21 CFR Part 26 - 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