Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the Prime Minister's speech to the UN on 24 September 2019, what assessment he has made of the regulatory framework for the use of nanotechnology in medicine.

Currently nanotechnology used in medicine is regulated under the legislation that applies to medical devices and medicinal products.

The medical device regulations require that all medical devices are safe and perform as intended. The regulations have recently been updated and the new regulations include specific requirements for medical devices containing nanomaterials. This means that any medical device containing nanomaterials will be subject to more detailed regulatory scrutiny than under the current regulations.

As with all medicinal products, before a nanomedicine is granted a marketing authorisation and becomes available in the United Kingdom, it must be fully evaluated in relation to the appropriate standards required in the relevant legislation on medicinal products. In addition, specific scientific guidelines on nanomedicines have been developed to help medicines developers prepare marketing authorisation applications for nanomedicines.

No specific assessment of the regulatory framework for the use of nanotechnology in medicine has been undertaken.