Pharmaceutical serialization has been looked upon as a panacea for the rampant global issue of counterfeiting. Now that enforcement data has become available on the US Drug Supply Chain Security Act (DSCSA) and EU Falsified Medicines Directive (FMD), it’s time to analyze the results. Has serialization put an end to counterfeiting?
Spoiler alert. According to the EU IP Office, pharmaceutical counterfeiting has not slowed down but is a growing threat.
Serialization was introduced by governments as a mechanism to protect the pharmaceutical supply chain over 10 years ago. Major serialization mandates in the US, EU and other regions are now live. Now is a good time to reflect back on this massive undertaking and review some “lessons learned”. We say this because serialization isn’t “over” in pharma.
In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System. Chinese versions of the drafts are available now but the agency is requesting feedback from stakeholders and the public to be submitted by September 20, 2018. Final versions are likely to appear soon after that.
In 2017, the largest market for pharmaceuticals—the United States—delayed enforcement of their key pharma serialization requirement. The revised deadline for serialization and verification here is November 27, 2018, one year later than originally specified by Congress in the Drug Supply Chain Security Act. A few months before that delay was announced, Brazil withdrew their entire regulation, changed their law, and published a more reasonable timeline that would result in full serialization by...
Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019. If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.
The EU FMD deadline of Feb 9, 2019 is approaching fast, with only a year of implementation time left. While big pharma has largely implemented serialization, medium and small manufacturers, as well as CMOs and virtual pharmas, are lagging in beginning their implementation. Knowledgeable integration help is in short supply, as is associated hardware. The newly signed serialization regulation for Russia’s pharmaceutical market adds to the workload in EMEA.
The EU Falsified Medicines Directive (FMD) deadlines are now live. It is now time to reflect on this massive undertaking, and look at some “lessons learned”. We say this, because we are hearing grumblings in the field that serialization implementation projects are still ongoing. Additionally, the data integration requirements require live data connectivity to repositories like the EU Hub. Finally, when companies create new packaging lines, they will need to be equipped for serialization –...
GS1 Ireland and Enterprise System Partners (ESP) just published an interesting Serialization Industry Readiness Report 2017 . The report is based on their survey of drug manufacturers, CMOs, virtual manufacturers and others who will fall under the European Union Falsified Medicines Directive (FMD) when it goes into effect on February 9, 2019. The readiness survey was conducted between May and July 2017.
