The Medicines and Healthcare products Regulatory Agency (MHRA) have published a consultation on proposals for legislative changes for clinical trials.
The consultation aims to amend the existing requirements for clinical trials in the UK, regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended. Any amendments are intended to streamline approval of clinical trials, enable innovation, enhance transparency of clinical trials, enable greater risk proportionality, and further promote patient and public involvement in trials.
Although this legislation is specific to medicines, BIVDA is aware that this may impact a number of manufacturers whose products feature medicinal components, such as companion diagnostics or combination products.
BIVDA intends to provide a response to this consultation on behalf of members. Therefore, please provide any opinions and comments to Ashleigh Batchen by 9 March to allow for a response to be drafted.
This consultation will run until 14 March.
