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Strong regulatory system essential for effective quality medicines – NAFDAC DG

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Only a strong regulatory system will 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, the Director General, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye has said.

Adeyeye 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.

The only panelist selected from Africa at the summit, the NAFDAC DG 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.

The theme of the summit is “Building a Global Vision for Product and Drug Development: Challenges and Opportunities”.

She said the that the World Health Organisation (WHO) supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening Really Simple Syndication 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 (Food and Drug Administration) as reference which is categorised as Maturity Level 4’’, she said, adding: “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 noted that the GBT essentially facilitated NAFDAC to identify weaknesses and strength in licensing of products, in the manufacturers and distributors compliance, and in effective post marketing surveillance”.

Accoring to a statement on Wednesday by NAFDAC media consultant, Sayo Akintola, the NAFDAC DG said that the agency was benchmarked on seven functions and licensing establishment, which is under the Pharmacy Council of Nigeria jurisdiction, stressing that both agencies were benchmarked together.

She said that NAFDAC met and satisfied 268 indicators and 860 recommendations, adding that the 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.

She said that attaining Maturity Level 4 would not be too difficult, adding that “some of the standards or indicators we have already met” and that the agency is working round the clock as she has already set out targets for Maturity Level 4.

In low middle income countries, Adeyeye said that 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 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 disclosed.

Adeyeye emphasised the importance of reliance for different regulatory agencies in the world. She said that reliance represents a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources.

She explained that there has to be a reliance between agencies, adding that they have to collaborate, identify weak links and leverage on the experience of others.

She said that NAFDAC is doing that right now in terms of Traceability and GBT, noting that Reliance is also 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 themselves.

“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”, Adeyeye said.

She disclosed that the agency employs detection devices to get rid of infiltrations in the supply chain, adding: “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 said that clinical trials could be optimised 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.

She however said that the importance of informativeness cannot be over-emphasised because it has to be subject-centric. “If we do not consider the subject when we are designing or during the course of study then it’s very likely that a low percentage of success rate will be achieved,” the NAFDAC DG said.

She said that the agency started using the DAC system in 2019 just before the pandemic “and we have our own electronic clinical application platform’’.

For research funders and investigators, she said using the informative approach mitigates risks, it is hypothesis-driven, it increases likelihood of moving an intervention to a cure, adding that it also ensures that there is confidence that is built in them.

She commended the community involvement, stressing that it helps in no small measure. “We were quite successful in that particular clinical trial that culminated in us getting an IND approval from the US’’.

The event was UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) fourth annual Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development.

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