Suzhou Youzhihe Pharmaceutical to share a simple: What is chemical material?

The raw materials of chemical drug preparations refer to raw materials; Raw materials of biological products refer to raw materials; Raw materials of traditional Chinese medicine preparations refer to traditional Chinese medicine, traditional Chinese medicine decoction pieces and purchased extracts of traditional Chinese medicine; Raw materials of an API refer to materials other than packaging materials used in the production of API.

Drug classification

1. Drugs not sold at home and abroad:

(1) Active substances and their preparations prepared by synthetic or semi-synthetic methods;

(2) new active monomers and their preparations extracted from natural substances or by fermentation;

(3) optical isomers of known drugs and their preparations prepared by means of resolution or synthesis;

(4) Drugs with fewer components are prepared from the multi-component drugs already on the market; 

(5) New compound preparation.

2. Preparations that have changed the route of administration and have not been marketed at home and abroad.

3. Drugs that have been marketed abroad but not yet marketed in China:

(1) active substances and their preparations that have been marketed and sold abroad;

(2) compound preparations that have been marketed and sold abroad;

(3) Preparations that have changed their route of administration and have been marketed abroad.

4. Active substances and their preparations that change the acid roots, bases (or metallic elements) of salt drugs on the market but do not change their pharmacological effects.

5. Change the dosage form of drugs already on the market in China, but do not change the preparation of drug routes.

6. Active substances or preparations that have established national drug standards.