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Can pharmaceutical packaging materials and pharmaceutical excipients be declared in connection with drug supplement applications?
Medical Devices
Jul. 25th, 2023
When the drug registration applicant submits supplementary applications for items 1, 6 and 10 in accordance with Annex 4 of the Measures for the Administration of Drug Registration, or submits supplementary applications for Item 12 in accordance with the Provisions on the Administration of Drug Technology Transfer Registration (Note No. 518 of the Stat

  When the drug registration applicant submits supplementary applications for items 1, 6 and 10 in accordance with Annex 4 of the Measures for the Administration of Drug Registration, or submits supplementary applications for Item 12 in accordance with the Provisions on the Administration of Drug Technology Transfer Registration (Note No. 518 of the State Food and Drug Administration), the relevant drug packaging materials and pharmaceutical excipients may be declared in connection with the supplementary applications.

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