The critical importance of quality for pharmaceutical medicines has never been more evident than it has been as the result of the COVID-19 public health crisis. Supply chains to bring quality medicines to patients have faced significant challenges, for example, the shutdown of certain manufacturing facilities, disruptions in transportation infrastructure and weaken urgent needs to find alternative sources of medicines. As a result, traditional approaches to bringing quality medicines to patients have undergone rapid change. Pharmacopeias, including the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP) have been working together on these critical issues facing medicine quality including setting specifications for wide variety of active pharmaceutical ingredients (APIs), formulations, excipients, and packages, as well as their standard test methods, with the goal to ensure that patients have trust in their medicines. USP and JP/the Ministry of Health Labour, and Welfare (MHLW)/Pharmaceutical and Medical Devices Agency (PMDA) have a long history of collaboration and cooperation, and have developed an effective working partnership in the contribution to global public health. As such, USP and MHLW/PMDA would like to promote a workshop on the topic of “Role of Quality in Pharmaceuticals” in East Asia including Japan by introducing our activities to ensure quality of medicines, the role we have played in the response to the current crisis and changes including global COVID-19 pandemic, and what this means for the future of the intersection of pharmacopeias, regulators, and industry in responding to a public health emergency, and how this may change our operations in the future.
Potential topics for the workshop include an analysis of supply chain vulnerabilities, and the roles that USP and MHLW/PMDA/JP can play in ensuring resilient supply chain. In addition, new and emerging areas for USP and MHLW/PMDA/JP collaboration may be explored, including examples such as Impurities Management, qNMR, and Biotechnological standards such as monoclonal antibodies and oligonucleotides. Furthermore, the workshop will explore ICH Quality Topics that intersect with USP and MHLW/PMDA/JP, specifically in the areas of Pharmaceutical Continuous Manufacturing, Analytical Method Validation, and Impurities (including mutagenic impurities).
USP and MHLW/PMDA look forward to your participation in our joint workshop!
MHLW, PMDA and USP /
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