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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.
European Union, regulation. Conditional marketing authorisation is provided for by Article 14-a of Regulation (EC) No 726/2004 and detailed in Commission Regulation (EC) No 507/2006; China wrote conditional approval into its Drug Administration Law in 2019 and Japan has a statutory conditional early approval system from 2020. Primary text: EUR-Lex for the two EU regulations; the EMA conditional marketing authorisation page explains the procedure.
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.
Shares Sakigake designation (Japan), Japan conditional early approval and time-limited approval, Regulation (EC) No 726/2004: the EU centralised procedure, Accelerated approval.
Shares FDORA 2022 accelerated approval reforms, Indication withdrawal, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares Full (traditional, regular) approval, FDORA 2022 accelerated approval reforms, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Accelerated approval.
Shares France: early access (accès précoce), formerly ATU, Regulation (EC) No 726/2004: the EU centralised procedure, Accelerated approval.
Shares France: early access (accès précoce), formerly ATU, EU pharmaceutical package reform (2023 proposal), Regulation (EC) No 726/2004: the EU centralised procedure.
Shares France: early access (accès précoce), formerly ATU, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Cancer Drugs Fund (England).
Shares Confirmatory trial, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).
Shares Innovative Medicines Fund (England), France: early access (accès précoce), formerly ATU, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Cancer Drugs Fund (England).