Dr. Ning Zhang started her career in drug regulation and administration in 2001 and had worked in CDE (Center for Drug Evaluation), NMPA for more than 22 years. She specializes in regulatory strategies, innovative drug development strategies, and CMC evaluation. Since 2011,  Dr. Zhang was appointed as the senior reviewer and later the chief examiner for CMC reviewing of innovative chemical drug applications including more than 3000 INDs and 130 NDAs. Dr. Zhang was also in charge of writing 5 official new drug CMC development guidelines, implementing specially regulatory requirements for innovative drugs (as opposed to generic drugs, innovative drug applications require risk evaluation and progressive development efforts at different clinical trial phase stage), and organized over 40 advisory committee meetings and 75 product discussion meetings.  Dr. Zhang initiated and led the efforts for building the CMC review team of innovative drugs in CDE, and took the responsibility of training and tutoring many of them. From 2020 to 2023, Dr. Zhang acted as the Executive Director of Office of Policy and Management( CDE, NMPA),built the project management team coordinating all CDE projects, implemented over 20 project management protocols to improve efficiency, transparency, and compliance.

regulatory sicence

chemistry,manufacture&control evaluation

pharmaceutics