Generally, for the categories:Herbal Medicines / Botanical Drug Products / Biological Products
Clinical trials must be conducted in
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
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
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).