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Report: China mulls expedited approval for 48 therapies; to seek public comments

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Report: China mulls expedited approval for 48 therapies; to seek public comments

China is considering expedited approvals for 48 therapies as the country looks to speed up the introduction of needed drugs to its market, FiercePharma reported.

Most of the drugs on the country's list are already approved by regulators in the U.S., EU and Japan but are not yet sold in China — including Roche Holding AG's cancer therapy Alecensa, Novartis AG' psoriasis drug Cosentyx and GlaxoSmithKline PLC's shingles vaccine Shingrix, among others.

The list was formed by experts gathered by China's State Drug Administration.

The Chinese drug agency said drugmakers can apply for approval using overseas data. Once approved, the applications will be placed under priority review.

Some drugs on the list have already applied for Chinese approval, including Merck & Co. Inc.'s blockbuster cancer drug Keytruda and AstraZeneca PLC's breast cancer therapy Lynparza.

China's Center for Drug Evaluation plans to take public comments on the shortlist and to receive required documents for accelerated approval until Aug. 18.