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The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.
FDA and the United States Pharmacopeia cosponsored the APEC Medical Product Supply Chain Dialogue event from April 25–26, 2023. The event, which was conducted both in-person and virtually, featured a range of topics regarding the medical products supply chain in the Asia-Pacific region and worldwide. Experts from FDA, USP, the World Health Organization, various regulatory bodies, industry, and academia spoke about vulnerabilities in the supply chain including the pandemic, elemental impurities, and ingredient quality, as well as a variety of proposed solutions to strengthen the supply chain.
On Wednesday, pandemic preparedness was discussed by representatives of Chile’s Institute of Public Health, Duke-National University of Singapore Centre, the Brazilian Health Regulatory Agency, and Peru’s General Directorate of Medicines, Supplies and Drugs.
John CW Lim, executive director, Duke-National University of Singapore Centre of Regulatory Excellence; chairman of Consortium for Clinical Research & Innovation Singapore; and chair, USP Asia Pacific Regional Chapter, stressed how the pandemic highlighted the importance of real-world data and that new technologies should define how the industry moves ahead. He also discussed the importance of having the patient’s voice in decision making and involving stakeholders from all economic areas.
Lim’s talk echoed similar comments from other experts: communication and collaboration are key in securing the supply chain. Regulatory authorities must continue to work together and involve all sections of government in decision making. The importance of trust was a common theme in the talks.
In a Wednesday afternoon session, “Safeguarding Patients from Impurities in the Drug Supply Chain,” Jason Bunting from FDA’s Center for Drug Evaluation and Research (CDER) and Gary Condran, manager, Quality Risk Management and Operations Division, Bureau of Pharmaceutical Sciences, Pharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada, gave some background and an update to the nitrosamines contamination problem. One takeaway from this discussion was how complicated and ongoing the problem is, with regulators and industry continuing to work on better testing, monitoring, and risk assessment in pharmaceutical manufacturing. Manufacturers must look at their process and products and assess risks with help by regulators and pharmacopeias. They also need to look at potential compounds they might create, and if they are a safety risk, according to the panelists.
Once again, the overall theme of these discussions focused on harmonization, information sharing, and communication to address the various supply chain problems. The pandemic and the nitrosamines problem have highlighted the importance of working together.
For more information on the event, visit USP.org.