The consistency evaluation work plan for the quality of generic drugs is expected to be introduced in the near future。Recently,The State Food and Drug Administration (SFDA) Registration Department organized & ldquo;。
Discussion draft has made specific arrangements for the planning of the quality of the quality of generic drugs in the future,Clarified evaluation target、Evaluation method、The responsibilities of each unit and the evaluation content and time arrangement。Clarified that the consistency of the quality of generic drugs is mainly aimed at basic drugs and clinical commonly used chemical varieties,It aims to eliminate the internal quality and clinical efficacy of the internal quality and clinical efficacy through quality consistency.,Promote the overall level of the general level of generic drugs in my country,Learn or approach the international advanced level。
Plan initially
The above discussion draft points out,Due to the relatively weak foundation for the research on the research of generic pharmaceutical Stake Sports Bettingmedicines stake online sports bettingin the early days,The quality gap between the quality of some generic drugs and the imitation drugs is large,The clinical efficacy of the generic drug cannot be achieved。For this,"National Drug Safety & LDQUO; Twelve Five -Year Plan" Planning "clearly proposed,Take 5-10 years,The "Measures for the Management Measures for the Registration of Drug Registration" revised in 2007,Comprehensive comparison of staging in batches with generic drugs,Make the generic drugs consistent with the generic drugs。
According to the requirements of the work plan,The National Food and Drug Supervision and Administration Department will organize the formulation of the work plan of the quality consistency evaluation of the quality of generic drugs,Post related evaluation methods、Standards and Technical Guidance Principles,Organize the consistency evaluation data submitted by pharmaceutical manufacturers。Provincial drug supervision and management department is responsible for the organization and coordination of the quality consistency evaluation work in the jurisdiction。The implementation and publicity of the consistency evaluation of the quality of generic drugs。
The reporter learned,At present, SFDA and relevant agencies have already started research and discussion of related technical standards for consistency evaluations,The technical requirements will be formed in the end。
The consistency of the quality of the generic drug will be selected in the basic drug catalog.、Large market sales、There are many manufacturers and have a clear pilot of the variety of original research enterprises,Subsequent promotion; Category category according to the nature of the drug itself and the characteristics of the drug dosage、Steps implementation of the preparation type。stake betting appFirst carry out the consistency evaluation of oral solid -solid institutional My stake betting appagents; Stake Sports Bettingsecondly, the consistency evaluation of the injection is carried out;。
Specific work will include selection and evaluation varieties、Determine the reference preparation and establish an evaluation indicator、Enterprise self -evaluation、The acceptance of the consistency evaluation data of the quality of the generic drug and the on -site inspection and the review of the self -evaluated information of the enterprise in the drug regulatory department。
On the time arrangement,Expand variety survey,Introduce the principles of guidance related guidance for oral solid preparations,Starting reference preparation screening evaluation work; 2013 establishment of reference preparation directory,Construct a database database of oral solid -solid -making preparations in the special network,Establishing National Bureau、Data transmission and declaration network system,and complete the selection and confirmation of the reference preparation; comprehensively carried out the comparison research and evaluation of the comparison research and evaluation of oral solid -solid -made dharma imitation drugs and reference preparations in 2014,Complete the evaluation of the quality consistency of some varieties; work tasks for the quality consistency evaluation of solid oral preparation in the basic drug catalog in 2015。2015 ~ 2020,The quality consistency evaluation work of the injection and other dosage forms。
Improve quality
According to statistics from the China Foreign Investment Enterprise Association Drug Development and Development Industry Committee (RDPAC),In the next 4 years, my country will complete 570 chemical medicines、33,000 approval number、More than 2,400 pharmaceutical manufacturers' imitation drug quality consistency assessment work。
From the perspective of industrial development,Drug quality and medication safety has been raised to the national height My stake betting appof the country to & ldquo; 125 & rdquo;,With this stake sports betting appas the goal, a series of supporting policy portfolios will be formed to support its target implementation,The consistency evaluation work of generic drugs is regarded as the main entry point that comprehensively improves my country's drug quality level。
Because of this,The consistency evaluation of the quality of generic drugs is currently attracted the high attention of the entire pharmaceutical industry。The boss of a large private pharmaceutical company in Guangdong spoke at the relevant seminars and believed,As a major country of generic drugs,Evaluation and evaluation effect,Price of my country's pharmaceutical industry、Tender、Medical Insurance and other links may form a reaction chain effect。
& ldquo; Consistency evaluation will be the domestic pharmaceutical industry and enterprise,Especially important opportunities for the growth of local enterprises。If this job can be well implemented,Current generic drugs are priced at medicine、Drug tendering and medical insurance reimbursement may use this as an opportunity to get a fundamental transformation。& rdquo; The above person in charge believes,Local enterprises must actively meet the quality consistency evaluation work of the quality of generic drugs,Related research and tests on its own key varieties first,to ensure the pass。
RDPAC is also very concerned about the consistency evaluation of the quality of the generic drug,At the recent media seminar held by the committee,The relevant person in charge of the committee believes,The consistency evaluation of the quality of generic drugs will provide a historic opportunity for the overall improvement of the quality of the generic drug in my country。This requires the determination and huge investment of the country,More importantly, the top -level design needs to be done at the beginning of the project,Develop scientific and strict evaluation indicators stake online sports bettingand perfect incentive policies,and resolutely implement it。
stake betting appFirst carry out the consistency evaluation of oral solid -solid duct; Stake Sports Bettingsecondly, the consistency evaluation of the injection is carried out; finally the consistency evaluation of other dosage forms (authors: Yang Junjian)
