THE Medicines Control Authority of Zimbabwe (MCAZ) has registered a total 202 pharmaceutical products and medicines over the past 12 months in a bid to expand treatment options for various diseases and health complications.
By Michael Gwarisa
According to MCAZ, 116 products were registered in 2020 while 86 were registered in 2021 while 34 medicines were rejected between 2020 and 2021. A total seven products were withdrawn under the same period.
In an Interview with HealthTimes, MCAZ Projects and Public Relations Officer, Mr Shingai Gwatidzo said some of the medications were rejected due to a plethora of reasons chief among them being failure to submit adequate data.
So far, 15 applications have been rejected in 2021. The reasons for rejection include (but not limited to not submitting adequate active pharmaceutical ingredient (API) information, failure to demonstrate stability of the active pharmaceutical ingredient (API).
“Failure to submit Inadequate pharmaceutical development information, unacceptable finished pharmaceutical product (FPP) specifications, poor control of the manufacturing process and failure to demonstrate stability (both accelerated and long-term stability data) also contributed to this development,” said Mr Gwatidzo.
He added that there have been delays in registering some of the medications as they also failed to submit good quality submissions by manufacturers resulting in multiple assessment review cycles.
“The authority asses submissions using the Common Technical Document (CTD) format and within this, it is expected that applicants provide adequate info ration to assure that their products meet the standards for safety and efficacy.”
Meanwhile, MCAZ has to date received only five applications from five COVID-19 vaccine manufactures and they have all been granted Emergency Use Authorization (EUA). These vaccines include Sinopharm, Sinovac, Sputnik V, COVAXIN and Johnson & Johnson (J&J).
