Problem drugs to be recalled faster

By Shan Juan (China Daily)
Updated: 2007-09-12 07:12

Potentially hazardous drugs will be withdrawn from the market at the first sign of a problem, according to a draft action plan.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The recall system will shorten the period in which potentially dangerous drugs are withdrawn, and lower the risks patients are exposed to, Yan told China Daily.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.

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