Subpart A. 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
- 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