Nigeria will soon manufacture her own vaccines

The National Agency for Food and Drug Administration and Control (NAFDAC) has assured that the country will soon begin manufacturing her own vaccines and that products approved by the agency will soon be easily traded globally.

Director General, NAFDAC, Prof. Mojisola Christianah Adeyeye, at a press conference to mark the fourth anniversary of her administration, said efforts by the agency are serving as stepping stones that will soon lead to Nigeria manufacturing her own vaccines once World Health Organisation (WHO) visits the agency physically and declares it ML3 compliant.

‘ML3’ is the minimum WHO accreditation needed to oversee vaccine manufacturing.
Adeyeye said NAFDAC is working toward ML4, which will enable products approved by NAFDAC to be easily traded continentally and globally.

It was reliably gathered that if NAFDAC becomes a WHO Maturity Level 4 (ML4) regulator, it will have the capacity to Emergency Use Listing (EUL) with an emergency authorisation from the ML4 regulator. However, if the vaccine will be manufactured in a country whose regulatory agency is not ML4 but is considered “functional for purposes of vaccine oversight”, it should be determined as early as possible what was the level of authorisation (if any) in the manufacturing country that will be required prior to EUL filing.

Adeyeye said the foundation is being laid through quality management system (QMS) and WHO Global Benchmarking Tool (GBT), which will lead to a regulatory agency built on legacy building blocks.

She said regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products. Effective regulatory systems are an essential component of health systems and contribute to desired public health outcomes and innovation.

GBT represents the primary means by which the WHO objectively evaluates regulatory systems, as mandated by World Health Assembly (WHA) Resolution 67.20 on Regulatory System Strengthening for medical products.

The press conference offered a golden opportunity for the public to take stock of the flurry of events, regulatory activities, challenges, opportunities and achievements in the last four years that took NAFDAC through charting a new course to where the agency is today.

“The goal of the last four years, according to the present administration, is to safeguard public health, strengthen the industry, pursue customer-centric regulatory activities, play pivotal role in the growth of Micro, Small and Medium Enterprises (MSMEs), enthrone top notch QMS and strive towards attaining the WHO’s Level 3 GBT ranking.”

Adeyeye said it would take putting in place seven internationally defined building blocks that are based on WHO recommendations in order to strengthen the agency. “For strong regulatory framework, a quality system approach or template must be in place that places premium on the customer. Therefore, we decided to adopt an agency-wide quality management system (ISO 9001) that took the entire staff through training (from February 2018-June 2019) in use of self-auditing, standard operating procedures, proper documentation, transparency, digitalisation of her processes etc.,” she said.

She also said that part of effective governance is having a well-motivated staff to share the vision of making the agency strong.

The agency disclosed that under the current DG leadership, staff training and capacity development have been given great priority. No fewer than 3,600 staff were trained and retrained in the last four years. Similarly, the staff are being encouraged to undertake academic programmes to improve their expertise on the job, provided it does not interfere with their official assignments. With a transparent and quality-driven work environment that is expected of a regulatory agency, our staff are now well motivated, disciplined and more dedicated.

The DG added: “It is my belief that every state should have at least three vehicles for operation as an essential tool for the agency. Before I assumed office, the newest vehicles in the agency were bought as far back as 2014. Because of the rate of usage, most of them are ramshackle. These are the vehicles that are always on the road. The directors too don’t have vehicles. The contract for the 73 vehicles has been awarded and by December or January the vehicles will be distributed among the directors for official use. There has been a tremendous increase in staff welfare. There have been some allowances that were not in existence before. We are pursuing the possibility of creating another salary structure for the staff while we are also pursuing the National Salaries, Wages Commission for the possibility of getting additional allowance that we never enjoyed before. For instance, we are looking at how we can increase our hazard allowance, regulatory allowance, and others like that to make our staff well-motivated and more efficient.”

Adeyeye spoke explicitly about suitable environment for regulatory activities. She explained that while going round many state and zonal offices in the country, she saw a pitiable environment to attend to customers that have negatively impacted staff productivity. Therefore, from NAFDAC’s prudent financial management, they budgeted for construction of some Zonal/State Offices. She said plans are underway to construct five additional

State Offices in Edo, Delta, Kano, Enugu and Kaduna from the 2021 budget. She added that the NAHCO Ports Inspection Office in Ikeja, expansion of Yaba Drug Laboratory and upgrading of the Biologics/Vaccine laboratory are all under construction.

There was also emphasis on local manufacturing of pharmaceuticals in Nigeria. The NAFDAC DG said it has put a premium on local manufacturing of regulated products to ensure that Nigeria will have drug security and turn the tide from 70 per cent imports to about 30 per cent imports by year 2025.

NAFDAC also said it has placed emphasis on local herbal medicines by revealing it is stepping down approval of imported herbal medicines that have equivalence in Nigeria. Adeyeye said this is to create a renaissance of the country’s herbal medicines and mitigate possible falsification and counterfeiting.

“In this bid, NAFDAC inaugurated the Herbal Medicine Product Committee in March 2019 and has fostered collaboration between herbal researchers and local practitioners. This has led to joint submission of research proposals for funding for clinical trials of products that have been given listing approval by NAFDAC so that the products can be given full approval,” she said.

Chukwuma Muanya

The Guardian

https://guardian.ng/features/health/nigeria-will-soon-manufacture-her-own-vaccines/