Vaccine Manufacturing and NAFDAC's Pursuit of WHO ML4

Nigeria's efforts to strengthen local pharmaceutical manufacturing and reduce dependence on imported health products have received renewed attention following a call by the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, for international partners to support the establishment of vaccine manufacturing facilities in the country.

Adeyeye made the call while serving as Guest of Honour at the 8th Nigeria Pharma Manufacturers' Expo, held in Lagos and organised by the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN) in collaboration with PGE Expo Pvt. Ltd.

She specifically highlighted the need for investment in fill-and-finish modular vaccine production, identifying it as an important step towards developing Nigeria's domestic vaccine manufacturing capacity and advancing the country's regulatory capabilities.

The proposed investment is expected to support the development of local infrastructure for vaccine production while strengthening NAFDAC's capacity to regulate vaccine manufacturing in line with international standards.

Vaccine Manufacturing and NAFDAC's Pursuit of WHO ML4

Adeyeye noted that establishing vaccine manufacturing facilities, particularly those supporting fill-and-finish operations, would help address a critical gap in Nigeria's regulatory development and support NAFDAC's pursuit of World Health Organization (WHO) Maturity Level 4 (ML4) for vaccine lot release.

Fill-and-finish is a key stage of vaccine production that involves filling formulated vaccine products into sterile vials, syringes or other approved containers, followed by sealing, labelling and packaging. Modular facilities can provide a structured approach to establishing this production capacity, although they still require appropriate infrastructure, validated processes, quality systems and regulatory oversight.

According to the NAFDAC Director-General, vaccine lot release certification remains an outstanding benchmark in the agency's efforts to attain full global regulatory recognition in this area.

WHO's Global Benchmarking Tool assesses national regulatory authorities against internationally recognised indicators covering essential regulatory functions. Achieving the relevant maturity level demonstrates that a regulatory authority has developed the systems and competencies required to perform its functions consistently.

For Nigeria, strengthening vaccine lot release capacity would be particularly significant as the country seeks to develop local vaccine production and improve its preparedness to respond to public health emergencies.

NAFDAC Highlights Progress in Regulatory Strengthening

At the expo, Adeyeye also highlighted the agency's progress in strengthening pharmaceutical regulation and supporting local manufacturing.

She cited NAFDAC's successful re-certification at WHO Maturity Level 3 (ML3), which she described as a landmark achievement and the first of its kind in Africa. The agency's ML3 status reflects the development of a stable, integrated regulatory system that operates in line with recognised international standards.

Another achievement highlighted was the WHO prequalification of NAFDAC's Yaba laboratory in 2023, strengthening Nigeria's laboratory capacity and its contribution to the quality assurance of regulated health products.

Adeyeye also pointed to the impact of the agency's 5+5 Policy and Ceiling Initiative, which are designed to encourage local pharmaceutical production by supporting domestic manufacturers and reducing reliance on imported finished medicines.

She reported a 70 per cent reduction in the importation of products covered by the initiatives, highlighting the role of regulatory policies in supporting the growth of Nigeria's pharmaceutical manufacturing sector.

These developments form part of broader efforts to improve the competitiveness of local manufacturers, strengthen quality assurance and create an enabling environment for investment in pharmaceutical production.

Executive Order Supports Local Pharmaceutical Manufacturing

The NAFDAC Director-General also commended President Bola Ahmed Tinubu's 2024 Executive Order on the local production of pharmaceuticals, medical devices and other healthcare products, noting that it had introduced important incentives for domestic manufacturers.

The Executive Order was designed to address some of the fiscal and non-fiscal barriers affecting local pharmaceutical production, including measures relating to the importation of essential manufacturing inputs and equipment.

The policy is part of the Federal Government's broader efforts to strengthen the healthcare value chain, attract investment and improve access to essential medicines and other health products.

For pharmaceutical manufacturers, sustained implementation of these measures, alongside improved infrastructure, access to financing, technology transfer and regulatory support, will be important to expanding production capacity and maintaining international quality standards.

PMG-MAN Commends NAFDAC's Regulatory Leadership

The Chairman of PMG-MAN, Mr Oluwatosin Jolayemi, commended Adeyeye for her leadership in promoting Good Manufacturing Practice (GMP) compliance and aligning Nigeria's pharmaceutical manufacturing industry with international best practices.

He noted that NAFDAC's regulatory policies were contributing to changes within the pharmaceutical manufacturing ecosystem, particularly by encouraging local production and strengthening compliance with established quality standards.

The commendation reflects the importance of collaboration between regulatory authorities and pharmaceutical manufacturers in developing a sustainable domestic pharmaceutical industry.

The expo provided a platform for stakeholders across the pharmaceutical and life sciences sectors to discuss manufacturing capacity, regulatory development, technology transfer and opportunities for investment in Nigeria and the wider African market.

Building Nigeria's Vaccine Manufacturing Capacity

The call for international partnerships highlights the importance of collaboration in developing the technical expertise, infrastructure and financial investment required for vaccine manufacturing.

Although fill-and-finish facilities can provide an entry point into vaccine production, developing a sustainable domestic vaccine industry also requires reliable access to vaccine antigens and other essential inputs, specialised manufacturing equipment, skilled personnel, quality control systems and effective regulatory oversight.

For Nigeria, expanding local vaccine manufacturing capacity could contribute to greater supply-chain resilience and reduce dependence on international suppliers during global health emergencies. However, achieving these objectives will depend on the ability to attract long-term investment, establish sustainable production systems and meet stringent international quality requirements.

NAFDAC's pursuit of vaccine lot release maturity and the establishment of local manufacturing facilities are therefore closely connected. Regulatory capacity is essential to ensuring that locally manufactured vaccines meet required standards of quality, safety and efficacy, while a functioning manufacturing ecosystem can support the practical development of regulatory expertise.

As Nigeria continues to pursue greater pharmaceutical self-sufficiency, international partnerships, technology transfer and sustained investment will remain important to translating policy commitments into operational manufacturing capacity.