China Proposes Fast-Tracking Registration for “High-priority” Generics

China’s State Food and Drug Administration has announced proposals to reform the country’s drug registration process, including a special “fast-track” for generics which answer an unmet clinical need.



Drugs involving Chinese intellectual property (IP) and paediatric treatments will also be eligible for fast-tracking under the new system. Drugs in these categories will be rewarded with accelerated technical reviews and regulatory approvals and incentives within the tendering and reimbursement processes will be used to foster the development of new paediatric medicines. Measures have also been proposed to discourage applications for drugs of low clinical value or lacking in innovation.

The proposals are in part a response to the difficulty the SFDA faces coping with a rising tide of new applications; a report by the SFDA’s Centre for Drug Evaluation (CDE) revealed that nearly 60% of the 3,950 new drug applications received by the Centre during 2012 involved products for which at least 20 generic alternatives were already available. In an extreme case, 20 different companies last year sought approvals for generic versions of Merck & Co.’s patented medication Zocor (simvastatin), 116 generic versions of which had previously been approved in China. Plans for compulsory bioequivalence testing to be done on all new generics have been issued in an attempt to deter purely imitative drug applications. The potential lessening of the CDE’s workload should come as good news for companies looking to expand into the Chinese market – at the moment, according to IHS Global Insights, the average time spent registering a drug in China is a lengthy 4 years (compared to 2.5 years in America).

Other changes to the drug registration process were proposed which could ease foreign firms’ entrance into China, including a commitment by the SFDA to match international Drug Regulation Rules, with the possibility it might begin allowing data from overseas clinical trials to be submitted during applications. Also on the cards is more devolution of responsibilities to provincial regulatory bodies like that seen in Guangdong province last year,  another measure intended to take the stress off the CDE.

IHS Global Insights suggested that while the proposals favour local innovation and Chinese IP, this doesn’t need to be at the expense of foreign firms. Indeed, for companies with strong local connections who are willing to work in joint-ventures with Chinese firms, the planned reforms will facilitate access to the Chinese market.