Notice Regarding Matters Concerning the Certificate of Pharmaceutical Product Approval (CPP) for Marketing Authorization
Release time:
2020-12-16
Source:
Author:
Given the FDA’s adjustment to its policy on CPP documents, it is agreed that for FDA-approved drugs exported from countries other than the United States, the CPP document will no longer be required when filing a registration application in China. Instead, applicants may submit a screenshot of the FDA website or other supporting documentation to substantiate the information provided in the registration application.
The above-mentioned content shall take effect from the date of issuance of this notice. This is to notify you accordingly.
Center for Drug Evaluation, National Medical Products Administration
November 27, 2020
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