Monitoring and Improving Medicines Quality through AMR National Action Plans

Meeting Organizer

U.S. Pharmacopeia

Thailand FDA and DMsc and USAID

Contact Person : Katherine Bond,

29 January 2018
09:00 - 17:30 hrs.

Closed Meeting Invitation Only


The political declaration of the high-level meeting of the UNGA on AMR notes “with concern that the fulfilment of the right to the enjoyment of the highest attainable standard of physical and mental health, as well as access for millions of people to health services and to quality, safe, efficacious and affordable antimicrobial medicines, food, clean water and a healthy environment, remain a distant goal, especially in developing countries.” Furthermore, the declaration recognizes that the keys to tackling AMR include “promoting access to existing and new quality safe, efficacious and affordable antimicrobial medicines.” AMR is driven, in part, by pathogens being exposed to sub-therapeutic doses of medicines, which may be caused by several factors, including: • Treatment errors by healthcare professionals • Non-adherence by patients to appropriately prescribed treatment regimens • Medicines supply interruptions for diseases requiring long duration of treatment • Taking poor quality medicine Poor quality medicines could result from products being produced under high quality standards but degraded due to inappropriate storage or distribution (i.e., supply chain issues), or products being produced under low quality standards, whether inadvertently (i.e., through negligent practices of a registered manufacturer) or intentionally (i.e., through gross negligence of a registered manufacturer or fraud/falsification by an unregistered manufacturer). Regardless of the root cause, medicine quality concerns abound. In fact, 8.4% of medicines in low-and middle-income countries failed a basic quality test, according to a 2015 evaluation of over 1,000 medicines . The framework for National Action Plans for AMR under Objective 4 - “Optimize the use of antimicrobial medicines in animals and humans” – suggests several actions that refer to effective and enforceable regulation, governance, licensing, distribution, use and quality assurance of antimicrobial medicines, and guidance with respect to defining essential medicines lists. It also refers to WHO and Member State actions to support the development and enforcement of relevant regulations and support to strengthen regulatory systems at the national and regional levels. A core component of the regulatory system to address quality assurance is medicines quality monitoring and surveillance. While the National Action Plan framework refers to strengthening surveillance of resistant pathogens, it does not explicitly point to the need for systems to monitor medicines that may contribute to resistance due to poor quality. Strengthening medicines quality surveillance in the context of AMR will have multiple benefits: 1) increasing evidence on the scope and scale poor quality antimicrobials in the supply chain and market; 2) removal of substandard and falsified medicines from the market place; and 3) shining a spotlight on other weaknesses in the quality assurance system. Stronger medicines quality monitoring systems will have wide-reaching benefits to anti-microbial stewardship as well as other health initiatives that rely on the delivery of quality-assured products.


• To review the status of medicines quality assurance in the context of AMR National Action Plans • To share best practices among national medicines regulatory authorities and national AMR response teams in incorporating medicines quality assurance, including surveillance, into their national action plans on AMR.