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What are the requirements for related declaration of pharmaceutical packaging materials, pharmaceutical excipients and drug registration applications?
Medical Devices
Jul. 25th, 2023
In the application stage of drug clinical trials, the unused drug packaging materials and pharmaceutical excipients in domestic and foreign listed preparations should be declared or submitted by the drug registration applicant in accordance with the requirements of Circular No. 155 of 2016. For other pharmaceutical packaging materials and pharmaceutica

In the application stage of drug clinical trial, the unused drug packaging materials and pharmaceutical excipients in domestic and foreign listed preparations should be declared or submitted by the drug registration applicant in accordance with the requirements of Circular No. 155 of 2016; For other pharmaceutical packaging materials and pharmaceutical excipients, the drug registration applicant shall, at least in the drug registration application materials, provide the relevant pharmaceutical packaging materials and pharmaceutical excipients manufacturing enterprise information, product basic information, quality standards and inspection reports and other relevant information.

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