The National Agency for Food and Drug Administration and Control (NAFDAC) has announced its intention to conduct Malaria Vaccine Clinical Trials across Nigeria.
During an interactive session on Pharmacovigilance Inspection with Pharma Stakeholders in Lagos, Professor Mojisola Adeyeye, the Director General of NAFDAC, revealed that the country is fully prepared to initiate clinical trials for a malaria vaccine as part of its commitment to eliminating the malaria epidemic in Nigeria.
In a statement issued by NAFDAC, the agency also mandated the Nigerian pharmaceutical industry to establish a dedicated Pharmacovigilance Surveillance Department, as it is ready for the comprehensive implementation of pharmacovigilance practices nationwide.
Adeyeye emphasized the need for the pharmaceutical industry to establish robust systems to ensure thorough monitoring of their products throughout the supply chain.
It is of utmost importance for Marketing Authorization Holders (MAHs) to train and actively involve all relevant stakeholders in their supply chain, emphasizing the significance of pharmacovigilance and the utilization of appropriate reporting platforms for adverse drug reactions (ADRs) and adverse events following immunization (AEFIs) to report such incidents to NAFDAC.
“The continued safety of medical products in Nigeria relies on the collaboration of a wide range of stakeholders, and it is essential that we continuously improve our pharmacovigilance processes for effective safety monitoring,” stated Adeyeye.
Pharmacist Wale Oladigbolu, the National President of the Community Pharmacists Association of Nigeria, lauded NAFDAC for this initiative, highlighting that “while pharmacovigilance is not a novel concept, this new approach ensures that we engage with the public in a scientifically rigorous manner to safeguard their health.”