[Federal Register Volume 69, Number 61 (Tuesday, March 30, 2004)]
[Notices]
[Pages 16580-16581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0118]


International Conference on Harmonisation; Draft Guidance on Q5E 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availability of a draft guidance entitled ``Q5E Comparability of 
Biotechnological/Biological Products Subject to Changes in Their 
Manufacturing Process.'' The draft guidance was prepared under the 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The purpose of the draft guidance is to provide principles for 
assessing the comparability of biotechnological/biological products 
before and after changes are made in the manufacturing process to 
ensure that the process changes did not have an adverse impact on the 
quality, safety, and efficacy of the

[[Page 16581]]

product. The draft guidance is intended to assist in the design and 
conduct of studies that establish the comparability of products 
following a change in the manufacturing process.

DATES: Submit written or electronic comments on the draft guidance by 
May 19, 2004.

ADDRESSES: Submit written comments on the draft guidance to the 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requests for single copies of the draft guidance to the Division of 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 
draft guidance may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800. Send two self-
addressed adhesive labels to assist the office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Barry Cherney, Center for Drug Evaluation 
and Research (HFM-536), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852, 301-827-1795; 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 November 2003, the ICH Steering Committee agreed that a draft 
guidance entitled ``Q5E Comparability of Biotechnological/Biological 
Products Subject to Changes in Their Manufacturing Process'' should be 
made available for public comment. The draft guidance is the product of 
the Quality Expert Working Group of the ICH. Comments about this draft 
will be considered by FDA and the Quality Expert Working Group.
    The purpose of the draft guidance is to provide principles for 
assessing the comparability of biotechnological/biological products 
before and after changes are made in the manufacturing process to 
ensure that the process changes did not have an adverse impact on the 
quality, safety, and efficacy of the product. The draft guidance is 
intended to assist in the design and conduct of studies that establish 
the comparability of products following a change in the manufacturing 
process.
    The draft guidance applies to:
     Proteins and polypeptides, their derivatives, 
and products of which they are components (e.g., conjugates). These 
proteins and polypeptides are produced from recombinant or 
nonrecombinant cell-culture expression systems and can be highly 
purified and characterized using an appropriate set of analytical 
procedures;
     Products where changes are made by a single 
manufacturer, including those made by a contract manufacturer, who can 
directly compare results from the analysis of prechange and postchange 
products; and
     Products where process changes are made in 
development or for which a marketing authorization has been granted.
    The principles outlined in the draft guidance might also apply to 
other product types, such as proteins and polypeptides isolated from 
tissues and body fluids.
    This draft guidance, when finalized, will represent the agency's 
current thinking on this topic. 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 draft 
guidance. 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 draft 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/publications.htm.

    Dated: March 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7104 Filed 3-29-04; 8:45 am]
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