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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR

§ 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.
   § 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 of Part 26--List of Applicable Laws, Regulations, and Administrative Provisions
    Appendix B to Subpart A of Part 26--List of Authorities
    Appendix C to Subpart A of Part 26--Indicative List of Products Covered by Subpart A
    Appendix D to Subpart A of Part 26--Criteria for Assessing Equivalence for Post- and Preapproval
    Appendix E to Subpart A of Part 26--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 of Part 26--Relevant Legislation, Regulations, and Procedures.
    Appendix B to Subpart B of Part 26--Scope of Product Coverage
    Appendixes C-F to Subpart B of Part 26 [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.

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