The European Medicines Agency (EMA) and the Massachusetts Institute of Technology’s (MIT's) Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals, according to an EMA press release.
The project, which is scheduled to be completed by December 2011, will be conducted within the framework of CBI’s New Drug Development Paradigms (NEWDIGS) research program in cooperation with EMA and CIS. The project will address the following specific questions:
• How to adapt current regulatory requirements to support the efficient development of safe and effective drugs
• How to incorporate patient valuation of health outcomes and benefit–risk preferences into regulatory decision-making
• How to implement “staggered and progressive” approaches to drug approval
• How to improve the fulfillment of postmarketing regulatory requirements.
The data and recommendations from this project are expected to link to the implementation of EMA’s Roadmap to 2015, a plan for the agency's strategic development for the next five years, and to the NEWDIGS research program. The project will explore the feasibility of, priorities for, and practical considerations of implementing demonstration projects on some of the issues addressed during the course of the research.