Industry probes regulators on speeding up CMC for early access pathways

Industry representatives proposed several ways to overcome the common bottleneck of collecting sufficient CMC data while pursuing approval via accelerated development pathways such as FDA's breakthrough therapy and EMA's PRIority MEdicines (PRIME).

At a joint FDA-EMA workshop on Monday in London to discuss CMC data for products in development via accelerated pathways, representatives from U.S. and European pharmas and biotechs posed questions to regulators about the potential for using streamlined CMC data or tests that could be utilized postapproval to ensure CMC data submissions are in line with accelerated review timelines. Industry representatives and regulators widely acknowledged at the meeting that efficacy and safety data are often available very early in the review process for PRIME and breakthrough therapies; however, CMC data are often the last generated, and in some cases can delay regulatory decision-making on an application...