Drugmakers withdraw thousands of product applications
New regulator is tackling a huge backlog, some of it dating back to the 1990s, but it is struggling to attract a CEO
Pharmaceutical manufacturers have voluntarily withdrawn thousands of applications to register new products with SA’s medicines regulator, as the SA Health Products Regulatory Authority (Sahpra) seeks to clear the huge backlog it inherited when it replaced the Medicines Control Council last February. At the end of 2018 Sahpra estimated that it faced a backlog of 16,000 medicinal product applications, some of which dated back to the early 1990s. The backlog includes applications for new chemical entities, generic copies of older drugs no longer protected by patents and requests to make changes to formulations or suppliers of active pharmaceutical ingredients. Sahpra has worked with the pharmaceutical industry and external consultants to tackle the backlog while redesigning its systems to make sure it never happens again, said board chair Helen Rees. “We have to clear out the past and get it [Sahpra] fit for purpose. You can’t have a functioning regulator with a backlog of that s...