ICH Project Briefing on ICH M14 Draft Guideline
Jul 09, 2024
The ICH M14 Expert Working Group (EWG) has been studying to develop the ICH M14 Guideline. As a result, Step 2 was reached as of May 21, 2024 and published on the official ICH website. In Japan, a call for public comments on "ICH M14: General principles for the planning, design and analysis of pharmacoepidemiological studies using real-world data in the safety evaluation of medicinal products (draft)" was launched on June 17, 2024.
In order to promote understanding of the draft guideline and to support the collection of public comments, a briefing session on the ICH M14 draft guideline was held.
The program and other details of the briefing can be found on the PMDA Website.
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