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The APEC Medical Products Supply Chain Security Toolkit Goes Live

Rx-360 teams with FDA and countless international regulatory authorities culminating in an amazing five year project that took thousands of expert hours; selflessly benefiting regulatory authorities, industry, and most importantly, patients across the globe.

The collaboration created and launched the “The APEC Supply Chain Security Toolkit for Medical Products” led by FDA’s CDER Deputy Director, Office of Compliance, Ilisa Bernstein. The Toolkit is a compilation of the various toolkits from the ten working groups that were established as part of the APEC Roadmap for Medical Product Quality and Supply Chain Integrity initiative.

As explained within the Supply Chain Security Toolkit, “Member economies of the Asia Pacific Economic Cooperation (APEC) and non-APEC economies alike are adversely impacted by the international movement of substandard and falsified (S&F) medical products. As the medical products industry has become more globalized and specialized, economies must increasingly rely on the global marketplace to provide the medical products needed to keep citizens healthy and ensure that access to legitimate products is not disrupted. In an effort to address this modern issue, regulators, industry stakeholders, representatives from non-governmental organizations, international organizations, and academics from across the globe have come together as members of the “Roadmap to Promote Global Medical Product Quality and Supply Chain Security” (“Roadmap for Supply Chain Security”) project, a collaborative multi-year project commissioned by APEC with oversight by its Life Science and Innovation Forum (LSIF) and the Regulatory Harmonization Steering Committee (RHSC). This work culminated in the development of this Supply Chain Security Toolkit. The Supply Chain Security Toolkit is intended to cover the entire supply chain and life cycle of medical products (i.e. raw materials to use by patients) and focuses on developing— and implementing through training programs— processes, procedures, and tools directed at enhancing global medical product quality and supply chain security. The Supply Chain Security Toolkit contains recommended best practices and tools to prevents and detect S&F medical products before they reach the consumer and to efficiently respond to incidents involving S&F medical products.

Comprehensive product quality and supply chain security requires a multilayer approach that includes prevention, detection, and response strategies and actions. The Supply Chain Security Toolkit is a comprehensive resource that addresses areas of vulnerability in the medical product supply chain. It contains recommended best practices and tools to prevent and detect S&F medical products before they reach the consumer and to efficiently and effectively respond to incidents involving S&F medical products. This section highlights the utility of the toolkit in the prevention, detection, and response of S&F medical products.

In addition, the Supply Chain Security Toolkit can be used in conjunction with the World Health Organization’s (WHO) guidance on developing a national plan for preventing, detecting, and responding to actions, activities, and behaviors that result in S&F medical products.”