[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.0]

[Page 274-276]
 
                        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.

   REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL 
   DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN 
   COMMUNITY--Table of Contents




Sec.
26.0 General.

      Subpart A_Specific Sector Provisions for Pharmaceutical Good 
                         Manufacturing Practices

26.1 Definitions.
26.2 Purpose.
26.3 Scope.
26.4 Product coverage.
26.5 Length of transition period.
26.6 Equivalence assessment.
26.7 Participation in the equivalence assessment and determination.
26.8 Other transition activities.
26.9 Equivalence determination.
26.10 Regulatory authorities not listed as currently equivalent.
26.11 Start of operational period.
26.12 Nature of recognition of inspection reports.
26.13 Transmission of postapproval inspection reports.
26.14 Transmission of preapproval inspection reports.

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26.15 Monitoring continued equivalence.
26.16 Suspension.
26.17 Role and composition of the Joint Sectoral Committee.
26.18 Regulatory collaboration.
26.19 Information relating to quality aspects.
26.20 Alert system.
26.21 Safeguard clause.

Appendix A to Subpart A--List of Applicable Laws, Regulations, and 
          Administrative Provisions.
Appendix B to Subpart A--List of Authorities.
Appendix C to Subpart A--Indicative List of Products Covered by Subpart 
          A.
Appendix D to Subpart A--Criteria for Assessing Equivalence for Post- 
          and Preapproval.
Appendix E to Subpart A--Elements to be Considered in Developing a Two-
          Way Alert System.

        Subpart B_Specific Sector Provisions for Medical Devices

26.31 Purpose.
26.32 Scope.
26.33 Product coverage.
26.34 Regulatory authorities.
26.35 Length and purpose of transition period.
26.36 Listing of CAB's.
26.37 Confidence building activities.
26.38 Other transition period activities.
26.39 Equivalence assessment.
26.40 Start of the operational period.
26.41 Exchange and endorsement of quality system evaluation reports.
26.42 Exchange and endorsement of product evaluation reports.
26.43 Transmission of quality system evaluation reports.
26.44 Transmission of product evaluation reports.
26.45 Monitoring continued equivalence.
26.46 Listing of additional CAB's.
26.47 Role and composition of the Joint Sectoral Committee.
26.48 Harmonization.
26.49 Regulatory cooperation.
26.50 Alert system and exchange of postmarket vigilance reports.

Appendix A to Subpart B--Relevant Legislation, Regulations, and 
          Procedures.
Appendix B to Subpart B--Scope of Product Coverage.
Appendixes C-F to Subpart B [Reserved]

                   Subpart C_``Framework'' Provisions

26.60 Definitions.
26.61 Purpose of this part.
26.62 General obligations.
26.63 General coverage of this part.
26.64 Transitional arrangements.
26.65 Designating authorities.
26.66 Designation and listing procedures.
26.67 Suspension of listed conformity assessment bodies.
26.68 Withdrawal of listed conformity assessment bodies.
26.69 Monitoring of conformity assessment bodies.
26.70 Conformity assessment bodies.
26.71 Exchange of information.
26.72 Sectoral contact points.
26.73 Joint Committee.
26.74 Preservation of regulatory authority.
26.75 Suspension of recognition obligations.
26.76 Confidentiality.
26.77 Fees.
26.78 Agreements with other countries.
26.79 Territorial application.
26.80 Entry into force, amendment, and termination.
26.81 Final provisions.

    Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 1905; 
21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 360e, 360f, 
360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393; 42 
U.S.C. 216, 241, 242l, 262, 264, 265.

    Source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.


    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

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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.