[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: 21CFR26.6]
[Page 248-249]
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. 26.6 Equivalence assessment.
(a) The criteria to be used by the parties to assess equivalence are
listed in Appendix D of this subpart. Information pertaining to the
criteria under European Community (EC) competence will be provided by
the EC.
(b) The authorities of the parties will establish and communicate to
each other their draft programs for assessing the equivalence of the
respective regulatory systems in terms of quality assurance of the
products and consumer protection. These programs will be carried out, as
deemed necessary by the regulatory authorities, for post- and
preapproval inspections and for various product classes or processes.
(c) The equivalence assessment shall include information exchanges
(including inspection reports), joint training, and joint inspections
for the purpose of assessing regulatory systems and the authorities'
capabilities. In conducting the equivalence assessment, the parties will
ensure that efforts are made to save resources.
(d) Equivalence assessment for authorities added to Appendix B of
this subpart after the effective date described in Sec. 26.80(a) will
be conducted as
[[Page 249]]
described in this subpart, as soon as practicable.
Back to Top
© 2007 Betterchem Corp.
|
