Medicines and Healthcare products Regulatory Agency

Structure

The MHRA is divided into three main centres:

History

In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from Office for National Statistics. Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form the MHRA. In April 2012, the GPRD was expanded and relaunched as the Clinical Practice Research Datalink (CPRD). In April 2013, the MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for the parent organisation and one of the centres within the group. At the same time the CPRD was formally declared a separate centre of the MHRA, too.

Roles

1. Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
2. Assessment and authorisation of medicinal products for sale and supply in UK.
3. Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
4. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
5. Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
6. Regulate clinical trials of medicines and medical devices.
7. Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
8. Promote safe use of medicines and devices.
9. Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.

MHRA hosts and supports a number of expert advisory bodies, including the Commission on Human Medicine which replaced the Committee on the Safety of Medicines in 2005, and the British Pharmacopoeia Commission.

As part of the European system of approval, MHRA or other national bodies can be the rapporteur or co-rapporteur for any given pharmaceutical application, taking on the bulk of the verification work on behalf of all members, while the documents are still sent to other members as and where requested.

Funding

The MHRA is funded by the Department of Health for the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry. This has led to suggestions by some MPs that the MHRA is too reliant on industry, and so not fully independent.

Criticism

The MHRA has been criticised by the House of Commons Health Committee for, among other things, lacking transparency, and for inadequately checking drug licensing data.

The MHRA (and US Food and Drug Administration) have been criticised in the book Bad Pharma, and by David Healy in evidence to the House of Commons Health Committee, for having undergone regulatory capture; advancing the interests of the drug companies rather than the interests of the public.

Donald Light at the Netherlands Institute for Advanced Study summarised as such:

...the industry has shaped the rules of the regulators, funded their operations, and lobbied them constantly in a classic pattern of regulatory capture....