New, draft and final guidance as it is published: FDA notices of availability (including the ICH guidelines FDA adopts) from the Federal Register, EMA scientific and procedural guidelines and public consultations (including ICH texts adopted in the EU), and MHRA guidance. Each entry links to the official document.
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.
UK reference medicinal products authorised in the period 2014 – 2021 and their associated dates of expiry of data protection, marketing exclusivity.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Overview of the key regulatory steps and guidance to consider when bringing software as a medical device (SaMD) to market in Great Britain and Northern Ireland.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
MHRA guidance on the use of non-clinical data generated outside the OECD MAD framework in support of UK Clinical Trial Authorisation applications.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How we engage and involve patients and the public in our regulatory decision-making.
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Guidance on the use and side effects of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), their safety, use in pregnancy and the risk of suicidal behaviour.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
A series of explainers to help you understand the parts of the MHRA Strategy to 2030 most relevant to you, and what they mean in practice.
Keep up to date with the latest information from the UK GLP monitoring authority.
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.
Current eAF forms are available for applicants to download and use. Existing submission routes, validation requirements and assessment processes remain unchanged.
Patient factsheet providing information on pneumococcal disease and pneumococcal vaccination.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.
10 guiding principles that can inform the development of good machine learning practice (GMLP).
How new recommendations could make healthcare AI safer, clearer and fairer for patients, professionals, providers and developers across the UK.
How to renew marketing authorisations for products granted through different routes and at different times.
ICH's own website can't be monitored automatically, so ICH guidelines are tracked through FDA's Federal Register notices and EMA's guideline feeds, the two routes by which ICH texts take effect in the US and EU.