National 1.2.3 What are the new drugs?

Definition of new drug: A new drug refers to a drug that has not been produced in China. The drugs that have been produced have added new indications and changed the route of administration and dosage form.

Belonging to the scope of new drugs.

According to international and domestic drug classification standards, the State Administration of Pharmaceutical Products classifies new drugs into the following five categories according to drug management requirements:

National first-class new drugs: refers to the brand-new raw material drug composition and its preparation invented for the first time in the world; Or raw materials and drugs reported in the literature.

Preparation, and the curative effect is remarkable, "class I" new drugs are the best drugs.

National second-class new drugs: raw materials and their preparations that have been approved for production abroad but not included in the national pharmacopoeia.

Three national new drugs: pharmaceutical preparations made from several existing ingredients, including compound preparations of western medicine and compound preparations of Chinese and western medicine.

National four kinds of new drugs: drugs made by synthetic or semi-synthetic methods of known effective monomers in natural drugs; Drugs that change dosage form or route of administration.

Five national new drugs: drugs with increased indications.