Navigating the EMA Qualification Process: Opportunities and Challenges for Accelerating Market Entry for Breakthrough Treatments and Vaccines

OBJECTIVES: To provide practical and strategic insights into the European Medicines Agency (EMA) qualification process, with a specific focus on understanding how the EMA qualification procedure can be aligned with Joint Scientific Consultation (JSC) to facilitate faster and more effective market entry of innovative treatments and vaccines.

METHODS: A document analysis was performed of publicly available EMA Opinions or Advice, related to the qualification procedure of novel methodologies. Semi-structured interviews will be conducted with previous applicants from consortia (such as IMI-PREFER, IMI-CARE, ConCEPTION and EUnetHTA) and industry as well as assessors of the EMA qualification procedure. Adopting a Grounded Theory approach, transcripts will be analysed according to the QUAGOL method, supported by the qualitative data analysis software Nvivo.

RESULTS: Preliminary results indicate the need for increased procedural flexibility, more patient involvement, and the development of user-friendly guidance and training. Initial findings suggest that the high scientific rigor required ensures excellence but can be challenging for early-stage methodologies, emphasizing the importance of early interaction with EMA. Effective triage mechanisms are necessary to appropriately direct applicants and conserve resources across the ecosystem. The resource-intensive nature of the process, demanding significant time, expertise, and financial investment, poses challenges particularly for smaller organizations. Additionally, there is a lack of visibility and awareness about the EMA qualification process and its benefits, highlighting the need for increased outreach and education to enhance engagement and improve drug development outcomes.

CONCLUSIONS: The EMA qualification process offers significant opportunities for accelerating scientific innovation, yet its complexity and rigorous evaluation requirements pose substantial challenges for applicants. Aligning the process with joint scientific advice can facilitate more efficient market entry for innovative treatments and vaccines, thereby enhancing the overall effectiveness of the qualification procedure. Enhanced outreach, patient involvement, and tailored guidance are essential to maximize the benefits of the EMA qualification process.