RECENTWestern media reports blaming China for the flood of counterfeit malar- ia drugs sent to Africa have once again highlighted a major health problem on the continent. Malaria remains the main cause of death for c...RECENTWestern media reports blaming China for the flood of counterfeit malar- ia drugs sent to Africa have once again highlighted a major health problem on the continent. Malaria remains the main cause of death for children under five in Sub-Saharan Africa. and costs the continent an estimated $12 billion in lost productivity each year. Counterfeit anti-malaria medicines are contributing to deaths across the world and also leading to drug resistance - putting billions of people at risk. According to a World Health Organization （WHO） study, an estimated one third of the drugs used worldwide to combat malaria are substand- ard. This is a critical problem, particularly serious in Africa. where Tanzania and Uganda have the highest number of malaria cases in the world.展开更多
The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“swi...The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.展开更多
In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Count...In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.展开更多
文摘RECENTWestern media reports blaming China for the flood of counterfeit malar- ia drugs sent to Africa have once again highlighted a major health problem on the continent. Malaria remains the main cause of death for children under five in Sub-Saharan Africa. and costs the continent an estimated $12 billion in lost productivity each year. Counterfeit anti-malaria medicines are contributing to deaths across the world and also leading to drug resistance - putting billions of people at risk. According to a World Health Organization （WHO） study, an estimated one third of the drugs used worldwide to combat malaria are substand- ard. This is a critical problem, particularly serious in Africa. where Tanzania and Uganda have the highest number of malaria cases in the world.
文摘The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed,including the process of approval for generic drugs,bioequivalence issues including“switchability”,bioequivalence for complicated dosage forms,patent extension,generic drug safety,generic substitution and low-cost generics.The backlog in generic review,generic drug user fees,and“quality by design”for generic drugs is also discussed.The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.
文摘In order to assure the safety and efficacy of the Chinese Medicines in Europe, the quality of TCM herbals should be guaranteed so that they can be freely imported in the European Union and other Western European Countries which are signatories of the European Pharmacopoeia Convention. Consequently, new Ph Eur TCM herbal drug Monographs should be elaborated, based on preexisting Monographs in the Chinese Pharmacopoeia(Ch P) 2010.Such a program has been inaugurated in 2005 by the Ph Eur Groups of Experts 13 A and B(Phytochemistry). Since then good progress has been made, elaborating of about one third of the originally proposed 100 TCM herbals being identified as important monographs for the European Market. Taking into account the many challenges still laying ahead, the establishment of a specialized Working Party(WP) on TCM with specialists and experts from many EU Member States has been decided by the Ph Eur Commission in 2008 which is highly active ever since in the examination and elaboration of new TCM herbal drug monographs, primarily to assure the safety of the European patient and further to provide quality parameters extremely important for all registration and licensing procedures of the respective National Authorities all over Europe.This paper is a survey of results and difficulties obtained so far which has been encountered meanwhile in the elaboration process by the Ph Eur TCM WP of these monographs and will discuss these in detail. Moreover the role of Ph Eur TCM monographs in the European community is addressed.
