Regulatory Issues in China Li Yajie SFDA·CDE 9/21/2018

About CDE The CDE is the organization primarily responsible for technical evaluation of the drug market approval in compliance with the related regulations and guidelines governed by China SFDA. It is also the organization that provides technical support to scientific management and standardization of drug market approvals or investigational new drug applications 9/21/2018

This presentation will be purely based on my personal understanding 9/21/2018

About China Drug Registration Drug applications are classified into clinical study application and market approval application The clinical study for the drug registration (including global multi-center clinical study) is initiated only after the regulatory authority’s approval 9/21/2018

Current Status For applications to register drugs used for treatment, prevention and diagnosis of AIDS, it is the SFDA practice to fast-track these applications provided that the registration requirements are not compromised, the drug safety and efficacy are assured, and the drug qualities are controlled. 9/21/2018

Current Status (Cont.) No application has been made so far for drug registration of microbicides in China The regulatory issues on clinical studies of microbicides in China have yet to be developed 9/21/2018

Regulatory Issues China lacks the experiences in approval or conduct of microbicide clinical studies, which may result in more potential challenges in the regulatory management 9/21/2018

Regulatory Issues (Cont.) Great attention should be paid to protect subjects - When the study and what kind of study could be permitted - How to evaluate the microbicide clinical study processes - How to ensure the clinical subjects’ long-term treatment rights 9/21/2018

Regulatory Issues (Cont.) Different regulatory agencies may have different requirements for the safety and efficacy data packages for drug registration. There are no guidelines and consensus about microbicides registration requirements in China 9/21/2018

Regulatory Issues (Cont.) A number of other challenges of ethical, practical, managerial and supervising issues of clinical studies resulted from Chinese culture and legal background may not be rolled out. 9/21/2018

Conclusion With increased sexual transmitted AIDS in China, female’s self-protection from HIV transmitted through sex will be enforced. Therefore, microbicides have large potential of clinical demand. It is necessary to carefully consider how to manage the microbicide studies scientifically. 9/21/2018

THANK YOU 9/21/2018