The procedure for Import Drug SFDA Registration of China

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The procedure for Import Drug SFDA Registration

In brief, if your products need not to be conducted clinical trials, and the Application Dossier are appropriate, you shall obtain IDL within about 9-12 months after submission. If clinical trials must be conducted, the general procedure is:

Step 1. Submitting an application and if the Application Dossier are appropriate, you shall obtain Clinical Trials Permission (CTP) within about 10-12 months after submission

Step 2. Conducting the clinical trials, if just carry out bioequivalence trials, it might be take 3 to 6 months, but other clinical trials might be take more than 1-1.5 year to complete.

Step 3. Submitting the Application Dossier (include the reports of clinical trials) and if the Application Dossier are appropriate, you shall obtain IDL within about 12-18 months after submission Please contact us for details about this and for more information including, we shall send the further information and our quotation to you after receive the introduction of your products.

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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;　

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CFDA	CFDA Registration for Cosmetics, Health Food, Infant Formula, FSMP , Medical Device, IVD,Drug etc.
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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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