Evolving World of Pharma: Navigating the choppy waters of serialization

A few months ago I explained that serialization was becoming an essential offering in Europe or the United States (US). Since then, the US Food and Drug Administration (FDA) has enforced its deadline for manufacturers to apply a serialized product identifier on drug packages as part of the Drug Supply Chain Security Act (DSCSA). The European Union’s deadline to have a similar serialization process in place has also since passed, as of February this year. This means that anyone who deals with the US or Europe should now have their processes for compliance be in place. The new regulations demand a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain.

Despite strong buy-in from industry (a KPMG survey in 2017 suggested that 70% of industy leaders in the US believed serialization would positively transform their business processes), it needs to be acknowledged that the complexity of these serialization projects has been high, and their influence on previously existing procedures probably cannot be underestimated. It has required analysis and standardization of processes, many of which have needed to be tailored to individual production and packaging requirements. Perhaps most importantly, financial and other resources have presented a barrier to many companies, as serialization has required significant investments in new technologies.

Commenting especially for this column, Chris Nerreau, Area Sales Manager of Laetus in North America, offered some first-hand insight into the situation, saying: “The DSCSA law has impacted our customers by adding complexity to their production lines and data management, and affecting their packaging design by adding additional information to the package itself. However, their products are now traceable, more visible throughout the supply chain. This has a positive impact and provides a cost-saving benefit in the event of a recall. This traceability has secured our customers’ product integrity and reputation.”

But we haven’t reached the end of this journey. Subsequent DSCSA deadlines will impact wholesale distributors (November 2019) and dispensers (November 2020) and, from 2023, full unit level traceability – including aggregation – will be mandatory in the US. Moreover, the EU and US are not alone in introducing new track and trace laws and regulations to help secure pharmaceutical products supply around the world. Either already in place, pending or still in development, a large number of directives developed in different individual countries have (or will have) differing scopes, formats and requirements, resulting in a wide variety of factors to be considered by the truly international trader.

For example, a little known fact is that Turkey was one of the earliest adopters of serialization, and is listed among several countries (other than the EU and US) that already require a track and trace system for pharmaceutical products. These countries include Argentina, China, Iceland, Iran, Japan, Norway, Saudi Arabia, South Korea and Switzerland. Antibiotics and anti-malaria drugs are serialized in Nigeria. Pakistan will be implementing pharmaceutical serialization in December 2019, and Jordan will see it become a legal requirement in January 2020. Brazil has plans to introduce serialization in 2021.

This not an exhaustive list. As the saying might go, “other countries and serialization legislations are available”! But it demonstrates that, with hundreds of countries involved in the global pharmaceutical supply chain, and nearly 50 legislations in place or to come, compliance with pharmaceutical serialization is increasingly challenging. Different deadlines, different requirements for serialization, aggregation and coding, and any updates to existing directives, all combine to present a highly complex situation. One obvious example is China’s continued use of a 1D barcode, while most countries are now using a 2D data-matrix. Both China and Japan have mandatory requirement for bar-coding but are yet to introduce the requirement for data aggregation. In South Korea, aggregation is currently optional.

“The legal landscape for drug serialization is always changing which means long-term compliance is a two-fold challenge,” advises the team at Adents, a company created in 2007 specifically to develop software solutions for serialization. They continue, “Not only will you have to follow changes in the markets you currently cater for, but you will also have to be prepared to adhere to new legislations that are likely to come into place in markets not yet regulated.” 

Companies trading internationally need to be aware of serialization requirements in the countries to which they are exporting, and they need to be flexible and adaptable enough to accommodate any requirements posed by relevant directives. Of course, this has always been the case when dealing with different regulatory bodies, but now these companies also need to ‘future-proof’ their serialization equipment and technology to make sure they can be reactive when faced with new legislations or expanding into new markets.

Also by Dr. Harding: Serialization Will Be An Essential Offering For Any Companies in EU or US

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and has more recently taken up the role of Editorial Director at Chemicals Knowledge. She continues to also provide independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

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