ICH Project ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products (Draft Guideline)
September 06, 2021
The ICH Q13 Expert Working Group (EWG) has been studying to develop guidelines for continuous production, an innovative manufacturing technology. As a result, the ICH Q13 draft guideline reached Step 2 on July 27, 2021, and was published on the ICH official website. In Japan, a public comment period on ICH Q13: "Draft Guideline for the Continuous Production of Drug Substances and Drug Products" is scheduled to begin in October 2021. In order to promote understanding of the draft guideline and to support the collection of public comments, we have decided to hold a Guideline Workshops on ICH Q13.