China Considers New Drug Recall Measures
Pharmaceutical International has today learnt of a radical new reform to China’s pharmaceutical sector – the implementation of which is currently being contemplated by the Chinese government. The essence of it is that Chinese drug manufacturers would be made to instigate and finance their own product recalls, should said products be determined to be dangerous.
If taken up, the new regulation would be the initial one of its kind to apply to drug recalls, and would strengthen the regulatory control of the State Food and Drug Administration. The regulatory body has been oft-criticised in recent times, in the wake of a string of drug scandals and underperformance.
In the most recent incident, reported in the Chinese media and which occurred on the 16th September, a leukaemia drug was ordered to be recalled after being linked to pains in patients’ legs.
A draft version of the regulation was posted on the SFDA’s website yesterday, which highlights how “Producers must take major responsibilities for drug safety”.
The projected new rules are designed to make voluntary recalls compulsory for pharmaceutical firms in China. If, however, these did not take place, the recalls would instead be ordered by the SFDA. As detailed in the online draft, when issued with a government notice linking a product to “serious health injuries or death”, drug manufacturers would have 24 hours to send out the recall. This time limit would be extended to 3 days, if the product in question is associable with less serious side effects.
If a recall was not issued, the company in question would be fined as much as three times the product’s value. Ultimately, its licence could be revoked.
The proposed regulation follows last month’s measures implemented in respect of China’s food and toy manufacturers, in which industries, similar quality issues have been experienced.
Source – Pharmaceutical International’s Far East Correspondent
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