March / April 2017

Regulatory Changes Affecting Pharma Supply Chain

Scott Fotheringham, PhD

The global nature of the supply chain has meant that pharmaceutical manufacturers have to adhere to a hodgepodge of regulations in the diverse regions in which they operate. Efforts to harmonize standards and inspection procedures between countries continue, most notably with ICH. All this is aimed at protecting consumers from products that are illegitimate, substandard, counterfeit, or unapproved, as well as maintaining the integrity of the supply chain. Here are some of the ongoing changes affecting supply chain compliance.

DSCSA In the United States, the 2013 Drug Supply Chain Security Act created an electronic system to identify and trace drugs down to the level of the individual package. Provisions related to this act continue to be rolled out by the US Food and Drug Administration, including product identification, lot-level product tracing, the establishment of systems for the verification and handling of suspect or illegitimate product, and confirmation that trading partners are licensed.1

FMD The 2011 Falsified Medicines Directive of the European Union (EU) has mandated implementation of a track-and-trace system using identification codes on individual packages-a 2D barcode—as well as antitampering devices on products by February 2019. It requires serialization at the point of manufacture and verification at point of sale by dispensers. Risk-based verifications at the wholesaler level will occur for products at greater risk of falsification, which is different than the tracking of packages at every transaction that will be required in the United States.2

In the United Kingdom, the Secretary of State for Health said he believes the nation will not be part of the European Medicines Agency (EMA) or the EU’s drug regulatory framework post-Brexit.3 As the UK Medicines and Healthcare Products Regulatory Agency makes significant contributions to EMA research, however, it is likely that the two authorities will continue to work together closely.

SNCM In 2016 a revised version of Brazil’s National Drug Control System legislation set a timeline to bring drug product traceability to the country. While the process is moving more slowly than officials anticipated, the aim is to mandate a national track-and-trace system in the next few years.4

  • 1US Food and Drug Administration. “Drug Supply Chain Security Act (DSCSA).”
  • 2European Commission. Public Health. Medicinal Products for Human Use. “Falsified Medicines.”
  • 3FiercePharma. “The Top Three International Regulatory Compliance Challenges.” 9 January 2016.
  • 4Summerfield, J. “UK to Seek Close Relationship with EMA Post-Brexit.” Hogan Lovells Focus on Regulation. 27 January 2017.