ICH Project Briefing on the draft guideline reaching Step 2 of ICH Q5A (R2) "Viral safety evaluation of biotechnology-applied medicinal products manufactured using human or animal cell lines" (draft)
Jan. 21, 2023
The ICH Q5A (R2) Expert Working Group (EWG) has been studying to revise the guideline for the viral safety evaluation of biotechnology-based medicinal products manufactured using human or animal cell lines. As a result, the draft guideline for ICH Q5A(R2) was published on the official ICH website on September 29, 2022, and ICH Q5A(R2): "Viral Safety Evaluation of Biotechnology Medicinal Products for Human Use or for Use in Animal Cell Lines" (draft) was also published in Japan on January 20, 2023. On January 20, 2023, a call for public comments on ICH Q5A(R2): "Viral Safety Assessment of Biotechnology-based Drugs Manufactured Using Human or Animal Cell Lines" (draft) was launched in Japan. In order to promote understanding of the draft guideline and to support the collection of public comments, an explanatory meeting on the ICH Q5A (R2) draft guideline was held.
The program and other details of the briefing can be found on the PMDA Website.
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