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The special report written by Medicilon CEO, Dr. Chunlin Chen, was posted on Pharmaceutical Forum

2016-02-03
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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.

chunchunlin

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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