The choice of reference listed drugs is to ensure the quality and efficacy of generic drugs, so pharmaceutical companies must not be sloppy when choosing, and must choose according to requirements. How to choose a reference listed drug? TOSUN PHARM suggests starting from the following points:

　　1. You can choose drugs that have been marketed in your own country as reference listed drugs

　　For drugs that have already been marketed in China, the reference listed drugs will give priority to the products imported from the original research and marketing license holders. Or choose the original research marketing license to hold the manufacturer's imported products from other origins, but the product must be marketed in the European Union, the United States, and Japan, and has the status of a reference listed drug. If the original research marketing license holder and the place of origin have changed, it is necessary to prove that it is the original research product, and it is marketed in the European Union, the United States, and Japan, and has the status of a reference listed drug.

　　If none of the above can be determined, the internationally recognized same drug can be selected as the reference listed drug.

　　2. Drugs that are not marketed in the country can be selected as reference listed drugs

　　For the selection of this reference listed drug, the product of origin of the original research marketing license holder can be preferred. If the original product has other origins, the product must be marketed in the European Union, the United States, and Japan, and has the status of a reference listed drug. Or you can choose the internationally recognized same drug as the reference listed drug.

　　3. The reference listed drug can choose to change the specification, dosage form, and base imitation products

　　According to the "General Considerations for the Evaluation of Modified Drugs in the Quality and Efficacy Consistency Evaluation of Generic Drugs" (to be released), "General Considerations for the Evaluation of Modified Drugs (Ordinary Oral Solid Preparations) in the Evaluation of the Quality and Efficacy Consistency of Generic Drugs" (to be released) , According to the requirements of "General Considerations for the Evaluation of Modified Basic Drugs in the Evaluation of Quality and Efficacy Consistency of Generic Drugs", select reference listed drugs.

　　4. For reference listed drugs, you can choose the varieties produced and marketed by the original research company in China

　　1) For the original domestic localized products produced on the same production line and listed in the EU, the United States or Japan at the same time, the original research company shall provide corroborating data, in accordance with the "Guiding Opinions on the Classification of Generic Drug Quality and Efficacy Consistency Evaluation" (soliciting Opinions, hereinafter referred to as the “Guidelines for Variety Classification”, prove that the original domestic localized product is consistent with the quality and efficacy of the original drug. After being reviewed and confirmed by the expert committee and issued by the Food and Drug Administration, it can be selected as a reference listed drug.

　　2) If there is no change in the original domestic localized product and the original researched product's prescription process, the original research company shall provide corroborating information, and follow the procedures described in the category classification guidelines to prove that the original researched domestic localized product has the same quality and efficacy as the original drug After being reviewed and confirmed by the expert committee and issued by the Food and Drug Administration, it can be selected as a reference listed drug.

　　3) The original researched domestic localized products and the original researched product's prescription process have changed, and the manufacturer must prove that the localized products and the original researched products are consistent in quality and efficacy, and follow the procedures described in the category classification guidelines to prove that the original researched domestic localized products are compatible with If the quality and efficacy of the original drug are consistent, it can be selected as a reference listed drug after being reviewed and confirmed by the expert committee and issued by the Food and Drug Administration.

　　4) If there is a change in the prescription and technology of the original domestic localized product and the original product, and the manufacturer cannot self-certify the consistency, the foreign original drug reference listed drug shall be determined separately.