The Reference Listed drug(RLD)plays a critical role in the development and research of generic medicinal products,serving as the comparator product used in the marketing authorization application of new generic medici...The Reference Listed drug(RLD)plays a critical role in the development and research of generic medicinal products,serving as the comparator product used in the marketing authorization application of new generic medicinal product and re-evaluation of generic medicinal product.In China,RLDs are sourced from various origins,but their quality and market availability can be constrained by multiple factors,including emergent issues such as nitrosamine impurities.Five classes of medicinal products have been reported to be at risk for containing nitrosamine impurities:sartan-based medicines,metformin-containing products,ranitidine medicines,rifampicin medicines,and Champix.This paper explores the control strategies implemented by drug regulatory agencies in the United States and the European Union to manage nitrosamine impurities and assesses their impact on the market availability and quality of RLDs in China.The aim is to offer valuable insights for generic drug manufacturers and regulatory bodies both domestically and internationally.展开更多
The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential...The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.展开更多
基金Subject construction funding project of Institute for Chemical Drug Control(Grant No.2024HYZX42)in National Institutes for Food and Drug Control,Beijing,China。
文摘The Reference Listed drug(RLD)plays a critical role in the development and research of generic medicinal products,serving as the comparator product used in the marketing authorization application of new generic medicinal product and re-evaluation of generic medicinal product.In China,RLDs are sourced from various origins,but their quality and market availability can be constrained by multiple factors,including emergent issues such as nitrosamine impurities.Five classes of medicinal products have been reported to be at risk for containing nitrosamine impurities:sartan-based medicines,metformin-containing products,ranitidine medicines,rifampicin medicines,and Champix.This paper explores the control strategies implemented by drug regulatory agencies in the United States and the European Union to manage nitrosamine impurities and assesses their impact on the market availability and quality of RLDs in China.The aim is to offer valuable insights for generic drug manufacturers and regulatory bodies both domestically and internationally.
基金Carry out quality evaluation research of generic medicinal product control based on domestic product,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing,China。
文摘The Approved Drug Products with Therapeutic Equivalence Evaluations(commonly known as the Orange Book)includes the products approved by Food and Drug Administration(FDA)to be marketed in the USA,and it is an essential source for the selection of suitable reference listed drugs(RLD)for a chemical generic medicinal product.The Orange Book assigns a therapeutic equivalence(TE)evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection.In the present study,we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example.As a result,it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product,which can improve the probability of success of clinical bioequivalence(BE)test and reduce the risk of generic medicinal product development.
