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Strategies for clearing Backlog of marketing authorization applications

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  • Create Date February 9, 2022
  • Last Updated February 15, 2022

Strategies for clearing Backlog of marketing authorization applications

The Pharmacy and Poisons Board on a daily basis receives a number of new applications for marketing authorization of Health Products and Technologies. However, the Board, just like any NRA in low to middle income country, does not have sufficient capacity in terms of expertise and financial resources to fulfil core regulatory function of timely

marketing authorization have a direct bearing on access to HPTs and consequently impact on public health.
Due to the increasing number of medicine applications being received, it has become necessary for Pharmacy and Poisons Board to come up with mechanisms to clear its applications for marketing authorization backlog. PPB needs to develop a detailed strategy to clear the backlog of marketing authorization applications for Health products including human medicines, medical devices, nutritional supplements and borderline products which are yet to receive final approval or verdict.

Given the magnitude of pending marketing applications for health products and technologies that dates back to 2015 and beyond, if PPB maintains the current capacity and current processes, it would take several years to clear the backlog – assuming no new applications are received.

The Strategies for clearing backlog of applications for marketing authorizations provide mechanisms that can be used by Pharmacy and Poisons Board to clear pending backlog.

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050_HPT_PER_GUD_Strategies_Clearing_Backlog_Marketing_Authorization_Applications.pdfDownload

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