Guidelines tracker: ICH, FDA, EMA, MHRA

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.

RegulatoryGuideline · final

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus Gallus

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #114 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Chickens--Gallus gallus." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to provide study design recommendations specific to chickens that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in animal species.

🇺🇸 FDA · Wed 24 Jun 2026

RegulatoryGuideline · draft

Forms FDA 3542a and FDA 3542: Questions and Answers

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.

🇺🇸 FDA · Mon 15 Jun 2026

RegulatoryGuideline · final

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments that appeared in the Federal Register of March 3, 2026. In the notice, FDA requested comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. The Agency is taking this action to allow interested persons additional time to submit comments.

🇺🇸 FDA · Thu 11 Jun 2026

RegulatoryGuideline · draft

Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing." The draft guidance document provides sponsors engaged in the development of human gene therapy (GT) products incorporating ex-vivo and in vivo genome editing (GE) of human somatic cells (GE products) with FDA's recommendations on the type of prior knowledge that may be scientifically appropriate to leverage to advance product development.

🇺🇸 FDA · Wed 03 Jun 2026

RegulatoryGuideline · draft

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers." This revised draft guidance, when finalized, will provide answers to common questions regarding the communication of health care economic information (HCEI) about approved prescription drugs and approved/ cleared (as defined in the guidance) medical devices (collectively referred to in the guidance as approved/cleared medical products) by medical product manufacturers, packers, distributors, and their representatives (collectively referred to as firms) to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis, carrying out their responsibilities for the selection of medical products for coverage or reimbursement (collectively referred to as payors).

🇺🇸 FDA · Wed 03 Jun 2026

RegulatoryGuideline · final

M15 General Principles for Model-Informed Drug Development; International Council for Harmonisation

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M15 General Principles for Model-Informed Drug Development." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides general recommendations for the planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD). It establishes a harmonized assessment framework (including the associated terminology) for the MIDD evidence. It also provides recommendations for related regulatory interactions, reporting, and submission. This guideline is intended to facilitate a multidisciplinary understanding of MIDD and associated evidence generation. The guidance finalizes the draft guidance of the same title issued on December 30, 2024.

🇺🇸 FDA · ICH · Wed 03 Jun 2026

RegulatoryGuideline · draft

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products." When finalized, this guidance will assist sponsors in implementing streamlined approaches for general toxicology, for nonclinical safety assessments of certain oncology pharmaceuticals. The guidance is intended to facilitate drug development for biological products and conjugated products for the treatment of cancer while avoiding unnecessary animal use. The recommendations in this draft guidance are informed by data analysis of general toxicology studies and practices developed during the COVID-19 pandemic to reduce use of non-human primates.

🇺🇸 FDA · Mon 01 Jun 2026

RegulatoryGuideline · final

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.

🇺🇸 FDA · Fri 29 May 2026

RegulatoryGuideline · final

Statistical Approaches To Establishing Bioequivalence

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Statistical Approaches to Establishing Bioequivalence." This guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and amendments and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.

🇺🇸 FDA · Fri 29 May 2026

RegulatoryGuideline · draft

Product-Specific Guidances; Draft and Revised Draft Guidances for Industry

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 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.

🇺🇸 FDA · Fri 22 May 2026

RegulatoryGuideline · final

M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders.

🇺🇸 FDA · ICH · Fri 22 May 2026

RegulatoryGuideline · final

Clostridioides Difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention." The purpose of this guidance is to assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI). This guidance finalizes the draft guidance titled "Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention" issued on October 28. 2022.

🇺🇸 FDA · Mon 11 May 2026

RegulatoryGuideline · final

Postapproval Pregnancy Safety Studies

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Postapproval Pregnancy Safety Studies." The purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA (i.e., pregnancy safety studies) in the postapproval setting. This guidance finalizes the draft guidance of the same name issued on May 9, 2019.

🇺🇸 FDA · Mon 11 May 2026

RegulatoryGuideline · final

Pulmonary Tuberculosis: Developing Drugs for Treatment

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Pulmonary Tuberculosis: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB). This guidance finalizes the draft guidance of the same title issued on December 15, 2022.

🇺🇸 FDA · Mon 11 May 2026

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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.