ICH Project Workshop on the Draft Guideline: ICH Q5A(R2) “Viral Safety Evaluation of Biotechnolgy Products Derived from Cell Lines of Human or Animal Origin” reached Step 2
January 21, 2023
The ICH Q5A (R2) Expert Working Group (EWG) has been continuing its deliberations toward revising the guidelines on the viral safety assessment of biotechnology-derived medicinal products manufactured using human or animal cell lines.As a result, on September 29, Reiwa 4, the draft ICH Q5A (R2) guideline reached Step 2 and was published on the official ICH website. In Japan, on January 20, Reiwa 5, a call for public comments was issued on the draft ICH Q5A (R2):“Viral Safety Assessment of Biotechnology-Derived Medicinal Products Manufactured Using Human or Animal Cell Lines” (Draft). To promote understanding of this draft guideline and support the collection of public comments, we recently held Guideline Workshops on the ICH Q5A (R2) draft guideline.
Details regarding the program and other information for this briefing session are available on the PMDA website.