[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.17]
[Page 250-251]
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
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.
[[Page 251]]
(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.
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