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Zhonghui pharmaceutical low density polyethylene film and bag registration number and successful evaluation of Drug Enterprise Association

Author: Scan:0 TIME:Apr 06, 2020

In March 2019, the registration number of our company's medical low-density polyethylene film and bag is b20180001073. In the "publication of registration information of APIs, pharmaceutical excipients and drug packaging materials" of the drug review center of the State Drug Administration, "the result of joint review and approval with the preparation" is "a", which means that our company's product is a packaging material approved for use in the listed preparation.

Raw materials, pharmaceutical excipients and pharmaceutical packaging materials shall be reviewed and approved at the time of approving the registration of pharmaceutical preparations. The APIs, pharmaceutical excipients and drug packaging materials shall be reviewed and approved together with the application for drug preparation registration.

On November 30, 2017, the General Administration issued the announcement on adjusting the review and approval items of APIs, pharmaceutical excipients and drug packaging materials (No. 146, 2017), which opened the prelude of the related review of APIs, pharmaceutical excipients and drug packaging materials. The announcement clearly indicates that since the date of announcement, the food and drug administration at all levels will no longer accept the application for registration of APIs, pharmaceutical excipients and drug packaging materials separately. The drug review center of the State Food and Drug Administration (hereinafter referred to as the drug review center) establishes the API, pharmaceutical excipients and drug packaging materials Registration Platform (hereinafter referred to as the Registration Platform) and database, which can be registered through the The platform shall submit the registration data of APIs, pharmaceutical excipients and drug packaging materials as required, obtain the registration numbers of APIs, pharmaceutical excipients and drug packaging materials, and review them together after the application for registration of related drug preparations is submitted.

Our company registered products according to the requirements of the national laws and regulations. By the end of 2018, we had obtained the registration mark of 16 products, and issued letters of authorization for many enterprises to approve and approve the products. In March 2019, our company's medical low density polyethylene film and bag took the lead in the joint approval with pharmaceutical enterprises, and the record number was successfully activated, which means that other pharmaceutical preparation applicants can safely use our company's drug packaging materials for drug declaration, so as to reduce the risk of drug packaging materials in the process of Association review. Our company is in line with the concept and attitude of win-win cooperation and common development to work together with pharmaceutical enterprises to make good packaging for the world's good medicine, so that human health is more guaranteed!

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400-082-0368

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