This study aims at identifying the challenges being faced by NAFDAC in the monitoring of adverse drug reactions (ADRS) and to proffer solutions for the purpose of enhancing pharmacovigilance activities in Nigeria. To achieve this, the study sought to determine if NAFDAC has the capability to monitor and address reported ADR cases, to identify the factors that hinder the effective monitoring of ADRs and to suggest recommendations that can improve the level of ADR monitoring in Nigeria. In conducting this study, the quantitative approach was used. A sample size of 152 was generated and data was collected through the aid of close-ended electronic survey questionnaires. Out of the 152 questionnaires administered to respondents, only 139 was answered and submitted. This shows a response rate of 91%. Descriptive statistics with the aid of the Statistical Package for Social Sciences (SPSS) version 20.0 was used to analyse obtained data and results were presented in frequencies and percentages in tables, pie charts and bar charts. In testing the study’s hypotheses, simple linear regression and Karl Pearson’s correlation were used. Findings from the study revealed that poor and inconsistent training of staff on recent developments in ADR monitoring, neglect of latest technological solutions in the monitoring of ADR, reluctance of most healthcare professionals to report ADR issues and the refusal of drug users to report experienced ADR issues remain the main factors that hinder NAFDAC from effectively carrying out ADR monitoring in the nation. The study recommends that regular trainings where staff’s knowledge are updated with current trends regarding ADR monitoring should be conducted. Also, NAFDAC should adopt the use of latest technological solutions in the monitoring practice of ADRs. Emphasis should be placed on the use of digitised reporting system to make the tracking of ADR cases easier and faster and a welldesigned educational program should be implemented to enlighten medical practitioners and users of pharmaceutical products on the need for the reporting of known ADR issues. Effecting these recommendations would improve the level of ADR monitoring in the nation.