the state food and drug supervision and administration bureau recently issued the “Chinese listed drugs directory set” (hereinafter referred to as the “directory”). This for China this generic power, role is immeasurable.
& other; The listed drugs directory set & throughout; In the United States is known as medicines & other; Orange Book & throughout; .
, said an official with the national food administration of drug safety drug approval centre “directory set” represents the human medicinal system reform for more than 2 years. To ensure that after the examination and approval of generic drugs to Europe and the United States laid the standard drug quality, and laid the guarantee systems of generic drugs and the innovation medicine balance development foundation.
the directory set are determined by the state food drug safety administration approved drug carrier of information, include the innovation of the approved drug, improved new drugs, new classification of generic drugs and chemicals through the details of the quality and consistency curative effect evaluation of drugs. In addition, the directory is set to specify generic drug preparations and standard reference, specific generic label can replace the original drug product, etc., for the pharmaceutical industry and medical personnel and the social public understanding and query.
& other; In the beginning of the generic consistency evaluation of many companies can’t find the reference preparations, and China is also not his Orange Book, a lot of drug companies are difficult. Throughout the &; Experts say a medicine field.
the Chinese version of the drug & other; Orange Book & throughout; Has a guiding effect on the pharmaceutical industry development, the main significance lies in: one is by promoting generic drugs to replace the original drug, to improve the accessibility of pharmaceuticals, Second, by listing the patent information, protecting the legal rights and interests of the patentee, reduce the risk of patent infringement, the implementation of the data protection system; 3 it is through the preparations and standard reference, clear generic standards.
& other; In the past, foreign branded drugs not to enter the Chinese market in time, all the problems of imported drugs and information acquired. The relatively small number at the same time, China’s own drug innovation, from the resource acquisition and management system are restricted by some objective conditions. Throughout the &; The officials said.
open, according to data from 2001 to 2016, a total of 433 species of the United States approved the original drug, but only in China’s listed more than 100 kinds, typical of the original drug on the market in China of time average 5 to 7 years later than Europe and the United States. At the same time, the lack of a specified reference preparations, generic drugs in our country in the long-term low level repeated construction, difficult to generics and branded drugs on the curative effect and quality is consistent, can’t implement generics real alternative to the original drug.
on October 1, 2017, “on deepening the review the opinions of the examination and approval system reform to encourage pharmaceutical medical equipment innovation”, explicitly proposed the listed drugs directory set, complied with the industrial development and the people demand for high quality drugs and expectation, and generic drugs research and development for new drug innovation provides a better institutional guarantee.
at present, the directory set first includes 131 varieties, 203 specifications, including consistency through the quality of generic drugs and curative effect evaluation of 13 varieties, 17 varieties and specifications, and updated in real time, the network can be found out.