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The drugs which can be exempted from clinical trials in China

Generally, for the categories:Herbal Medicines / Botanical Drug Products / Biological Products    

Clinical trials must be conducted in China, no matter what the drug product¡¯s sub-categories are.

However, with regard to Chemical Drugs, the situation is discussible, as follows:

First of all, you need to make sure whether similar product has been approved onto market in China. If a similar products has been approved in China, or has been approved to be imported into China since Jan 1st, 1998, that means your drug product belongs to the ¡°Drug Products with National Standard¡±, which have the possibility of being exempted from or derate the Clinical Trials in China.

Secondly, supposing your product belongs to the Drug Products with National Specifications:

If your product is kind of normal injection (not the controlled-release or other special way release dosage forms) which meet some pharmaceutical and clinical requirements (if you want to know the detail, contact with us), the clinical trials might be exempted.

If your products are solid oral dosage forms, the bioequivalence trials might be carried out in China to substitute for 100 pairs Clinical Trials (comparison trials of your products and marketed similar product, and your products are in accordance with the marketed one).

If your products are kind of special oral preparation like non-absorbable or solution wise, the situation will be different and complex (contact with us for detail).

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