China's pharmaceutical watchdog will tighten the approval
procedures for new medicines with the revised regulation on
medicine registration taking effect on Oct. 1.
Wu Zhen, deputy-director of the State Food and Drug
Administration (SFDA), made the remarks on Wednesday at the SFDA's
first regular press conference.
Wu said the SFDA would take stricter measures to check drugs
under approval, including intensifying examinations of production,
spot testing samples, and re-examining drugs already on market.
The current regulation on medicine registration came into effect
on May 1, 2005.
"Before its revision, the regulation allowed for lax monitoring
and examination of production," Wu said.
"Application documents have been inadequate and there have even
been serious forgery problems, so it's pretty hard to ensure the
safety of drugs," Wu said.
"In the past, the functions of some approved drugs were found to
vary from the original applications, which endangered public
health," Wu said.
Research institutes, manufacturers and individuals who apply for
registration of new drugs should provide comprehensive, reliable
research documents to prove the safety, effectiveness and quality
of the drug, and pledge the truth and accuracy of all information
in the application materials.
Under the revised regulation, those who use false application
documents will be fined or deprived of the right to file
applications, and the government will blacklist those who break the
rules.
"Once a medicine manufacturer enters the blacklist, its products
will also be listed," he added.
"This way, medicine approval will be placed under public
supervision and avoid misuse of power," Wu said
(Xinhua News Agency July 12, 2007)