21 CFR Part 26 — Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
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.
Subpart B — Specific Sector Provisions for Medical Devices
- § 26.31— Purpose.
- § 26.32— Scope.
- § 26.33— Product coverage.
- § 26.34— Regulatory authorities.
- § 26.35— Length and purpose of transition period.
- § 26.36— Listing of CAB's.
- § 26.37— Confidence building activities.
- § 26.38— Other transition period activities.
- § 26.39— Equivalence assessment.
- § 26.40— Start of the operational period.
- § 26.41— Exchange and endorsement of quality system evaluation reports.
- § 26.42— Exchange and endorsement of product evaluation reports.
- § 26.43— Transmission of quality system evaluation reports.
- § 26.44— Transmission of product evaluation reports.
- § 26.45— Monitoring continued equivalence.
- § 26.46— Listing of additional CAB's.
- § 26.47— Role and composition of the Joint Sectoral Committee.
- § 26.48— Harmonization.
- § 26.49— Regulatory cooperation.
- § 26.50— Alert system and exchange of postmarket vigilance reports.
Subpart C — “Framework” Provisions
- § 26.60— Definitions.
- § 26.61— Purpose of this part.
- § 26.62— General obligations.
- § 26.63— General coverage of this part.
- § 26.64— Transitional arrangements.
- § 26.65— Designating authorities.
- § 26.66— Designation and listing procedures.
- § 26.67— Suspension of listed conformity assessment bodies.
- § 26.68— Withdrawal of listed conformity assessment bodies.
- § 26.69— Monitoring of conformity assessment bodies.
- § 26.70— Conformity assessment bodies.
- § 26.71— Exchange of information.
- § 26.72— Sectoral contact points.
- § 26.73— Joint Committee.
- § 26.74— Preservation of regulatory authority.
- § 26.75— Suspension of recognition obligations.
- § 26.76— Confidentiality.
- § 26.77— Fees.
- § 26.78— Agreements with other countries.
- § 26.79— Territorial application.
- § 26.80— Entry into force, amendment, and termination.
- § 26.81— Final provisions.