The Medicines for Human Use (Clinical Trials) Regulations 2004

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Directive 2001/20/EC on the approximation of 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 for human use (“the Directive”).

The Regulations provide that the licensing authority established in accordance with the Medicines Act 1968 for the purpose of Part II of that Act (licences and certificates relating to medicinal products) shall exercise the functions of the competent authority under the Directive and certain functions falling to be performed by Member States under that Directive (regulation 4), unless those functions are conferred on any other person or body (for example, enforcement functions are conferred on the Secretary of State for Health, the National Assembly for Wales, the Scottish Ministers and the Department for Health, Social Services and Public Safety in Northern Ireland).

Regulations 5 to 10, and Schedule 2, make provision for ethics committees in the United Kingdom, which are to be responsible, amongst other things, for giving opinions on the ethics of clinical trials involving medicinal products. Regulation 5 provides for the United Kingdom Ethics Committees Authority, which is to be responsible for establishing, recognising, and monitoring ethics committees.

Regulations 11 to 27, and Schedules 3 to 5, make provision for clinical trial authorisations by the licensing authority and for ethics committee opinions. In particular: regulation 12 provides that a clinical trial may be conducted only if it has been authorised by the licensing authority and an ethics committee has given a favourable opinion; regulation restricts the supply of medicinal products for the purposes of clinical trials; regulations 14 to 16 and Schedules 3 and 4 make provision for applications for ethics committee opinions; and regulations 17 to 21 and Schedule 3 deal with requests to the licensing authority for authorisation. Regulations 22 to 25 make provision for amendments to clinical trial authorisations; and regulation 26 and Schedule 5 make provision for the reference to the appropriate committee or the Medicines Commission of decisions to refuse authorisations, amendments etc. Regulation 27 makes provision for the conclusion of a trial.

Regulations 28 to 31, and Schedules 1 and 5, make provision for: the conduct of a clinical trial, including the requirement to adhere to the principles of Good Clinical Practice; urgent safety measures to protect trial subjects from immediate hazards; and the suspension and termination of a trial. Schedule 5 includes provisions for referral to the appropriate committee or the Medicines Commission where a trial is suspended or terminated by the licensing authority.

Regulations 32 to 35 make provision for pharmacovigilance; i.e. the recording and reporting of adverse events and reactions to medicinal products being used in a clinical trial.

Regulations 36 to 45, and Schedules 6 to 8, make provision for the manufacture and importation of medicinal products to be used in clinical trials. In particular they make provision for: authorisations for manufacture, assembly and importation (regulations 36 and 37); the applications for, consideration of and grant or refusal of such authorisations (regulations 38 to 40 and Schedules 6 to 8); the application and effect of authorisations (regulations 41 and 42); the qualified persons responsible for checking the quality of products being manufactured, assembled or imported (regulation 43); and the variation, suspension and revocation of authorisations (regulations 44 and 45 and Schedule 8).

Regulation 46 concerns the labelling of such medicinal products.

Regulations 47 to 52, and Schedule 9, make provision for enforcement and related matters, including powers of inspection, infringement notices, offences and penalties for breaches of the Regulations.

Regulations 53 to 56, and Schedules 10 to 12, contain miscellaneous provisions for the construction of references in authorisations to pharmacopoeias and other publications, for the consequential amendment and revocation of legislation, and for transitional arrangements.

A full regulatory impact assessment of the effect that this instrument will have on the costs of business is available from the Medicines and Healthcare products Regulatory Agency, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. A copy of that assessment, and a Transposition Note in relation to the implementation of Directive 2001/20/EC, have been placed in the libraries of both Houses of Parliament.