[exclusive] thinking about whether vitamins enter the list of drugs on the market in China

1、 The scope of drugs included in the catalogue of Chinese listed drugs 1 Innovative drugs, improved new drugs and imported original research drugs approved based on the research data of safety and effectiveness of complete specifications; 2 Generic drugs approved according to the new registration and classification of chemical drugs; 3 Drugs evaluated through the consistency of quality and efficacy; 4 Other drugs with safety and effectiveness determined by the evaluation of the former CFDA 2、 At present, according to incomplete statistics, there are 5655 vitamin related drug approval numbers, 28 import drug registration numbers, and more than 1100 domestic drug related enterprises There are 3489 approval numbers of domestic health food and 59 approval numbers of imported health food In terms of price, take vitamin C tablets as an example The price of drugs is about 3-5 yuan per bottle for 100 tablets, while health food costs more than 20 yuan According to the latest administrative measures for registration and filing of health food and the list of health food raw materials (the first batch) (Draft for comments), the following vitamin products can be qualified for production by filing: Vitamin A (4 compounds), vitamin D (vitamin D2, vitamin D3), vitamin B1 (2 compounds), vitamin B2 (2 compounds), vitamin B6, vitamin B12, niacin (2 compounds), folic acid 3、 Foreign vitamin analysis table 1: common vitamins in Chinese and English control table: according to the above name to search, found that some vitamins were included in the American orange book and Japanese orange book 1 In terms of American orange book, 58 records can be retrieved through vitamin, including 11 prescription drugs and 47 withdrawn from the market At the same time, we analyzed the information of not withdrawn from the market, two were vitamink1 injection, one was VitaminD capsule, the rest were vitamin injection of compound preparation, and only the compound preparation was listed as reference preparation At the same time, we analyzed vitamin D (mainly D2), and we knew that its chemical name was ergocalciferol The following 13 pieces of information were retrieved in the orange peel book, with the same specifications, in which NDA was listed as reference preparation and standard preparation Of course, we also noticed that seven of the records have been withdrawn from the market In addition, the chemical name of vitamin C is ascorbicacid; 18 pieces of information are retrieved, only one single prescription, the other is compound preparation; the single prescription is NDA, and has the status of reference preparation and standard preparation 2 Japanese orange peel Book searched by vitamin, only two pieces of information were found, one was unilateral and the other was compound However, Japanese orange peel book contained oral solid preparation, so we can't see the situation of injection temporarily Through ascorbic acid (ascorbic acid) retrieval, we can find several pieces of information, one of which is single, the other is compound preparation Open the first capsule, you can see that the tympanum variety can be used as a reference preparation Data also shows that Japanese orange peel book mainly contains vitamin related compound preparations 4、 At present, the consistency evaluation is being carried out in China There are three vitamins involved in the 289 catalog, namely vitamin B6, vitamin B2 and vitamin D2 soft capsules According to the latest "basic information table of 289 catalog varieties reference preparations" released by CDE, it can be seen that although the three varieties do not specify the reference preparations, they indicate that the reference preparations can be selected by changing the specifications Secondly, it was found by querying the catalogue of 13 batches of reference preparations published by CFDA that some of the vitamin related varieties had designated reference preparations Among them, vitamin B6 and vitamin D2 soft capsules are only different in specifications and 289 catalogue Finally, by querying the reference preparation filing data, we found that there are 31 vitamin reference filing information, including 12 reporting information In addition to Bayer medicine, some domestic enterprises also actively declare their own varieties as reference preparations It can be seen that enterprises are still relatively active in the consistency evaluation of vitamin related products 5、 It is suggested that vitamin products include various types and dosage forms, including single or compound, used to treat specific diseases, and used to supplement vitamin deficiency It is difficult to give a unified management rule, and the management systems of different countries are different The management of different vitamins in the same country is also different In view of the present situation of domestic vitamin, there are many kinds of vitamins in health food The price of health food is much higher than that of national medicine, but the quality may not be guaranteed Based on this situation, the following suggestions are put forward: 1 China's conventional vitamin products can be sold as health food based on nutritional supplements, while maintaining the current situation of "vitamin can be used as drug management and drug approval number" So that the public can buy vitamin products with low price and guaranteed quality at ease 2 Refer to the original intention and scope of China's list of listed drugs, combined with the precedent of foreign (US / Japan) orange peel Book Vitamin drugs It is suggested that the vitamin products that pass the consistency evaluation can enter the catalogue set of Chinese listed drugs, and be included according to the principle of the catalogue set, and the reference preparation and standard preparation that cannot be specified can not be specified temporarily The above is only the author's point of view We welcome you to express your opinions in the message area at the end of the article~