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Classification of new Chinese medicines: In accordance with the provisions of the "Administrative Measures for the Registration of Drugs" of the State, new Chinese medicines are registered and classified according to the classification at the time of drug development and production declaration.

Five new types of Chinese medicine

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Classification of new Chinese medicines: In accordance with the provisions of the "Administrative Measures for the Registration of Drugs" of the State, new Chinese medicines are registered and classified according to the classification at the time of drug development and production declaration.

Chinese name

Five new types of Chinese medicine

Concept

Classification of new Chinese medicine

Chemicals

Drugs not marketed at home and abroad

Classification

Chinese medicine new drug registration is divided into 9 categories

Classification of new Chinese medicines: In accordance with the provisions of the "Administrative Measures for the Registration of Drugs" of the State, new Chinese medicines are registered and classified according to the classification at the time of drug development and production declaration.

A class of drugs that are not marketed at home and abroad:

(1) APIs and their preparations made by synthetic or semi-synthetic methods;

(2) New effective monomers and their preparations extracted from natural substances or extracted by fermentation;

(3) Optical isomers and their preparations in known drugs made by resolution or synthesis;

(4) Preparation of a multi-component drug that has been marketed into a smaller component;

(5) New compound preparations;

(6) Preparations that have been marketed in China increase new indications that have not been approved at home or abroad.

The second category of preparations that change the route of administration and have not yet been marketed at home and abroad.

Three types of drugs that have been marketed abroad but not yet marketed in China:

(1) A formulation and its drug substance that have been marketed abroad, and / or a formulation that changes the dosage form of the formulation without changing the route of administration;

(2) A compound preparation that has been marketed abroad, and / or a preparation that changes the dosage form of the preparation but does not change the route of administration;

(3) Preparations that change the route of administration and have been marketed abroad;

(4) New formulations that have been approved for sale abroad are added to domestically marketed preparations.

Four types of APIs and preparations that change the acid radicals, bases (or metal elements) of salt drugs that have been marketed, but do not change their pharmacological effects.

Five types of preparations that change the dosage form of domestic marketed drugs, but do not change the route of administration.

Six types of APIs or preparations that have national drug standards.

According to the state's "Administrative Measures for the Registration of Drugs", the registration of new Chinese medicines is divided into 9 categories.

1. Active ingredients and their preparations extracted from plants, animals, minerals and other substances that are not marketed in China.

2. Newly discovered medicinal materials and their preparations.

3. New Chinese herbal medicine substitutes.

4. New medicinal parts of medicinal materials and their preparations.

5. Effective parts and preparations extracted from plants, animals, minerals and other substances that are not marketed in China.

6. Traditional Chinese medicine and natural medicine compound preparations that are not on the market in China.

7. Preparations that change the route of administration of traditional Chinese medicine and natural medicine in China.

8. Change the formulations of Chinese medicines and natural medicines that have been marketed in China.

9. Chinese medicine and natural medicine that have national standards.

It refers to effective parts and preparations thereof that are not marketed in China and are extracted from plants, animals, minerals and other substances.

It also refers to preparations that change the dosage form of drugs already on the market in China, but do not change the route of administration.