First WHO implementation workshop on regulatory evaluation of biotherapeutics including biosimilars in the African region

Overview

The first implementation workshop in the African region on WHO guidelines for biotherapeutics (BTPs) and similar biotherapeutic products (SBPs) was organized by WHO HQ in collaboration with the Ghana Food and Drugs Authority in Accra, Ghana in September 2015. The workshop was a step towards the implementation of the two guidelines into the regulatory practices of African regulatory agencies, and towards developing African national regulatory frameworks to meet current international regulatory expectations. By reviewing and practicing a case study on SBPs exemplified by erythropoietin, better understanding on the importance of head to head comparability studies was achieved. Pre-workshop preparation was achieved using an online platform. This interactive forum was seen as a stage that could be developed for future collaboration and possible work sharing in the region. Various approaches for immediate and long term regulatory capacity building were discussed as an issue of critical importance for the future.