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Strong regulatory system necessary for quality medicines – Adeyeye

The Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye, has said only a strong regulatory system would guarantee and accelerate the development, approval, and access to safe and effective quality therapeutic medicines and vaccines in low- and medium-income countries of the world.

 

The NAFDAC boss 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 in low- and 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 told 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 U.S. FDA as reference, which is categorised 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 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 strengths 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 yesterday, Prof. 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,” adding that “her agency is working round the clock as she has already set out targets for Maturity Level 4.”

According to NAFDAC, there is what is called the World Listed Authority where it’s almost like a specialised grouping in which 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- and middle-income countries, testing is sacrosanct unlike FDA where products are not tested because the system works. In low- and middle-income countries, 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 well-functioning and stable regulatory system. “I took over as DG NAFDAC in November 2017. Right from the beginning, my experience in the U.S. in terms of Quality Management System was brought to bear. We committed to Global Benchmarking using Quality Management System as a baseline.”

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 further explained that there is 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.

“It’s extremely important to strengthen the regulatory system. There cannot be local manufacturing without a strong regulatory system. As far as NAFDAC is concerned we use a lot of tools to ensure that our products are more affordable and are of high quality using different GMP inspection.”

She disclosed that NAFDAC employs detection devices to get rid of infiltrations in the supply chain. “We use enforcement. We work with Interpol, The FBI and of course, we use vigilance within the country and outside the country. NAFDAC is now known using traceability Track and Trace GS1 to monitor falsified medicines. We used that for vaccines during the Pandemic.”

 

She opined that clinical trials could be optimized to make medicines and vaccines affordable and affordable to the low, medium income countries. She disclosed that Nigeria was fortunate to be funded by the Gates Foundation in terms of using Design Assessment and Community approach to develop our clinical trials data base or platforms.

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