The National Agency for Food and Drug Administration and Control (NAFDAC) has made it compulsory for the pharmaceutical industry in Nigeria to establish a Pharmacovigilance (PV) Surveillance department as part of the agency’s nationwide implementation of PV.
The Director General of NAFDAC, Prof. Mojisola Adeyeye, shared this information during an interactive session on Pharmacovigilance Inspection with Pharma Stakeholders in Lagos recently.
Adeyeye stated that the agency is preparing to initiate a clinical trial for a Malaria Vaccine in its efforts to eradicate malaria in Nigeria.
She acknowledged that the country currently lacks an effective pharmacovigilance system.
The NAFDAC Director General emphasized that the pharmaceutical industry must establish appropriate structures to ensure thorough monitoring of their products throughout the supply chain.
Moreover, she emphasized the importance of developing strategies, goals, and clear objectives to ensure the safe use of their products.
In a statement released by NAFDAC’s Resident Media Consultant, Sayo Akintola, Adeyeye highlighted that Marketing Authorization Holders (MAHs) must prioritize training and engaging relevant stakeholders within their supply chain to promote pharmacovigilance and utilize appropriate reporting platforms to report Adverse Drug Reactions (ADRs) and Adverse Events Following Immunization (AEFIs) to the agency.
Adeyeye stressed that the safety of medical products in Nigeria relies on a wide range of stakeholders and it is crucial to continually enhance pharmacovigilance processes for safety monitoring.
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She also emphasized that public health programs involved in importing medical products for their respective programs are considered marketing authorization holders and encouraged them to establish key personnel responsible for coordinating pharmacovigilance activities within their programs.
Regarding the six pharmacovigilance centers established across the country’s six geopolitical zones, Adeyeye expressed the need to further strengthen them as convergence centers from the community level to the state level and eventually to the national center.
She personally pledged to take charge of enhancing these approved centers.
Adeyeye further highlighted the strategic role of community pharmacists in reaching the population and their involvement in immunization delivery services.
She stressed the importance of inspecting their pharmacovigilance systems to ensure compliance with PV regulations and guidelines.
Adeyeye mentioned that NAFDAC has been actively involved in activities aimed at ensuring the safe use of medical products in Nigeria since its inception.
She noted that pharmacovigilance has gained significant attention during the COVID-19 pandemic, with the African Union smart safety surveillance (AU 3S) program playing a crucial role in ensuring the safety of products used in member countries, including Nigeria.
Having reached this milestone, Adeyeye stated that NAFDAC is now ready to venture into pharmacovigilance inspections, an aspect that was previously unexplored.
She emphasized that inspecting Marketing Authorization Holders (MAHs) is a crucial part of pharmacovigilance that cannot be overlooked by any regulatory authority committed to ensuring patient safety and advancing regulatory processes.
