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The main points of the development and reform process of my country's pharmaceutical packaging materials policies, regulations and management

 Last Update: 2022-08-30
 Source: Internet
 Author: User

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stage	Policies and regulations on pharmaceutical packaging materials	gist
Production license	Measures for the Administration of Pharmaceutical Packaging (Trial)	Implement production license management for pharmaceutical packaging material manufacturers .
Registration certificate	On October 1, 2000, the former State Food and Drug Administration promulgated the "Administrative Measures for Drug Packaging Materials and Containers" (provisional) (Order No. 21 of the Bureau) for implementation	It is stipulated that pharmaceutical packaging materials must be registered with the drug supervision and administration department and obtained the "Registration Certificate for Pharmaceutical Packaging Materials" or "Registration Certificate for Imported Pharmaceutical Packaging Materials" before they can be produced or used .
	On August 4, 2002, "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China"	It established a legal basis for the management system of the registration certificate of pharmaceutical packaging materials .
	On July 20, 2004, the former State Food and Drug Administration promulgated the "Administrative Measures for Packaging Materials and Containers in Direct Contact with Drugs" (Order No. 13 of the Bureau) for implementation	It is clarified that the State Food and Drug Administration implements a registration approval system for pharmaceutical packaging materials, requiring companies to provide "research materials for stability testing (drug compatibility testing) jointly conducted with drugs packaged in the declared product" when submitting application materials.
Related review and approval	On August 9, 2016, the former State Food and Drug Administration issued the "Announcement of the General Administration on the Related Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs" (2016 No. 134)	From the date of this announcement, pharmaceutical packaging materials and pharmaceutical excipients shall be reported, reviewed and approved in association with the drug registration application according to the procedures, and the "Requirements for Application Materials of Pharmaceutical Packaging Materials and Pharmaceutical Excipients" shall be announced separately . Food and drug administrations at all levels will no longer accept applications for registration of pharmaceutical packaging materials and pharmaceutical excipients, and will no longer issue relevant registration approval documents .
	On November 30, 2017, the former State Food and Drug Administration issued the "Announcement on Adjusting the Review and Approval Matters of APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (2017 No. 146)" .	The approval of pharmaceutical excipients and packaging materials and containers in direct contact with drugs (hereinafter referred to as pharmaceutical packaging materials) shall be cancelled, and APIs, pharmaceutical excipients and pharmaceutical packaging materials shall be reviewed and approved together when examining and approving drug preparation registration applications .
	On July 16, 2019, the State Food and Drug Administration issued an announcement on matters related to further improving drug-related review, approval and supervision (2019 No. 56)	Clarified the registration, management and registration data requirements of pharmaceutical packaging materials .
	August 27, 2019, "The Drug Administration Law of the People's Republic of China"	The legal basis for the related review system of pharmaceutical packaging materials has been established .

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