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The Next Frontier in Ensuring the Quality of Medicines: Maintaining International Quality and Safety Standards in the Manufacturing and Supply of Active Pharmaceutical Ingredients

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Today Pugatch Consilium launches The Next Frontier in Ensuring the Quality of Medicines: Maintaining International Quality and Safety Standards in the Manufacturing and Supply of Active Pharmaceutical Ingredients. Authored by Professor Meir Pugatch, Dr. David Torstensson and Ma’ayan Laufer this report provides a deep-dive analysis of the next generation of challenges facing drug regulators across the globe.

Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span – 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.

Building on and complementing the earlier work of Pugatch Consilium including the 2014’s Developing a Culture of Pharmacovigilance and the 2015’s The Evolution of Pharmacovigilance, this report examines some of the major gaps & challenges in the areas of manufacturing and supply of Active Pharmaceutical Ingredients (APIs). The report provides a thematic discussion of these areas, the new pharmacovigilance challenges they pose and the different policies and actions taken by major DRAs in addressing (or not fully addressing) these challenges.
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. However, recent legislative developments within the two leading stringent DRAs – the FDA and the EMA – suggest that divergent paths are being taken.

It is equally imperative that medicines and APIs exported from manufacturing countries to developing country markets as well as produced for local consumption meet the highest international quality standards. Simply put if stringent regulatory authorities and their counterparts in India and China can successfully build on existing efforts of cooperation and harmonization it is possible that international standards of quality manufacturing can be more firmly anchored within existing national and regional regulatory frameworks. By examining the highest standards and best practices in place internationally the report assembles a ‘Gold Standard’ for API manufacturing and pharmacovigilance.

To access the report please use the below link: The Next Frontier in Ensuring the Quality of Medicines is available here


About the Author:

Amir specializes in the semiconductor industry, both in hardware and software spanning multi and cross market experience in Mobile, Security, Consumer Electronics, Embedded, Telecom, e-Commerce and Military segments. Amir has held senior management roles at a number of organisations and his skills have been utilised to lead and establish new business, integrate new technology and developed measurable outcomes for success with emerging new companies. Amir’s work is international and he had an extensive experience with the North American, European, Asian and the Middle East markets.
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