UK patients, the healthcare system and the life sciences sector
are set to benefit from a new scheme that will see the time taken
by the Medicines and Healthcare products Regulatory Agency (MHRA)
to approve the lowest-risk clinical trials reduced by more than
50%.
The scheme is based on that outlined in the MHRA’s clinical trials
consultation which was endorsed by 74% of those who
responded. It forms a significant part of the regulator’s
overhaul of the clinical
trials regulation, supporting the government’s ambition for
the UK to be one of the best countries in the world to conduct
clinical research for patients and researchers.
Initial applications for the lowest-risk Phase 3 and 4 trials
will be processed by the MHRA within 14 days instead of the
statutory 30 days, provided the sponsor can demonstrate the trial
meets the MHRA’s criteria,
including by confirming there are no known safety issues with the
medicine being investigated.
About 20% of UK initial clinical trial applications are expected
to be eligible for the scheme. Applications for clinical trial
amendments will not be eligible.
Dr June Raine, MHRA Chief Executive said:
“We are excited to introduce this new streamlined clinical trials
system. Clinical trials regulation should be flexible and
risk-proportionate so that the regulatory requirements are geared
to the risk that a trial presents.
“Our new notification scheme is exactly that. It will reduce the
time taken to get the lowest-risk clinical trials up and running
without undermining patient safety. This will help give UK
patients quicker access to the potentially life-saving medicines
being studied.
“Our message to all clinical trial sponsors is that it’s in
everyone’s best interest now to use the new scheme for all
eligible trials.”
Dr Janet Messer, Director of Approvals at the Health
Research Authority said:
“We’re delighted to support the MHRA with this new scheme.
Combined review has already reduced the time taken to review
clinical trials to half what it was five years ago, and we’re
keen to explore how the UK’s fast-track Research Ethics Service
can complement the new notification scheme to further accelerate
high quality health and social care research.
“We look forward to feedback from the research community to make
sure that together we continue to make it easier to do research
that people can trust.”
Steve Bates OBE, Chief Executive Officer of the
BioIndustry Association (BIA), said:
“It is great to see this streamlined process for lower-risk late
stage trials rolled out, which Dr Raine commented on at the BIA
Future of UK Regulation Conference last week. This is another
measure by the agency to speed up clinical trial approvals and
provide a timely and effective service to the life sciences
sector.”
An opinion from a research ethics committee would remain a
requirement for eligible trials.
The MHRA’s criteria for the scheme has been reviewed and endorsed
by the government’s independent expert scientific advisory group
the Commission on Human Medicines (CHM), the Clinical Trials,
Biologicals and Vaccines Expert Advisory Group (CTBVEAG) and
representatives from trade associations, industry and academia
who have recently helped to support service delivery in clinical
trials and investigations by ensuring the MHRA interventions are
robust and that delivery meets expectations.
The criteria for notification of clinical trials will be kept
under continual review and may be subject to change if evidence
is there to support the need for this, including the potential to
expand the scheme to some medium-risk clinical trials.
Notes to editors:
