Security of Pharmaceuticals - Comparing US and EU Standards

Both the FMD as well the DSCSA require inspection systems with the ability to print serialized 2D codes to verify them and which can handle communication with a centralized database/ERP system. Manufacturers who make their production lines fit both the requirements of US serialization from 27 November 2017 as well as the EU's FMD requirements from 9 February 2019 will be in a position to comply with the pending 2023 DSCSA specifications.

Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, with 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain. These new legal frameworks have been introduced to combat this global threat.

This white paper describes the legal frameworks adopted by the European Union and the United States and the resulting requirements for pharmaceutical companies. It provides practical tips on best practice for coding, production processes, packaging design and data infrastructure.

In addition, the white paper compares the similarities and differences between the FMD and the DSCSA in the following areas:

  • Tamper protection
  • Supply chain documentation
  • Three-pronged security design
  • Data matrix codes, product identifiers & SNI
  • Protection against counterfeiting
  • Management of serialization data
  • Aggregation