[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Notices]
[Pages 7024-7027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3343]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0186]


International Conference on Harmonisation; M4 Common Technical 
Document; Request for Comments on Initial Components; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of initial components of a draft guidance \1\ entitled 
``M4 Common Technical Document,'' which is being developed under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
Because of the large size of the draft guidance, FDA is making some 
components of the draft guidance available to the public at this time 
to help explain the overall scheme of the draft guidance and to request 
comments. When completed, the guidance entitled ``M4 Common Technical 
Document'' will describe a harmonized format and content for designated 
new product applications for submission to the regulatory authorities 
in the three ICH regions. The agency intends to make the entire draft 
guidance available to the public for comment once all the components 
have been drafted.
---------------------------------------------------------------------------

    \1\ In accordance with FDA's good guidance practices (62 FR 
8961, February 27, 1997), ICH guidance documents are now being 
called guidances, rather than guidelines.

DATES:  Submit written comments on the initial components of the draft 
---------------------------------------------------------------------------
guidance by March 13, 2000.

ADDRESSES:  Submit written comments on these components of the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. An 
electronic version of the components is available on the Internet at 
http://www.fda.gov/cder/guidance/index.htm or at http://www.fda.gov/cber/publications.htm.

[[Page 7025]]


FOR FURTHER INFORMATION CONTACT: For the safety components: Joseph J. 
DeGeorge, Center for Drug Evaluation and Research (HFD-24), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-
5476.
    For the quality components: Charles P. Hoiberg, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2570, and Neil D. Goldman, 
Center for Biologics Evaluation and Research (HFM-20), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0377.
    For the efficacy sections: Robert J. DeLap, Center for Drug 
Evaluation and Research (HFD-105), Food and Drug Administration, 9201 
Corporate Blvd., Rockville, MD 20850, 301-827-2250.
    Regarding the ICH: Janet J. Showalter, Office of Health Affairs 
(HFY-20), 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 medical product development among regulatory agencies.
    ICH was organized to provide an opportunity for harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives. ICH is concerned with harmonization 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 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, the Canadian Therapeutics Products Programme, and 
the European Free Trade Area.
    The ICH process has achieved significant harmonization of the 
technical requirements for the approval of pharmaceuticals for human 
use in the three ICH regions. However, until recently, the application 
documents in the three ICH regions had not been examined, and there are 
significantly different requirements in each region for the composition 
and organization of product applications. As a result, three Expert 
Working Groups for Quality, Safety, and Efficacy have been developing 
harmonized guidance for the content and format of common sections of an 
application, called the ``common technical document.'' Once finalized, 
the guidance entitled ``M4 Common Technical Document'' will describe an 
acceptable format and content for applications for human 
pharmaceuticals that, once supplemented with regional particulars, can 
be used with designated new products for submission to the regulatory 
authorities in the three ICH regions.
    The ICH Steering Committee is overseeing the work on the common 
technical document through the use of milestones that reflect the 
stages of completion as work proceeds. A key goal is to ensure that the 
process for developing the common technical document is transparent. As 
part of this transparency, the ICH Steering Committee agreed, in 
October 1999, that the components of the draft guidance entitled ``M4 
Common Technical Document'' be made available for public comment as 
they evolve. The components being made available by this notice are the 
product of the Quality, Safety, and Efficacy Expert Working Groups of 
the ICH. Received comments on these components will be considered by 
FDA and the appropriate expert working group as the draft guidance ``M4 
Common Technical Document'' is finished. Once it is finalized, the 
guidance entitled ``M4 Common Technical Document'' will describe the 
format and content for a common technical document that, when 
supplemented by regional information, is suitable for submission to the 
regulatory authorities in the three ICH regions.

II. Organization of the Common Technical Document

    The common technical document should be viewed as the common part 
of a submission for designated new products, presented in a modular 
fashion with summaries and tables. It is intended that one of the 
modules in the common technical document be reserved as a region-
specific module.
    The common technical document modular structure is envisioned as 
shown in the graphic at the end of this document and includes the 
following:

------------------------------------------------------------------------
 
------------------------------------------------------------------------
                               Components
------------------------------------------------------------------------
Module I                  Regional                 (not part of Common
                          Administrative           Technical Document)
                          Information
Module II                 IIA Executive            Quality (pending)
                          Summaries
                                                   Nonclinical
                                                   (provided)
                                                  Clinical (pending)
                         IIB Nonclinical          IIB1 Written Summary
                          Summaries                (provided)
                                                  IIB2 Tabulated Summary
                                                   (provided)
                         IIC Clinical Summaries,  (pending)
                          comprising written and
                          tabulated summaries
Module III               Quality                  (provided--nine
                                                   attachments pending)
Module IV                Nonclinical Data Study   (provided)
                          Reports
Module V                 Clinical Data Study      (provided)
                          Reports
------------------------------------------------------------------------

III. Components Being Made Available at This Time

    In addition to the preamble to the draft guidance entitled ``M4 
Common Technical Document,'' and an organizational graphic, the 
following components are being made available in the docket and on the 
Internet at this time:
    1. Module IIA--Nonclinical Executive Summary;
    2. Module IIB--Nonclinical Written and Tabulated Summaries;
    3. Module III--Quality table of contents and explanatory notes 
(nine attachments still pending);
    4. Module IV--Nonclinical Data Study Reports table of contents and 
explanatory notes; and
    5. Module V--Clinical Data Study Reports table of contents and 
explanatory notes.
    These components detail the tables of contents for Modules III, IV, 
and V accompanied by explanatory notes. Module III will be supplemented 
further by a series of nine detailed attachments, which may be 
available in summer of 2000. (The exact content of Module III may 
evolve as the Expert Working

[[Page 7026]]

Group's discussions progress.) Modules IIA Clinical and Quality and IIC 
should also be available for consultation in summer 2000. Module IIA/B 
Nonclinical is being made available at this time.
    The ICH Steering Committee and Expert Working Groups are requesting 
comments on the components being made available by this notice. Once 
all the components of the draft guidance entitled ``M4 Common Technical 
Document'' are ready, a compiled text will be released to complete step 
2 of the ICH process. It is anticipated that this will occur in summer 
2000.
    These components of the draft guidance represent the agency's 
current thinking on the content and format of a common application for 
designated new products (i.e., the common technical document). These 
components do not create or confer any rights for or on any person and 
do not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statute, regulations, or both.

IV. Comments

    Interested persons may, on or before March 13, 2000, submit to the 
Dockets Management Branch (address above) written comments on these 
components of the draft guidance. 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 components of the draft guidance, made available 
by this notice, and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

BILLING CODE 4160-01-F

[[Page 7027]]

[GRAPHIC] [TIFF OMITTED] TN11FE00.065



    Dated: February 8, 2000.
Margaret Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3343 Filed 2-9-00; 11:32 am]
BILLING CODE 4160-01-C