[Federal Register: June 14, 2002 (Volume 67, Number 115)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0435]
International Conference on Harmonisation; Draft Guidance on
Electronic Common Technical Document Specification; Availability
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a second draft guidance entitled ``Electronic Common
Technical Document Specification'' (eCTD). The draft guidance was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 The draft guidance defines the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 The draft guidance is intended
to assist industry in transferring electronically their marketing
applications for human drug and biological products to a regulatory
DATES: Submit written or electronic comments on the draft guidance by
August 1, 2002. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 that office in processing your
requests. Submit written comments on the draft guidance to the Dockets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. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the draft guidance: Robert Yetter, Center for Biologics
Evaluation and Research (HFM-25), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-0373, or Gregory V.
Brolund, Center for Drug Evaluation and Research (HFD-70), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
Regarding the ICH: Janet J. Showalter, Office of International
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0864.
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
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 GGP style before publication.
In June 2001, the ICH Steering Committee agreed that a draft
guidance entitled ``Electronic Common Technical Document
Specification'' would be made available for public comment and testing.
The draft guidance, a product of the Multidisciplinary Group 2 (M2)
Expert Working Group (EWG) of the ICH, was made available for comment
in the Federal Register of November 28, 2001 (66 FR 59431). Comments
about the draft guidance were considered by FDA and the M2 EWG, and in
February 2002, the ICH Steering Committee agreed that a second draft
guidance should be made available for public comment (step 2).
The draft guidance on the eCTD provides guidance on industry-to-
agency electronic transfer of marketing applications for human drug and
biological products. The draft 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 draft guidance is intended to assist
industry in transferring their marketing applications for human drug
and biological products to a regulatory authority. The second draft
guidance includes the following changes:
The language in the guidance has been edited to improve
The maximum length of a file name has been increased from
32 characters to 64 characters.
Throughout the guidance, references to Common Technical
Document (CTD) sections have been updated to reflect the current CTD.
Appendix 4 has been reorganized.
The examples in Appendix 6 have been updated.
The Glossary of Terms has been completed.
This draft guidance, when finalized, will represent the agency's
current thinking on ``Electronic Common Technical Document
Specification.'' 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.
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments on the draft guidance by
August 1, 2002. 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
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
Dated: June 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15003 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S