Joint Clinical Assessment: How to align your regulatory and access strategies

In this episode of RegRapPod – InConversation, host Claire McDermott talks with Sangeeta Budhia, Senior Vice President and Global Head of Pricing, Market Access and Evidence Evaluation, and Sinan Sarac, Senior Vice President and Head of Oncology Europe, Regulatory Consulting, both at Parexel, about Joint Clinical Assessment (JCA) implementation in Europe. Established under Regulation EU 2021/2282, with the aim of providing a standardised process for evaluating clinical evidence of health technologies, the JCA process is mandatory. It was implemented in January 2025 for oncology drugs and cell and gene therapies and extends to orphan drugs in 2028 and all products in 2030. This podcast walks listeners through not only the basics of JCA, but also the key challenges in preparing submissions, how to navigate them, how to integrate your evidence generation strategy and how JCA will influence regulatory strategy and clinical development planning for future products.