The UK government has tabled three amendments to the Health Bill to modernise the legislative framework for the regulation of medicines and medical devices in the UK.
They are part of a wider package of reforms that impact the Medicines and Healthcare products Regulatory Agency (MHRA) and will now face parliamentary scrutiny.
The amendments will focus on three areas:
· Amended information sharing powers for medicines and medical devices
· Measures to make medicines and medical devices legislation easier to update
· Powers to support the future development of a medical device licensing regime.
The first amendment would give the MHRA clearer legal powers to share specific information about medicines and medical devices with UK government organisations and global regulatory partners.
The second would let specific technical, administrative or minor regulatory changes take effect unless Parliament formally objects, helping the UK's regulatory system keep pace with advances in science, medicine and healthcare technology.
The third would provide the MHRA with enabling powers for the future development of a medical device licensing regime.
The proposed powers would amend the Medicines and Medical Devices Act 2021, creating the legal foundation for a future licensing framework.
It will require further policy work, public consultation, impact assessment and parliamentary scrutiny before being implemented.
Under the approach being explored, medical devices placed on the Great Britain market through a domestic route could in future require a licence issued by the MHRA. Previously, this was carried out through third-party conformity assessment.
The proposals do not introduce immediate changes to the regulation of medicines or medical devices, and any measures agreed would require further development and consultation before being implemented.
The amendments will be considered as part of the Bill's remaining stages through Parliament.
