Freedom of Information request (FOI 22/897)
Published 17 January 2024
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FOI 22/897
4th September 2022
Dear
Thank you for your email.
The majority of our income comes from the pharmaceutical industry, through fees. For example, all Marketing Authorisation applicants have to pay a fee. The licensing of medicines is an independent, scientific process which is overseen by the Commission on Human Medicines (CHM).
The CHM is an independent body which advises on applications for marketing authorisations. This includes considering further representation against our provisional advice in respect of national applications; advises on the need for, and content of, risk management plans for new medicines; advises on the impact of new safety issues on the balance of risks and benefits of licensed medicines – e.g. adding warnings, restricting or suspending use of a medicine and advises the licensing authority on changes to legal status of marketing authorisations.
We are an executive agency of the Department of Health and Social Care. Our Annual report (link below) contains information on page 13 and 48 regarding our funding. If you require more details about the level of Government Funding, please refer to the financial statements in the Annual report.
MHRA_Annual_Report_and_Accounts_2021-22.pdf (publishing.service.gov.uk)
Last year our activities were funded as follows:
- Medicines regulation was funded from fees charged to the regulated industry according to the full cost recovery rules set out in Her Majesty’s Treasury’s Managing Public Money
- Devices regulation was primarily funded by DHSC with approximately 10% of its revenue from fees charged for services
- NIBSC derived almost half its revenue from fees charged for services, including the sale of biological standards; NIBSC also received research funding, including DHSC research funding through the Regulatory Science Research Unit (RSRU); and DHSC provided the remaining funding to finance its important public health functions
- CPRD is jointly funded by the Agency and DHSC’s National Institute for Health Research (NIHR) and managed and operated by the Agency with DHSC having equal voting rights in direction setting and decision making
If you have a query about the information provided, please reply to this email.
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Information Commissioner’s Office
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Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre