NAFDAC Launches Malaria Vaccine Clinical Trial.


The National Agency for Food and Drug Administration and Control (NAFDAC) said it has mandated the pharmaceutical industry in Nigeria to establish a Pharmacovigilance (PV) Surveillance department as the agency was set for full implementation of PV across the country.

The Director General of NAFDAC, Prof. Mojisola Adeyeye, dropped the hint at the weekend, at the Pharmacovigilance Inspection interactive session with Pharma Stakeholders in Lagos.

She said the agency was about to begin a Malaria Vaccine Clinical trial as part of its resolve to exterminate malaria scourge in Nigeria.

Adeyeye, said the country still lacks a good pharmacovigilance system.

The NAFDAC boss explained that the pharmaceutical industry must put structures in place to ensure adequate monitoring of their products throughout the supply chain.  

She, however, added that they must have strategies, goals, and clear objectives that would ensure the safe use of their products.

In a statement by NAFDAC’s Resident Media Consultant, Sayo Akintola, yesterday, Adeyeye pointed out that the MAHs must as a matter of importance, train and further engage all relevant stakeholders along their supply chain on the need for pharmacovigilance and use of relevant reporting platforms for reporting ADRs/AEFIs to the agency.

According to her, the sustained safety of medical products in Nigeria lies on a vast array of stakeholders and it has become imperative to continually improve on our pharmacovigilance processes for safety monitoring.

She also noted that the various public health programs involved in the importation of medical products for use in their respective programmes were regarded as marketing authorisation holders for their products.

She therefore encouraged them to establish and identify key personnel that will coordinate the activities of pharmacovigilance within their programmes.

She however noted that the six pharmacovigilance centers established across the six geopolitical zones of the country would be strengthened further to serve as convergence centers from the states to the centre: but most importantly from the communities to the states to the Centers.

She said those centers that have been approved should also be involved, as she vowed to take charge of strengthening them personally.

She explained that community pharmacists are strategic in this call because they reach the populace more than any other sector with impressive records.

She noted that since community pharmacists are also involved with immunisation delivery services, it has become imperative that their pharmacovigilance system should be inspected to ensure compliance with PV regulations and guidelines.

Adeyeye said NAFDAC since its inception had engaged in some level of activities towards ensuring the safe use of medical products in-country.

She stated that in recent times, pharmacovigilance has been brought to the fore with the COVID-19 pandemic and the key role that the African Union smart safety surveillance (AU 3S) played in assuring safety of products used in the pandemic within the member countries including Nigeria.

The AU-3S programme, led by African Union Development Agency (AUDA-NEPAD), aims to create a sustainable continental safety monitoring system to improve the safety of priority medical products for patients across Africa.

The AU3S coordinated surveillance system was piloted with the COVID 19 vaccines in the five member countries with the goal of future continent-wide safety surveillance of other medical products.

Adeyeye further explained that the AU3S also provided platform for capacity building of our Staff on various aspects of Pharmacovigilance, noting that this greatly contributed towards NAFDACs attainment of Maturity Level 3 (ML3) under the WHO global benchmarking system.

“This means that we are now a stable, well-functioning and integrated regulatory system,” she added.

Having achieved this feat, she said the agency was now poised to delve into aspects of pharmacovigilance inspection which before now we had not ventured into.

She opined that Pharmacovigilance Inspections of Marketing Authorization Holders (MAHs) was a key aspect of Pharmacovigilance which cannot be ignored by any regulatory authority that has intent on ensuring patient safety with use of medical products and attaining higher levels of maturity in its regulatory processes.

She added that this entailed that all MAHs must have a well-established pharmacovigilance system in place and most importantly, vigilance activities are being carried out in accordance with national regulations and guidelines.

Adeyeye recalled with pain the parlous state of Pharmacovigilance in NAFDAC when she got to the agency in 2017, prompting her resolve to change the tide.