Potentially hazardous drugs will be withdrawn from the market at
the first sign of a problem, according to a draft action plan.
The system would require drug makers to pull problematic
products off the shelves even before results of lab examinations
are out, said Yan Jiangying, spokeswoman for the State Food and
Drug Administration (SFDA).
Under the current practice, only when laboratory examination
results come out and major problems identified, can authorities
seal, seize, or destroy hazardous products.
The draft plan will be posted on the administration's website to
solicit public feedback.
The recall system will shorten the period in which potentially
dangerous drugs are withdrawn, and lower the risks patients are
exposed to, Yan told China Daily.
"It takes time to figure out the problem when adverse effects of
drugs are detected among users. The new recall system can prevent
damage from spreading."
At yesterday's press briefing, Yan also said the country is
facing a shortage of human albumin, or plasma protein, but said
blood products were safe.
"We found no serious violation of laws or regulations (during
recent inspections) and most manufacturers have strictly abided by
the good manufacturing practice," she said.
She said the government will not ease a ban on imported blood
products out of safety concerns and called for more blood
donations.
"I hope more of our people give blood, as this is the only way
to solve the problem at its root," Yan said.
China imposed the ban in the mid-1980s after HIV infection was
detected in imported blood products.
To safeguard product safety, all plasma-based products and
vaccines will undergo mandatory tests starting from next January
before they hit the market, Yan said.
Besides, a 90-day quarantine period will be applied to raw
plasma used in blood products to ensure there are no virus
infections such as HIV.
(China Daily September 12, 2007)