Zhou Siyuan Nominated as China Center for Drug Evaluation's New Director

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.

CDE’s Functions

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

Year	Event
1985	The Drug Administration Law was implemented. The Drug Evaluation Committee of the Ministry of Health was established, with the Drug Evaluation Office under its administration. Drug review still relied on external experts.
1993	The Drug Evaluation Office was renamed the Drug Evaluation Center of the Ministry of Health, with the authorized strength of 50-member staff.
1998	The Drug Evaluation Center was transferred to the newly established National Medical Products Administration (NMPA) and renamed the Center for Drug Evaluation (CDE), NMPA. CDE’s functions were expanded to include technical review of generic drugs and imported drugs.
2002	CDE’s staff size increased to 120 people. The evaluation gradually shifted from external experts to internal staff.
2005	CDE was restructured, with the implementation of a review mechanism centered around the project leader system.
2011	CDE’s organization was reformed, with the following mechanisms and systems established: Mechanisms for correcting mistakes in review, academic supervision, and quality evaluation; A more professionalized and specialized position system of staffs involved in drug review.
2015	Bi Jingquan became the director of the former National Food and Drug Administration (now the State Administration for Market Regulation (SAMR), to which NMPA is affiliated). CDE’s personnel increased to 190 people, with the establishment of a new position of Chief Scientist.
2016	CDE launched a large-scale recruitment of talents and reduced the backlog of unreviewed drug applications.
2017	CDE’s internal departments and their responsibilities were adjusted. Inside CDE, new departments were established, including the Compliance Department, Clinical Trial Management Department, Data Management Department, and the Office of the Party Committee (Discipline Inspection and Supervision Office).
2018	CDE was relocated from No. 1 Fuxing Road Jia, Haidian District, Beijing, to No. 128 Jianguo Road, Chaoyang District, Beijing.
2023	CDE was relocated to Buildings 1-5, Zone 2, No. 22 Guangde Street, Economic and Technological Development Zone, Beijing.

Contact BaiPharm if you’d like to know more about drug regulatory compliance in China.