Pharma Supply Chain Security


The law established a 10-year roadmap with enforcement and adaptations in 2015 and 2018 related to Product Tracing, Product identifiers, Authorized Trading Partners, and Verification.   The last section of the law, Electronic Drug Distribution Security (EDDS). Among other things, EDDS directs all trading partners to have in place a secure, electronic, and interoperable system for the exchange of transaction documentation [transaction information (TI) and transaction statements (TS)] to enable the tracing of prescription medications.



The ineffective management of supply chains by manufacturers and distributors has allowed counterfeiters and smugglers to evolve rapidly and become very creative and excel in producing counterfeit medicines and inserting them into the legitimate supply chains, meaning that many fake medicines go undetected. To counter this issue, global organizations, such as the World Health Organization (WHO), the European Union (EU), and the US Food and Drug Administration (FDA), work together to reduce the incidence of fraud and to protect the safety and security of patients


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