14/15 June 2022
The European Medicines Agency EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". In this document, EMA proposes a plan for "advancing the Agency's engagement with regulatory science over the next five to ten years".
In his foreword, EMA Executive Director Prof. Guido Rasi sais that "regulators need to be ready to support the development of increasingly complex medicines" keeping in mind the introduction and combination of new technologies. And it should be questioned if there is sufficient new guidance and "sufficient levels of advice to facilitate the utilisation and translation of these innovations".
The agency defined the following strategic goals and core recommendations for human medicines:
These are ambitious goals. And EMA is aware that the regulatory landscape, which is still outdated in some areas, needs to be adapted; and this includes GMP requirements and standards. So the agency proposes to modernise relevant regulations to facilitate novel manufacturing and novel therapies. As a consequence it will be necessary to "facilitate a flexible approach in application of Good Manufacturing Practice". Regulatory challenges in point-of-care manufacturing should also be addressed, e.g. the responsibility for the manufacturing process, the concept of batch control and the role of the Qualified Person (QP).
The "Strategic Reflection - EMA Regulatory Science to 2025" is open for six-month public consultation. Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.