[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: 21CFR26.9]

[Page 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.  26.9  Equivalence determination.

    (a) Equivalence is established by having in place regulatory systems 
covering the criteria referred to in Appendix D of this subpart, and a 
demonstrated pattern of consistent performance in accordance with these 
criteria. A list of authorities determined as equivalent shall be agreed 
to by the Joint Sectoral Committee at the end of the transition period, 
with reference to any limitation in terms of inspection type (e.g., 
postapproval or preapproval) or product classes or processes.
    (b) The parties will document insufficient evidence of equivalence, 
lack of opportunity to assess equivalence or a determination of 
nonequivalence, in sufficient detail to allow the authority being 
assessed to know how to attain equivalence.