China mulling ways to speed up drug approvals

|By:, SA News Editor

Heeding public demand for new medicines, the China Food and Drug Administration (CFDA) is considering ways to quicken the time to market for approved imported drugs.

Among the changes under review are the elimination of the requirement that sponsors of international multicenter studies in China (except vaccines) secure prior foreign approval or currently be in Phase 2 or 3 studies ex-China. Also, makers of imported drugs will be allowed to directly apply for marketing authorization after completing international multicenter trials.

According to a Chinese newspaper, the average review clock is three-to-four years compared to 10 months in the U.S.

Another positive development was the recent updating of the list of medicines covered by basic insurance plans, a boost to drug makers in the world's second largest drug market. Many meds have been excluded from coverage due to the high cost.

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