NAFDAC D-G seeks regulation for therapeutic medicines, vaccines in low-income countries 

NAFDAC D-G seeks regulation for therapeutic medicines, vaccines in low-income countries 

By Aderogba George, Abuja.


Prof.  Moji Adeyeye, Director-General,  National Agency for Food and Drug Administration and Control (NAFDAC), has solicited a regulatory system for effective quality therapeutic medicines and vaccines in low and medium income countries.


She made the call in a statement signed by the agency’s Resident Media Consultant, Mr Olusayo Akintola on Wednesday in Abuja.


The D-G voiced the proposal 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.


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


The NAFDAC chief said 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 admonished nations on the premise of strengthening regulatory system in compliance with the World Health Assembly Resolution 67.20 of 2014, to build the capacity of member states with the ultimate goal to have access to quality medicines, particularly in low, medium income countries.


According to her, the World Health Organisation (WHO) supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.


She informed to the global audience of 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 the U.S. Food and Drug Agency, which was categorised as Maturity Level 4 as a reference, Adeyeye said that “you cannot get Maturity Level Three without taking care of all the indicators under Levels One and Two and indicators in Maturity Level One, Maturity Level Two and Maturity Level three.”


Speaking on “Global Benchmarking Tool and Access to Medicines’’ at the annual global event, the NAFDAC boss noted that there was no 95 or 99 per cent in terms of WHO Global Benchmarking.


She disclosed that the GBT essentially facilitated NAFDAC to identify weaknesses and strengths in licensing of products, in manufacturers’ and distributors’ compliance and how effective its post-marketing surveillance was in market control in terms of illicit trade.


She disclosed that NAFDAC was benchmarked on seven functions, including licensing establishment, which was under the Pharmacy Council of Nigeria (PCN) jurisdiction, adding that both agencies were benchmarked together.


Adeyeye said the agency met and satisfied 268 indicators and 860 recommendations, noting that 268 indicators were distributed under Maturity Levels One, Two, Three and Four and it was were able to attain Maturity Level Three, after meeting all the requirements in March 2020.


She, however, noted that attaining Maturity Level Four would not be too difficult, as some of the standards or indicators had already been met.


She said that NAFDAC was working round the clock toward the achievement of the set targets for Maturity Level Four, adding that the agency was working to ensure that the system was well-established and stable and functioning as a regulatory agency.


The NAFDAC boss, however, emphasised the importance of inter-agency reliance among different regulatory agencies in the world, adding that such reliance represented 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.”


Adeyeye underscored the need for inter-agency relations, saying that agencies had to collaborate, identify weak links, leverage the experience of others and mentor others.


She stated that there could not be local manufacturing without a strong regulatory system, adding that NAFDAC was using a lot of tools to ensure that products from Nigeria were more affordable and were of high quality, using different GMP inspection.


She also said that the agency had employed detection devices to get rid of infiltrations in the supply chain, adding that NAFDAC was now using traceability Track and Trace GS1 to monitor falsified medicines.

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