Introduction

The development of science and technology is moving at an ever increasing rate, resulting in significant innovations in treatments. Currently, 20% of approved medicinal products are combination products, comprising of both a medicine and a medical device. However, Europe is lacking an integrated approach for the assessment of combination products, which represent more than 1 in 5 of current products in development. This creates uncertainty and puts European patients at a disadvantage when compared to the developments underway and regulatory pathways in other major territories for combination products, companion diagnostics and digital tools. With the rapid expansion of digital tools for personalized medicines, combination product manufacturers have become increasingly interested in making them available with their combination products. If Europe wants to catch this medical technology wave and ensure rapid access to innovative medicines for its patients, it needs to adapt its regulatory regime[1],[2]. In particular to drive improved alignment and connectivity between the existing separate and distinct regulatory frameworks for medicines and  medical devices.

Which changes are needed?

It is suggested that a clear legal basis and framework within the medicines legislation needs to be established that enables EMA to take responsibility and accountability for tasks concerning both combination products and companion diagnostics. This would reinforce EMA’s role to facilitate the research, development, approval and monitoring of these products. Thus allowing EMA to manage (co)development support (including integrated Scientific Advice), qualification procedures, lead/coordinate policy development and issue procedural guidance.    

A legal definition for “combination product” would encourage the conjunction of two detached and discrete legal frameworks to create the foundation of a clear regulatory pathway for combination products in Europe, putting European requirements on a similar level to other regions. This definition would not include companion diagnostics, as they are already defined in the In-Vitro Diagnostic (IVD) Regulation (2017/746) [3].

Furthermore, an extended responsibility would allow EMA to lead coordination of required stakeholder input in a timely manner thus ensuring an effective process for the consultation and approval of combination products as well as companion diagnostics. This would increase clarity and predictability for sponsors, European regulators and other stakeholders supporting the delivery of innovative medicines to patients. Moreover, the extension of EMA’s responsibilities, suitably resourced with applicable medical device and IVD expertise, could be accomplished through a network of European experts selected by national Competent Authorities. This way, an aligned approach would be guaranteed together with optimal co-ordination of (co-)development aspects through all relevant stakeholders, including Notified Bodies.

Conclusion

In conclusion, a harmonised framework is required to enable a smooth and aligned development and authorisation of combination products and companion diagnostics. Furthermore, governance should permit flexibility and distinguish the diverse responsibilities regarding particular regulations to leverage those to best effect., These changes should be implemented with the ultimate goal that European patients are able to experience the transformation of modern medicine and have prompt access to innovative medicines.

[1] https://www.efpia.eu/media/636798/efpia-regulatoryroadtoinnovation_triptych_v07-final-neworder_pbp.pdf

[2] https://www.efpia.eu/media/636564/evidence-mix_final-9-dec-2021.pdf

[3] https://eur-lex.europa.eu/eli/reg/2017/746/oj