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Drug Safety

China speeds up drug approvals

China Food & Drug Administration targets medicines that have been available for years in other countries

by Jean-François Tremblay
August 22, 2018 | A version of this story appeared in Volume 96, Issue 34


A table of drugs marked for expedited approval in China.
Critically needed
Some of the 48 drugs China has designated for expedited approval.
Source: China Center for Drug Evaluation

“Dying to Survive,” a low-budget movie popular in China this summer, depicts the efforts of an aphrodisiac peddler to smuggle cancer drugs from India that were too expensive at home. The film’s success highlighted public discontent with drug access in China.

Now, the Chinese government is taking one step to address the discontent: It has launched a program to speed the review and approval of dozens of drugs sold abroad but not yet approved in China.

Foreign companies that had long complained about the arduous path to product launch in China, the world’s second-largest drug market, are seeing the results. On Aug. 20, Roche saluted China’s expedited approval of Alecensa (alectinib), a treatment for certain types of lung cancer.

Sandra Horning, Roche’s chief medical officer, commented that the approval “represents a significant regulatory shift, with the approval received under unprecedented timelines.” The drug was first approved in Europe just eight months ago, Roche notes.

Alecensa is one of 48 drugs marked for expedited review by the China Center for Drug Evaluation (CDE), the part of the China Food & Drug Administration (CFDA) that reviews new drug applications. Another cancer treatment on the list to recently win Chinese approval is Merck & Co.’s Keytruda (pembrolizumab). All of the drugs are already available in Western countries or Japan.

The agency noted that the drugs chosen are the only possible lines of treatment for certain rare diseases, cancers, and other ailments. CDE said it will consider approving drugs that have not been tested on Chinese patients when racial differences aren’t a major concern.

Chronically understaffed and plagued by high-level corruption only a few years ago, CFDA has recently benefited from the injection of resources enabling it to reform its drug approval procedures. Among the changes, CFDA is assigning innovative new drugs to a different review process from the one it uses to review generic drugs. In the past, lumping the reviews together contributed to approval backlogs.


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