21 CFR Subpart A
Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices
June 25, 2020
§
26.21
Safeguard clause
§
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
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
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