Post by regenold

JCA has now been live since January 2025 (with a step-wise implementation plan). For regulatory affairs teams, this creates a second clock running in parallel with the EMA centralised procedure; it essentially adds another workstream to oversee. The big challenge of the HTA EU Regulation is that the various market access aspects (e.g., comparator selection, endpoint justification, ...) need to be defined well before submission and aligned with the Marketing Authorization application. It can make a lot of sense to seek early regulator feedback from both EMA and the HTA Coordination Group via parallel Joint Scientific Consultation (JSC), to get a clearer picture as early as possible (only limited number of slots per year are available!). It is clear, this is exactly where regulatory and market access teams need to work together. That’s why we’ve partnered with Ecker + Ecker GmbH to bring RA and HTA expertise into a single approach for clients navigating JCA and parallel JSC. At Regulatory Affairs Professionals Society (RAPS) we are discussing this directly with regulators and policy makers. Daria Mari and Thomas Ecker (Ecker + Ecker GmbH) will be on a panel at RAPS Euro Convergence 2026 in Lisbon on May 8, together with Matteo Scarabelli (Associate Director, Market Access, EFPIA), Noémie Manent (European Medicines Agency), and Anne Willemsen (Head of Subgroup for Joint Clinical Assessment), discussing: “One Year After – Observations, Insights, Implications on Joint Clinical Assessment.”