The National Biosafety Authority (NBA) has called for the establishment of a robust, science-based, and internationally aligned regulatory framework to support Ghana’s ambition of becoming a regional hub for vaccine research, development, and manufacturing.
Mr Kwame Dei Asamoah-Okyere, Chief Executive Officer of the NBA, made the call at a stakeholder workshop on, “Vaccine Development and Manufacturing in Ghana: Regulatory Readiness,” in Accra.
The workshop brought together representatives of government ministries, regulatory institutions, academia, research organisations, the pharmaceutical industry, healthcare professionals, and development partners to deliberate on Ghana’s preparedness for local vaccine production.
Mr Asamoah-Okyere said the COVID-19 pandemic exposed Africa’s dependence on imported vaccines and underscored the need for countries to build resilient health systems and local manufacturing capacity.
He said Ghana had since taken significant steps towards becoming a regional hub for vaccine development and manufacturing, stressing that the country’s success would depend on an effective regulatory system that protected public health, workers and the environment while promoting innovation.
“Our shared commitment is to make Ghana a vaccine development and manufacturing hub in sub-Saharan Africa to meet national, regional and continental needs and reduce dependence on foreign vaccine supplies,” he said.
The NBA Chief Executive noted that while much attention had focused on medicine regulation, the role of biosafety regulation in vaccine development had received less recognition.
He explained that under the Biosafety Act, 2011 (Act 831), the NBA was responsible for ensuring the safe development, transfer, handling and use of genetically modified organisms and biotechnology-derived products.
According to him, the new generation of biological medicines, including biosimilars, gene therapies, viral-vector vaccines and gene-edited therapies, required effective biosafety oversight throughout research, development, manufacturing, and deployment.
“Scientific advancement must always be accompanied by effective regulatory oversight that protects human health and the environment while promoting innovation and investment,” he said.
Mr Asamoah-Okyere disclosed that the NBA and the Food and Drugs Authority (FDA) had recently held bilateral and regulatory roundtable discussions to define institutional roles and regulatory oversight across the vaccine development pipeline, drawing lessons from international regulatory systems.
He expressed the hope that the workshop would produce a shared understanding of existing regulatory gaps, a draft national regulatory framework and roadmap, and stronger collaboration among institutions responsible for Ghana’s vaccine ecosystem.
Dr Daniel Amaning, Director of the Pharmacy Unit at the Ministry of Health, speaking on behalf of the Minister of Health, reaffirmed Government’s commitment to vaccine development and manufacturing as a strategic priority for strengthening national health security and improving access to safe and quality vaccines.
He urged stakeholders to develop a regulatory framework that clearly defined institutional mandates, promoted inter-agency collaboration, built on existing legal structures, and aligned with international best practices while responding to Ghana’s needs.
“The framework should support the entire vaccine value chain with clear governance, accountability and sustainable implementation arrangements,” he said.
Dr Amaning assured stakeholders of the Ministry’s commitment to creating an enabling environment that promoted innovation, protected public health and positioned Ghana as a regional vaccine manufacturing hub.
Mr Jasper Sablah, Component Manager of the PharmAccess Ghana Programme at GIZ, said the European Union and the German Government were supporting Ghana to strengthen its pharmaceutical and vaccine manufacturing ecosystem through the programme being implemented from 2024 to 2028.
He said the initiative focused on governance and regulation, research and development, skills development, and private sector support to improve the competitiveness of local manufacturers.
Mr Sablah described regulation as a critical requirement for attracting investment and ensuring Ghana met international manufacturing standards.
He noted that engagements involving the NBA, FDA and National Vaccine Institute had identified biosafety regulation as an important gap that needed urgent attention to support research, manufacturing, and international collaboration.
Representing the Chief Executive Officer of the National Vaccine Institute (NVI), Mr Paramount Eli, said lessons from the COVID-19 pandemic had reinforced the need for Ghana to build domestic vaccine manufacturing capacity to reduce vulnerability during future public health emergencies.
He said the establishment of the NVI demonstrated Government’s commitment to developing a sustainable vaccine manufacturing ecosystem covering research, development, manufacturing, regulation, and market access.
Mr Eli stressed that manufacturing alone would not guarantee success without a strong, efficient, and internationally recognised regulatory system capable of assuring the quality, safety, and efficacy of vaccines.
“Regulatory readiness is not merely a technical requirement but a strategic investment in national health security, industrial development and economic transformation,” he said.
He called for stronger collaboration among regulators, researchers, manufacturers, policymakers, and development partners to strengthen Ghana’s regulatory systems and align them with global standards.
Mr Eli reaffirmed the NVI’s commitment to working closely with the NBA, FDA, academia, industry, and development partners to establish a coordinated regulatory system that supported innovation while ensuring public safety and confidence.
The workshop is expected to produce practical recommendations and a roadmap to strengthen Ghana’s regulatory readiness and accelerate the country’s vision of becoming a trusted regional centre for vaccine development and manufacturing.
