The National Agency for Food and Drug Administration and Control (NAFDAC) has guaranteed a strong regulatory system to access safe medicines in Nigeria and other developing countries
It said such strong institutions can 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 Director General of NAFDAC, Prof Mojisola 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.
Adeyeye, in her presentation, urged nations on the premise of strengthening of the 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 access quality medicines to different low, medium income countries.
“In low and middle-income countries, testing of food and drugs is critical, unlike developed economies where products are not tested because the system works. In low and middle-income countries, testing has to be conducted because of the propensity for substandard falsified medicines.”
Adeyeye maintained that the commitment from top management of the regulatory agencies is required to get the WHO Maturity level 3 which is the minimum required in terms of a well-functioning and stable regulatory system.
“I took over as Director General of 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 a quality management system as a baseline,” she added.
Prof Adeyeye emphasised the importance of reliance for different regulatory agencies in the world, noting that reliance simply represents a smarter way of regulating medical products through collaboration, shared knowledge, experience, and resources.
She confirmed 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 the experience of others, mentor other MNRAs.
She confirmed that WHO support member states in reaching and sustaining effective regulatory oversight of medical products through the Regulatory Systems Strengthening (RSS) programme.
Adeyeye also explained that NAFDAC under her leadership used the WHO Global Benchmarking Tools (GBT) to achieve the Maturity Level 3 WHO Certification Status in March 2022, and its significance to Nigeria.
“Using US FDA as a reference which is categorised as Maturity Level 4. You cannot get Maturity Level 3 without taking care of all the indicators under Levels 1, and 2. You can also not get Maturity Level 4 without taking care of all the indicators in ML1, ML2 and ML3”. She added.
