International – WHO drafts recommendations for regulatory reliance

The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making aimed at increasing efficiency and allowing regulators to focus their efforts on critical activities.
 
The draft guideline applies to regulatory activities for a range of medical products, including drugs, vaccines, blood/blood products, medical devices and in vitro diagnostics, and covers the total product lifecycle for those products.
 
“This principle enables leveraging the output of others whenever possible while placing a greater focus at the national level on value-added regulatory activities that cannot be undertaken by other authorities, such as in-country vigilance activities and oversight of local manufacturing and distribution,” WHO says, noting that, “Regulatory systems can be very resource-intensive.”…