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Information on when software applications (apps) are considered to be a medical device and how they are regulated.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
Key insights of simulation workshops from the AI Airlock testing programme. You should note that these documents are not formal guidance.
Guidance on clinical trials that are categorised as ‘notifiable’.
Fees payable to the MHRA from 2025.
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
How to use the procedure for medicines licensing applications.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
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