Regulatory Manager: Comparing GCP Requirements for Medical Device Clinical Trials in the US and Japan

The convergence of US and Japanese medical device regulations and practices provides an opportunity to accelerate delivery of innovative medical devices to patients in need of medical treatment. Reciprocal acceptance of Good Clinical Practices (GCPs) would facilitate multinational studies and promote the use of clinical data to support regulatory submissions in multiple countries. The process of regulatory convergence involves first recognizing differences between the regulations and practices of the governments or governing organizations involved.