China speeds up drug approval process, favoring high-quality generics

China’s Food and Drug Administration (CFDA) recently issued a policy, aiming to shake off its long-term reputation for being extremely slow on new drug approvals, as well as largely improve the quality of Chinese made generics, reports The Pharma Letter’s local correspondent, Wang Fangqing.

Under the policy, which was out on November 11 and took effect immediately, Abbreviated New Drug Applications (ANDA) are in principle reviewed and approved only if they are therapeutically equivalent to their brand-name version. If a brand-name drug is not available in China, the generic version manufacturer has to import it into China to conduct bioequivalence (BE) comparison tests.

Previously, brand-name drugs were preferred, but not necessary as China allowed generic versions to be the reference. One serious result is the poor quality of Chinese-made generics, which “have great difference from the branded version,” according to a 2014 report by the RDPAC, the Beijing based lobbying organization for multinational pharmas in China. In 2009, the CFDA tested the high blood pressure treatment hydrochlorothiazide from five Chinese manufacturers, and had four very different dissolution profiles.