UK GMP for IMPs

The new UK Clinical Trials Regulations (CTR) have been implemented on 28 April 2026. Sponsors and investigators must, therefore, ensure that they are fully aware of the information within this guidance and act accordingly to achieve and maintain regulatory compliance. The guidance is also relevant to the manufacturing sites that are named in clinical trial application submissions, and involved in the processing of investigational medicinal products (IMPs).

Good Manufacturing Practice (GMP) for IMPs

The UK CTR now states “the principles and guidelines of GMP means the principles and guidelines of GMP set out in Commission Directive 2003/94/EC in respect of Great Britain or Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”. This is defined as such as the UK exited the European Union prior to the implementation date of the EU Regulation 536/2014 on Clinical Trials. Hence the new Commission Regulation (EU) 2017/1569 on GMP for IMPs is not directly applicable in Great Britain. 

The EU GMP for IMPs Guidelines (Detailed Commission Guidelines) are commonly referred to as "revised" Annex 13 of EU GMP. Specific Guidelines for GMP for IMPs within Great Britain will be published in a separate document. This is intended to reflect the previous EU GMP Annex 13 together with updates (and other factors as appropriate) and should not add any additional burden on UK manufacturing sites but will clarify requirements.

Overall, the MHRA remains committed to and aligned with the internationally harmonized standards of Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the EU, including requirements for the Qualified Person (QP).

Labelling requirements

A dedicated guidance has been generated on "Labelling for investigational medicinal products (IMPs) used in clinical trials". Labels may also include (in small text) a local identification code to manage the generation of artwork and controlled printing, such that unique reference numbers are allocated to each label and version if required to support site quality systems.

For more information please see the information provided in UK Good manufacturing practice (GMP) for investigational medicinal products (IMPs) used in clinical trials.