Challenge
Regulations are in place to serve patients and society as well as to facilitate the development of medicines. However, regulation may also be a challenge for bringing promising therapies to patients. For innovators, it may be complex to design a regulatory strategy for their therapies in development. Furthermore, sometimes innovators may not be aware of potential regulatory requirements or topics that are especially relevant for their innovation. Crafting an appropriate regulatory strategy is a balancing act between building an evidence and value dossier that shows convincingly the quality, safety and efficacy of a therapy under development, investment considerations, and assuring that the product profile aligns with real-world patient needs.

Project goals

To support innovators in navigating the regulatory space, FAST has requested the Regulatory Science Network Netherlands (RSNN) to develop a framework for a regulatory support service for the development of medicines. Within this project, together with the RSNN, we will explore and experiment with a multilayer model consisting of:

1. Regulatory Service Desk (Target: innovators. Purpose: provide guidance and disclose information on possible solutions and routes, and publish general FAQs)
2. Multistakeholder regulatory advice service (Target: innovators. Purpose: advise on the drug development path based on a support trajectory, including guidance and support by an expert (team) in preparation of a multistakeholder round table discussion where all relevant stakeholders are brought around the table at once.)
3. Regulatory sandboxing (Target: system failure. Purpose: generate solutions to overcome or cope with system failure based on multistakeholder discussion).

Project status

The research phase for setting up the multilayer model will be concluded in 2022. In early 2023, pilots will be conducted. The results of these pilots will be finalized during 2023.

Executing party

The project will be executed by the RSNN. RSNN is a network of experts from industry, academia, government bodies, and the broader regulatory science field. RSNN offers a unique platform for stakeholders from different backgrounds to meet and discuss regulatory science as equal partners. For more information, see www.RSNN.nl.

Contribution of FAST

FAST is the sponsor of the project. As sponsor FAST advices the project team and monitors the progress of the project.

Would you like to learn more about the project? Please contact FAST.