NAFDAC SET FOR MALARIA VACCINE CLINICAL TRIAL All OVER NIGERIA…

20/06/23

GABRIEL O.G

PRESS RELEASE

LR: Director, Veterinary Medicines and Allied Products (VMAP) National Agency for Food and Drug Administration and Control NAFDAC, Mrs Sonny Afoekelu Uchenna Marilyn, Managing Director/CEO of Embassy Pharmaceuticals, Sir Pharm Nnamdi Obi, Director General, NAFDAC, Prof Mojisola Adeyeye, Pharm Kunle Ademola, of NIROPHARM and Director, Pharmacovigilance and Post Marketing Surveillance (PV/PMS), Dr. Momodu Rametu, at the NAFDAC Pharmacovigilance Inspection Interactive Session with Pharma Stakeholders in Lagos on Friday.

NAFDAC TO COMMENCE GOOD PHARMACOVIGILANCE INPECTIONS,SENSITIZES PHARMA STAKEHOLDERS ON REPORTING ADVERSE DRUG REACTIONS/ADVERSE EVENTS FOLLOWING IMMUNIZATION ADR/AEFI

… Set for Malaria Vaccine Clinical Trial All Over Nigeria.

The National Agency for Food and Drug Administration and Control NAFDAC has mandated the Pharmaceutical Industry in Nigeria to establish Pharmacovigilance Surveillance department as the Agency is set for full implementation of PV across the country.

The Director General of NAFDAC, Prof. Mojisola Adeyeye, dropped the hint on Friday at the Pharmacovigilance Inspection interactive session with Pharma Stakeholders in Lagos, where she also disclosed the preparedness of the nation to begin Malaria Vaccine Clinical trial in its resolve to exterminate malaria scourge in Nigeria.

The NAFDAC Boss further 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 will ensure the safe use of their products.

In a statement by the NAFDAC Resident Media Consultant, Sayo Akintola, Prof 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 are regarded as marketing authorization holders for their products and 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 will be strengthened further to serve as convergence centers from the States to the Centre and 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 immunization delivery services, it has become imperative that their pharmacovigilance system should be inspected to ensure compliance with PV regulations and guidelines.
Going down the memory lane, Prof. 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 AU-3S 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.