Chinese medicine orange peel book database (folk Edition) came out

Orange book is a publication issued by FDA according to the requirements of hatch Waxman act, which is divided into electronic version and database version For each drug approved by treatment equivalence evaluation, it gives detailed drug approval information, and gives all patents involved in the new drug and market exclusive protection information The Japanese medicine orange peel book is issued by the drug administration of the Ministry of health and welfare of Japan It contains the research and evaluation information of the dissolution of oral solid preparations in detail (such as the standard dissolution curve information under different dissolution media) The orange peel books of the two countries have a great guiding role in promoting the development of the generic pharmaceutical industry This year, with the launch of the evaluation opinions on the consistency of generic drugs in China, it has triggered a rare big shock in the pharmaceutical industry It has become the heartache of most pharmaceutical companies that there is no place to look for information about generic reference preparations and original research drug manufacturers People in the industry have called for the publication of Chinese medicine orange peel book as soon as possible In order to actively cooperate with the national generic drug consistency evaluation work and provide convenience for the colleagues in the pharmaceutical industry in the generic drug consistency evaluation work, drug intelligence network organized experts to hold a symposium, referred to the United States FDA orange book, Japan orange book and other relevant data and information, followed the CFDA related guidelines, created the Chinese Orange Book Database (private version), and matched with the same Thematic database of sexual evaluation It is hoped that this will provide data and information support for the industry in the process of consistency evaluation Main content of China orange peel book database (folk Edition): you can query by drug name, active ingredient (Chinese + English), dosage form, etc you can directly find the relevant information of a drug: (as shown in the figure) 1 The original manufacturer of the product and the reference preparation of the United States and Japan; 2 The number of domestic approval documents of the product and the basic information of the manufacturer 3 The reference preparation recommended by yaozhi.com according to CFDA guidelines 4 BCS classification information and exemption information of the drug This database gives BCS classification (2011) jointly issued by NICHD and FDA and BCS classification (2005) issued by the World Health Organization BCS classification information of the drug can be obtained quickly At present, the online varieties are only 289 varieties that need to be evaluated for generic drug consistency by the end of 2018, and will be gradually extended to all listed drugs in the later stage It is hoped that the publication of yaozhi.com's China orange book database (folk Edition) will be able to draw lessons from others and promote the early release of CFDA's China medicine orange book As the database has just been launched, there are inevitably some errors and omissions You are welcome to correct and supplement Free query of China orange book database (folk Edition), please click: http://db.yaozh.com/orange Book note: the content of this article is original by the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!