China's State Food and Drug Administration (SFDA) has announced proposals to fast-track the review of generic drugs for which there is high unmet clinical need, of innovative new products which involve Chinese intellectual property (IP) and of paediatric drug treatments.
The SFDA has now closed a public consultation on these proposals to reform the country's drug registration process. Its plans for reviewing generics include a fast-track process for high-priority drugs, measures to discourage applications for products which are of low clinical value and an emphasis on bioequivalence testing.
These developments follow a report by the SFDA's Center for Drug Evaluation (CDE) at the end of last year which showed that nearly 60% of the 3,950 abbreviated new drug applications received by the Center during 2012 had involved products for which more than 20 generic versions had already been approved.
A fast-track approval process would also be used for new drug products which involve or would lead to the creation of China-based IP and Chinese government-sponsored research, and for paediatric-use generics, it is proposed. The development of drugs for use in children would also be encouraged through new pricing and reimbursement incentives.
The SFDA is also considering whether to allow data from clinical trials conducted overseas to be included in approval applications and to involve China's provincial authorities in the drug approval process to a far greater degree.
Commenting on the proposals, analysts at IHS Global Insight suggest that the emphasis on encouraging domestic innovation and IP would not necessarily exclude overseas-based firms; the importance of those with strong local connections and joint-venture relationships in the country is likely to be reinforced.
"Foreign firms would also stand to benefit directly if the SFDA eventually accepts overseas clinical trial data, with streamlined, more transparent review processes theoretically leading to faster drug development and approvals," adds IHS Global Insight.
The SFDA has also announced a survey of exports of active pharmaceutical ingredients (APIs) by pharmaceutical companies in the country, which will be required to provide details of their APIs' names, license numbers and major export destinations. The firms will also have to tell the authorities whether they hold a European Union (EU) Good Manufacturing Practices (GMP) certificate.
China is the world's biggest exporter of APIs, but such products can currently be sold without official approval, which can create potential safety risks, reports the Xinhua news agency.
• Starting February 1, the prices in China of 400 medicines in 20 therapeutic classes will be cut by an average of 15%, while for some more expensive treatments the reduction will be as much as 20%, the National Development and Reform Commission has announced.
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