Author: Anna Cesar – Manager, Regulatory Compliance EMEA
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has ran, from January 17 to March 14, a public consultation on 10 issued proposals regarding the regulation of clinical trials in the UK. These proposals aim to revise the current Medicines for Human Use (Clinical Trials) Regulations.
At the present, the Medicines for Human Use (Clinical Trials) Regulations 2004, transpose the requirements of the EU Clinical Trials Directive 2001/20/EC into UK law, which will be retired on 31st January 2025 following implementation of the EU Clinical Trials Regulation (Regulation (EU) 536/2014) on 31st January 2022.
The proposals specifically concerns clinical trials and the medicinal products used in clinical trials (Investigational Medicinal Products, ‘IMPs’), and focus on key areas:
1. Patient and public involvement
To ensure protection of participants remains at the heart of legislation by Involving people with relevant lived experience in the design and development of research can improve its quality and relevance to participants.
2. Research transparency
In line with international standards, introduce a requirement to register a trial in a World Health Organization compliant public register prior to its start and to publish summary of results within 12 months of the end of the trial, including with participants.
3. Clinical trial approval processes
A proposal to simplify and streamline processes, supporting quicker timelines for overall trial approval compared with the current processes, and provide a competitive advantage, encouraging sponsors to run trials in the UK. This include changes to requests for information (RFIs) and amendments, as well as a notification scheme for low-intervention trials.
4. Research Ethics review
Streamline the requirements for the make-up of an ethics committee and delete the current granular requirements, and introduce legislative requirements to support diversity in clinical trial populations (including underserved populations such as pregnant and/or breast-feeding individuals).
5. Informed consent in cluster trials
The proposal aims to introduce simplified means of seeking agreement from participants for low-intervention clinical trials and therefore widen the reach and participation of this type of research.
6. Safety reporting
To remove some reporting requirements considered in duplicity or not generally helpful.
7. Good Clinical Practice
Propose to update the current GCP principles to ensure that they are flexible and can be applied to a broad range of clinical trials, including identification of critical to quality factors, risk proportionality, and support more efficient approaches to trial design and conduct.
8. Sanctions and corrective measures
Propose to introduce the ability for regulators to refuse to approve a new study based on ongoing serious non-compliance with the legislation, and ability to terminate only a specific part of the trial e.g., recruitment, dosing, a specific arm of the trial or related to a particular trial site.
9. Manufacturing and assembly
Main proposed changes are in regard to the so called “non-investigational medicinal products” concept, which would be allowed to be extend to non-medicinal products that may currently be unregulated (such as non-medicinal ‘challenge agents’), and the exemption from the need to hold a Manufacturers Authorisation for IMPs (MIA(IMP)) for the preparation of radiopharmaceuticals used as diagnostic IMPs where the process is carried out in hospitals, health centres and clinics.
10. Definitions and other terminologies
Mainly targeting the update of a number of definitions and terminology to promote international harmonisation.
When assessing all that has been proposed, it’s clear that the revisions aim to make the UK a more appealing destination for the healthcare industry.
With the official withdrawal from the EU being completed for over 2 years now, the effects of Brexit and the new additional provisions for crossing the border have proven to be a burden for the clinical trials and its sponsors.
Reframing the clinical trial legislation, can mean sponsors would experience a more streamlined and flexible process, with a notably quicker timeframe for the approval of new studies.
The responses from the consultation are being reviewed by the MHRA, albeit without a date for it to be finalised.
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