Challenges of medicines registration process in Tanzania.

Abstract

Background: Medicines are only authorized to circulate in the market after being registered. The Tanzania Food and Drugs Authority (TFDA) has been mandated by the Ministry of Health and Social Welfare (MOHSW) to ensure quality, safety and efficacy of medicines. Since about 70% 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 variety of medicines registered in the country.

Study objective: The aim of this study was to identify challenges of medicines registration process in Tanzania.

Methodology: A descriptive cross sectional study design was used to survey the regulatory authority and pharmacies in Dar es Salaam region. Forty one pharmacies were involved in the study. A total of 42 medicines evaluators, 41 pharmacists’ in-charge and 41 representatives of manufacturers were interviewed using structured questionnaires. An in-depth interview was conducted to two key informants at the regulatory authority using interview schedule. A designed medicines status form was used to assess dossier applications received in the past two years; 2010 and 2011. A total of 743 dossiers of applications submitted at TFDA during this period were assessed.

Results: Among forty two (42) medicines evaluators; 33 pharmacists, 4 medical doctors and 5 veterinary doctors were included in this study. Among them 27 had high knowledge regarding medicines registration concept with a statistically significant association between training and knowledge of medicines evaluation (P = 0.001). Out of 41 manufacturers’ representatives; 11 pharmacists, 25 businessmen, 3 marketing managers, one IT specialist and one economist were interviewed. Among 41 pharmacists in-charge, more than half (61.0%) had low knowledge on medicines registration process with a significant association between training and knowledge of medicines evaluation (P = 0.007). The average evaluation time per dossier was found to be 2.98 ± 0.811 days, with 95% CI for the mean value ranging from 2.169 to 3.791. Majority of evaluators (72.93%) are supported by TFDA management with significant association between management support and payment satisfaction (P = 0.002). Out of 743 applications received in two years, 478 applications were evaluated. Among those, only 170 were registered, 220 rejected, 62 queried and 26 had their status not determined as on April 2013. This indicated that more than half (58.60%) of the applications were either rejected or queried due to poor quality of dossiers submitted. The challenges identified include inadequate evaluators, insufficient payment, lack of regular training of expertise, instability of management information system, insufficient evaluation time, poor submitted dossiers, long registration time and communication gap between applicants and TFDA.

Conclusion and recommendations: Medicines registration in Tanzania is faced with challenges multifaceted from TFDA management, manufacturers and their representatives. Due to inadequate number of evaluators the process of medicines registration has been observed to take longer time than the time of 12 months as suggested in the Client Service Charter. Furthermore, the pharmacist in-charge had limited knowledge on medicines registration concept. Based on these findings, it is proposed that TFDA management should deploy sufficient number of qualified personnel to undertake evaluation activities. The Government through MOHSW and Schools of Pharmacy in Tanzania should review their training curricula in order to impart pharmacist in-charge with knowledge on how to review and prepare dossiers for medicines registration. TFDA in collaboration with Pharmacy Council should provide regular on-job training and continuing professional development to improve pharmacist’s knowledge and skills in order to enable them to cope with developments in pharmaceutical science and technology.