Tag Archives: ICMRA

WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020.  The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates.  That pool of countries shrinks each year as more and more new mandates are announced, but considering the wide variations in the quality of the existing regulations, guidance aimed at those who would create new mandates is welcome.  Let’s take a look at the draft.

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Global Regulators Recommend Track & Trace Interoperability Features

Back in the fall of 2017 the International Coalition of Medicines Regulatory Authorities (ICMRA) published a paper containing recommendations for pharmaceutical product regulators around the world to consider for achieving future interoperability of national or market pharma track and trace systems.  That is, their recommendations were aimed at enabling interoperability between and among the various current and future pharma track & trace regulated systems around the globe.  For example, their recommendations could help the US FDA exchange and accept information from the European Medicines Verification System (EMVS), and vice versa.  In this way, regulators in each market could learn about problems with drug products circulating within each other’s markets.  Why would you want to do such a thing?  Let’s take a look at their 2017 paper.

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