Tracking and Tracing Drugs and Vaccines: WHO Drafts New Policy

Regulatory NewsRegulatory News
| 10 February 2020 | By Zachary Brennan 

The World Health Organization (WHO) is seeking comments on a draft policy to help guide national regulators seeking to use international harmonized standards for creating systems to track and trace pharmaceuticals and vaccines through their supply chains.

The policy is part of efforts to help already stretched regulators minimize the risk of substandard and falsified (SF) medical products, shortages and expired products.

WHO discusses seven common features of traceability systems in the policy, including identifying the products, stakeholders and locations of production; using global standards (for pharmaceuticals, GS1 standards are currently the only international family of standards in wide use); batch-level traceability; unit-level serialization; data aggregation and verification.

On the aggregation of data, WHO notes that some countries mandate the collection and use of such data (e.g., Brazil, Pakistan and Russia), while others mandate actions by members of the supply chain that can only be accomplished efficiently when aggregation data is captured by the manufacturer or repackager (e.g., EU and US).

The draft also discusses what constitutes an appropriate regulation for traceability, noting that establishing voluntary pilots to test draft regulations before finalizing them can help to expose unexpected complexities, missing requirements and unnecessary steps.

“Whilst this policy brief aims to outline the features of existing traceability features and providing guidance on developing workable regulation, this remains only a starting point,” WHO adds.

And although this draft policy is not applicable to medical devices, as WHO notes that there are wide differences among the regulations and supply chains for pharmaceuticals and devices, a situation analysis is provided in the first appendix. WHO says a future iteration of this policy brief may include details on the traceability for devices.

Comments on the draft are due by the end of this month.

World Health Organization


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