NAFDAC calls for strong regulatory system for therapeutic medicines, vaccines

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Lagos, Jan. 12, 2023 – Prof Mojisola Adeyeye, the Director General of NAFDAC, says only strong regulatory system can guarantee the development and approval of safe and effective quality therapeutic medicines and vaccines.

Adeyeye made this assertion recently 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.

She was the only panelist selected from Africa at the summit on the theme: “Building a Global Vision for Product and Drug Development: Challenges and Opportunities”.

 She advised nations to strengthen their 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 of accessing quality medicines in low and medium income countries.

Adeyeye said the World Health Organisation (WHO) supported 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, 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’’, Adeyeye said that there is no 95 or 99 percent in terms of WHO Global Benchmarking.

She said that the GBT had “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?”

A statement by NAFDAC Media Consultant, Sayo Akintola, in Lagos on Wednesday, said Adeyeye told 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 had 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 said.

Adeyeye said that attaining Maturity Level 4 would not be too difficult due to “some of the standards or indicators we have already met’’.

She said her Agency was working round the clock as she had already set out targets for Maturity Level 4.

According to Adeyeye, “there is what is called the World Listed Authority where it’s almost like a specialized grouping”.

She said that part of Maturity Level 4 indicators also applied to World Listed Authority.

‘’We are working for both in order to ensure that our system is well established, stable and well-functioning as a regulatory agency’, she said.

Adeyeye said that testing was sacrosanct in low middle income countries, unlike FDA where products were not being tested because the system worked.

She also said that testing had to be conducted in low middle income countries because of propensity for substandard falsified medicines.

The NAFDAC boss said 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’’.

Adeyeye emphasized the importance of reliance for different regulatory agencies in the world.

She said reliance represented a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources.

“Reliance is among the different functions such as regulatory inspection, lab testing, clinical trials, market authorization, pharmacovigilance, market control and licensing establishment,” she said.

Adeyeye said there should be a lot of reliance within different functions and there has to be reliance between agencies, adding that agencies must collaborate, identify weak links and leverage on the experience of others.

She said that NAFDAC was doing that right now in terms of Traceability and GBT, noting that Reliance was also being facilitated within the West African region and between regions.

‘’Uganda came to us, and we have been interacting on different aspects of our regulatory activities.

“Reliance promotes good regulatory practices which is the focus. It helps bring trust amongst NRAs and allow NRAs to seize the opportunity to strengthen them.

‘’ 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 said that the Agency employed 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 for using traceability Track and Trace GS1 to monitor falsified medicines. We used that for vaccines during the Pandemic’’.

She said that clinical trials could be optimized to make medicines and vaccines affordable and affordable to the low, medium income countries.

Adeyeye said 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. (GBN)

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