New veterinary drugs refer to veterinary raw materials and preparations newly developed in my country.
New veterinary drug preparations refer to veterinary drug preparations newly developed and processed from veterinary drug raw materials that have been approved by the state. Veterinary drug preparations that have been approved for production, such as changing the prescription, dosage form, route of administration, or adding new indications, are all new veterinary drug preparations.
New biological products for veterinary use refer to biological products created or produced for the first time in my country for the prevention, treatment and diagnosis of animal diseases such as livestock and poultry. Fundamental improvements to the bacterial (toxic, insect) species and production processes used in approved biological products also fall within the management scope of new biological products.
According to veterinary drug management requirements, new veterinary drugs and new preparations of veterinary drugs can be divided into five categories, and new biological products are divided into three categories.
(1) New veterinary drugs and new preparations of veterinary drugs:
The first category includes raw materials and preparations created in my country (including newly discovered effective single drugs extracted and synthesized from natural drugs). body and its preparations); raw materials and preparations developed in my country that have not been approved for production abroad and have only been reported in literature; newly discovered Chinese medicinal materials; new medicinal parts of Chinese medicinal materials.
The second category includes raw materials and preparations developed in my country that have been approved for production abroad but are not included in the National Pharmacopoeia, Veterinary Pharmacopoeia or national legal drug standards; the effective parts extracted from natural medicines and their preparations .
The third category includes raw materials and preparations developed in my country that have been approved for production abroad and have been listed in the National Pharmacopoeia, Veterinary Pharmacopoeia or national legal drug standards; known effective monomers in natural drugs are synthesized Or raw materials and preparations prepared by semi-synthetic methods. Western veterinary drug compound preparations, Chinese and Western veterinary drug compound preparations.
Category 4: Drugs that change dosage forms or administration routes.
New traditional Chinese medicine preparations (including ancient prescriptions, secret recipes, proven prescriptions, and those that change the composition of traditional prescriptions); proprietary Chinese medicines that change the dosage form but do not change the route of administration.
The fifth category includes Western veterinary drug preparations and Chinese veterinary drug preparations (Chinese patent medicines) with added indications.
(2) New biological products:
The first category is products created in my country and only reported in foreign literature but not approved for production.
The second category includes products that have been approved for production abroad but have not yet been produced in my country.
The third category is products that have fundamentally improved the bacterial (toxic, insect) species and production processes used in biological products that have been approved in my country.