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Launch of 50 varieties of generic drug consistency evaluation during the year
Release time: 2013-01-18 & nbsp & nbsp & nbsp Source: Anonymous

    This year,The National My stake betting appFood stake online sports bettingand Drug Administration will establish the quality consistency evaluation method and standard of 50 generic drug varieties,Priority Evaluation of the Basic Drug Catalog Copper Wide、Large market sales、Multi -variety of manufacturers。The National Bureau will also formulate relevant technical guidance principles,Guide drug manufacturers to carry out consistency evaluation research。

    It is understood,205 kinds of chemicals in the basic drug catalog involved in more than 30,000 approval number,Need to complete the quality consistency evaluation during the twelve five five & rdquo;。Evaluation of the consistency of the quality of generic drugs,Organize the formulation technology standard system of national generic drug reference preparations,Formulate my country's generic drug reference preparation directory (orange book); establish a clear prescription process、My stake betting appStake Sports BettingThe Quality Control Indicator System based on objective data such as dissolved curve and other objective data,Ensure the quality and safety of the medicine。

    In consistency evaluation,It will focus on in vitro evaluation,Unable to draw conclusions for individual varieties for extraction methods,Experts demonstrate it when it is necessary,can increase the body evaluation method。Consistency evaluation will be implemented step by step,Take the pilot first、Explore experience,The mode of pushing it all over。At the same time,Give full play to the strength of scientific research institutions and pharmaceutical inspection institutions,Research method of determining consistency evaluation,Encourage the self -study of drug manufacturers,Draft of the evaluation method。

    Another,According to "National Drug Safety stake online sports betting& LDQUO; Twelve Five -Year My stake betting appPlan",For generic drugs that have reached the international level,Prices at medicine、Bidding purchase、Medical insurance reimbursement and other aspects will be supported,Do not register for generic drugs that have not passed consistency evaluation。The National Bureau will cooperate with relevant departments to introduce encouraging measures,Guide enterprises to actively improve product quality,Make sure the quality and safety of the drugs of the market。