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China Ramps-up its Regulatory Capabilities for Evaluation of New Drugs

Apr. 30, 2011

In a recent policy release, "Notice on issuing principles and procedures for technical evaluation of drugs," the China SFDA Center for Drug Evaluation (CDE) highlighted major changes including a restructuring which creates a team of reviewers focused on innovative/ new-to-China drugs and which groups evaluators by technical expertise rather than therapeutic area. The policy also specifies that new drugs will receive simultaneous review by different departments while others will undergo a slower serial evaluation process. The changes clearly aim to markedly reduce approval times for new products while pushing generics to the sideline.