(88a) Biologics Application CR Trend Analysis and Advancing Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Network (invited talk)

The presentation will provide a brief analysis of the causes of Complete Responses (CRs) to recent original and Biosimilar BLA applications, including the impact of applications using CMOs, and factors cited in facility inspections. The presentation will also include an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of the learnings from two pilot programs on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities. FDA has been leading the effort with other Regulators and Industry to use two pilot programs to understand opportunities and challenges in developing a Global submission pathway, enabling Reliance in CMC assessment and facility inspection, and thus reduce and even eliminate need for duplicative Regulatory submissions and inspections. Given the increased use of advanced and innovative technologies to speed up the development of medicines and the limited regulatory resources, our efforts are aimed to ensure the most appropriate deployment and use of tools and knowledge to speed up regulatory reviews to make safe and high-quality drugs available to patients on a global basis.