[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: 21CFR26.0]
[Page 247]
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
Sec. 26.0 General.
This part substantially reflects relevant provisions of the
framework agreement and its sectoral annexes on pharmaceutical good
manufacturing practices (GMP's) and medical devices of the ``Agreement
on Mutual Recognition Between the United States of America and the
European Community'' (the MRA), signed at London May 18, 1998. For
codification purposes, certain provisions of the MRA have been modified
for use in this part. This modification is done for purposes of clarity
only and shall not affect the text of the MRA concluded between the
United States and the European Community (EC), or the rights and
obligations of the United States or the EC under that agreement. Whereas
the parties to the MRA are the United States and EC, this part is
relevant only to the Food and Drug Administration's (FDA's)
implementation of the MRA, including the sectoral annexes reflected in
subparts A and B of this part. This part does not govern implementation
of the MRA by the EC, which will implement the MRA in accordance with
its internal procedures, nor does this part address implementation of
the MRA by other concerned U.S. Federal agencies. For purposes of this
part, the terms ``party'' or ``parties,'' where relevant to FDA's
implementation of the MRA, should be considered as referring to FDA
only. If the parties to the MRA subsequently amend or terminate the MRA,
FDA will modify this part accordingly, using appropriate administrative
procedures.
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