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The Standing Committee of the National People’s Congress in China passed the revised Drug Administration Law (Revised Law) on 26-Aug-19. Effective 1-Dec-19, it is the first overhaul since 2001.The Revised Law addresses the major issues in the pharmaceutical industry, demonstrating the government’s efforts in strengthening supervision to ensure drug safety.

随着医药科技不断发展和进步，中国的药品审评标准在不断改变和提高，过去的药品审评标准没有强制要求仿制药与原研药质量和疗效一致，所以有些药品在质量、疗效上与原研药存在一定差距，需要改进提高。自2015年开始，国家药品监督管理局（原国家食品药品监督管理总局）推出仿制药质量和疗效一致性评价，借以提高我国仿制药的质量和疗效。质量和疗效视为等同于原研产品的仿制药将在公立医院的招标和处方中享受优先待遇。

It has been over a year since China Food and Drug Administration (CFDA) announced Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs (Document No.134 [2016]). As a result, the China pharmaceutical packaging industry is experiencing a revolution.

In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.

Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.