[Federal Register Volume 70, Number 171 (Tuesday, September 6, 2005)]
[Notices]
[Pages 53021-53022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17597]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0324]


International Conference on Harmonisation; Draft Guidance on M5 
Data Elements and Standards for Drug Dictionaries; 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availability of a draft guidance entitled ``M5 Data Elements and 
Standards for Drug Dictionaries.'' The draft guidance was prepared 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 The draft guidance describes the data elements and standards 
that ICH recommends be made available to interested parties to assist 
in the development and maintenance of drug dictionaries. The draft 
guidance is intended to facilitate the exchange and practical use of 
medicinal product information at the international level, such as with 
postmarketing safety reporting.

DATES: Submit written or electronic comments on the draft guidance by 
October 21, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments on the draft guidance to the 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requests for single copies of the draft guidance to the Division of 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draft guidance may also be obtained by mail by calling the CBER Voice 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access to the draft guidance document.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: Randy Levin, Center for Drug Evaluation and 
Research (HFD-001), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7784; or Ann Schwartz, Center for 
Biologics Evaluation and Research (HFM-475), Food and Drug 
Administration, 1401 Rockville Pike, rm. 300N, Rockville, MD 20832, 
301-827-3070.
    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 
ICH's sponsors and IFPMA, as well as observers from the World Health 
Organization, Health Canada, and the European Free Trade Area.
    In May 2005, the ICH Steering Committee agreed that a draft 
guidance entitled ``M5 Data Elements and Standards for Drug 
Dictionaries'' should be made available for public comment. The draft 
guidance is the product of the M5 Expert Working Group of the ICH. 
Comments about this draft will be considered by FDA and the M5 expert 
working group.
    The draft guidance describes the data elements that ICH recommends 
be made available to interested parties to assist in the development 
and maintenance of drug dictionaries. The draft guidance outlines each 
data element and provides recommended standards for the data elements. 
The draft guidance addresses medicinal products (drugs and biologics) 
and is intended to accomplish the following goals:
    <bullet> Improve the exchange of medicinal product information,
    <bullet> Improve consistency in evaluating and comparing medicinal 
products for postmarketing surveillance activities,
    <bullet> Provide consistent terminology for the health care 
community, and
    <bullet> Reduce administrative burdens for the pharmaceutical 
industry when complying with different regional regulatory 
requirements.
    The draft guidance refers to approved medicinal products. The draft 
guidance does not apply to homeopathic medicinal products or 
investigational medicinal products. The draft guidance does not cover 
the establishment and maintenance of a drug dictionary.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on M5 data 
elements and standards for drug dictionaries. 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.

[[Page 53022]]

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the 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/reading.htm.

    Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17597 Filed 9-2-05; 8:45 am]
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