NAFDAC Advocates Strong Regulatory System For Safe, Quality Medicine, Vaccines

Director-general, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, on Wednesday, disclosed 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.

She spoke 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.

Speaking as the only panelist selected from Africa at the summit with the theme- Building a Global Vision for Product and Drug Development: Challenges and Opportunities, Prof Mojisola Adeyeye, admonished nations on the premise of strengthening of regulatory system in compliance with the World Health Assembly Resolution 67.20 of 2014 in other to build the capacity of member states with the ultimate goal to have access to quality medicines to different low, medium income countries.

She said WHO supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.

She 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’’, she said; ‘’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’’.

On ‘’Global Benchmarking Tool and Access to Medicines’’ at the annual global event, Prof Mojisola Adeyeye noted that there is no 95 or 99 percent in terms of WHO Global Benchmarking.

She said 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?

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. ‘’We were able to attain Maturity Level 3 after meeting all the requirements. We were declared in March 2020.’’

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’’. She said her Agency is working round the clock as she has already set out targets for Maturity Level 4.

According to Prof Mojisola Adeyeye, there is what is called the World Listed Authority where it’s almost like a specialized grouping, adding that part of Maturity Level 4 indicators also applies to World Listed Authority. ‘’We are working for both in order to ensure that our system is well established and stable and well-functioning as a regulatory agency’’.

In low middle-income countries, she said testing is sacrosanct unlike FDA where products are not tested because the system works. In low middle-income countries, she added that testing has to be conducted because of propensity for substandard falsified medicines.

The NAFDAC boss pointed out that commitment from top management of the regulatory agencies is required to get Maturity level 3 which is the minimum required in terms of a 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.’’