New serialization legislation required for pharmaceutical products has the potential to transform how we think about pharmacovigilance and quality control, and help connect information relevant for these industry functions.
New serialization legislation, package-level identifiers and safety features
The Falsified Medicines Directive of 2011 introduces new harmonized, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. These new measures include:
Obligatory safety features on the outer packaging of the medicines (Commission Delegated Regulation (EU) 2016/161)\
A common, EU-wide logo to identify legal online pharmacies.
Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients,
And strengthened record-keeping requirements for wholesale distributors.
The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013.
Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, inter-operable system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain.
Historically the U.S. Pharmacopeia has worked to ensure their standards and General Chapters complement regulatory documents such as the FDA Title 21 of the Code of Federal Regulation Part 211 on current Good Manufacturing Practices. USP 1083 covers all areas of sourcing and distribution of packaging materials, active pharmaceutical ingredients, excipients and final products, including clinical trial materials. The guideline applies to not only pharmaceuticals, but also medical devices, combination products, and dietary supplements.
In March 2010, the FDA issued recommendations in the Standard Numerical Identifier (SIN) Guidance explaining the FDA’s current thinking on the structure, format, and content of uniquely labeled package-level identifiers. The guidance is intended to assist with the development of standards and systems for identification, validation, authentication, and tracking and tracing of prescription drugs at package level.