NAFDAC Commences Clinical Trial of Malaria Vaccine in Nigeria

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By Onyebuchi Ezigbo

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 the product across the country.

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

Mojisola the agency was about to begin a Malaria Vaccine Clinical trial as part of its resolve to exterminate malaria scourge in Nigeria, adding that the country lacks a good pharmacovigilance system at the moment.

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 safe use of their products.

On her part, the NAFDAC’s Resident Media Consultant, Sayo Akintola, Adeyeye pointed out that the MAHs must 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 since it has become imperative to continually improve on 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.

Sayo Akintola encouraged them to establish and identify key personnel that will coordinate the activities of pharmacovigilance in their programmes, noting that the six pharmacovigilance centers established across the six geopolitical zones of Nigeria 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.

The  NAFDAC’s Resident Media Consultant added that community pharmacists are strategic in this call considering the role they play in the outreach of the populace more than any other sector with impressive records.

NAFDAC since its inception,Akintola said, 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), is aimed to create a sustainable continental safety monitoring system to improve the safety of priority medical products for patients across Africa.

It has 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.

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.

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