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2005 FDA cGMP Chinese Training
Program (Background Information)
PKU NEWS 2005--12-5
http://ennews.pku.edu.cn/news.php?s=133854365
Peking University, Beijing, Dec 5th 2005: The ―2005 FDA cGMP Chinese Training
Program‖ was launched on Dec. 5th in Yingjie Communication Center of PKU. The
program is jointly sponsored by American Food and Drug Administration (FDA),
Peking University and The International Society for Pharmaceutical Engineering
(ISPE).
It is the first time for FDA to organize an official training program in China. The
purpose of the program is to provide opportunities for the export enterprises working
on active pharmaceutical intermediate (API) and oral solid drug (OSD), the quality
managers of other Chinese pharmaceutical enterprises, as well as the government‘s
officials in charge of the cGMP (Good Manufacturing Practices for Drugs) law
enacting and supervision to learn modern international quality system of
pharmaceutical manufacture and to communicate with FDA officials and ISPE
experts face to face.
With the hot wave of the globalization of economics, more and more Chinese
pharmaceutical enterprisers expect to enter international market. The certificate of
FDA has become the most important qualification for their entry, thereby Chinese
pharmaceutical industry has spent great efforts for this goal, but so far none of the
manufacturers has got the FDA‘s approval to enter American market.
Chinese State Food and Drug Administration (SFDA) has attached much importance
to this program. The director of the Department of Drug Safety & Inspection Bian
Zhenjia emphasized that all the Chinese pharmaceutical administrative departments
and pharmaceutical manufacturers were taking much count of the training program
and China hoped to learn the actual GMP criterion of other countries in order to
improve Chinese GMP level.
PKU bears in mind the faith of servicing the nation with science and technology and
is now making contributions to the research, manufacturing and modernization of our
pharmaceutical industry by hosting such a training program.
Edited By : Wang Yi
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