TraceLink Publishes Full Analysis from the Global Drug Supply, Safety and Traceability Report, Industry’s Largest Survey on Life Science Companies’ Readiness for Serialization Deadlines
- Only one-third of the 146 respondents from pharmaceutical companies with U.S. Drug Supply Chain Security Act (DSCSA) requirements believe they are “very ready” for serialization, a regulation that went into effect in November 2017, which requires pharmaceutical companies to place unique identifiers, or serial numbers, on each saleable unit of product sold into the United States;
- Compared to their pharma counterparts, half of the 88 respondents from contract manufacturing organizations (CMOs) serving customers with DSCSA requirements believe they are “very ready” for serialization;
- In both the DSCSA pharmaceutical company and CMO groups that feel “very ready,” not one respondent has completed all of the necessary basic steps for serialization;
- For pharmaceutical companies and CMOs with EU Falsified Medicine Directive (FMD) requirements, only one-third of respondents believe they are “very ready” for their serialization deadline in February 2019;
- After applying the basic steps to serialization in the analysis, the report found that only 15 percent of the EU FMD respondents are truly ready for serialization;
- The report also found that one-quarter of wholesale distributor respondents and 11 percent of hospital and pharmacy respondents are “early movers” in serialization, due to their progressive serialization preparations and ability to be ready ahead of their respective DSCSA deadlines.