eCFR Reference Browser

---

title: "21 CFR §26.18"

source: "https://www.ecfr.gov/current/title-21/section-26.18"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "26"

part_subject: "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_code: "A"

subpart_subject: "Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices"

section_number: "26.18"

section_subject: "Regulatory collaboration."

cfr_reference: "21 CFR 26.18"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)The parties and authorities shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.

(b)The parties shall notify each other in writing of any changes to appendix B of this subpart.

§26.18 - Regulatory collaboration.