This workstream addresses industry and regulatory concerns over inconsistent bioassay standards.
Industry may not be consistent with guidance and regulatory expectations and concerns
There are concerns around consistent bioassay standards. Industry interpretations of the current ICH guidelines vary and there is an apparent lack of understanding and a general inconsistency between guidance and regulatory expectations. If data addressing this area is not provided, it will lead to delayed submissions.
Harmonization of bioassay best practice across the industry
The workstream is harmonizing cross-industry ways of working, including anticipating and avoiding future challenges, particularly relating to statistics and understanding the most appropriate tools for bioassays. Providing advanced warning of changes to requirements in this area is important, as is building greater industry knowledge. Members’ work is leading to reduced development delays, and fewer regulatory questions/feedback.
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