The special report written by Medicilon CEO, Dr. Chunlin Chen, was posted on Pharmaceutical Forum
著者: アップロード:2016-02-03 閲読回数:
The special report written by
Medicilon CEO, Dr. Chunlin Chen, was posted on Pharmaceutical Forum of
Zhejiang Pharmaceutical Association
Dr. Chunlin Chen, CEO of Medicilon, wrote a report with the topic of “How to comply both US FDA and CFDA standard of preclinical studies?” and was posted on the first issue of Pharmaceutical Forum of Zhejiang Pharmaceutical Association.
Medicilon CEO, Dr. Chunlin Chen
Dr.
Chen summarized the reasons of failure of innovative drug research and
pointed out that IND is an important stage for drug research. Whether
in China or US, there are 2 steps needed to be done for the application
of innovative drugs. In US FDA, those 2 steps are Investigational New
Drug, IND and New Drug Application, NDA. Both IND and NDA correspond to
“Clinical Trial Application” and “Declare and Approve of New Drug
Application” of CFDA respectively. The goals of IND are to benefit the
patients, encourage the research of innovative drugs, develop the
effective drugs for human diseases and ensure the safety of the drugs.
Recently, Medicilon helps a lot of foreign pharmaceutical companies on
the new drugs projects to file the both US FDA and CFDA IND. Dr. Chen
shared the case study of “Three Way Collaboration” in the special
report. Dr. Chen would like to take this opportunity to give some
references to other pharmaceutical companies by sharing the experiences, providing strategy
of new drug development and application and comparing the difference of
IND application between US FDA and CFDA.
“Pharmaceutical Forum”
is supported by Zhejiang Food and Drug Administration and established
by Zhejiang Pharmaceutical Association. “Pharmaceutical Forum” is
published by Chinese Journal of Modern Applied Pharmacy. The “Chinese
Journal of Modern Applied Pharmacy” has founded for 32 years. It is one
of the core journals in China pharmaceutical industry.
To read the full report, please send the email to
marketing@medicilon.com.cn
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