FOI release

MHRA Oncology Marketing Authorisation Review Timelines and Performance Metrics

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2026/00629

Received 12 June 2026

Published 12 August 2026

Request

Under the Freedom of Information Act, I respectfully request the following information regarding MHRA review timelines for oncology Marketing Authorisation Applications: 1. The average duration, in calendar days, of MHRA reviews for oncology Marketing Authorisation Applications that received a final determination between January 1, 2020 and the present. 2. The median duration, in calendar days, of MHRA reviews for oncology Marketing Authorisation Applications that received a final determination between January 1, 2020 and the present. 3. The longest review duration, in calendar days, for any oncology Marketing Authorisation Application that received a final determination during that period. 4. The number of oncology Marketing Authorisation Applications currently under review that have remained under assessment for: • More than 12 months • More than 24 months • More than 36 months 5. Any publicly releasable policies, guidance documents, performance targets, service standards, or internal metrics relating to expected review timelines for Marketing Authorisation Applications. I am not requesting confidential information relating to any specific applicant, product, or active application. I am seeking statistical and process-related information regarding MHRA review timelines and regulatory performance.

Response

See attached

Documents

• FOI2026_00629 (redacted).pdf (770.5 KB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.