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China finalises drug reform targets

The Chinese State Food and Drug Administration finalises the targets of its national reform campaign for the domestic pharmaceutical industry

The Chinese State Food and Drug Administration (SFDA) has finalised the targets of its national reform campaign for the domestic pharmaceutical industry, according to Interfax China reports.

The reforms include pharmaceutical registration, production, distribution, consumption, as well as the medical device industry.

Drugs under review by the SFDA from the beginning of 2005 to 31 August 2006 and those allowed to begin production between the start of 2006 until 31 August 2006 will be subject to manufacturing inspections.

Also, medicines which were first licensed at the provincial level and then upgraded to the state level will be the focus of the on-site checks. Many were approved during the tenure of the SFDA's former leader, Zheng Xiaoyu, who was executed in July 2007 for accepting bribes in exchange for approving dangerous, untested medicines.

The SFDA says it will investigate any drugs which should not have been licensed and will also establish a complete and accurate database of licensed medicines. It will also ensure that manufacturers comply with good manufacturing practices and check the production, distribution and storage of restricted narcotics and class-one psychotropic drugs.

The agency added that it will overhaul the distribution market by the end of 2007, while wholesalers who began operations in 2006 will have their licenses re-examined. Pharmaceutical advertising featuring endorsements by celebrities, experts or patients will now be banned.

The Ministry of Health said it will collaborate with the SFDA to offer guidance to doctors to reduce "unnecessary, expensive and dangerous prescriptions." The government will also augment its ADR (adverse drug reaction) monitoring.

3rd September 2007

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