CAMBRIDGE, MA—The European Medicines Agency (EMA) and the Massachusetts Institute of Technology’s (MIT) 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.
Specific questions addressed by this project include how to adapt current regulatory requirements to best 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 what have been termed staggered and progressive approaches to drug approval; and how to improve fulfillment of post-marketing regulatory requirements.
The data and recommendations from this project are expected to link to implementation of the “EMA roadmap to 2015” and the overall CBI’s New Drug Development Paradigms (NEWDIGS) Research Program. It will explore the feasibility, priorities, and practical considerations of implementing demonstration project(s) on some of the issues addressed during the course of the research.
The project, scheduled to be completed by December 2011, will be conducted within the framework of CBI’s NEWDIGS research program in cooperation with EMA and MIT CIS.
EMA is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products. One of the EMA’s roles is to provide EU member states and institutions of the European community with advice on questions related to the assessment of medicinal products.
CBI is a cross-disciplinary research center, formed as a collaboration among the MIT Schools of Engineering, Management, Science and Humanities Arts and Social Sciences, and the Harvard-MIT Division of Health Sciences & Technology (HST). Its mission is to improve global health by overcoming obstacles to the development and/or implementation of biomedical innovations.