Global Regulatory

Context

Regulatory issues in different countries or regions of the world affect the oversight and conduct of clinical trials. Oftentimes, regulatory changes in one country will influence other regulatory agencies to examine and change existing policies.

Challenge

There is a need for targeted engagement of regulators and influential thought leaders to develop authentic partnerships with those with a shared mission in improving the ethics and design of multi-regional clinical trials.

MRCT Center Projects

Our approach has been to work with our stakeholders and identify major issues in global clinical trial practice and, in our role as advisors, adopt a country-specific and culturally-relevant approach. By bringing a more global perspective to MRCT Center projects and assisting in training and implementation of trials in the developing world we expand our reach.

Current projects in this area include:

China Clinical Regulatory Program
In November 2014, the China Food and Drug Administration (CFDA) issued a Draft Guidance on Multi-Regional Clinical Trials (Provisional) to set forth requirements for clinical trials in China. The guidance outlined CFDA’s new, conservative interpretation of existing regulatory requirements.   Read more

India Regulatory
In 2013, Indian regulators moved towards implementing a series of clinical trial regulations that had far-reaching detrimental effects on the Indian clinical research industry.   Read more