Measures will speed up drug approvals and decentralise controls on generics

While the investigation into the corruption scandal engulfing GlaxoSmithKline indicates China is strengthening its drug regulation regime, the newly formed China Food and Drug Administration (CFDA) is also introducing radical measures to speed up the drug approval process and possibly loosen controls on generics.

China’s slow drug approval process has been a cause for complaint for both Chinese subsidiaries of multinational pharmaceuticals and domestic drug developers. Jin Tuo, a professor of pharmacology at Shanghai Jiaotong University, explains that the accusations that China’s drug watchdog is overcautious – the CFDA and its predecessor the State Food and Drug Administration (SFDA) – coupled with chronic understaffing at its Center for Drug Evaluation and Review, has led to this problem. The centre has fewer than 150 staff, while more than 3000 scientists work for the US Food and Drug Administration.

The problem is compounded by the fact that generics receive the same kind of scrutiny as novel drugs.  But the CFDA appears to be determined to change that.

In February, the SFDA outlined reforms for the drug review and approval process. These included a redefinition of innovative drugs that focused on clinical endpoints rather than scientific originality; flexible reviewing to allow new drug sponsors to amend applications and add new documents; and prioritising generics.

When the SFDA was restructured in March to create the CFDA, the agency’s powers were expanded. In June, CFDA officials announced that in order to support the proposed reforms, the agency wants to revise the country’s drug regulation law.

Wang Chenguang, a law professor at Tsinghua University, says that China’s legislature plans to revise its drug law. ‘We suggest that the law revision should dramatically change the principles and procedures of drug review, approval and regulation to facilitate new drug development,’ Wang tells Chemistry World. He suggests that branches of the CFDA and professional associations should be mobilised to address the CFDA’s understaffing problems.

The highly centralised drug regulation system created in the late 1990s is already being relaxed. In July, China’s State Council announced that control of drug re-registration and supplemental applications will be transferred from the CFDA to its provincial branches. Industry insiders say some branches of the CFDA in highly developed regions, such as Shanghai and Guangdong, may also be given the right to approve generics on a trial basis.

Despite the moves, industry remains cautious. ‘[Besides deregulation measures] the key is to assure a transparent, just and highly capable drug regulation system,’ says Hou Dakun, president of Beijing-based pharmaceutical consulting firm Kelvin King.