Title 21

PART 26

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

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 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.

21:1.0.1.1.20.0.63.1SECTION 26.0
   26.0 General.
21:1.0.1.1.20.1SUBPART A
Subpart A - Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
21:1.0.1.1.20.1.63.1SECTION 26.1
   26.1 Definitions.
21:1.0.1.1.20.1.63.2SECTION 26.2
   26.2 Purpose.
21:1.0.1.1.20.1.63.3SECTION 26.3
   26.3 Scope.
21:1.0.1.1.20.1.63.4SECTION 26.4
   26.4 Product coverage.
21:1.0.1.1.20.1.63.5SECTION 26.5
   26.5 Length of transition period.
21:1.0.1.1.20.1.63.6SECTION 26.6
   26.6 Equivalence assessment.
21:1.0.1.1.20.1.63.7SECTION 26.7
   26.7 Participation in the equivalence assessment and determination.
21:1.0.1.1.20.1.63.8SECTION 26.8
   26.8 Other transition activities.
21:1.0.1.1.20.1.63.9SECTION 26.9
   26.9 Equivalence determination.
21:1.0.1.1.20.1.63.10SECTION 26.10
   26.10 Regulatory authorities not listed as currently equivalent.
21:1.0.1.1.20.1.63.11SECTION 26.11
   26.11 Start of operational period.
21:1.0.1.1.20.1.63.12SECTION 26.12
   26.12 Nature of recognition of inspection reports.
21:1.0.1.1.20.1.63.13SECTION 26.13
   26.13 Transmission of postapproval inspection reports.
21:1.0.1.1.20.1.63.14SECTION 26.14
   26.14 Transmission of preapproval inspection reports.
21:1.0.1.1.20.1.63.15SECTION 26.15
   26.15 Monitoring continued equivalence.
21:1.0.1.1.20.1.63.16SECTION 26.16
   26.16 Suspension.
21:1.0.1.1.20.1.63.17SECTION 26.17
   26.17 Role and composition of the Joint Sectoral Committee.
21:1.0.1.1.20.1.63.18SECTION 26.18
   26.18 Regulatory collaboration.
21:1.0.1.1.20.1.63.19SECTION 26.19
   26.19 Information relating to quality aspects.
21:1.0.1.1.20.1.63.20SECTION 26.20
   26.20 Alert system.
21:1.0.1.1.20.1.63.21SECTION 26.21
   26.21 Safeguard clause.
21:1.0.1.1.20.1.63.22.1APPENDIX Appendix A
   Appendix A to Subpart A of Part 26 - List of Applicable Laws, Regulations, and Administrative Provisions
21:1.0.1.1.20.1.63.22.2APPENDIX Appendix B
   Appendix B to Subpart A of Part 26 - List of Authorities
21:1.0.1.1.20.1.63.22.3APPENDIX Appendix C
   Appendix C to Subpart A of Part 26 - Indicative List of Products Covered by Subpart A
21:1.0.1.1.20.1.63.22.4APPENDIX Appendix D
   Appendix D to Subpart A of Part 26 - Criteria for Assessing Equivalence for Post- and Preapproval
21:1.0.1.1.20.1.63.22.5APPENDIX Appendix E
   Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System
21:1.0.1.1.20.2SUBPART B
Subpart B - Specific Sector Provisions for Medical Devices
21:1.0.1.1.20.2.63.1SECTION 26.31
   26.31 Purpose.
21:1.0.1.1.20.2.63.2SECTION 26.32
   26.32 Scope.
21:1.0.1.1.20.2.63.3SECTION 26.33
   26.33 Product coverage.
21:1.0.1.1.20.2.63.4SECTION 26.34
   26.34 Regulatory authorities.
21:1.0.1.1.20.2.63.5SECTION 26.35
   26.35 Length and purpose of transition period.
21:1.0.1.1.20.2.63.6SECTION 26.36
   26.36 Listing of CAB's.
21:1.0.1.1.20.2.63.7SECTION 26.37
   26.37 Confidence building activities.
21:1.0.1.1.20.2.63.8SECTION 26.38
   26.38 Other transition period activities.
21:1.0.1.1.20.2.63.9SECTION 26.39
   26.39 Equivalence assessment.
21:1.0.1.1.20.2.63.10SECTION 26.40
   26.40 Start of the operational period.
21:1.0.1.1.20.2.63.11SECTION 26.41
   26.41 Exchange and endorsement of quality system evaluation reports.
21:1.0.1.1.20.2.63.12SECTION 26.42
   26.42 Exchange and endorsement of product evaluation reports.
21:1.0.1.1.20.2.63.13SECTION 26.43
   26.43 Transmission of quality system evaluation reports.
21:1.0.1.1.20.2.63.14SECTION 26.44
   26.44 Transmission of product evaluation reports.
21:1.0.1.1.20.2.63.15SECTION 26.45
   26.45 Monitoring continued equivalence.
21:1.0.1.1.20.2.63.16SECTION 26.46
   26.46 Listing of additional CAB's.
21:1.0.1.1.20.2.63.17SECTION 26.47
   26.47 Role and composition of the Joint Sectoral Committee.
21:1.0.1.1.20.2.63.18SECTION 26.48
   26.48 Harmonization.
21:1.0.1.1.20.2.63.19SECTION 26.49
   26.49 Regulatory cooperation.
21:1.0.1.1.20.2.63.20SECTION 26.50
   26.50 Alert system and exchange of postmarket vigilance reports.
21:1.0.1.1.20.2.63.21.6APPENDIX Appendix A
   Appendix A to Subpart B of Part 26 - Relevant Legislation, Regulations, and Procedures.
21:1.0.1.1.20.2.63.21.7APPENDIX Appendix B
   Appendix B to Subpart B of Part 26 - Scope of Product Coverage
21:1.0.1.1.20.2.63.21.8APPENDIX
   Appendixes C-F to Subpart B of Part 26 [Reserved]
21:1.0.1.1.20.3SUBPART C
Subpart C - “Framework” Provisions
21:1.0.1.1.20.3.63.1SECTION 26.60
   26.60 Definitions.
21:1.0.1.1.20.3.63.2SECTION 26.61
   26.61 Purpose of this part.
21:1.0.1.1.20.3.63.3SECTION 26.62
   26.62 General obligations.
21:1.0.1.1.20.3.63.4SECTION 26.63
   26.63 General coverage of this part.
21:1.0.1.1.20.3.63.5SECTION 26.64
   26.64 Transitional arrangements.
21:1.0.1.1.20.3.63.6SECTION 26.65
   26.65 Designating authorities.
21:1.0.1.1.20.3.63.7SECTION 26.66
   26.66 Designation and listing procedures.
21:1.0.1.1.20.3.63.8SECTION 26.67
   26.67 Suspension of listed conformity assessment bodies.
21:1.0.1.1.20.3.63.9SECTION 26.68
   26.68 Withdrawal of listed conformity assessment bodies.
21:1.0.1.1.20.3.63.10SECTION 26.69
   26.69 Monitoring of conformity assessment bodies.
21:1.0.1.1.20.3.63.11SECTION 26.70
   26.70 Conformity assessment bodies.
21:1.0.1.1.20.3.63.12SECTION 26.71
   26.71 Exchange of information.
21:1.0.1.1.20.3.63.13SECTION 26.72
   26.72 Sectoral contact points.
21:1.0.1.1.20.3.63.14SECTION 26.73
   26.73 Joint Committee.
21:1.0.1.1.20.3.63.15SECTION 26.74
   26.74 Preservation of regulatory authority.
21:1.0.1.1.20.3.63.16SECTION 26.75
   26.75 Suspension of recognition obligations.
21:1.0.1.1.20.3.63.17SECTION 26.76
   26.76 Confidentiality.
21:1.0.1.1.20.3.63.18SECTION 26.77
   26.77 Fees.
21:1.0.1.1.20.3.63.19SECTION 26.78
   26.78 Agreements with other countries.
21:1.0.1.1.20.3.63.20SECTION 26.79
   26.79 Territorial application.
21:1.0.1.1.20.3.63.21SECTION 26.80
   26.80 Entry into force, amendment, and termination.
21:1.0.1.1.20.3.63.22SECTION 26.81
   26.81 Final provisions.