[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Pages 37861-37862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0118]


International Conference on Harmonisation; Guidance on Q5E 
Comparability of Biotechnological/Biological Products Subject to 
Changes in Their Manufacturing Process; 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 ``Q5E Comparability of 
Biotechnological/Biological Products Subject to Changes in Their 
Manufacturing Process.'' 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 purpose of the guidance is to provide principles for assessing the 
comparability of biotechnological/biological products before and after 
changes are made in the manufacturing process for the drug substance or 
drug product. The guidance is intended to assist in the collection of 
relevant technical information that serves as evidence that the 
manufacturing process changes will not have an adverse impact on the 
quality, safety, and efficacy of the drug product.

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

ADDRESSES: 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.fda.gov/dockets/ecomments. Submit written requests for 
single copies of the 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 the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800. Send one self-
addressed adhesive label to assist the office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Barry Cherney, Center for Drug Evaluation 
and Research (HFD-122), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852, 301-827-1790; or Andrew Chang, Center for 
Biologics Evaluation and Research (HFM-340), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-496-4833.
    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

    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 March 30, 2004 (69 FR 16580), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``Q5E Comparability of Biotechnological/Biological 
Products Subject to Changes in Their Manufacturing Process.'' The 
notice gave interested persons an opportunity to submit comments by May 
19, 2004.
    After consideration of the comments received and revisions to the 
guidance, a final draft of the guidance was submitted to the ICH 
Steering Committee and endorsed by the three participating regulatory 
agencies in November 2004.
    The document provides guidance on the principles for assessing the 
comparability of biotechnological/biological products before and after 
changes are made in the manufacturing process for the drug substance or 
drug product. The document does not prescribe any particular 
analytical, nonclinical, or clinical strategy. The main focus of the 
document is on quality aspects.
    This guidance is being issued consistent with FDA's good guidance 
practices regulations (21 CFR 10.115). The guidance represents the 
agency's current thinking on Q5E comparability of biotechnological/
biological products subject to changes in their manufacturing process. 
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.
    Note that FDA may have existing guidance on this or related topics, 
such as ``FDA Guidance Concerning Demonstration of Comparability of 
Human Biological Products, Including Therapeutic Biotechnology-derived 
Products,'' available at http://www.fda.gov/cber/gdlns/comptest.txt.

[[Page 37862]]

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. 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. The guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

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/reading.htm.

    Dated: June 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12908 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S