Third strategic field of the EMA’s network strategy
Innovation in many different areas of medicine
In this context, the term innovation covers many different areas of medicine. It not only refers directly to new treatment options, but also to new developments in the field of genetics or biomarkers, thus building a bridge to personalized medicine. According to the joint strategy paper, the patient should stay in the focus, not only in the development of new therapies but also beyond that. Through the application-accompanying data collection, the benefit of the therapy should be monitored, and the entire development process thus made more cost-efficient.
In this area, the strategy aims to achieve four main objectives:
- Accelerating the integration of technology and science into medical development and ensuring that the network has sufficient skills to support developers at different stages.
- Promoting evidence sharing - improving the scientific quality of the available evidence and ensuring that the available evidence is useful to all stakeholders, including regulatory authorities and HTA.
- Enabling and improving research in heavily regulated areas.
- Improving collaboration with other stakeholders, including medical device experts, SMEs and academic groups.
The objectives further highlight the increasing importance of high-quality evidence throughout the EMA's 5-year strategy, not only for marketing authorization, but especially afterwards. Another significant aspect is the development of a joint "EU Horizon Screening Initiative". This initiative is being initiated to make regulatory authorities in the EU aware of new innovations and thus enable them to contact the developers at an early stage in order to proactively avoid problems during the approval process. Once enacted, this change would have a profound impact on all market access procedures in the European Union.
As in the other areas of the strategy paper, the EMA poses various challenges in the field of innovation that should also be addressed, including:
- Development of EU-wide, homogenous regulations regarding pharmaceutical and medical technology therapies;
- Appropriate and targeted integration of patient-centered and personalized medicine into existing regulatory systems
- Adequate evaluation and implementation of new and innovative study designs by regulatory authorities;
- Further implementation and increased global integration of regulatory authorities, especially in dealing with innovations.
This topic area clearly shows the dynamics gaining momentum in the health and pharmaceutical sector. In particular, the market access of new, innovative therapies and the link between innovations and the generation of evidence are important to the EMA and the HMA. One possible element to underpin this linkage in a regulatory review is a value story that clearly connects the available evidence with the benefits of the pharmaceutical product. At SKC, we develop tailor-made value stories with our clients and are looking forward to advice you.
About the author
M. Sc. Economics
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