Since 2012, the Argentinian regulatory body, ANMAT, has been in the process of rolling out a phased implementation of its traceability system to record serialized drug products and the sale or exchange of these drugs.
Brazil’s serialization track and trace regulation landscape is one of the most complex in the world. Legislation passed in 2013 called for a phased rollout of requirements unique to this country.
China has announced that current drug track and trace regulations have been suspended. Prior to the suspension announcement, China was in its last phase of rolling out requirements for all drugs, an initiative that began in 2007 with a shortlist of applicable drugs, and was scheduled to include all drugs as of 2015.
With the publication of the Delegated Act on safety features, a key part of the Falsified Medicines Directive (FMD), the European Union has recently issued track and trace regulations with an expected rollout by 2019.
India’s Directorate General of Foreign Trade (DGFT) has mandated track and trace regulations for products exported from the country. The phased rollout of these requirements was completed as of October 2015.
Saudi Arabia has a planned implementation of serialization requirements for rollout by early 2017. Requirements are based on GS1 standards.
South Korea’s serialization requirements cover 100% of pharmaceutical drug products. The goal is to achieve compliance for all medications in 2016, with full reporting requirements rolled out by 2017.
Mandates for serialization and tracking in Turkey began with rollout of its initial scheme in 2010.
The US FDA has commenced a comprehensive multi-phase serialization & track and trace rollout taking place between 2015 and 2023. The first phase of the Drug Supply Chain Security Act (DSCSA) is in effect and the next DSCSA phase (Item Serialization) increases complexity significantly.