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.
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.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance contributes to the international harmonization of methods used for the target animal safety (TAS) evaluation of veterinary monoclonal antibody products (VMAPs) and aids in preparing and conducting VMAP TAS studies under laboratory and field conditions. A harmonized standard is intended to aid in development of mutually acceptable VMAP TAS programs.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The guidance document provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method and on regulatory submissions to FDA for such products. This guidance is intended for manufacturers of blood collection, processing, and storage systems. The guidance announced in this notice finalizes the draft guidance of the same title dated October 18, 2024.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage." This guidance assists sponsors in the design and analysis of studies that assess the influence of hepatic impairment on the pharmacokinetics and, where appropriate, the pharmacodynamics of a drug, including therapeutic biological products. When final, this guidance will represent FDA's current thinking. FDA is also withdrawing the guidance for industry titled "Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling" (May 2003), which formerly provided FDA's thinking relating to studies to assess the effect of hepatic impairment on the pharmacokinetics or pharmacodynamics of a drug and recommendations to include hepatic impairment information in labeling.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance of the same title issued in July 2022.
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products." The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on "Potency Assurance for Cellular and Gene Therapy Products" with additional advice and considerations specifically for ACTIMPs, including peptide- and-protein based ACTIMPs that are not cellular or gene therapy products.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application" issued in May 2019 and, when finalized, will replace the 2019 guidance for industry.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This guidance describes FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Container Closure Systems for Human Drugs and Biological Products." This document provides guiding principles for evaluating the quality of container closure systems (CCSs) used to package drugs and biological products, for human use. This includes CCSs that are also device constituent parts of combination products and CCSs used to package the drug or biological product constituent parts of combination products.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #152 entitled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern." This guidance document informs interested parties about FDA's current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs." This revised draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation (and sensitization, if applicable) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS). The recommendations in this revised draft guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The revised draft guidance is intended to clarify FDA's recommendations and expectations related to in vivo skin irritation and in vivo combined skin irritation and sensitization studies. This draft guidance replaces the draft guidance "Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs" (April 2023).
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs." This guidance provides recommendations for the design and conduct of studies evaluating the adhesion performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a generic TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only, or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this guidance relate to studies submitted in support of an abbreviated new drug application (ANDA). The guidance replaces the draft guidance (Revision 2) "Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs," issued on April 13, 2023.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts." This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency's recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the guidance for industry entitled "Questions and Answers on Biosimilar Development and the BPCI Act" and the guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product" for biosimilar and interchangeable biosimilar products, respectively.
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial participants. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommendations to applicants who submit abbreviated new drug applications (ANDAs) for topical dermatologic corticosteroids of all potency groups (referred to in this notice as topical corticosteroids). The guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence (BE) of topical corticosteroids. This guidance provides clarity for potential ANDA applicants on the appropriate pilot dose duration vasoconstrictor response and pivotal vasoconstrictor BE studies and other recommendations for pharmacodynamic approaches to assess the BE of topical corticosteroids. This guidance finalizes the draft guidance of the same title "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence" issued on October 24, 2022, and replaces the guidance for industry of the same title issued on June 2, 1995.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials." The guidance is intended to provide recommendations in the application of quantitative systems pharmacology (QSP) modeling when a minimum anticipated biological effect level (MABEL) in first-in- human (FIH), phase 1 trials for drugs and biological products is recommended. This guidance focuses on drugs and biological products for which the MABEL approach can be used to guide starting doses for FIH trials. This includes, but is not limited to, drugs and biological products that may cause cytokine release, T-cell activation, or other potent pharmacological reactions.
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.