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Information on when software applications (apps) are considered to be a medical device and how they are regulated.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Supporting guidance, publications and resources on the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making for medicines and medical devices in the UK.
How to use the procedure for medicines licensing applications.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
Supporting information to accompany the National Patient Safety Alert on patient hoists and slings NatPSA/2026/005/MHRA.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
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.
Guidance on using non-investigational medicinal products in a clinical trial.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Detailed guidance on advertising and promoting medicines.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
A national programme to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
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