[Federal Register: March 30, 2004 (Volume 69, Number 61)]
[Notices]
[Page 16579-16580]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr04-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0117]
International Conference on Harmonisation; Draft Guidance on E2E
Pharmacovigilance Planning; 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availability of a draft guidance entitled ``E2E Pharmacovigilance
Planning.'' The draft guidance was prepared under the auspices of the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 The draft guidance
describes a method for summarizing the identified risks of a drug, the
potential for important unidentified risks, and the potentially at-risk
populations and situations that were not studied before the drug was
approved. The draft guidance is intended to foster better and earlier
planning of pharmacovigilance activities, especially in preparation for
the early postmarketing period of a new drug.
DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written comments on the draft guidance to the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
[[Page 16580]]
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single copies of the draft guidance to the Division of Drug Information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draft guidance may also be obtained by mail by calling the CBER Voice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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Paul J. Seligman, Center for Drug
Evaluation and Research (HFD-030), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-6276, 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
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 ``E2E Pharmacovigilance Planning'' should be made
available for public comment. The draft guidance is the product of the
Efficacy E2E Expert Working Group of the ICH. Comments about this draft
will be considered by FDA and the Efficacy E2E Expert Working Group.
The draft guidance describes a method for summarizing the
identified risks of a drug, the potential for important unidentified
risks, and the potentially at-risk populations and situations that were
not studied before the drug was approved. The draft guidance is
intended to foster better and earlier planning of pharmacovigilance
activities, especially in preparation for the early postmarketing
period of a new drug.
The draft guidance proposes a structure for a pharmacovigilance
plan and sets out principles of good practice for the design and
conduct of observational studies. The draft guidance does not describe
other methods to reduce risks from drugs, such as risk communication.
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. 04-7105 Filed 3-29-04; 8:45 am]
BILLING CODE 4160-01-S