[Federal Register: December 31, 2002 (Volume 67, Number 251)]
[Notices]
[Page 79939-79940]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31de02-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96D-0041]
International Conference on Harmonisation; Draft Guidance on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availability of a draft guidance entitled ``Addendum to E2C Clinical
Safety Data Management: Periodic Safety Update Reports for Marketed
Drugs.'' The draft guidance was prepared under the auspices of the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). In the Federal
Register of May 19, 1997 (62 FR 27470), FDA published the guidance
entitled ``Clinical Safety Data Management: Periodic Safety Update
Reports for Marketed Drugs'' (ICH E2C guidance), which recommends a
unified standard for the format, content, and reporting frequency for
postmarketing periodic safety update reports for drug and biological
products. This draft guidance, an addendum to the ICH E2C guidance of
May 19, 1997, provides additional information on the content and format
of PSURs, including clarification of the objectives, general
principles, and model for PSURs. The draft guidance is intended to help
harmonize collection and submission of postmarketing clinical safety
data.
DATES: Submit written or electronic comments on the draft guidance by
January 24, 2003.
ADDRESSES: You may submit written comments on the draft guidance to the
Dockets Management Branch (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single copies of the draft guidance to the Division of Drug Information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, 301-827-
3844, FAX: 888-CBERFAX. 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: 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 (HFM-220), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6090.
Regarding the ICH: Janet Showalter, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0864.
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
[[Page 79940]]
sponsors are the: European Commission; European Federation of
Pharmaceutical Industries Associations; Japanese Ministry of Health,
Labour, and Welfare; Japanese Pharmaceutical Manufacturers Association,
Centers for Drug Evaluation and Research and Biologics Evaluation and
Research, FDA; and 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's Health Products and Food Branch,
and the European Free Trade Area.
In accordance with FDA's good guidance practices regulation (21 CFR
10.115), this document is being called a guidance, rather than a
guideline.
To facilitate the process of making ICH guidances available to the
public, the agency has changed its procedure for publishing ICH
guidances. As of April 2000, we no longer include the text of ICH
guidances in the Federal Register. Instead, we publish a notice in the
Federal Register announcing the availability of an ICH guidance. The
ICH guidance will be placed in the docket and can be obtained through
regular agency sources (see ADDRESSES). Draft guidances are left in the
original ICH format. The final guidance is reformatted to conform to
the style before publication.
In September 2002, the ICH Steering Committee agreed that a draft
guidance entitled ``Addendum to E2C Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs'' should be made
available for public comment. The draft guidance is the product of the
Efficacy Expert Working Group of the ICH focusing on pharmacovigilance
topics. Comments about this draft will be considered by FDA and the
Efficacy Expert Working Group.
The ICH E2C guidance of May 19, 1997, recommends a unified standard
for the format, content, and reporting frequency for PSURs for drug and
biological products. This draft guidance, an addendum to the ICH E2C
guidance, provides additional information on the objectives, general
principles, and model for PSURs. The draft guidance includes, for
example, recommendations regarding:
[sbull] Synchronization of National Birthdates with the
International Birthdates,
[sbull] Use of the latest version of the reference safety
information,
[sbull] Submission of executive summaries as part of the PSUR,
[sbull] Options to submit summary bridging reports and addendum
reports, and
[sbull] Handling of solicited reports.
The document should be used in conjunction with the E2C guidance.
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 Dockets Management Branch (see
ADDRESSES) written or electronic comments on the draft guidance by
January 24, 2003. 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 draft guidance and received comments may be seen in
the Dockets Management Branch 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.
guidance/index.htm, or http://www.fda.gov/cber/publications.htm.
Dated: December 23, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32979 Filed 12-30-02; 8:45 am]
BILLING CODE 4160-01-S