A future-proof EU regulatory framework – key challenges to be addressed

The upcoming revision of the EU’s pharmaceutical #legislation is a once in a generation opportunity to reshape #medicines regulation for better public health in the EU. But what is needed to make the regulatory framework fit for innovative medicines and public health challenges of the future, in a rapidly changing environment?

Here are some thoughts I shared during some recent events.

• The review of the Pharmaceutical strategy provides an opportunity to address challenges such as those posed by new types of medicines, greater promises from data and increasing blurring of boundaries between different types of products, particularly medicines and devices. There is a need to simplify structures and procedures so that we can rationalise the use of the limited resources in the network. This will help us deal more effectively with complex regulatory processes as a basis for a future-proofed system.

• The pandemic has shown us that the current regulatory system can react and adapt, but we also experienced pressure in terms of capacity and ability. We need a more agile and expertise-based system in which we can have the right know-how when and where we need it. We must further develop expert knowledge, capacity and capability across the network. For example, greater use of Multi-National Assessment Teams and the EU Network Training Centre can help to achieve this.

• There is a lot we can do to improve collaboration with non-regulatory stakeholders in the development, review and approval of medicines. We are doing some of this work now at European level, including by engaging with the Health Technology Assessment (HTA) and Payer communities. In this way we can help drive common evidence generation. We are also putting a lot of effort into modernising the environment for clinical trials through the transformation programme Accelerating Clinical Trials in the EU (ACT EU) together with the implementation of the Clinical Trials Regulation and the use of CTIS for initial clinical applications in the EU. We are also establishing a multi-stakeholder platform on clinical trials. An environment that supports the conduct of large multinational clinical trials and creates links between the research and development communities and the regulators, as well as patients and health care professionals will ultimately deliver better medicines for patients. 

#Patients #PublicHealth #HealthUnion #ACTEU #CTIS