ICH Project ICH Q2(R2) / Q14: Briefing session on the draft guideline "ICH Q2(R2): Validation of Analytical Procedures" and "ICH Q14: Analytical Procedure Development" reached in Step 2
June 21, 2022
The ICH Q2 (R2) / Q14 Expert Working Group (EWG) has continued its deliberations toward revising and drafting guidelines on analytical method validation and analytical method development.As a result, on March 24, Reiwa 4, the draft ICH Q2 (R2) / Q14 guidelines reached Step 2 and were published on the official ICH website. In Japan as well, during May Reiwa 4, a call for public comments on the draft ICH Q2 (R2):“Analytical Method Validation” (Draft) and ICH Q14: “Analytical Method Development” (Draft). To promote understanding of these draft guidelines and support the collection of public comments, we held Guideline Workshops on the ICH Q2 (R2) / Q14 draft guidelines.