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.

The file is part of China’s efforts to speed up the approval of novel drugs that are in urgent demand in China, according to the NMPA.

 Differing scenarios

There are several scenarios for a foreign novel drug. For example, if its global studies include Chinese ethnic data to prove efficacy and safety in this population, these data can be used to apply for the NDA approval, and the NMPA authorities will decide if Chinese clinical studies are necessary.

If the global study does not have Chinese data but has evidence to show the drug is not sensitive to ethnic groups, it might get a conditioned NDA approval depending on factors such as how urgent the clinical need is and if it presents much greater advantages than available treatments.

If a company has a drug that is already available in China but intends to get approval for a new indication that is cleared outside of China, it will have to communicate with the authorities to see if Chinese studies are required to gain Chinese clearance for the indication.

The file also reiterates that the Chinese government encourages foreign companies to include China sites in a novel asset’s every stage of global studies. Doing so might accelerate the NDA approval in China as the complete China data will help “Chinese authorities analyse differences in safety and efficacy between ethnic Chinese and other ethnic groups, and weigh between risks and benefits for Chinese patients.”

Unlike novel drugs, a generic version of a drug that is not available in China usually will have to go through clinical studies in China to prove its efficacy and safety to get an ANDA approved.

Reference:

https://www.thepharmaletter.com/article/china-details-clinical-studies-for-imported-drugs?__cf_chl_jschl_tk__=pmd_uZikMSPiTVJ2B1ESlcIGMQ3VuZNe2ZqkiNHaqLwPBaI-1629873766-0-gqNtZGzNAlCjcnBszQil