Transcript Regulatory Issues in China

Regulatory Issues in China
Li Yajie
SFDA·CDE
7/17/2015
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
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This presentation will be purely
based on my personal understanding
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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
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Current Status
For applications to register drugs used
for treatment, prevention and diagnosis
of AIDS, it is the SFDA practice to fasttrack these applications provided that the
registration requirements are not
compromised, the drug safety and
efficacy are assured, and the drug
qualities are controlled.
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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
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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
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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
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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
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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.
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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.
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