China's medicines regulatory body announced proposals to speed up the market review of generic medicines for which there is a high unmet clinical need, as well as innovative products and pediatric drug treatments.
China's State Food and Drug Administration has in fact closed a public consultation on some proposals to reform the drug registration process in the country. Its plans for generics reviews include a fast-track procedure for high-priority products, measures to discourage green light applications for medicines with little clinical value, and a boost to bioequivalence studies.
These moves follow a report from the Chinese body's Medicines Evaluation Center, which found that nearly 60% of the 3,950 quick go-ahead applications for new products it received in 2012 were for drugs for which more than 20 generic versions were already available.
An expedited approval process will also be available for new drugs with Chinese intellectual property and sponsored by the national government.
The Agency is also considering whether to allow data from clinical trials carried out abroad to be included in applications for authorisation.
BDC – January 24, 2013 – PharmaKronos
