[Federal Register: April 2, 2003 (Volume 68, Number 63)]
[Notices]
[Page 16060-16061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap03-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0435]
International Conference on Harmonisation; Guidance on Electronic
Common Technical Document Specification; 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 ``M2 eCTD: Electronic Common
Technical Document Specification.'' The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The guidance defines the means for industry-to-agency transfer of
regulatory information that will facilitate the creation, review, life
cycle management, and archiving of the electronic submission. The
guidance is intended to assist industry in transferring electronically
their marketing applications for human drug and biological products to
a regulatory authority.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: 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 (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. Submit written comments on the 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. 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: Robert Yetter, Center for Biologics Evaluation
and
[[Page 16061]]
Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-0373, or Timothy M. Mahoney, Center for
Drug Evaluation and Research (HFD-73), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-3540.
Regarding the ICH: Janet Showalter, Office of International Programs
(HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0865.
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's Health Products and Food Branch,
and the European Free Trade Area.
In accordance with FDA's good guidance practices (GGPs) 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 is 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 GGP style before publication.
In the Federal Register of June 14, 2002 (67 FR 40948), FDA
announced the availability of a second draft guidance entitled
``Electronic Common Technical Document Specification.'' The notice gave
interested persons an opportunity to submit comments by August 1, 2002.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in September 2002.
The eCTD guidance describes the recommended method for industry-to-
agency electronic transfer of marketing applications for human drug and
biological products. The guidance defines the means for industry-to-
agency transfer of regulatory information that will facilitate the
creation, review, life cycle management, and archiving of the
electronic submission. The guidance is intended to assist industry in
transferring their marketing applications for human drug and biological
products to a regulatory authority. The guidance includes the following
changes:
[sbull] The Document Type Definition (DTD) and specificaton version
numbers were harmonized to 3.0.
[sbull] Throughout the guidance, references to Common Technical
Document (CTD) sections were updated to reflect the current CTD
specifications.
[sbull] Path names in Appendix 4 were abbreviated to avoid
exceeding maximum path character limits.
[sbull] The Glossary of Terms was updated.
[sbull] Technical errors discovered during testing were corrected.
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 submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments on the guidance at any time.
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 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
http://www.fda.gov/cber/publications.htm.
Dated: March 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-7818 Filed 4-1-03; 8:45 am]
BILLING CODE 4160-01-S