China details clinical studies for imported drugs

By Wang Fangqing

Pharma companies wishing bring their commercialized drugs to the Chinese market will now have to comply with new requirements by Chinese National Medical Products Administration (NMPA) when applying for a New Drug Application (NDA)/Abbreviated NDA approval in the country, reports The Pharma Letters local correspondent.

Named “requirements on China clinical studies for drugs sold outside China,” the file applies to foreign novel drugs and generic copies of the drugs that are not available in China. While the novel drugs are usually supplied by foreign pharmas, generics are often made by Chinese manufacturers.