The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

The Secretary of State in relation to England and Wales and Scotland, and the Department of Health in Northern Ireland and the Secretary of State acting jointly in relation to Northern Ireland, make the following Regulations in exercise of the powers conferred by sections 2(1), 5(1)(a) to (e), 6(1)(b) and 43(2)(a) to (d) of the Medicines and Medical Devices Act 2021. The Secretary of State and the Department of Health in Northern Ireland have carried out a public consultation in accordance with section 45(1) of that Act. In accordance with section 2(2) to (4) of that Act, the overarching objective of the Secretary of State and the Department of Health in Northern Ireland in making these Regulations is safeguarding public health. The Secretary of State and the Department of Health in Northern Ireland have had regard to the matters specified in section 2(3) of that Act and consider that, where these Regulations may have an impact on the safety of human medicines, the benefits of making these Regulations outweigh the risks. In accordance with section 47(3) and (6)(c) of that Act, a draft of this instrument was laid before Parliament and the Northern Ireland Assembly and approved by a resolution of each House of Parliament and the Northern Ireland Assembly.