[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.17]

[Page 255]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
   PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
     Subpart A--Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices
 
Sec. 26.17   Role and composition of the Joint Sectoral Committee.

    (a) A Joint Sectoral Committee is set up to monitor the activities 
under both the transitional and operational phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who each will 
have one vote. Decisions will be taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment, which must be agreed by both parties, 
of the equivalence of the respective authorities;
    (2) Developing and maintaining the list of equivalent authorities, 
including any limitation in terms of inspecting type or products, and 
communicating the list to all authorities and the Joint Committee;
    (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that an authority may be no longer equivalent and 
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.
    (d) The Joint Sectoral Committee shall meet at the request of either 
party and, unless the cochairs otherwise agree, at least once each year. 
The Joint Committee will be kept informed of the agenda and conclusions 
of meetings of the Joint Sectoral Committee.