China's New ADR Reporting Regulations Still Leave Uncertainty For Clinical Requirements
This article was originally published in PharmAsia News
Executive Summary
SHANGHAI - China implemented revised guidelines for adverse drug reaction reporting July 1 to increase postmarket reporting responsibilities of manufacturers, distributors and hospitals. However, the regulations need to be improved to provide specific responsibilities and qualifications for company-appointed ADR monitors as well as how to deal with adverse drug reactions during clinical research, according to a clinical expert