Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2022-18516 · Docket No. FDA-2022-D-1503

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances for industry entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development.” These draft guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. These draft guidances harmonize scientific approaches for analytical procedure development and include validation of a wider range of analytical techniques. The draft guidances are intended to facilitate regulatory evaluations and facilitate potential flexibility in postapproval change management of analytical procedures. The draft Q2(R2) guidance revises the ICH guidance for industry “Q2(R1) Validation of Analytical Procedures: Text and Methodology” published in November 2005.

Dates

Submit either electronic or written comments on the draft guidance by September 28, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 two draft guidances for industry entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development.” The draft guidances were prepared under the auspices of ICH. 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. 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 March 2022, the ICH Assembly endorsed the draft guidelines entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development” and agreed that the guidelines should be made available for public comment. The draft guidelines are the product of the Quality Expert Working Group of the ICH. Comments about these draft guidances will be considered by FDA and the Quality Expert Working Group. The draft Q2(R2) guideline revises the Q2(R1) guideline published in 2005 to cover a broader range of analytical procedures, including those used for process control and that apply to multivariate methods. The draft Q14 guideline harmonizes scientific approaches for analytical procedure development and describes principles to facilitate more efficient and science-based and risk-based postapproval change management. The two guidelines are intended to facilitate regulatory evaluations and facilitate potential flexibility in postapproval change management of analytical procedures where scientifically justified. These draft guidances have been left in the original ICH format. The final guidances will be reformatted and edited to conform with FDA's good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidances, when finalized, will represent the current thinking of FDA on the topics they address. They do not establish any rights for any person and are 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. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information for investigational new drug applications have been approved under OMB control number 0910-0014; the collections of information for review of new drug applications have been approved under OMB control number 0910-0001; and the collections of information for review of biologics license applications have been approved under OMB control number 0910-0338. III. Electronic Access Persons with access to the internet may obtain the draft guidances at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Dated: August 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022-18516 Filed 8-26-22; 8:45 am]