02-15003. International Conference on Harmonisation; Draft Guidance on Electronic Common Technical Document Specification; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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The Food and Drug Administration (FDA) is announcing the availability of a second draft guidance entitled “Electronic Common Technical Document Specification” (eCTD). The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of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 The draft guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority.

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Submit written or electronic comments on the draft guidance by August 1, 2002.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Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,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 Submit written comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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Regarding the draft guidance: Robert Yetter, Center for Biologics Evaluation and Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373, or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, 301-827-3517.

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.

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 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 clarity.
• 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.

II. Comments

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 Friday.

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://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: June 6, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.