.
- TermLabel, indication and label expansion
Shares Full (traditional, regular) approval, Accelerated approval.