Guidance and regulation

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

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 10 April 2024

Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 March 2024

How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 April 2024

The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 December 2020

How to join the phase I accreditation scheme.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 10 November 2023

The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 September 2021

Points to consider when using real-world data in clinical studies

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 16 December 2021

Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 4 August 2020

The review of the safety of isotretinoin has concluded.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 31 October 2023

The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.

• From: UK Health Security Agency
• Updated: 20 May 2024

How investigators and sponsors should manage clinical trials during COVID-19

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 16 November 2021

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.

• From: Department of Health and Social Care
• Updated: 31 March 2023

The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 23 February 2022

Actions that trial sponsors should consider to build resilience into clinical trial design

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 13 November 2020

Deficiencies in Omega’s pharmacovigilance system are not thought to affect the safety of the products that they market.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 26 June 2014

Guidance for healthcare professionals on providing free prescriptions for participants in the HEAL-COVID or STIMULATE-ICP long COVID clinical trials.

• From: Department of Health and Social Care
• Updated: 29 March 2023

VDEC’s Discovery and Surveillance capabilities provide unique services across a spectrum of molecular immunology platforms

• From: UK Health Security Agency
• Updated: 20 May 2024

We use decades of experience in safe bioagent handling to support partners in research, development and testing of vaccines and therapeutics

• From: UK Health Security Agency
• Updated: 20 May 2024

VDEC works with global leaders from all sectors to develop and deliver the vaccine and therapeutic products we need to protect us from infectious diseases.

• From: UK Health Security Agency
• Updated: 20 May 2024