Differences between the official draft and the opinion draft

Compared with the draft on October 30, 2015, CFDA issued guidelines on March 18, 2015, there are mainly three changes: 1 Internationally recognized generic drugs refer to generic drugs approved to be listed in the EU, the United States and Japan and obtained the status of reference preparations Compared with the opinion draft, "Japan" has been added The quality re evaluation project in Japan has been very successful, which is worth our learning At the same time, some drugs were imitated in Japan at that time, which is in line with the public opinion 2 The formal draft specifies the conditions for the local product to be used as the reference preparation: if the original research enterprise can prove that the local product is consistent with the original research product, the local product can also be used as the reference preparation However, according to some industry personnel, it is not easy to prove this If there is import, it is better to use imported drugs as reference 3 If the original research drug is not listed in China, the official draft is "the original research drug that can be listed in foreign countries can be selected", while the opinion draft is: "the same kind of drug that can be listed in China and internationally recognized can also be selected as the reference preparation" It is suggested that the reference preparations listed in China should be selected preferentially rather than the original drugs In this way, the reference preparation is relatively easy to obtain Appendix: guidelines for the selection and determination of reference preparations for general oral solid preparations these guidelines are applicable to the selection and determination of reference preparations for the consistency evaluation of generic quality and efficacy of general oral solid preparations 1、 The term generic drug refers to a drug with the same active ingredients, dosage forms, routes of administration and therapeutic effects as the generic drug Reference preparation refers to the reference drug used for the consistency evaluation of quality and efficacy of generic drugs, which is usually the object to be imitated, such as the original drug or internationally recognized drug of the same kind The reference preparation should be a drug with reasonable prescription, stable quality and definite curative effect The original research drug refers to the first drug approved for listing at home and abroad, and has complete and sufficient safety and effectiveness data as the basis for listing Internationally recognized generic drugs refer to generic drugs approved to be listed in the European Union, the United States and Japan and obtained the status of reference preparation 2、 Principle of selection (1) the reference preparation shall be the original drug listed in China The imported original research drug as reference preparation shall be consistent with the drug listed in its country of origin If the original research enterprise can prove that its local drugs are consistent with the original research drugs, the local drugs can also be used as reference preparations （2） If the original drug is not listed in China or there is evidence to prove that the original drug does not meet the conditions of the reference preparation, the same kind of drug that is internationally recognized for listing in China can also be selected as the reference preparation, and its product should be the same as that listed in the country that is listed as the reference preparation （3） If the original drugs and internationally recognized drugs of the same kind are not listed in China, the drugs listed in the European Union, the United States and Japan and listed as reference preparations can be selected 3、 It is proposed and recommended that (1) pharmaceutical manufacturers shall, in accordance with the above principles, choose their own reference preparations and report them to the generic drug quality conformity assessment office of the food and Drug Administration (hereinafter referred to as the conformity assessment office) for filing （2） The industry association may, in accordance with the above principles, organize the pharmaceutical manufacturers of the same variety to put forward suggestions on the selection of reference preparations and recommend them to the consistency evaluation office （3） If the products of the original research drug manufacturer and internationally recognized drug manufacturers of the same kind can meet the conditions of the reference preparation, they can take the initiative to apply to the consistency evaluation office as the reference preparation 4、 Filing and auditing (I) pharmaceutical manufacturers shall carry out advanced research, prepare reference preparations and report to the office of consistency evaluation for filing according to the task requirements of national consistency evaluation on quality and efficacy of generic drugs and the situation of the varieties to be evaluated If the conformity assessment office does not raise any objection within 60 working days, the enterprise can carry out relevant research work （2） For reference preparations filed by enterprises, recommended and selected by industry associations, and voluntarily declared by enterprises, the consistency evaluation office shall organize experts to review and determine them （3） If there is any dispute on the reference preparation, it shall be determined by the consistency evaluation office after the experts' public demonstration 5、 Requirements for reference preparation (1) the reference preparation shall be purchased by the enterprise itself, and there shall be legal documents When purchasing reference preparations for quality and efficacy consistency evaluation and research of generic drugs abroad, the approval for imported drugs required for one-time import shall be provided The batch and quantity of the reference preparation obtained shall meet the needs of the enterprise's own research and the reexamination and inspection of the drug inspection agency （2） The pharmaceutical manufacturers who actively declare the reference preparation shall guarantee the quality and accessibility of the reference preparation （3） The conformity evaluation office may make the information of reference preparations filed by enterprises, recommended and selected by industry associations and declared by enterprises on their own initiative public to the public for reference by drug manufacturers （4） The food and drug administration shall timely publish the information of the determined reference preparations In principle, drug manufacturers shall select the published reference preparations for consistency evaluation.