The risk management of drug is a big challenge for the drug regulatory authorities all over the world.

药品上市后风险管理是全世界各国药品管理部门面临的严峻挑战。

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Article 46: drug labels and insert sheets (direction for use) shall be consistent with those approved by drug regulatory authorities in content, style and written language.

第四十六条药品的标签、使用说明书必须与药品监督管理部门批准的内容、式样、文字相一致。

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The company also said it had shared this data with European regulatory authorities and the U.S. Food and Drug Administration, and that the information had been included in its regulatory analysis.

FORBES: What Did Glaxo Know?