[Federal Register: August 24, 2000 (Volume 65, Number 165)]
[Notices]
[Page 51621-51624]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au00-90]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-0186]
International Conference on Harmonisation; Draft Guidance on M4
Common Technical Document; 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availability of a draft guidance entitled ``M4 Organization of the
Common Technical Document for the Registration of Pharmaceuticals for
Human Use'' (M4 Common Technical Document). The draft guidance was
developed under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH). The draft guidance, which is being
made available simultaneously in four parts, describes a harmonized
format and content for new product applications (including applications
for biotechnology-derived products) for submission to the regulatory
authorities in the three ICH regions. The M4 Common Technical Document
is intended to reduce the time and resources used to compile
applications, ease the preparation of electronic submissions,
facilitate regulatory reviews and communication with the applicant, and
simplify the exchange of regulatory information among regulatory
authorities.
DATES: Submit written comments on the draft guidance by September 30,
2000.
ADDRESSES: Submit written comments on the draft guidance to the Dockets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. Copies of the draft guidance are
available on the Internet at http://www.fda.gov/cder/guidance/index.htm
or at http://www.fda.gov/cber/publications.htm. Submit written requests
for single copies of the draft guidance to the Drug Information Branch
(HFD-210), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers
[[Page 51622]]
Lane, Rockville, MD 20857; or the Office of Communication, Training and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), 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.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: For the safety (nonclinical) 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 (clinical) 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 International
Programs (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.
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
different requirements in the regions 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 ``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 new products for submission to the regulatory authorities
in the three ICH regions. In the Federal Register of February 11, 2000
(65 FR 7024), the agency announced the availability of initial
components of the draft guidance and requested public comment. Comments
from that announcement were considered in developing this draft
guidance.
In July 2000, the ICH Steering Committee agreed that a draft
guidance entitled ``M4 Common Technical Document'' should be made
available for public comment. Comments about the draft guidance will be
considered by FDA and the appropriate expert working group.
To facilitate the process of making ICH guidances available to the
public, the agency is changing its procedures for publishing ICH
guidances. Since 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 placed in the docket and can be obtained through
regular agency sources (see the ADDRESSES section). The draft guidance
is left in the original ICH format. The final guidance will be
reformatted to conform to the GGP style before publication.
In accordance with FDA's good guidance practices (GGP) (62 FR 8961,
February 27, 1997), ICH guidance documents are now being called
guidances, rather than guidelines.
II. The Common Technical Document
The draft guidance describes a harmonized format and content for
new product applications (including applications for biotechnology-
derived products) for submission to the regulatory authorities in the
three ICH regions. The common technical document is intended to reduce
the time and resources used to compile applications, ease the
preparation of electronic submissions, facilitate regulatory reviews
and communication with the applicant, and simplify the exchange of
regulatory information among regulatory authorities.
The draft guidance addresses the organization of information
presented in new product applications. With appropriate modifications,
the draft guidance may be applied to abbreviated or other applications.
The draft guidance is not intended to indicate what studies should be
included, but merely to indicate an appropriate format for data that
are submitted.
The common technical document should be viewed as the common part
of a submission for new products, presented in a modular fashion with
summaries and tables. It is intended that one of the modules (module I)
in the common technical document be reserved as a region-specific
module, and thus will not be harmonized.
When finalized, the common technical document modular structure is
envisioned as shown in the graphic at the end of this notice and the
following table of contents for the document:
Module I: Administrative Information and Prescribing Information
Documents are region specific; for example, application forms,
prescribing information.
Module II: Common Technical Document Summaries
A. Overall Common Technical Document Table of Contents
B. Overall Summaries
1. Introduction
2. Quality Overall Summary
3. Nonclinical Overall Summary
4. Clinical Overall Summary
C. Nonclinical Summaries
1. Pharmacology
a. Written summary
[[Page 51623]]
b. Tabulated summary
2. Pharmacokinetics
a. Written summary
b. Tabulated summary
3. Toxicology
a. Written summary
b. Tabulated summary
D. Clinical Written Summary
1. Biopharmaceutics and Associated Analytical Methods
2. Clinical Pharmacology
3. Clinical Efficacy
4. Clinical Safety
5. Synopses of Individual Studies
Module III: Quality
A. Table of Contents
B. Body of Data
Module IV: Nonclinical Study Reports
A. Table of Contents
B. Study Reports
C. Key Literature References
Module V: Clinical Study Reports
A. Table of Contents
B. Study Reports
C. Key Literature References
The draft guidance being made available with this notice is the
product of the ICH Common Technical Document Expert Working Groups for
Quality, Safety, and Efficacy. To facilitate the handling of the
guidance, it is being made available in four parts: (1) A description
of the organization of the M4 Common Technical Document; (2) the
Quality section; (3) the Safety, or nonclinical section; and (4) the
Efficacy, or clinical section.
This draft guidance represent the agency's current thinking on the
content and format of a common application for new products (i.e., the
common technical document). The draft guidance 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, regulations, or
both.
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the draft guidance by September 30,
2000. 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 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
[GRAPHIC] [TIFF OMITTED] TN24AU00.000
[[Page 51624]]
Dated: August 15, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21563 Filed 8-23-00; 8:45 am]
BILLING CODE 4160-01-C