EUCOPE’s latest position paper outlines our vision for the evolution of the EU Regulatory framework and a modernisation of the Centralised Procedure to ultimately bring novel medicines earlier to patients.
The European Centralised Procedure (CP) has helped and accelerated the approval of novel medicines across EU Member States since its first introduction in 1995. While updates have occurred over the past 25 years, the revision of the General Pharmaceutical Legislation, as part of the Pharmaceutical Strategy for Europe, presents an opportunity to modernise the procedure and ensure it is fit for purpose and future-proofed for innovative therapies.
A regulatory approval process that is well equipped to assess novel and increasingly complex medicines is critical to accelerating patient access to innovative treatments in the EU and beyond. While the European Medicines Regulatory Network (EMRN) and the CP are unique examples of regulatory best practices globally, these need to further progress to keep pace with current and future innovation.
Understanding the human and financial resources constraints of the EMRN, we want to put forward EUCOPE’s proposal for the evolution of the Regulatory framework over the next decade. Our position paper takes into account the goals of the European Regulatory Network Strategy and the EMA’s Regulatory Science Strategy to 2025.
To modernise the Centralised Procedure, EUCOPE calls for improvements along the value chain, accompanied by the updated scope of the CP, simplification of its complex operations, streamlined timelines and increased global competitiveness.
These improvements can be achieved by making substantial changes at three steps of the marketing authorisation’s process: pre-submission, evaluation, and decision-making. In addition to helping accelerate the speed at which patients can access potentially life-saving and transformative therapies, these reforms can help make the EU a more competitive region for investment in the R&D pharmaceutical sector.
To accomplish this, EUCOPE proposes three (3) core recommendations:
- Update and streamline the eligibility criteria and assessment based on most current needs and health care challenges by focusing the scope on the complexity of the products while remaining flexible to capture different levels of innovation.
- Reduce the standard timeline for EMA assessment to 170 days by streamlining the process through the introduction of collaborative trained and qualified Multi-National Assessment Teams thus resulting in shorter evaluation and clock-stock times, whilst maintaining a thorough and scientific review.
- Re-consider the requirement for a European Commission’s decision step, and decouple the decision-making and the translation of the patient information in all EU languages.
EUCOPE’s proposals to reform the Centralised Procedure aim to develop a more future-proofed system that responds to the needs of developers and patients. The proposed streamlined regulatory approval process is designed to assess novel and increasingly complex medicines more efficiently, accelerating patient access to innovative treatments within the EU and beyond.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) is Europe’s trade body for small to medium-sized innovative companies working in the field of pharmaceuticals, biotechnologies and medical devices. Through our members, we give a voice to more than 2600+ research-orientated innovative companies and associations active in the research and development of pharmaceuticals, biotechnologies and medical devices. www.eucope.org