[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: 21CFR26.6]

[Page 252-253]
 
                        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. 26.6   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

[[Page 253]]

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 described in this subpart, as soon as practicable.