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
0.5-1 Months
CFDA Application Dossier Draft, Pre-review, Submit
3-5 Months
NICPBP Excipient Tests & Follow up
3-6 Months
Bioequivalence /Pharmacokinetics Study & CRO Service Cost
CDE Technical Evaluation & Follow up
6-9 Months
CFDA IPEL Approval & Follow up
Other (Document Notarization etc.)
Total:
18-24
Months
Not include the BE cost