August 26, 2024 (NAIVASHA, Kenya): The Intergovernmental Authority on Development (IGAD) in partnership with the East, Central and Southern Africa- Health Community (ECSA-HC) and in collaboration with the Kenya Ministry of Health (Division of Health Products and Technologies ) are convening Good Manufacturing Practice (GMP) experts and inspectors from the National Medicines Regulatory Authorities (NMRAs) from Kenya and Ethiopia in the IGAD region and from the East, Central and Southern African countries ; Burundi, DRC Congo, Rwanda, Sao Tome, Malawi and Zambia.
The meeting aims to undertake a joint desk review of the status of the Good Manufacturing Practices (GMP) of local manufacturers of medical products through the assessment of GMP inspection reports, guidelines, Standard Operating Procedures (SOPs) and templates with the objective to harmonize the GMP of local manufacturers of Health Products and Technologies (HPTS) and develop specific and targeted interventions for selected manufactures based on the risk-classification through a collaborative approach.
The experts will also focus on the GMP inspection findings and the Corrective and Preventive Actions (CAPAs) in view of the status of their implementation in view of fostering compliance of the manufactures with the GMP requirements as a way to strengthen cross-country and cross-regional collaboration thus providing opportunities for cross-learnings and work sharing among the experts from the participating countries. The joint activity will build confidence across the National Medicines Regulatory Authorities (NMRAs) on regulatory decisions made as an outcome of regulatory GMP inspections.
This meeting is in line with implementation of the Health Emergency Preparedness, Response and Resilience (HEPRR) Multi-phase Programmatic Approach (MPA) Project that is being implemented by IGAD and ECSA-HC with the support from the World Bank since its launch in May 2024. The Project is focusing on access to quality assured, safe and effective health products and technologies including building capacity for local manufacturing of vaccines and pharmaceuticals and the compliance of local manufacturers with requirements of the current GMP.
Dr. Fatuma Adan the IGAD Head of Mission to the Republic of Kenya represented the Executive Secretary of IGAD and in her welcoming remarks stressed that access to quality assured, safe, effective and affordable health products and technologies is critical for healthcare services delivery as well as Universal Healthcare Coverage (UHC) as espoused under Sustainable Development Goal (SDG) Goal 3. Target 3.8.
“To achieve this IGAD, AU NEPAD, other regional economic communities (RECs) technical & development partners and all relevant stakeholders need to enhance their collaboration through existing and new initiatives to establish a strong ecosystem to support and accelerate local production of health products and technologies to ensure self-sufficiency and self-sustainability in the IGAD region, continent and global in line with the African Union new public health order targeting 60% of vaccines to be manufactured on the continent by the year 2040” Dr. Adan stressed.
She expressed that IGAD and ECSA-HC are working closely towards implementation of the agenda on local manufacturing of health products and technologies with the approval of the Regional Advisory Committee (RAC) of HEPRR program to establish the community of practice (COP) on local manufacturing of HPTs in the East and South African region (AFE) as well as engage the private sector in the pharmaceutical sector and work with local manufacturers to provide technical assistance in the area of current GMP and bio-equivalence.
On behalf of ECSA-HC; Dr Patrick Lungu, the Health Emergency and Response Specialist highlighted that health sectors in most developing countries face a persistent challenge of the shortage of health products and vaccines that became apparent during the COVID-19 pandemic thus the need to fast track support and develop core capacities and systems to support local pharmaceutical manufacturing industry
“ECSA-HC is proud to partner with IGAD and be a part of this journey of igniting the development of the health sector in our region with the goal of developing quality health products, enhance access, safeguard patient safety and address the issue of equity that continues to challenge developing countries” Dr. Lungu added.
Dr. Anthony Toroitich; Director Corporate Services at the Kenya Pharmacy and Poisons Board representing the Chief Executive Officer underscored the need for scientific research and statistics within the countries to inform the required decisions, policies and the required interventions to support local manufacturing of medical products.
The meeting was officiated by Dr. Stephen Njuguna representing the Principal Secretary of the Ministry of Health of the Republic of Kenya also called for the establishment of a conducive environment for local manufacturers to produce affordable, quality assured, safe and effective health products for the envisioned high-quality of life and health of all citizens.
“We need our local health product manufacturers from the region to be supported to benefit from the 2030 Africa Pharmaceutical Industry budget in order to promote and enhance the pharmaceutical industry to provide high quality, safe, accessible and affordable products as well as create jobs” Dr. Njuguna
Other key items to be discussed include;
- Creation of a conducive regulatory environment for local manufacturing of HPTs
- Harmonization of Standard Operating Procedures (SOPs) and templates for GMP inspections (planning, conducting and reporting)
- Harmonization of the review of corrective and preventive actions (CAPAs) following GMP inspections
- Review and harmonization of the format of the GMP inspection reports of the different participating countries (NMRAs) vs National, Regional and International GMP guidelines/ guidance
- References for the desk review of the GMP inspection reports
The implementation of the Health Emergency Preparedness, Response and Resilience (HPRR) Multi-phase Programmatic Approach (MFA) is with the support from the World Bank focusing on the access to quality commodities including building capacity for local manufacturing of vaccines and pharmaceuticals. The compliance and GMP certification of local manufacturers has been mainstreamed in this project as a key component for consistent manufacturing of quality assured, safe and effective medical products.
