Harare, Zimbabwe 13 October 2017 – Experts from ten African countries identified ways forward for boosting quality management systems (QMS) to help improve the quality of regulatory review outcomes to ensure medical products in national health systems are affordable and of assured quality, safety and efficacy.  

At a workshop in Harare, Zimbabwe, organised by the World Health Organization, experts reviewed the minimum standard requirements and outlined activities, which need to be implemented for establishing or improving Quality Management Systems in National Regulatory Authorities. With the use of the WHO Global Benchmarking Tool, a road map that includes indicators, technical and financial support needed, and required time frame was developed.

Countries in the Region are already implementing various levels of quality management systems. Although advanced expertise already exists in the region representing a valuable resource to continue building regulatory capacity for Quality Management Systems in Africa, numerous gaps remain to be addressed. These are in the areas of human resource and competency, actions to address risk and opportunities, management reviews, documented information, leadership commitment, control of externally provided processes, products and services, and customer satisfaction. Loud calls for action to improve QMS capacity were made towards increasing leadership commitment, using existing regional expertise to teach others, providing in-country and overseas learning and training opportunities, and in-country and regional resource mobilization for QMS implementation.

In his opening remarks, Dr David Okello, the WHO Representative in Zimbabwe noted that detecting quality risks in manufacturing processes, designing efficacy and safety data collection systems, ensuring integrity of the distribution and supply chains as well as pharmaceutical service provision, are the exclusive area of medical product regulators.

“As health professionals, we are committed to preventing harm and ensuring provision of high quality treatment. Communities and health systems look up to the regulatory authorities and rely on your judgement to guarantee expected health outcomes for patients, ensure public health protection through prevention, diagnose properly  and treat effectively”, he said.

In recognition of for the role of regulatory system governance in ensuring the quality, safety and efficacy of medicines and other health technologies, African Health Ministers endorsed the Regional Strategy for Regulation of  Medical Products in the African Region, 2016–2025. The Strategy established a set of targets and milestones to serve as the roadmap for the Member-States on the way towards effective regulation of medical products on the continent. The governance indicator emphasises the importance of quality management systems for National Regulatory Authorities (NRA).

The four-day meeting brought together about 20 senior managers of the National Regulatory Authorities to discuss practical approaches to implement Quality Management Systems. The workshop was conducted in the context of the Pandemic Influenza Preparedness Framework and the Partnership Contributions Implementation Plan on regulatory capacity building for pandemic influenza and other public health emergencies.