The European Medicines Agency and the European Commission published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries.
The rule, which takes effect February 2019, mandates that manufacturers include a bar code as a unique identifier and an anti-tampering device in the packaging of most medicines.
Last month’s regulation also specifies interim compliance guidance for drug companies with existing or new marketing applications in the EU.
The regulation was hardly a surprise. Five years ago the EU issued its Falsified Medicine Directive, and today’s action is part of the implementation of that directive. “The EU requirements have been expected and most manufacturers that sell products in Europe have been waiting for the delegated acts to be published,” Bill Fletcher, managing partner with Pharma Logic Solutions said.
However, the compliance effort could prove costly for drug manufacturers. Eli Lilly, for example, has committed more than $100 million to keep compliant with emerging track-and-trace standards in Europe and the United States. Many pharma firms are expected to outsource tasks dealing with specific track-and-trace requirements, such as placing bar codes and anti-tampering devices on drug packages, now required by the EU.
Global drugmakers face several challenges in complying with the new rules, according to Fletcher. For example, the addition of a tamper-evident seal may impact the space available for traceability information because the seals compete for space on the carton, he notes.
In addition, drug manufacturers now must manage the allocation of serial numbers for more products and deal with related serialization information, including serialized child-to-parent aggregation.
Manufacturers also must supply information to a regulatory database. However, most commercial off-the-shelf serial number management systems include an option to post data to regulatory systems, and vendors will have more than enough time to respond to the new requirements with updates to their systems.
In the United States, the FDA also has been extremely concerned about counterfeit, contaminated, and illegal drugs, and has published guidance for pharmaceutical manufacturers on track-and-trace issues following passage of the Drug Supply Security Act of 2013. The FDA’s track-and-trace regulation will be rolled out in stages, starting in 2017. At that time, information will need to be tracked at the product lot level.
“The EU’s package requirements are substantially equivalent to traceability labeling and machine readable symbol requirements in most other countries, including the United States,” Fletcher says. However, data reporting mandates are very different in the United States, where each trade requires the exchange of a transaction document comprised of transaction information, transaction statement, and in some cases, a transaction history. The EU model is similar to the Turkish model, where traceability information is posted by the manufacturer into a state-controlled central database and items are verified when dispensed in pharmacies or hospitals.
More than 150 countries will require pharma track and trace regulations over the next 10 years. Order our webinar Preparing for Global Track & Trace Regulations and hear from track and trace expert Bill Fletcher of Pharma Logic Solutions tackle the numerous issues and misconceptions surrounding new track and trace requirements.