[Federal Register: February 5, 2004 (Volume 69, Number 24)]
[Notices]
[Page 5551-5552]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe04-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1996D-0041]
International Conference on Harmonisation; Guidance on Addendum
to E2C Clinical Safety Data Management: Periodic Safety Update Reports
for Marketed Drugs; 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 ``Addendum to E2C Clinical Safety
Data Management: Periodic Safety Update Reports for Marketed Drugs''
(the ICH E2C guidance). The guidance was prepared under the auspices of
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH). In the Federal
Register of May 19, 1997 (62 FR 27470), FDA published the ICH E2C
guidance, which recommends a unified standard for the format, content,
and reporting frequency for postmarketing periodic safety update
reports (PSURs) for drug and biological products. This guidance, an
addendum to the ICH E2C guidance, provides additional information on
the content and format of PSURs, including clarification of the
objectives, general principles, and model for PSURs. This guidance is
intended to help harmonize collection and submission of postmarketing
clinical safety data.
DATES: You may submit written or electronic comments 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3844, FAX: 888-CBERFAX. Send two self-addressed adhesive labels to
assist the office in processing your requests. Requests and comments
should be identified with the docket number found in brackets in the
heading of this document. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Min Chen, Center for Drug Evaluation and
Research (HFD-430), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3159, or Miles Braun, Center for Biologics
Evaluation and Research (HFM-220), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-6090.
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
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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 December 31, 2002 (67 FR 79939), FDA
published a notice announcing the availability of a draft tripartite
guidance entitled ``Addendum to E2C Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs.'' The notice gave
interested persons an opportunity to submit comments by January 24,
2003.
After consideration of the comments received and revisions to the
draft guidance, a final draft of the guidance was submitted to the ICH
steering committee and endorsed by the three participating regulatory
agencies in February 2003.
This guidance provides additional information on the objectives,
general principles, and model for PSURs specified in the ICH E2C
guidance, including clarification of the following topics:
When separate PSURs will be considered
appropriate,
Synchronization of National Birthdates with the
International Birthdates,
Reporting frequency and time for submission
changes, and
Use of the reference safety information.
In addition, this guidance includes information on the following
topics not previously addressed in the ICH E2C guidance.
Summary bridging reports and addendum reports,
Executive summaries, and
Information on risk management programs and
risk-benefit analyses.
The document should be used in conjunction with the ICH E2C
guidance.
This guidance represents 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, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written comments on the guidance.
Two copies of any comments are to be submitted, except that individuals
may submit one 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.
v/cber/publications.htm.
Dated: January 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-2314 Filed 2-4-04; 8:45 am]
BILLING CODE 4160-01-S