Challenges of regulatory requirements on medicine registration in Zambia: perceptions of locally based pharmaceutical companies

The Zambia Medicines Regulatory Authority (ZAMRA) has been mandated by the by the Medicines and Allied Act of the laws of Zambia to ensure quality, safety and efficacy of medicines. Since about 90% of medicines are imported from abroad, registration process contribute to the availability of quality, safe and efficacious medicinal products in the country. In this regard the registration process needs to be effective and should avoid unnecessary delays in order to increase the classes of medicines registered in the country. The aim of this study was to identify challenges of medicines registration requirements as perceived by locally based pharmaceutical companies. A descriptive cross sectional study design was used to survey the regulatory local technical representative for foreign based applicants . Forty-Seven local technical representative was involved in the study. A designed medicines status form was used to assess dossier applications received in the past two years; 2018 and 2019. A total of 940 dossiers of applications submitted at ZAMRA during this period were assessed. Among 47 Local technical representative, more than half (74.46%) had low knowledge on medicines registration process with a significant association between training and knowledge of medicines evaluation. Medicines registration process in Zambia is faced with challenges mainly from Local technical representative to quality of dossiers submitted for registration representatives due to limited knowledge on medicines registration concept