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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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
| § 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] |
| 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. |