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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The guidance document provides blood establishments that collect blood and blood components, including Source Plasma, with FDA's recommendations for testing blood and blood components for hepatitis B virus (HBV) to reduce the risk of transfusion-transmitted HBV. The recommendations contained in the guidance apply to the collection of Whole Blood and blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance titled "Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen" (July 2025 Draft Guidance). The guidance also supersedes the documents titled "Recommendations for the Management of Donors and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)" (December 1987 Memorandum), "FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)" (September 1991 Memorandum), "Adequate and Appropriate Donor Screening Tests for Hepatitis B;
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we describe how to progressively implement a strategy for potency assurance during product development and provide additional considerations to help assure the potency of products that are undergoing rapid clinical development. For licensed products, we describe requirements for potency assurance, including testing required for lot release assays. The guidance announced in this notice finalizes the draft guidance of the same title issued on December 28, 2023.
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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug product or a prescription drug-led, drug-device combination product that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center. This guidance finalizes the draft guidance of the same title issued on September 19, 2023.
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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the draft guidance of the same title issued on July 23, 2024.
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).
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.