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June 15 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Q9(R1) Quality Risk Management.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

The current Q9 guideline published in 2006 provides a common, harmonized framework for Quality Risk Management (QRM) that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle.

This draft guidance is a targeted revision that addresses four areas for improvement, including high levels of subjectivity in risk assessments and in QRM outputs; product availability risks; lack of understanding as to what constitutes formality in QRM work; and lack of clarity on risk-based decision-making. The revisions are intended to update the original Q9 guideline based on implementation experience to promote improved lifecycle management of hazards and prevent defects, recalls, and shortages.

Submit either electronic or written comments on the draft guidance by July 15, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are the 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. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/​).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a 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 2021, the ICH Assembly endorsed the draft guideline entitled “Q9(R1) Quality Risk Management” and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Quality Expert Working Group of the ICH. Comments about this draft guidance will be considered by FDA and the Quality Expert Working Group.

FDA is thus announcing the availability of a guidance for industry entitled “Q9(R1) Quality Risk Management.” The current Q9 guideline published in 2006 provides a common, harmonized framework for Quality Risk Management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. This draft guidance is a targeted revision that addresses four areas for improvement: (1) high levels of subjectivity in risk assessments and in QRM outputs; (2) product availability risks; (3) lack of understanding as to what constitutes formality in QRM work; and (4) lack of clarity on risk-based decision-making. The revisions are intended to update the original Q9 guideline based on implementation experience to promote improved lifecycle management of hazards and prevent defects, recalls, and shortages.

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 “Q9(R1) Quality Risk Management.” 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.
 
Draft guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-management
FRN: https://www.federalregister.gov/d/2022-12919

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