Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2024-31027 · Docket No. FDA-2024-D-5580

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance discusses the multidisciplinary principles of model-informed drug development (MIDD). This includes recommendations on MIDD planning, model evaluation, and evidence documentation. The draft guidance also includes a harmonized framework for assessing evidence derived from MIDD. The draft guidance is intended to facilitate multidisciplinary understanding, appropriate use, and harmonized assessment of MIDD and its associated evidence.

Dates

Submit either electronic or written comments on the draft guidance by February 28, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background FDA is announcing the availability of a draft guidance for industry entitled “M15 General Principles for Model-Informed Drug Development.” The draft guidance was prepared under the auspices of ICH. ICH seeks to achieve greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory requirements in regions around the world, ICH guidelines enhance global drug development, improve manufacturing standards, and increase the availability of medications. For example, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, and standardized marketing application submissions. The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. ICH membership continues to expand to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ). ICH works by engaging global regulatory and industry experts in a detailed, science-based, and consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry. As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In November 2024, the ICH Assembly endorsed the draft guideline entitled “M15 General Principles for Model-Informed Drug Development” and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Multidisciplinary Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Multidisciplinary Expert Working Group. The draft guidance promotes multidisciplinary understanding and harmonized assessment of MIDD by discussing principles, assessment frameworks, evaluation, and reporting of MIDD and its generated evidence. Appropriate use of MIDD can enable greater efficiency in drug development, while harmonized approaches to assessment can promote consistent and transparent evaluation of MIDD evidence to inform regulatory decision making. This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDA's good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on “M15 General Principles for Model-Informed Drug Development.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information for submission of regulatory information, including nonclinical and clinical data, prior information of drug and disease characteristics derived from model-informed drug development, have been approved under OMB control numbers 0910-0014, 0910-0001, and 0910-0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https://www.regulations.gov , https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs , https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances , or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Dated: December 16, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2024-31027 Filed 12-27-24; 8:45 am]