What are new veterinary drugs, new preparations of veterinary drugs and new biological products for animals? How to classify?

New veterinary drugs refer to the newly developed raw materials and preparations of veterinary drugs in China.

New veterinary drug preparation refers to the newly developed and processed veterinary drug raw materials approved by the state. Veterinary drug preparations that have been approved for production, such as changing prescription, dosage form, route of administration and adding new indications, are all new veterinary drug preparations.

New biological products for animals refer to biological products created or produced for the first time in China for the prevention, treatment and diagnosis of animal diseases such as livestock and poultry. It also belongs to the management of new biological products to fundamentally improve the strains (viruses, insects) and production processes used in approved biological products.

According to the requirements of veterinary drug management, new veterinary drugs and preparations can be divided into five categories, and new biological products can be divided into three categories.

(1) New veterinary drugs and new preparations of veterinary drugs:

The first category, APIs and their preparations created by China (including newly discovered effective monomers extracted and synthesized from natural drugs and their preparations); Raw materials and their preparations developed in China that have not been approved for production abroad and have only been reported in the literature; Newly discovered Chinese herbal medicines; New medicinal parts of Chinese herbal medicine.

The second category, domestic raw materials and preparations that have been approved for production abroad but not included in the national pharmacopoeia, veterinary drug code or national legal drug standards; Effective components extracted from natural medicines and their preparations.

The third category, raw materials and preparations developed in China that have been approved for production abroad and have been included in the national pharmacopoeia, veterinary drug code or national legal drug standards; Raw materials and their preparations made from known effective monomers in natural medicines by synthetic or semi-synthetic methods. Compound preparation of western veterinary drugs, compound preparation of Chinese and western veterinary drugs.

The fourth category is drugs that change dosage forms or routes of administration.

New preparations of traditional Chinese medicine (including changes in ancient prescriptions, secret recipes, proven prescriptions and traditional prescriptions); Chinese patent medicine that changes dosage form but does not change the route of administration.

The fifth category, western veterinary drug preparations and Chinese veterinary drug preparations (Chinese patent medicines) with increased indications.

(2) New biological products:

The first category is products created by China, which are only reported in foreign literature, but not approved for production.

The second category is products that have been approved for production abroad but not yet produced in China.

The third category is products that have fundamentally improved the strains (viruses, insects) and production technology of biological products approved in China.