# Conditional marketing authorisation (EU)

Source: https://onco.cc/terms/conditional-approval/  
OnCo record `conditional-approval` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

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.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: 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

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/European_Medicines_Agency
- Wikipedia: https://en.wikipedia.org/wiki/European_Medicines_Agency
- EUR-Lex: Regulation (EC) No 507/2006: https://eur-lex.europa.eu/eli/reg/2006/507/oj
- EMA: conditional marketing authorisation: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Cancer Drugs Fund (England)](https://onco.cc/terms/cancer-drugs-fund/), [China Drug Administration Law (2019) and expedited pathways](https://onco.cc/terms/china-drug-administration-law/), [Confirmatory trial](https://onco.cc/terms/confirmatory-trial/), [EU pharmaceutical package reform (2023 proposal)](https://onco.cc/terms/eu-pharma-package/), [FDORA 2022 accelerated approval reforms](https://onco.cc/terms/fdora-2022/), [France: early access (accès précoce), formerly ATU](https://onco.cc/terms/france-early-access/), [Full (traditional, regular) approval](https://onco.cc/terms/full-approval/), [Indication withdrawal](https://onco.cc/terms/approval-withdrawal/), [Innovative Medicines Fund (England)](https://onco.cc/terms/innovative-medicines-fund/), [Japan conditional early approval and time-limited approval](https://onco.cc/terms/japan-conditional-early-approval/), [Regulation (EC) No 726/2004: the EU centralised procedure](https://onco.cc/terms/eu-regulation-726-2004/), [Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)](https://onco.cc/terms/regulatory-agencies/), [Sakigake designation (Japan)](https://onco.cc/terms/sakigake/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)

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