Part 2: Human Medicines Chapter 1: Regulations Section 5: Clinical trials
Section 5(1) lists matters relating to clinical trials that provisions made under section 2(1) may address.
	Subsection (1)(a) provides that provision may be made which is corresponding or similar to the EU Clinical Trial Regulation.
	Subsection (1)(b) provides that provision may be made about the authorisation and ethical approval of clinical trials. This is governed by Part 3 (authorisation for clinical trials and ethics committee opinion) of the Medicines for Human Use (Clinical Trials) Regulations 2004. Regulations made under this provision could, for example, amend the application process for applying for such an authorisation.
	Subsection (1)(c) allows provision to be made about the notification and reporting requirements that apply to clinical trials. Parts 4 (conduct of clinical trials) and 5 (pharmacovigilance) of the Medicines for Human Use (Clinical Trials) Regulations 2004 impose various obligations on trial sponsors and investigators responsible for the conduct of the trial to notify adverse events and safety measures to the UK licensing authority. Regulations made under section 2(1) and relying on this provision could, for example, update the existing requirements in order to make them more proportionate for trials that are considered to carry low levels of risk.
	Subsection (1)(d) allows amendments to be made to the requirements that must be satisfied before a trial is started. This could include either amending or removing existing requirements for some or all trials to ensure they remain proportionate or adding new requirements to ensure that trials continue to be conducted to high standards that maximise participant safety.
	Subsection 1(e) allows provision to be made about the conduct of clinical trials. Part 4 (good clinical practice and the conduct of clinical trials) of the Medicines for Human Use (Clinical Trials) Regulations 2004 requires, amongst other things, that clinical trials in the UK must be conducted in accordance with the conditions and principles of good clinical practice set out in Schedule 1 of those Regulations. Regulations made relying on this provision could amend and update these standards that clinical trials must comply with.