First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...
In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System.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...
A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:
From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson. The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.
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.
It’s difficult to keep up to date on all the milestones and requirements of the Drug Supply Chain Security Act (DSCSA). Because the law contains 10 years’ worth of deadlines and detailed requirements for every segment of the supply chain, it’s easy to get lost and miss what your company should be working on now. Fortunately, most companies need only focus on what is coming up next, while keeping an eye on the long-term requirements. Toward that end, Systech has just introduced the first...
President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia. It establishes January 1, 2020 as