China to Accelerate Review of 48 Foreign Drugs

China’s FDA publishes a list of drugs approved in the US, EU and Japan needed in the country.

China has been taking significant steps to accelerate drug approvals to meet the growing demand for safe and effective modern medicines in the country. Just eight months ago China’s Food and Drug Administration (China FDA) introduced a new priority review pathway. Now, the Chinese Center for Drug Evaluation (CDE) has issued a list of 48 drugs approved in either the US, EU or Japan that are needed in the clinical setting.

When preparing the list, according to the CDE, special consideration was given to new drugs that treat rare diseases and medicines that treat life-threatening diseases for which no effective therapies are available in China. Approximately one-fourth of the drugs treat one form of cancer or another. The top two products are Roche/Chugai’s ALK inhibitor alectinib hydrochloride (Alecensa) and Merck’s PD-1 star pembrolizumab (Keytruda). Other examples include Luxturna, a gene therapy from Spark; Spinraza, a spinal muscular atrophy drug from Biogen; and Soliris, a treatment for the rare disorder paroxysmal nocturnal hemoglobinuria from Alexion.

The makers of drugs on the list can immediately apply for marketing approval and be eligible for priority review with existing data if they can provide evidence that the drugs work equally well across different races. Recently the CDE reported that on average new drug applications accepted for priority review are processed within 59 working days, which is more abbreviated than regulatory agencies in the US and Europe.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.