The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has opened up proposed clinical trials legislation launched for input from the public. The aim of the ambitious suggestions is to improve and strengthen the country’s clinical trials legislation, to make the country a better place to conduct research and develop safe, innovative treatments.
The eight-week consultation period is intended to collect public views on new proposals designed to improve government oversight and regulation of clinical trials. According to the agency, the aim of the legislation and public input solicitation is to “make the UK the leading global centre for innovative research design and delivery, across all types of trials.”
Additionally, the effort to gather citizen feedback is to develop a system that better promotes the involvement of the public and potential patients, increases study inclusivity, streamlines clinical trial approvals, fosters innovation, and enhances trial transparency.
June Raine, MHRA chief executive, said, “This is a once-in-a-generation opportunity to review and update the UK legislation for clinical trials in order to make the UK the go-to place to develop new and innovative healthcare products.”
The hopeful end result, according to MHRA representatives, is to deliver a streamlined, transparent, and flexible regulatory framework, all the while protecting patient participants that sign up for studies.
In addition to input from the public and patient participants, the MHRA also hopes to gather feedback from clinical research professionals, developers, manufacturers, sponsors, investigators, and healthcare industry members. The consultation period is open from January 17 to March 14, 2022; the agency reportedly will review all responses and use them to inform the finalized legislation.
The MHRA is responsible for regulating all medicines and medical devices in the UK. It is an executive agency of the UK’s Department of Health and Social Care.