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China drug packaging DMF

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cfda (china food and drugs administration), china, drug master file (dmf), packaging standards and specifications
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  Post Number #1  
Old 5th January 2018, 05:18 AM
paulag

 
 
Total Posts: 80
Please Help! China drug packaging DMF

Happy New Year to everybody

I need your help regarding registration of drug primary packaging material im China, especially syringes.

Does anyone know if the CFDA takes the EU approach and wants the syringe to be part of the drug application, or if they follow kind of a DMF procedure, similar to US FDA DMF Type III or Health Canada DMF Type II?



Paula

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