[Federal Register: March 30, 2004 (Volume 69, Number 61)]
[Notices]
[Page 16580-16581]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr04-78]
-----------------------------------------------------------------------
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International Conference on Harmonisation; Draft Guidance on Q5E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.
-----------------------------------------------------------------------
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availability of a draft guidance entitled ``Q5E Comparability of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 The draft guidance was prepared under the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The purpose of the draft guidance is to provide principles for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 The draft guidance is intended to assist in the design and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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written comments on the draft guidance to the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requests for single copies of the draft guidance to the Division of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draft guidance may also be obtained by mail by calling the CBER Voice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.
v/cber/publications.htm.
Dated: March 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7104 Filed 3-29-04; 8:45 am]
BILLING CODE 4160-01-S