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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.

• Updated: 27 August 2024

Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.

• Updated: 20 February 2025

Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.

• Updated: 22 July 2021

Information on the new regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect on 23 July 2025.

• Updated: 19 March 2025

How the MHRA makes decisions on what is a medicinal product (borderline products).

• Updated: 8 January 2024

Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.

• Updated: 31 March 2023

How we evaluated pre-exposure prophylactic (preventative) treatments for COVID-19.

• Updated: 31 March 2023

Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.

• Updated: 19 December 2024

• Updated: 10 December 2021

How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).

• Updated: 19 December 2019