Strengthening the capacity of governments around the world to regulate biotherapeutics and biosimilars in the effort to increase patient access to high quality products will remain a key priority for the World Health Organization (WHO) in 2017.
Underpinning the increased focus WHO is placing on biotherapeutic product regulation and access are resolutions passed by WHO’s oversight body, the World Health Assembly, in 2014, directing WHO to assist member states in strengthening their regulatory frameworks [IPQ Dec. 17, 2015].
In the wake of the resolutions, WHO’s Expert Committee on Biological Standardization (ECBS) has been active in its international standards development and implementation program for new and similar biotherapeutics (BTPs/SBPs) as well as vaccines, and has a substantial project workload set for 2017.
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