Will EMA Plans change the Landscape of GMP?

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".

Strategic goals and core recommendations for human medicines

The agency defined the following strategic goals and core recommendations for human medicines:

• Catalysing the integration of science and technology in medicines development. This means for example to support developments in precision medicine, biomarkers and  ATMPs but also to facilitate the implementation of novel manufacturing technologies, including nanotechnology and new materials in pharmaceuticals.
• Improving the scientific quality of evaluations with the goal to foster innovations in the fields of clinical development and clinical trials.
• Advancing patient-centred access to medicines in partnership with healthcare systems.
• Addressing emerging health threats and availability/ therapeutics
• Enabling and leveraging research and innovation in regulatory science

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 And EMA is aware that the regulatory landscape, which is still outdated in some areas, needs to be adapted; and this includes GMP requirements and standards.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.