Guidelines tracker: ICH, FDA, EMA, MHRA

VICH GL49: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food producing animals: validation of analytical methods used in residue depletion studies - Revision 2

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - List of medically important (MI) VeDDRA terms

Reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products - Revision 1

Early-Phase IND Protocol Recommendations for Solid Tumors

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Early-Phase IND Protocol Recommendations for Solid Tumors." The purpose of this draft guidance is to provide recommendations to sponsors and clinical investigators developing early-phase trials, which include first-in- human (FIH) protocols or protocols for drugs and biologic products with limited human experience, submitted under an Investigational New Drug Application (IND) to the appropriate disease-specific division located within the Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) and the Office of Clinical Evaluation (OCE) in the Center for Biologics Evaluation and Research (CBER.) This draft guidance is specific to solid tumors and does not address protocols for investigational drugs intended to treat hematologic malignancies.

Innovative Licensing and Access Pathway (ILAP)

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.

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026

Draft guideline on predictive biomarker assays in the context of medicinal product lifecycle

Draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information - Revision 1

Periods of Data and Market Exclusivity for UK Reference Medicinal Products

UK reference medicinal products authorised in the period 2014 – 2021 and their associated dates of expiry of data protection, marketing exclusivity.

Clinical investigations for medical devices

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

Guidance on bringing software as a medical device to market

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.

Clinical trials for medicines: Good clinical practice inspections

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines

Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.

Use of non-OECD MAD non-clinical data in support of UK clinical trial authorisation applications

MHRA guidance on the use of non-clinical data generated outside the OECD MAD framework in support of UK Clinical Trial Authorisation applications.

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus

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;

Potency Assurance for Cellular and Gene Therapy Products

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.

Herbal medicines granted a traditional herbal registration (THR)

A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products." This revised draft guidance revises and replaces the draft guidance entitled "Essential Drug Delivery Outputs Intended to Deliver Drugs and Biological Products" announced in the Federal Register on July 1, 2024 (89 FR 54470). In accordance with its mission of protecting, promoting, and advancing public health, this guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of a human drug, including a biological product (herein referred to as drug delivery devices). This guidance provides recommendations for development and organization of device drug-delivery performance information and data to improve the consistency of this information in applications and to facilitate transparency and predictability in development and regulatory review.

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management." The draft guidance document provides recommendations for how an individualized human genome editing (GE) product that includes multiple product variants can be submitted in a single Biologics License Application (BLA). When finalized, this guidance will describe the FDA's current thinking on individualized GE products with respect to how to specify the extent of GE component variation in a BLA, how to add new product variants to the BLA after licensure, and related topics.

Notice to sponsors on validation and qualification of computerised systems used in clinical trials

Access, new active substance and biosimilar work sharing initiatives

Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.

Opportunities for patients and the public to be involved in the work of the MHRA

How we engage and involve patients and the public in our regulatory decision-making.

COVID-19 test validation approved products

Regulatory Considerations for Prescription Drug Use-Related Software

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.

Recommended submission dates for veterinary medicinal products

Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics

Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)

Reflection paper on methodological aspects in confirmatory platform trials

Register medical devices to place on the market

How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.

Concept paper on clinical trials in recipients of kidney transplantation

Antidepressants: use and safety

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.

Safety Public Assessment Reports

These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.

Draft reflection paper on the investigation of drug interactions of herbal medicinal products

Medicines: apply for a variation to your marketing authorisation

Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

MHRA Strategy to 2030: What it means for you

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.

Good laboratory practice (GLP) for safety tests on chemicals

Keep up to date with the latest information from the UK GLP monitoring authority.

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers

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.

MHRA Real-World Evidence: knowledge and guidance

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.

International Recognition Procedure