The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has said that only a strong regulatory system would guarantee and accelerate the development, approval, and access of safe and effective quality therapeutic medicines and vaccines in low, medium income countries of the world.
NAFDAC’s Resident Media Consultant, Sayo Akintola disclosed this in a statement issued on Wednesday, January 11, 2023.
According to the statement, the DG made the assertion while speaking at the hybrid University of California San Francisco UCSF)-Stanford Centre of Excellence in Regulatory Science and Innovation, (UCSF-Stanford CERSI) summit in the United States.
It said, Prof. Adeyeye admonished nations on the premise of strengthening of regulatory system in compliance with the World Health Assembly Resolution 67.20 of 2014 in order to build the capacity of member states with the ultimate goal to have access to quality medicines to different low, medium income countries.
She informed that, the World Health Organisation (WHO) supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.
She further explained to the global audience how NAFDAC under her leadership used the WHO Global Benchmarking Tools to achieve the Maturity Level 3 WHO Certification Status in March 2022 and its significance to Nigeria:
‘’Using US FDA as reference which is categorized as Maturity Level 4, you cannot get Maturity Level 3 without taking care of all the indicators under Levels 1, and 2. You cannot get Maturity Level 4 without taking care of all the indicators in ML1, ML2 and ML3’’.
Speaking on ‘’Global Benchmarking Tool ( GBT) and Access to Medicines’’ at the annual global event, the NAFDAC Boss noted that, the GBT essentially facilitated NAFDAC to identify weaknesses and strength in licensing of products, in the manufacturers and distributors compliance, in how effective is our post marketing surveillance- are we doing containment of market control in terms of illicit trade, are we doing well in terms of regulatory inspection; Good Manufacturing Practice compliance, are the manufacturers adhering to that? How good are our laboratories?
In a statement by NAFDAC media consultant, Sayo Akintola, in Lagos on Wednesday, Prof. Mojisola Adeyeye, disclosed to the summit that NAFDAC was benchmarked on seven functions plus licensing establishment which is under the Pharmacy Council of Nigeria (PCN) jurisdiction, stressing that both agencies were benchmarked together.
She said the Agency met and satisfied 268 indicators and 860 recommendations, adding that the 268 indicators were distributed under Maturity Levels 1, 2, 3, and 4.
She however, noted that attaining Maturity Level 4 would not be too difficult, adding that, ‘’some of the standards or indicators we have already met’’. In addition, her Agency was also working round the clock as she had already set out targets for Maturity Level 4.
The NAFDAC boss pointed out that commitment from top management of the regulatory agencies was required to get Maturity level 3 which is the minimum required in terms of well-functioning and stable regulatory system:
‘’I took over as DG NAFDAC in November 2017. Right from the beginning my experience in the US in terms of Quality Management System was brought to bear. We committed to Global Benchmarking using Quality Management System as a baseline’’, she said.
Prof. Mojisola Adeyeye however, emphasized the importance of reliance for different regulatory agencies in the world. She said reliance represents a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources.
The Reliance is among the different functions such as regulatory inspection, lab testing, clinical trials, market authorization, pharmacovigilance, market control and licensing establishment.
She also explained that there was a lot of reliance within different functions and there has to be a reliance between agencies, adding that agencies have to collaborate, identify weak links and leverage on the experience of others, mentor other MNRAs.
She said that NAFDAC was doing that right now in terms of Traceability and GBT, noting that Reliance was also facilitated within the West African region and between regions.
