China Medical News

China's top drug authority said it has been accelerating approval of new drugs researched and developed overseas, and a number of such new drugs will be available for patient use on the Chinese mainland this year.  The National Medical Products Administration released a list at the end of last year of 48 overseas new drugs, including 12 cancer drugs, for priority approval, and eight have been available in the domestic market, the administration said, China Central Television reported on Jan 14.  All these drugs are already available in overseas markets, and they are urgently needed by domestic patients, it said.

China has been simplifying inspection and approval procedures of overseas new drugs so they can be available in China more quickly. The administration would recognize data of clinical trials conducted outside China in the approval of new drugs, as long as their applicants believe the drugs will not cause different safety risks and effects to peoples of different races, according to a guideline released by the administration last year.

Previously, such data was not recognized by the administration, so lengthy clinical trials had to be conducted in China again before drugs could be approved, even though they had been available for use overseas for years. This was a cause for delay in the availability of many new drugs in the Chinese market. (Source: China Daily)