Measures for post marketing changes of drugs-Trial

On January 13, the National medical product Administration issued the measures for the administration of post marketing changes of drugs (for Trial Implementation), which is the first normative document specifically for the post marketing changes of drugs in China. The holder is the main body responsible for the post marketing change management of drugs. The post marketing change control system should be established. The post marketing change of drugs should not have adverse effects on the safety, effectiveness and quality control of drugs. The post marketing changes of drugs include the change of the holder, the change of the productionRead More →

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