The European Commission and EU Member States have launched a groundbreaking pilot project under the COMBINE programme to revolutionize the approval process for studies that combine clinical trials of medicines with performance studies of medical devices. This initiative represents a significant step toward streamlining regulatory pathways for complex therapeutic developments.
Streamlined Single Application Process
The pilot project introduces a coordinated assessment procedure that allows sponsors to submit a single application for combined studies. This approach is specifically designed to enable more harmonized interactions with the Member States involved in the approval process. The new system targets studies where the same sponsor is simultaneously testing a medicine and a companion diagnostic device.
Reducing Administrative Burden
The coordinated assessment procedure is expected to significantly reduce the administrative burden for sponsors while promoting transparency and consistency throughout the assessment process. By consolidating multiple regulatory pathways into a single application, the pilot aims to eliminate redundancies and create a more efficient regulatory environment for innovative therapeutic approaches.
Limited Pilot Scope and Learning Objectives
The pilot will accept a limited number of studies to test the effectiveness of this new approval mechanism. The primary objective is to evaluate how well this coordinated process works in practice and to gather valuable insights from the experience. This measured approach allows regulators to refine the system based on real-world implementation before broader adoption.
Focus on Medicine-Diagnostic Combinations
The pilot specifically targets studies involving the simultaneous development of medicines and companion diagnostics by the same sponsor. This focus addresses a growing need in personalized medicine, where therapeutic efficacy often depends on accurate diagnostic identification of patient populations most likely to benefit from treatment.
The COMBINE programme represents the European Union's commitment to modernizing regulatory frameworks to keep pace with advancing therapeutic technologies while maintaining rigorous safety and efficacy standards.
