– Says local pharma manufacturing cannot exist without it
For Nigeria and other low-income countries of the world to be able to boast of approval and accelerated access to safe and effective quality therapeutic medicines and vaccines, a mandatory and robust regulatory system must be institutionalised or functional, says Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Moji Adeyeye.
She enumerated the impacts of a vibrant regulatory system on the pharmaceutical industry of any country, stating that local pharma manufacturing cannot exist without it; while the authenticity, circulation and standardisation of locally produced medicines would be uncertain without a reliable regulatory system.
The NAFDAC boss elucidated on the necessity of having a strong supervisory system in place for medicines production and circulation, saying it is one of the requirements of 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 to different low, medium income countries. She noted that the WHO supports member states in reaching and sustaining effective regulatory oversight of medical products through the regulatory systems strengthening RSS programme.
Adeyeye made this assertion on Wednesday 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.
In a statement signed by Sayo Akintola, resident media consultant for the agency, the NAFDAC DG pointed out that commitment from top management of regulatory agencies is required to get Maturity level 3, which is the minimum required in terms of well-functioning and stable regulatory system.
According to her “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 the agency 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 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 assessment and community approach to develop our clinical trials data base or platforms.
Prof. Adeyeye however, emphasised 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. 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 reliance between agencies, adding that agencies have to collaborate, identify weak links and leverage on the experience of others, mentor other MNRAs.
“NAFDAC is doing that right now in terms of Traceability and GBT, as our 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”.
“ The essence of information 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.”