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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 |
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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 |