Regulators, a notable presence at the conference, included the U.S. Food and Drug Administration (FDA), Food, Medicine and Health Care Administration and Control Authority (FMHACA) of Ethiopia, Turkey’s Ministry of Health and the Brazilian government’s health agency (ANVISA).
In collaboration with governments, manufacturers are seizing the significant opportunity presented by regulations worldwide— and with that improving safety and quality of care for patients worldwide.
Presentations about the U.S. FDA’s Drug Supply Chain Security Act (DSCSA), the European Union’s Falsified Medicines Directive (FMD) and Brazil’s pharmaceutical legislation highlighted progress towards improving supply chain security and achieving traceability of pharmaceuticals to combat counterfeiting.
Review the DSCA presentation
Review the FMD presentation
Review the Brazil pharmaceutical traceability presentation
Director General Yehulu Denekew with Ethiopia’s FMHACA presented the country’s five-year strategy to transform its healthcare sector where 80% of medical products are imported. A planned pilot will leverage GS1 standards for full traceability and the verification of malaria medicines entering the Ethiopian market.
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Global pharmaceutical manufacturers, distributors and a retail pharmacy chain—AmerisourceBergen (ABC), Johnson & Johnson, McKesson and CVS Health—candidly shared their multi-disciplinary strategies for product serialisation and interoperability. They are standardising best practices to make continuous progress towards regulatory and process compliance.
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