By Nicole Golliher
First Secretary Weng Xinyu characterized China’s Food and Drug Administration’s (CFDA) reforms as a change in philosophy—a shift from perceiving the regulators’ roles as gatekeepers to facilitators, when he spoke to US-China Business Council members Wednesday.
He said the reforms are necessary to speed up the review process and address the large backlog of applications. For more on these reforms, see USCBC’s piece in China Market Intelligence.His presentation described the five areas the new reforms affect, including clinical trials, a Marketing Authorization Holder pilot program, stricter good clinical practice (GCP) inspections, user fees, and human resources.
Weng was joined by Pan Jianwei, first secretary in the Economic & Commercial Counsellor’s office, who discussed US medical device exports to China. Pan highlighted the necessity for these exports to meet China’s regulatory standards.