E8-3186. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a process for the evaluation and recommendation by the ICH Q4B Expert Working Group (EWG) of selected pharmacopeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry in favor of a common testing strategy in each ICH regulatory region.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Robert H. King, Sr., Center for Drug Evaluation and Research (HFD-003), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 3542, Silver Spring, MD 20993-0002, 301-796-1242;or

Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-20), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-435-5681.

Regarding the ICH: Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.” In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health, Labour, and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

In the Federal Register of August 8, 2006 (71 FR 45059), FDA published a notice announcing the availability of a draft guidance entitled “Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria.” The notice gave interested persons an opportunity to submit comments by October 10, 2006.

After consideration of the comments received and revisions to the guidance, a final draft guidance entitled “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions” was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in November 2007.

The guidance provides information on a Q4B process for evaluating harmonization proposals for specific pharmacopeial topics originating from the three-party Pharmacopoeial Discussion Group (PDG) or from individual PDG pharmacopeias. The PDG consists of representatives from the European Directorate for the Quality of Medicines in the Council of Europe; the Japanese Ministry of Health, Labour and Welfare, and the United States Pharmacopeial Convention, Inc. The results of the individual Q4B evaluations will move forward as topic-specific annexes to the core Q4B guidance. Each annex will be issued separately following the ICH step process, providing guidance to assist industry and regulators in the implementation of the specific topic evaluated by the ICH Q4B process. Following the receipt of comments on the draft guidance, the Q4B EWG made no substantive changes to the Q4B process or the use of annexes to convey the results of Q4B evaluations. The title of the guidance, as well as some of the text, was revised to more closely reflect the actual workings and process of the Q4B EWG.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only.

III. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​ohrms/​dockets/​default.htm,, http://www.fda.gov/​cder/​guidance/​index.htm, or http://www.fda.gov/​cber/​publications.htm.

Dated: February 12, 2008.

Jeffrey Shuren,

Assistant Commissioner for Policy.