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Associated review registration in pharmaceutical packaging

Dec 18 , 2018

On November 30, 2017, the CFDA issued the “Notice on Adjusting the Examination and Approval of Raw Material Medicines, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (No. 146 of 2017)”, and the removal of packaging materials and containers for pharmaceutical excipients and direct contact with pharmaceuticals. (hereinafter referred to as the pharmaceutical packaging materials) approval, raw materials, pharmaceutical excipients and pharmaceutical packaging materials are reviewed and approved at the time of application for registration of the approved pharmaceutical preparations. The pharmaceutical packaging material production enterprise shall carry out the stability test of the pharmaceutical packaging material itself, and register the drug packaging material with the drug evaluation center portal website, and obtain the registration number (instead of the “medical packaging material registration certificate”), so as to facilitate the follow-up with the pharmaceutical preparation enterprise. Conduct joint review and approval work.


Associated review registration in pharmaceutical packaging

pharmaceutical packaging


Up to now, Xinfuda has newly obtained four related review registration numbers, namely:

Oral solid medicinal polypropylene bottle, associated evaluation registration number: B20180000787.

Oral liquid medicinal high-density polyethylene bottle, associated evaluation registration number: B20180001455.

Oral liquid polypropylene measuring cup, associated evaluation registration number: B20180002904.

Oral solid pharmaceutical low-density polyethylene moisture-proof combination cap, associated evaluation registration number: B20180000786.



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