MHRA updates guidance on transitional arrangements for clinical trials ahead of April 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on transitional arrangements for the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025/538, which comes into force on 28 April 2026. The update clarifies timelines for submitting notification of intent to follow old pharmacovigilance rules, confirms that substantial labelling updates to comply with the amended regulations must be approved by the MHRA and adds guidance on post-QP certification labelling on or after 28 April 2026.