Subpart A - SPECIFIC sectOR PROVISIONS FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES
- 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
- Section 26.1 - Definitions
- Section 26.2 - Purpose
- Section 26.3 - Scope
- Section 26.4 - Product coverage
- Section 26.5 - Length of transition period
- Section 26.6 - Equivalence assessment
- Section 26.7 - Participation in the equivalence assessment and determination
- Section 26.8 - Other transition activities
- Section 26.9 - Equivalence determination
- Section 26.10 - Regulatory authorities not listed as currently equivalent
- Section 26.11 - Start of operational period
- Section 26.12 - Nature of recognition of inspection reports
- Section 26.13 - Transmission of postapproval inspection reports
- Section 26.14 - Transmission of preapproval inspection reports
- Section 26.15 - Monitoring continued equivalence
- Section 26.16 - Suspension
- Section 26.17 - Role and composition of the Joint Sectoral Committee
- Section 26.18 - Regulatory collaboration
- Section 26.19 - Information relating to quality aspects
- Section 26.20 - Alert system
- Section 26.21 - Safeguard clause
- Appendix E to Subpart A of Part 26 - Elements To Be Considered in Developing a Two-Way Alert System
- 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