China’s Center for Drug Evaluation (CDE) recently revealed a change in its leadership—Zhou Siyuan replaces Kong Fanpu as the new director.
Mr. Zhou is reportedly to have been working at CDE since 1990, after he graduated with a master’s degree from the School of Public Health, Tongji Medical University (now Tongji Medical College, part of Huazhong University of Science and Technology). Before promoted to CDE’s top leader, Mr. Zhou was the deputy director since 2015.
As an office under the National Medical Products Administration (NMPA), CDE is mostly known for its function of conducting technical review/evaluation of drug registration applications. It is also the regulator that companies need to timely communicate with before and during the process of applying for marketing authorization.
CDE’s functions include:
Accepting and conducting technical review of clinical trial application (CTA) / investigational new drug (IND) applications and marketing authorization applications.
Conducting technical review of generic drugs’ quality and therapeutic equivalence.
Undertaking technical review of medicines in emerging medical products, such as regenerative medicines and tissue engineering.
Participating in the formulation of laws, regulations, and normative documents related to drug registration management; organizing the formulation of drug review standards and technical guidelines, as well as coordinate their implementation.
Coordinating drug review related inspections, testing, and other works.
Conducting researches on theories, technologies, development trends, and legal issues related to drug review.
Organizing drug review related consulting services and academic communication; carrying out relevant international and regional exchanges and cooperation.
Undertaking technical work that is coordinated by NMPA and related to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Undertaking other matters assigned by NMPA.
CDE’s Brief History
The development of China’s pharmaceutical industry cannot be separated from the progress made by China’s drug regulators. To improve drug review efficiency, CDE has experienced a series of reforms.
Table 1: A Brief History of China CDE
Contact BaiPharm if you’d like to know more about drug regulatory compliance in China.