Regulatory Pathways For CGT And ATMP Products

According to the FDA, federal oversight of biologics began in 1902 under the Biologics Control Act, which provided government control over medical products made from living sources. Since that time, regulatory authorities around the world have made it their mission to provide guidance for manufacturing safe and effective therapeutic products.

As therapeutic strategies and technologies evolve, so do regulatory frameworks and guidance. Cell and gene therapy (CGT) is one of the fastest-growing therapeutic areas today, and for a good reason. These therapies provide hope to patients with the opportunity for cures instead of lifelong treatments. Regulatory agencies have responded to this promise and urgency by developing expedited approval pathways, such as Regenerative Medicine Advanced Therapy (RMAT) designation in the US and PRIME designations for Advanced Therapy Medicinal Products (ATMPs) in the EU. Expedited pathways have led to compressed CGT product development timelines, which present unique challenges and opportunities for developers. In addition, guidance and regulatory standards continue to tighten and evolve as the industry matures, so CGT developers must engage with regulatory authorities effectively. This infographic will review three tips for regulatory success.