The ZAZIBONA Collaborative Medicines Registration Procedure


The Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration is a the national regulatory authorities jointly assess medicinal product dossiers.

Active members include Zambia, Zimbabwe, Botswana, Namibia, Tanzania, Democratic Republic of Congo, Malawi, Mozambique and South Africa

Objective of ZAZIBONA
  • To reduce timelines for registration of medicines
  • To efficiently utilize available regional resources
  • To ensure the availability of good quality medicines within the region
What medicines can be assessed through ZAZIBONA
  • All essential medicines
  • Priority is for medicines for treatment of priority diseases as identified by SADC & reproductive health products listed by the UN Commission for Life-saving Commodities for Women and Children
  • Medicines required for effective treatment & expand treatment programs
  • Medicines prequalified by WHO or submitted under the WHO – Collaborative Registration procedures are NOT eligible
How to apply
  • Applicant must compile an application to CTD format and submit the application in at least two active country members of ZAZIBONA