[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Notices]
[Page 9575-9576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-69]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0081 (formerly Docket No. 2006D-0297)]
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.
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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,
[[Page 9576]]
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
athttp://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.
gov/cber/publications.htm.
Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3186 Filed 2-20-08; 8:45 am]
BILLING CODE 4160-01-S