The first category is patented drugs, including patented drugs and high-quality and high-priced Chinese patent medicines during the patent protection period. Patented drugs within the patent protection period refer to drugs that pharmaceutical enterprises, scientific research institutions or individuals enjoy exclusive rights within the patent validity period stipulated by law. In China, the original APIs and their preparations are subject to administrative protection, and the first class of new drugs during the administrative protection period are treated equally with patented drugs during the patent protection period. Chinese patent medicine with high quality and good price refers to the Chinese patent medicine whose government-guided price is determined by the national price department according to the difference of quality and curative effect.
The second category is GMP drugs, which refer to drugs produced by enterprises that have passed the certification organized by the State Drug Administration and hold the certification certificate according to good manufacturing practice (English full name is Good Manufacturing Practice, abbreviated as GMP).
The third category is non-GMP drugs, which refer to drugs produced in good manufacturing practice by enterprises that have not passed the certification organized by the State Drug Administration.
The classification of bidding drugs is based on the Measures for Government Pricing of Drugs (JJ [2000] No.2142) issued by the State Planning Commission. On the basis of comprehensive consideration of national macro-control policies, industrial policies and medical and health policies, this method follows the principle of "reflecting the differences in drug quality and efficacy, maintaining a reasonable price comparison of drugs, and encouraging the research and development of new drugs". It is required to distinguish between GMP and non-GMP drugs, original drugs and generic drugs, new drugs, famous drugs and ordinary drugs, with high quality and good price. Among them, the price difference rate of GMP drugs is less than 40% compared with non-GMP drugs for the same drug with the same dosage form specification, and the price difference rate of other dosage forms is less than 30%; Compared with generic drugs produced by GMP enterprises, the price difference of the original drug that has passed the patent protection period of the country of invention is not more than 35%, and the price difference of other dosage forms is not more than 30%. According to this regulation, the competent pricing department implements different price difference rates for drugs with the same generic name but different product effectiveness and safety according to the principle of high quality and good price. The original research drugs, GMP drugs and non-GMP drugs that have passed the patent protection period in the country of invention have different effectiveness and safety and belong to different quality grades. The original drugs that have passed the patent protection period of the country of invention mentioned here are patented drugs that have lost patent protection in the work specifications, and the national price authorities shall set prices for such drugs separately. These drugs are classified as GMP drugs in the work specification. Only patented drugs that are still within the patent protection period of the country of invention but are copied by other enterprises for various reasons can be classified as patented drugs.