People are encouraged to contribute their views on far-reaching
proposed revisions to the clinical trial legislation in the UK.
‘Better regulation…for better trials…for better
health’
The Medicines and Healthcare products Regulatory Agency (MHRA)
has today launched a public
consultation on a set of far-reaching proposals to improve and
strengthen the UK clinical trials legislation to make the UK
the best place to research and develop safe and innovative
medicines.
Clinical trials are vitally important for achieving advances in
medical treatment. Clinical trials may be conducted for a range
of purposes, for example to test whether a new treatment or
combination of treatments is safe and effective, or to explore
new ways to use existing medicines – as has been seen with the
rapid introduction of new vaccines and therapeutics for COVID-19.
This eight-week consultation seeks your views on new proposals to
improve regulation of clinical trials in the best interests of
patients. In line with the ambitions of the Life Sciences Vision
these proposals for UK legislation seeks to make the UK the
leading global centre for innovative research design and
delivery, across all types of trials. This consultation aims to
develop a system which promotes patient and public involvement in
clinical trials, improves the diversity of participants,
streamlines clinical trial approvals, enables innovation and
enhances clinical trials transparency.
June Raine, Chief Executive of the MHRA 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.
Through the proposals outlined in this consultation we aim to
reframe the legislation that underpins our regulation of clinical
trials to deliver a more streamlined, transparent and flexible
regulatory regime whilst always protecting patients and trial
participants.
We are seeking the views of the wider public, clinical trial
participants, researchers, developers, manufacturers, sponsors,
investigators, healthcare professionals to help shape
improvements for the future of clinical trials. We encourage you
to get involved and help shape this important future legislation,
for the ultimate benefit of patients.
This consultation will run from 17 January until 14 March 2022.
All responses will be carefully reviewed and will inform
decisions to finalise the drafting of the secondary legislation.
Notes to editors
- The Medicines and Healthcare
products Regulatory Agency is responsible for regulating
all medicines and medical devices in the UK.
- The MHRA is a centre of the Medicines and Healthcare products
Regulatory Agency which also includes the National Institute for
Biological Standards and Control (NIBSC) and the Clinical Practice Research
Datalink (CPRD). The MHRA is an executive agency of the
Department of Health and Social Care.
- The current UK legislation, The Medicines for Human Use
(Clinical Trials) Regulations 2004, as amended, transposed the EU
Clinical Trials Directive 2021/20/EC into national law.
- This consultation will run from 17 January, 11:00 until 14
March 2022, 23:00.
- Find the full list of the
consultation proposals and executive summary here.
