Cell and gene therapy (CGT) applications have increased rapidly over the past few years, with hundreds of candidate treatments entering the clinical pipeline annually. Although North America, Asia, and Europe are driving industry growth, drug sponsorsin those areas will not want to limit product distribution to their respective regions; rather, they will want to maximize patient impact. Thus, companies must understand global regulatory differences and their implications for therapy production. However, advancements in the CGT industry often outpace adjustments to regufatory guidances.
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