Michelle Nhuch


CIS announces joint EMA-NEWDIGS research project

November 8, 2010

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.

MIT's Center for International Studies, a dynamic international affairs research center, is home to a variety of research, education, and outreach programs. It seeks to bridge the worlds of the scholar and the policymaker by offering each a place to exchange perspectives, and by encouraging academics to work on policy-relevant problems. Center scholars, and the students they helped educate, have served at senior levels in every administration since the Kennedy years. They are today among the nation's most distinguished analysts and executives in government and the private sector.