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◄ Pharmaceutical Excipient IPEL china NMPA register Cost & time ►

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |



 Generic Pharmaceutical Excipient  IPEL china CFDA registration Cost:

ITEM

COST

TIME

NOTE

China CFDA Registration consulting & Legal responsibility Agency

Contact us

1 Months

 

Technical documents Translation

Contact us

0.5-1 Months

 

CFDA Application Dossier Draft, Pre-review, Submit

Contact us

3-5 Months

 

NICPBP Excipient Tests & Follow up

 Contact us

3-6 Months

 

Bioequivalence /Pharmacokinetics Study & CRO Service Cost

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3-6 Months

　

CDE Technical Evaluation & Follow up

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6-9 Months

 

CFDA IPEL Approval & Follow up

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3-6 Months

 

Other (Document Notarization etc.)

Contact us

0.5-1 Months

 

Total:

 Contact us

18-24

Months

Not include the BE cost