China drugs agency must play by new rules

Drugs in a Chinese pharmacy Copyright: Flickr/ThisParticularGreg

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[BEIJING] China has created new regulations for the registration and management of drugs in a bid to reform its ailing drug regulatory system and boost innovation.

The regulations were announced yesterday (11 July) by the State Food and Drug Administration (SFDA), just one day after its former head Zheng Xiaoyu was executed for taking bribes and approving unsafe products.

His actions have caused dozens of deaths over the past two years (see China’s former drug boss faces death sentence).

The new drug registration rules — replacing those issued in 2005 — are designed to increase drug safety by enhancing the requirements on drug quality and supervision, said Wu Zhen, deputy head of SFDA, at a news conference yesterday.

Compared with the old regulations, which require applicants to ensure the safety of their candidate drug, the new rules stipulate that drug evaluators will make surprise spot inspections, and take samples to check for safety and consistency of drugs.

Evaluators will also ensure that samples provided in the application are consistent with the final product.

To reduce possible corruption, the new regulations stipulate that drug evaluators names will be made public and evaluators with potential interest in the product or links with the applicant will not be involved.

Wu said that new regulations also aim to encourage innovation in China’s pharmaceutical sector — currently dominated by generics — by prioritising new drug applications.

The rules have also been tightened on previously loosely-defined ‘new drugs’. Before, generics with in a new dosage or even new packaging could be classed as a new drug, and sold at higher prices.

As a result, 11,086 drug applications, including 1,113 applications for new drugs, were approved in 2005, while in the same period, the United States Federal Drug Administration approved only 81 new drugs.

"This will push China’s pharmaceutical companies to do more research," Dai Shengming, secretary-general of the Beijing Pharmaceutical Profession Association, told SciDev.Net.

But consistent with the previous regulations, the new rules still define ‘new drugs’ as drugs that have not been sold in the Chinese market, rather than novel chemicals or biological-based medicines.

Dai cautioned that the new regulations cannot force Chinese pharmaceutical firms to develop original drugs, as many cannot afford to.

In related news, Cao Wenzhuang, Zheng Xiaoyu’s former secretary and former head of SFDA’s drug registration department, was sentenced to death with two years stay on 6 July, also for drug approval-related corruptions.