上市药品

上市药品生脉饮健康志愿者临床耐受性再评价

Clinical Reevaluate of the Tolerance of Marketed Drug - Shengmai Drink

上市药品的质量评价

The Quality Evaluation of Drugs on the Market

目的探讨上市药品风险管理的技术模式，为开展我国药品再评价提供技术参考。

Objective To explore risk management framework in order to provide information for China authority agency .

药品不良反应评价体系是目前上市药品再评价的重要渠道；

The evaluation system of drug adverse reactions is an important channel for re-evaluation of listed drugs .

方法：可从临床、生物等效性、药物经济学和药剂学角度对上市药品作出评价。

METHODS : The drugs have been evaluated from angles of clinic effectiveness , bioequivalence , pharmacoeconomics and pharmaceutics .

该措施有助于保证所有上市药品在安全性、有效性、质量和标签方面都能够符合现代标准。

This initiative promotes the goal of assuring that all marketed drugs meet modern standards for safety , effectiveness , quality and labeling .

结论：建议药品监督部门加强对上市药品特别是国产药品的抽检，以保证药品质量的稳定和安全性。

CONCLUSION : It is suggested that the drug control departments should strengthen the selective surveillance of drugs on the markets , especially the domestic produced drugs , to ensure the quality and safety .

44%明确ADR定义，91%认为上市后药品存在不良反应；

91 % believed that drugs had some adverse reaction after marketing ;

FDA拥有一项可使尚未批准但已上市的药品如秋水仙碱处于其管理框架下的措施。

The FDA has an initiative underway to bring unapproved , marketed products like colchicine under its regulatory framework .

气管炎丸载于部颁标准（WS3-B-0706&91），现作为9类新药，即改变国内已上市销售药品剂型的制剂。

Bronchitis Pill ( WS3-B-0706-91 ) was recorded in Drug Specification Promulgated by the Ministry of Public Health . It is also belonging to register administration ) the 9th register classification that changing the form of the drug , which was sold inland before .

根据我国药品食品监督管理局（SFDA）通过的《药品注册管理办法》，甲芬那酸分散片属于新药五类，即改变国内已上市销售药品的剂型，但不改变给药途径的制剂。

According to the management methods of drug registration issued from State Food and Drug Administration ( SFDA ), mefenamic acid belongs to the type five new drugs , namely , renewing the formulation while keeping the original administration route .

合理使用和分配上市后药品资源是中国的决策者面临的主要问题之一。

The rational use and allocation of marketed medicines remain a major concern for decision-makers in China .

仿制已在国外上市化学药品过程中需要特别关注的问题

Some special concerns during the developmental process of " chemical drugs which have been marketed out China "

药品不良反应监测是对上市后药品安全性监管的重要手段。

Adverse Drug Reaction ( ADR ) monitoring is an important method for safety management of post-marketing drug .

在过去两年中，食品和药物管理局八次允许不被批准在美国上市的药品在其他地方能够安全使用。

Eight times in the past two years the agency has allowed the import of drugs unapproved in America but used safely elsewhere .

上市后药品的经济学评价方法除了常用的成本效果分析方法以外，还注重于效益风险分析、药品列入报销目录的申请、药品的补偿和预算影响分析等。

The methods of economic evaluation in post-marketing pay more attention to the value-added pharmacoeconomics activities to maintain product status , such as risk-benefit analysis , drug reimbursement application and budget impact analysis , etc.

上市后药品安全性评价中的不良反应预警以及因果关系评价是药品安全性评价中关键和困难的问题，直接关系到对药品的正确评价，也是最值得探讨的问题之一。

The pharmacovigilance and causality assessment are the key and the most difficult problems in the drug safety assessment , which influences the appropriate evaluation over medicines . The problem is one of the most worthy of being discussed problems .

药品风险管理是在药品加快审批过程、迅速上市和药品因安全原因撤出市场的双重环境下产生和逐步发展的。

Drug risk management has emerged and been developing gradually under the circumstances of accelerating drug approval procedure to speed up the launch of new drugs to market on one hand , while withdrawing drugs from market due to safety problems on the other hand .

在儿童OTC用药事件中，十多年前，代理部门曾决定药品生产商可以上市他们的药品供儿童使用，尽管这些药品仅通过成人的测试。

In the case of pediatric over-the-counter medicines , the agency decided decades ago that drug makers could market the medicines for children even though they had only been tested in adults .

但是当药品专利保护期届满之后，仿制药可以大量上市，专利药品的价格理应下降。

After the patent expires , the price of patent medicine will decrease because the generic drugs can come to the market .

由于药品在获准上市前的不良反应研究的局限性，药品上市后依法报告药品不良反应尤其重要。

Because of the limitation of ADR studies before approval market , it is very important to report ADR after approval market by regulation .