In the context of the 2030 target for UHC for all, the World Health Organization recognizes that traceability systems and technologies could be leveraged to ensure the integrity and efficiency of supply chains. However, outstanding questions remain for WHO Member States on the implementation of existing standards and approaches, as well as on an appropriate governance in terms of data (use and ownership).
In 2019, WHO convened a drafting group of regulators, gathered in the framework of the Member State mechanism on substandard and falsified medical products, to develop a normative guidance on the establishment of traceability systems and on the policies needed at national and regional levels. In the long term, it is hoped that the harmonized approaches and management of product data can help facilitate improved functioning of supply chains.
A draft “Policy brief on traceability of health products” has been published for public comment by 28 February 2020. Please note that the transparency of received feedback may be considered, unless confidentiality is specifically requested.
A final version of this policy brief will be submitted to the 9th meeting of the Member State mechanism on substandard and falsified medical products which will take place the week of 26-30 October 2020. For the benefit of all, the draft policy brief will be made available until it is finalized and adopted.
It should be noted that this work is being conducted in parallel with the planned guidance developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) on interoperability of T&T systems. The mapping of the existing national or regional traceability systems and the glossary attached to the WHO Policy Brief will be developed and fully identical for both WHO and ICMRA guidance.
Comments (see the table for comments below) on the draft “Policy brief on traceability of health products” should be sent to Diana Lee, Technical Officer, Incidents and Substandard/Falsified Medical Products Team at [email protected] by 28 February 2020.
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