In early 2022 the government ran a consultation on planned revisions to the regulatory environment for medicinal product clinical trials, with proposals focusing on a more streamlined and flexible regulatory regime, whilst protecting the interests of patients and trial participants.

After receiving more than 2,000 responses, the consultation results have now been published, and the resulting proposals will be taken forwards into legislation.

There are a number of very positive changes proposed from a regulatory point of view.

A few highlights include:

• A combined MHRA and ethics review, taking a maximum of 30 days post validation, with a final decision within 10 days of an RFI response. This will help to ensure faster approval of applications as well as reducing the regulatory and clinical burden for the sponsor. Indeed, the pilot phase for joint MHRA and ethics review halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days.
  https://www.hra.nhs.uk/about-us/news-updates/combined-ways-working-pilot-one-year/
• Taking learnings from the Covid-19 response, the opportunity for assessors to share RFIs per discipline as they are ready, to allow for faster response times from industry. Provision will likewise be made to allow an RFI during the review of a substantial amendment, to avoid rejection for addressable issues.
• To ensure agility and futureproofing, the detailed information on what to include in an application, currently the “schedule 3” list, will remain within guidance, with legislation listing only the core documents (IMPD, protocol etc).
• Introduction of a notification scheme for low intervention trials (where the risk is similar to that of standard medical care), allowing the clinical trial to be approved without the need for a full regulatory assessment.
• Labelling for unblinded trials will become more flexible, meaning specific clinical trial labelling may not be required where a medicine is labelled according to its marketing authorisation.

The next step will be for the detailed legislation to be drawn up. Comprehensive guidance will also be prepared to accompany the new legislation, and will draw on inputs to the original consultation alongside working directly with relevant stakeholders.

Our experts at Jenson R+ look forward to contributing to the development of the new medicinal product clinical trials guidance, to ensure that it benefits our clients in delivering world class clinical trials from within the UK.

For more information, please get in touch at consultancy@jensongroup.com.