Global Regulatory Engagement

Regulatory issues in different countries and in different regions of the world impact the conduct, efficiency, and oversight of clinical trials. Our approach has been to work with representatives of the global clinical trial ecosystem to identify major issues in international clinical trial practice. We strive to promote a country-specific and culturally-relevant approach. There is a need for targeted engagement with regulators and influential thought leaders to develop trusted partnerships with a shared mission of improving the ethics, design, conduct, and oversight of multi-regional clinical trials.

From 2013 to 2019, the MRCT Center worked closely with leaders in India to determine tractable solutions to regulatory reform issues, many of which deterred both for-profit and not-for-profit sponsors from conducting trials in the country. The MRCT Center worked with government officials, industry stakeholders, investigators, and others to develop alternative reforms that would not only reinvigorate the industry but also ensure the welfare of trial participants. The MRCT Center visited India repeatedly to work with regulators and others to promote and sustain impactful change, and has submitted public comments on proposed updated draft rules in India. In March 2019, the MRCT Center co-hosted a special presentation and discussion with the Drugs Controller General of India to discuss the final New Drugs and Clinical Trials Rules, 2019, that were released by India’s Ministry of Health and Family Welfare.

From 2015 to 2017, in response to the China Food and Drug Administration (CFDA) issuing a Draft Guidance on Multi-Regional Clinical Trials that set forth requirements for clinical trials in China, the MRCT Center, in collaboration with Peking University, developed scientific principles upon which to ground decision-making for MRCTs. A focused effort on training has continued.

Currently, the MRCT Center has been working with government officials and regulators around the world to build capacity in drug and product development, ethics review and regulatory. As a component of the MRCT Center’s Promoting Global Clinical Research in Children project, we have been working on models of international regulatory communication, collaboration, and reliance. We have also been exploring health technology assessments (HTAs), the interactions of HTAs with regulators and industry, and access to medicines. Continued areas of programmatic efforts are international privacy laws, protections of private interests (both individual and corporate), transnational data and biospecimen transfer, and data sharing.

OBJECTIVES

Work closely with in-country leaders to determine tractable solutions to regulatory reform issues
Provide scientific approach for the utilization of results from an MRCT to demonstrate safety and efficacy in a particular study
Build capacity for regulatory and ethics review, cooperation, and reliance
Address international and national privacy laws and data/biospecimen sharing

Key Milestones

India

July 2019: Published article with update about the evolving regulatory landscape for clinical trials in India
May 2019: The MRCT Center, in collaboration with Ropes & Gray LLP, hosted a special presentation and discussion with the Drugs Controller General of India to discuss the final New Drugs and Clinical Trials Rules, 2019, that were released in March, 2019 by India’s Ministry of Health and Family Welfare
March 2019: New rules released in India
December 2018: Published article about the evolving regulatory landscape in India
June 2018: Meetings with regulators, investigators, and industry in Delhi and Mumbai, India
March 2018: Submitted comments on updated draft rules in India
May 2017: Submitted comments on draft rules in India
March 2017: Additional meetings with representatives in India
March 2016: Meetings with regulators, investigators, representatives of industry, academia, non-profit organizations and patient advocacy groups in Delhi and Mumbai, India
October 2015: Meetings with regulators and thought leaders in Delhi, India
November 2014- January 2015: Publications in Financial Express, Business Line, and Bloomberg BNA related to clinical trial regulations in India and proposed amendments to Drugs and Cosmetics Act.
January 2014: Output of January 20 and 21, 2014, Roundtable included a draft of detailed recommendations embodying the consensus of different stakeholders, including leading academicians, investigators, industry representatives, and government officials. This document also suggested additional issues that the Ministry of Health and Family Welfare, Government of India, may wish to reconsider when implementing clinical research regulatory reform in India.

China

March 2017: Patient-Centric Clinical Trials Conference in Shanghai
September 2016: China FDA Training at Yale University
May 2016: Global Simultaneous Drug Development Workshop in Beijing
October 2015: Workshop in Beijing
June 2015:
◦ Roundtable in Shanghai
◦ Launched Consistency and Region Working Group
April 2015: First roundtable teleconference
March 2015: Launched project with Peking University

Program Leadership & STAFF

Mark Barnes, JD, LLM. Faculty Co-Director, MRCT Center
Barbara E. Bierer, MD. Faculty Director, MRCT Center

CAPACITY BUILDING

Global Regulatory Engagement