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e-CFR data is current as of January 19, 2021

Title 21 → Chapter I → Subchapter A → Part 26

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL

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

General.

Subpart A—SPECIFIC SECTOR PROVISIONS FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES

Definitions.

Purpose.

Scope.

Product coverage.

Length of transition period.

Equivalence assessment.

Participation in the equivalence assessment and determination.

Other transition activities.

Equivalence determination.

Regulatory authorities not listed as currently equivalent.

Start of operational period.

Nature of recognition of inspection reports.

Transmission of postapproval inspection reports.

Transmission of preapproval inspection reports.

Monitoring continued equivalence.

Suspension.

Role and composition of the Joint Sectoral Committee.

Regulatory collaboration.

Information relating to quality aspects.

Alert system.

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

Subpart B—SPECIFIC SECTOR PROVISIONS FOR MEDICAL DEVICES

Purpose.

Scope.

Product coverage.

Regulatory authorities.

Length and purpose of transition period.

Listing of CAB's.

Confidence building activities.

Other transition period activities.

Equivalence assessment.

Start of the operational period.

Exchange and endorsement of quality system evaluation reports.

Exchange and endorsement of product evaluation reports.

Transmission of quality system evaluation reports.

Transmission of product evaluation reports.

Monitoring continued equivalence.

Listing of additional CAB's.

Role and composition of the Joint Sectoral Committee.

Harmonization.

Regulatory cooperation.

Alert system and exchange of postmarket vigilance reports.

Appendix A to Subpart B of Part 26—Relevant Legislation, Regulations, and Procedures.

Appendix B to Subpart B of Part 26—Scope of Product Coverage

Appendix

Appendixes C-F to Subpart B of Part 26 [Reserved]

Subpart C—“FRAMEWORK” PROVISIONS

Definitions.

Purpose of this part.

General obligations.

General coverage of this part.

Transitional arrangements.

Designating authorities.

Designation and listing procedures.

Suspension of listed conformity assessment bodies.

Withdrawal of listed conformity assessment bodies.

Monitoring of conformity assessment bodies.

Conformity assessment bodies.

Exchange of information.

Sectoral contact points.

Joint Committee.

Preservation of regulatory authority.

Suspension of recognition obligations.

Confidentiality.

Fees.

Agreements with other countries.

Territorial application.

Entry into force, amendment, and termination.

Final provisions.

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