For the past 10 years, ZaZiBoNa has helped Southern Africa Development Community (SADC) Member States protect their populations, assuring the availability and accessibility of good quality, safe and effective medicines. Its 10th anniversary was commemorated in Cape Town, Republic of South Africa, at a seminar conducted on the 26th and 27th of October 2023. The seminar brought together a number of partners in the health sector, such as the founding and current Heads of Agencies, SADC Secretariat, African Union Development Agency-NEPAD (AUDA-NEPAD) – the continental lead for African Medicines Regulatory Harmonisation (AMRH); the World Health Organisation (WHO) and the Federal Institute for Drugs and Medical Devices (BfARM). The Bill & Melinda Gates Foundation, as one of the funding partners, the German Agency for International Cooperation (GIZ) as the implementing partner and industry stakeholders were also in attendance. The seminar was a platform for introspection and discussion on ZaZiBoNa’s future, cementing the 5-year strategic plan from 2023 to 2027.
ZaZiBoNa, founded in 2013, is a collaborative medicines registration initiative in Southern Africa focusing on dossier assessments and good manufacturing practice inspections. It serves as a platform for work sharing, information exchange, capacity building and harmonisation of registration requirements. It was formally endorsed by the SADC Ministers of Health in 2014. It became part of the SADC medicines registration harmonisation (MRH) project in 2015. The initiative involves joint assessments and joint inspections of pharmaceutical products for registration under the umbrella of the SADC Medical Products Harmonisation initiative.
Through ZaZiBoNa, the harmonisation of registration requirements for pharmaceutical products has made it easier and less time-consuming for manufacturers and applicants to compile a single submission for all nine SADC member states who are active members of the initiative. In his keynote address, Mr Johannes Gaeseb, Director - Tertiary Healthcare and Clinical Support Services, Ministry of Health and Social Services of Namibia, who is also the founding Head of Agency for Namibia said that “ZaZiBoNa has largely enabled manufacturers and applicants to enter SADC member states markets simultaneously, lowering the cost of entry into new markets in the region. The initiative has reduced workload for regulators, built their capacity and reduced timelines for registration of medicines.”
Since its inception, the initiative has convened 44 joint assessment sessions and assessed over 350 products in its ten years of operation. This is the highest number of products assessed by any regional harmonisation initiative on the African continent.
Over 150 National Medicines Regulatory Authorities (NMRA) staff comprising assessors, inspectors, Quality Management Systems (QMS) auditors and laboratory managers have been trained through the initiative. Furthermore, pharmaceutical regulatory authorities have reported that participating in the initiative has increased their capacity to conduct assessments and good manufacturing practice inspections.
The programme “Support Towards Industrialisation and the Productive Sectors (SIPS)” has made possible the 10th-anniversary milestone of ZaZiBoNa. The programme SIPS is co-funded by the European Union and the Federal Ministry for Economic Cooperation and Development (BMZ). The Programme is implemented by the German Development Cooperation Agency (GIZ) and the SADC Secretariat.
