Explanatory Note
(This note is not part of the Regulations)
These Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the 2004 Regulations”) which implement Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products in humans.
Following withdrawal of the UK from the European Union, these Regulations are made in exercise of the powers conferred by sections 2(1), 5(1)(a) to (e), 6(1)(b) and 43 of the Medicines and Medical Devices Act 2021, in respect of clinical trials in the United Kingdom.
These Regulations make provision for the following matters:
(a)Part 3 amends the provisions on the operation and constitution of the ethics committee, which are contained in Part 2 of the 2004 Regulations.
(b)Part 4, which amends Part 3 of the 2004 Regulations, revises the approval procedure for clinical trials, combining the separate applications for regulatory authorisation and ethics committee opinion into one application route, leading to a co-ordinated review and a single UK decision. For trials considered lower risk, this will be notified and can be given automatic regulatory authorisation. The combined procedure is extended to substantial amendments to the trial approval, and references to amendments are replaced with references to modifications. This Part also introduces transparency requirements, which are to require registration of the trial in a public register, to publish a summary of the trial results, and to share those results with the participants.
(c)Part 5 amends the provisions on the principles and conditions of good clinical practice by reference to the ICH guideline and makes clear, in applying those principles and conditions that the functions of the sponsor include those in relation to the development and maintenance of trial specific computerised systems.
(d)Part 6 makes a number of changes to Part 5 of the 2004 Regulations, which concerns the pharmacovigilance requirements that apply to clinical trials under Part 5, in particular to allow aggregate reporting, and to impose specific requirements with respect to record keeping and the content of the annual report on the safety of trials.
(e)Part 7 amends Part 6 of the 2004 Regulations on manufacturing and importation, and provides for an exemption from the need, in certain circumstances, for a manufacturing authorisation in respect of radiopharmaceuticals used for diagnostic purposes.
(f)Part 8, which inserts a new Part 6A to the 2004 Regulations, makes a new provision concerning medicinal products which are used in the trial, but which are not being tested.
(g)Part 9, which amends Part 7 of the 2004 Regulations, makes similar provision to the EU Clinical Trials Regulation in respect of labelling of investigational and non-investigational medicinal products.
(h)Part 10 makes consequential changes to Part 8 of the 2004 Regulations relating to enforcement of the Regulations and extends the power of the licensing authority to issue infringement notices to facilitate compliance with the Regulations.
(i)Part 11 amends all the Schedules that are related to the changes made to Parts 2 to 4 of the 2004 Regulations.
(j)Part 12 inserts a new Schedule 14, which makes transitional provisions in relation to existing authorisations and applications.
References throughout the Regulations to a clinical trial subject are replaced with references to a participant; and similarly, references to a trial site, are replaced with references to a trial location.
A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, voluntary or public sector is foreseen. A de minimis assessment is available from the Department of Health and Social Care, 39 Victoria Street, London, SW1H 0EU and is published with the explanatory memorandum alongside this instrument at www.legislation.gov.uk.