{"entity":{"id":"conditional-approval","kind":"term","name":"Conditional marketing authorisation (EU)","aka":["conditional approval","conditional marketing authorisation","conditional marketing authorization","CMA","conditional authorisation","conditionally approved","approval under exceptional circumstances","exceptional circumstances","conditional NMPA approval","conditional approval in China","specific obligations","conditional approvals","conditional registration"],"tldr":"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.","summary":"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.\n\nThe 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.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/European_Medicines_Agency","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/European_Medicines_Agency"},{"label":"EUR-Lex: Regulation (EC) No 507/2006","url":"https://eur-lex.europa.eu/eli/reg/2006/507/oj"},{"label":"EMA: conditional marketing authorisation","url":"https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation"}],"tags":[],"related":["accelerated-approval","full-approval","confirmatory-trial","regulatory-agencies","eu-regulation-726-2004","china-drug-administration-law","japan-conditional-early-approval","fdora-2022","cancer-drugs-fund","france-early-access","eu-pharma-package"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/conditional-approval/","neighbours":{"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"cancer-drugs-fund","kind":"term","name":"Cancer Drugs Fund (England)","route":"/terms/cancer-drugs-fund/"},{"id":"china-drug-administration-law","kind":"term","name":"China Drug Administration Law (2019) and expedited pathways","route":"/terms/china-drug-administration-law/"},{"id":"confirmatory-trial","kind":"term","name":"Confirmatory trial","route":"/terms/confirmatory-trial/"},{"id":"eu-pharma-package","kind":"term","name":"EU pharmaceutical package reform (2023 proposal)","route":"/terms/eu-pharma-package/"},{"id":"fdora-2022","kind":"term","name":"FDORA 2022 accelerated approval reforms","route":"/terms/fdora-2022/"},{"id":"france-early-access","kind":"term","name":"France: early access (accès précoce), formerly ATU","route":"/terms/france-early-access/"},{"id":"full-approval","kind":"term","name":"Full (traditional, regular) approval","route":"/terms/full-approval/"},{"id":"approval-withdrawal","kind":"term","name":"Indication withdrawal","route":"/terms/approval-withdrawal/"},{"id":"innovative-medicines-fund","kind":"term","name":"Innovative Medicines Fund (England)","route":"/terms/innovative-medicines-fund/"},{"id":"japan-conditional-early-approval","kind":"term","name":"Japan conditional early approval and time-limited approval","route":"/terms/japan-conditional-early-approval/"},{"id":"eu-regulation-726-2004","kind":"term","name":"Regulation (EC) No 726/2004: the EU centralised procedure","route":"/terms/eu-regulation-726-2004/"},{"id":"regulatory-agencies","kind":"term","name":"Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)","route":"/terms/regulatory-agencies/"},{"id":"sakigake","kind":"term","name":"Sakigake designation (Japan)","route":"/terms/sakigake/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}]}}