MHRA releases draft guidance package for 2026 Clinical Trials Regulations
The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance to support implementation of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, which come into force on 28 April 2026. The guidance package, released on 25 June 2025, includes eight new documents covering trial approval processes, expert advice requirements, labelling standards, safety event reporting, and transitional arrangements. The draft guidance is intended to help trial sponsors prepare for the new regulatory framework while existing rules remain in force until the implementation date.