UK sets out on ‘once-in-generation’ opportunity to update clinical trial legislation

By Rachel Arthur

- Last updated on GMT


Related tags Uk Mhra Clinical trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation to improve and strengthen UK clinical trials legislation.

Launched this week, the consultation sets out new proposals and will run until March 14. The MHRA is inviting clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals and the wider public to respond to the consultation.

“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,”​ said June Raine, Chief Executive of the MHRA.

“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.”

Improving speed and efficiency of clinical trial approvals

The proposals set out to improve current UK clinical trials legislation (The Medicines for Human Use (Clinical Trials) Regulations 2004 as amended).

Proposed legislative changes seek to improve the speed and efficiency of approvals, support innovation, enhance transparency, encourage greater risk proportionality, and promote patient and public involvement in clinical trials.

“There are some blockers to innovation and overly prescriptive requirements in the current legislation that we have aimed to identify and remove where appropriate, whilst still ensuring regulatory oversight of trials,"​ notes the MHRA. "We are also aiming to update trial terminologies to reduce any confusion or duplication of requirements for multi-country trials.”

One proposed change is to amend legislation to enable sponsors to make a combined MHRA / research ethics application through a single UK ‘front door’, the Integrated Research Application System (IRAS).

It would also set out new maximum standard timeframes for the joint review and decision on a clinical trial application: proposed at 30 days from acknowledgement of a valid application.

The proposals also set out plans for a notification scheme where sponsors can notify the MHRA about a clinical trial where the risk is similar to standard medical care (for example, involving marketed products used in accordance with marketing authorization or supported by national guidance); and the clinical trial can be approved without need for regulatory review (ethics review would still be required).

There are also plans to introduce greater flexibility in the reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR).

The consultation can be found here.

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