All the below research is free to download to members of the public and can be disseminated and used without restrictions. We ask that whenever using our materials please provide a full reference to the relevant document, authors and publisher.<\/p>\n
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![\"\"](\"reports\/Generic_drugs_appraisal_and_approval_US_Final.png\")
<\/a>\nNov 2016<\/b><\/p>\n<\/div>\n
Generic Drugs Appraisal and Approval<\/b><\/h3>\n
Departing from the \u2018one-size-fits-all\u2019 approach<\/b><\/p>\n
Generic medicines \u2013 follow-on versions of off-patent innovative medicines \u2013 are designed to be interchangeable to the innovative reference product. As more sophisticated and complex medicines are developed, securing the safe and effective use of their follow-on products becomes increasingly challenging.
\nThis report zeroes in on the existing gaps and challenges within the \u2018one-size-fits-all\u2019 model of generic drugs approval vis-\u00e0-vis two particularly complex drugs: Narrow Therapeutic Index (NTI ) drugs \/ Critical Dose drugs and Non-Biologic Complex Drugs (NBCDs). <\/p>\n
The report examines current drug regulations in seven drug regulatory authorities from both developed and emerging markets including the FDA and EMA. <\/p>\n<\/div>
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<\/a><\/p>\n Maintaining International Quality and Safety Standards in the Manufacturing and Supply of Active Pharmaceutical Ingredients<\/b><\/p>\n Authored by Professor Meir Pugatch, Dr. David Torstensson and Ma\u2019ayan Laufer this report provides a deep-dive analysis of the next generation of challenges facing drug regulators across the globe.<\/p>\n Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span \u2013 from test tube to patient. As biopharmaceutical products are now manufactured and assembled through a complex global assembly line with numerous different suppliers, drug regulators are becoming cognizant of a new reality: ensuring high standards of quality is not just about monitoring and testing the safety of a finished product but also screening and monitoring the safety and quality of its key ingredients wherever in the world they are sourced and\/or manufactured.<\/p>\n Overall the report finds that the API manufacturing and pharmacovigilance environment in the two largest producing countries, China and India, is currently lacking with regards to both the presence of adequate GMP and pharmacovigilance regulations as well as their enforcement. Analysis of both FDA and EMA warning letters show significant problems relating to quality control and integrity of API manufacturing in India and China. This is particularly worrying as foreign inspection rates by the FDA and EMA are far behind equivalent inspection rates within the US and EU. In practical terms it means that drug regulators in purchasing markets must now actively inspect and have a presence outside their respective legal jurisdictions. <\/p>\n <\/a> Labeling, Packaging and Pharmacopeia Standards<\/b><\/p>\n This report provides a deep-dive analysis of the next generation of challenges facing pharmacoviglance regulators. <\/p>\n <\/a> New Report On the Monitoring of Safety of Medicines<\/b><\/p>\n Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span \u2013 from test tube to patient. As patients and healthcare professionals around the world access and use more biopharmaceutical products and technologies, the importance of maintaining and, in many cases, introducing and applying comprehensive pharmacovigilance regulations only increases.<\/p>\n<\/div> What it takes for patient associations to help shape public policy<\/b><\/p>\n This paper seeks to understand the environment in which patient associations emerge and play an active part in healthcare policy making, both theoretically and in practice, in a number of emerging markets. The first half of the paper identifies and examines the optimal group characteristics and external environment in which patient organisations develop and take part in the policy making process. The second half of the paper examines the existence of these factors in seven key emerging and growth markets: Argentina, Brazil, China, India, Mexico, Russia, and Thailand.<\/p>\n Overall, Brazil and Thailand have the most conducive environments compared to the five other countries examined. Russia has a formal structure in place to incorporate patients\u2019 viewpoints, however is deficient in ensuring patient organisations\u2019 seat at the table and has not enshrined patients\u2019 rights into legislation. Argentina, China, India and Mexico were found to have deficiencies in their environments and being the least conducive to the inclusion of the patient voice in health policy.<\/p>\n This paper is also available in Portuguese.<\/p>\n<\/div>![\"\"](\"reports\/frontier.png\")
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\n<\/div>\nThe Next Frontier in Ensuring the Quality of Medicines<\/b><\/h3>\n
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\n<\/div>\nThe Evolution of Pharmacovigilance<\/b><\/h3>\n
\nPharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span \u2013 from test tube to patient. As patients and healthcare professionals around the world access and use more biopharmaceutical products and technologies, the importance of maintaining and, in many cases, introducing and applying comprehensive pharmacovigilance regulations only increases.<\/p>\n<\/div>
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\n![\"\"](\"reports\/pharmacovigilance.png\")
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\n<\/div>\nDeveloping a Culture of Pharmacovigilance<\/b><\/h3>\n
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\n![\"\"](\"reports\/Patient_Power_Final_1.png\")
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\nEnglish Version<\/b>
\n<\/div>\n![\"\"](\"reports\/Patient_Power_Final_1_PT.png\")
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\nPortuguese Version<\/b>
\n<\/div>\nPATIENT POWER<\/b><\/h3>\n
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![\"\"](\"reports\/Keeping_Medicines_Safe_Final_Draft_2010.png\")
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