Which statement regarding the Medicines and Healthcare products Regulatory Agency (MHRA) is correct?

• A. The MHRA is a private industry body with no regulatory role.
• B. The MHRA is responsible for licensing new medicines and new combinations of active chemicals.
• C. The MHRA only regulates medical devices.
• D. The MHRA funds public health campaigns.

Answer: (B)

The key idea is that the MHRA acts as the UK regulator for medicines, responsible for assessing and authorising them before they can be marketed. This includes giving Marketing Authorisations for new medicines and for changes to existing medicines, such as combining active ingredients in new ways or forming new combinations. In other words, the agency evaluates safety, quality, and efficacy to permit a medicine’s use in the UK, and this includes approving new products as well as changes to their composition.

It’s not a private industry body with no regulatory role, since the MHRA is a government regulatory agency. It does more than regulate devices, so it’s not limited to medical devices. And it doesn’t fund public health campaigns, as its main function is regulation and licensing rather than public health messaging or funding.