The Asia-Pacific Economic Cooperation (APEC) is a regional economic forum established in 1989 to leverage the growing interdependence of the Asia-Pacific. APEC’s 21 members aim to create greater prosperity for the people of the region by promoting balanced, inclusive, sustainable, innovative and secure growth and by accelerating regional economic integration. ASOP Global is involved in the APEC Life Science Innovation Forum (LSIF). Under LSIF there is a Regulatory Harmonization Steering Committee that includes an Internet Sales Working Group.
APEC Supply Chain Security Toolkits
USFDA led a collaboration within Asia Pacific Economic Cooperation (APEC) economies under the Regulatory Harmonization Steering Committee to create a Supply Chain Security Toolkit for Medical Products to maximize available global resources and to deliver quality trainings and best practices and for securing the global supply chain for medical products. The toolkit covers the entire supply chain and lifecycle of medical products from raw materials to use by patients. It focuses on developing — and implementing through training programs — processes, procedures, and tools directed at enhancing global medical product quality and supply chain security. The following toolkits were developed. ASOP Global has a leadership role in developing the Toolkit to Combat Illegal Internet Sales.
- good manufacturing practices;
- good distribution practices;
- good import/export practices;
- clinical/retail pharmacy practices;
- product security;
- detection technology;
- internet sales;
- track and trace systems;
- surveillance and monitoring; and
- single points of contact.
APEC Supply Chain Centers of Excellence (CoE)
The toolkits will be used by industry stakeholders and regulators from around the globe to adopt best practices, for training purposes, and to strengthen laws and regulations to protect consumers from unsafe and substandard drug products. APEC Training Centers of Excellence for Regulatory Science (CoE) have been established to further training and use of the APEC Toolkits. APEC RHSC has endorsed the following two Centers of Excellence to conduct programs on medical product supply chain security a) United States Pharmacopeial Convention (USP) and b) the University of Tennessee Health Sciences Center (UTHSC).