Generic licences and treatment guidelines in place, but no registered products
According to SAHPRA, Gilead’s sofosbuvir products have not yet been registered due to the backlog of regulatory applications inherited from South Africa’s former regulatory body, the MCC. SAHPRA’s spokesperson, Yuven Gounden, explains that “with the establishment of the new health products regulator, processes were re-engineered and optimised, and a special programme was established for all product applications that remained in the pipeline of the previous regulatory body, the MCC”.
In June, the MPP raised this issue with SAHPRA in a letter seen by Spotlight. MPP Executive Director Charles Gore explains in the letter that daclatasvir “was originally developed by Bristol Myers Squibb under the brand name Daklinza, but the company has recently decided to cease production and will not be filing Daklinza for registration in other countries, including South Africa”.
“Where the first option is not feasible, and with motivation, SAHPRA will need the clinical data on which the now deregistered and forward-licensed innovator established its clinical safety and efficacy, in order to evaluate and establish the safety and efficacy of this now local innovator,” Gounden adds.
Either way, SAHPRA’s requirements have already disincentivised at least one generic manufacturer from trying to register in South Africa. A representative of a company whose generic daclatasvir product has been prequalified by the WHO, toldanonymously that the company had not sought registration of generic daclatasvir in South Africa due to “difficulties in registering the products in SA in absence of the originator’s products”.for the introduction and use of “reliance pathways” in July 2019.
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