Effective regulation guarantees quality medicines in low income countries - NAFDAC boss

• Published date: 15 January 2023
• Publication title: Nigeria - The Nation

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, Prof Mojisola Adeyeye, has said.

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC) 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.

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 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 said the 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.'

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

She 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?

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...