Pharmaceutical Excipient IPEL china CFDA register Cost & time of China

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Pharmaceutical Excipient IPEL china CFDA register Cost & time

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	Contact us	3-6 Months	??
CDE Technical Evaluation & Follow up	Contact us	6-9 Months
CFDA IPEL Approval & Follow up	Contact us	3-6 Months
Other (Document Notarization etc.)	Contact us	0.5-1 Months
Total:	Contact us	18-24 Months	Not include the BE cost

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Important Note

Due to the reorganization of the Chinese government in 2018,
CFDA (China Food and Drug Administration) was renamed to NMPA (National Medical Product Administration), and its food supervision function has been transferred to SAMR (State Administration for Market Regulation of China);
GACC (General Administration of Quality Supervision, Inspection and Quarantine of China) was abolished, and its import and export trade supervision function has been transferred to GACC (General Administration of Customs of China),
Therefore, all CFDA and SFDA on this website default to NMPA, GACC defaults to GACC;　

	Our Service Items
CFDA	CFDA Registration for Cosmetics, Health Food, Infant Formula, FSMP , Medical Device, IVD,Drug etc.
GACC	GACC Registration for Foreign Food Facility and Exporter
CNCA	CNCA Registration for Foreign Dairy, Meat, Aquatic Foods Facility
CIQ	CIQ Inspection & filing for Foods & Cosmetics Chinese Labeling, Batteries & Coatings Product etc.
MOA	CNCA Registration for Foreign Animal Feed, Dog, Cat Food, GMO etc.
MOH	MOH Registration for Disinfectant, New Food & Cosmetic Ingredient
GB	China National GB Standards English Translation & GB Standards Item Test
	Imported Commodity China Regulatory Compliance Review & Consulting

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