China Enlightens Opportunities for Pharmaceutical Giants


Notwithstanding the intensifying global trade tensions, China has finally taken a step for bracing it’s one of the areas – pharmaceuticals. China’s Center for Drug Evaluation, this week, has been approved by regulators in the U.S., Japan, and Europe for making 48 drugs. The move is in correspondence with Beijing’s policy which was announced last October for cutting red tape around its drug-approval process.

China, world’s second-largest drug market, has taken one step forward by launching a program for speeding up the review and approval of dozens of drugs, which are sold abroad but not yet in China. Many foreign companies who have been complaining about the difficult path of launching products in China, can now see the change.

Roche, a multinational healthcare company, acknowledged China’s approval of a certain cancer-treating drug, Alecensa. Roche’s Chief Medical Officer, Sandra Horning, expressed her views on the same, she said: “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.”

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Alecensa, one of the drugs amongst the 48, is marked for advanced review by the China Center for Drug Evaluation (CDE) and China Food & Drug Administration (CFDA). CFDA has recently benefited from the injection of resources that has enabled it to reform the drug approval procedures. By these changes, CFDA has decided to assign new and innovative drugs for establishing the new review process from that of the previous review of generic drugs.