ZAZIBONA is a collaborative medicines registration initiative in Southern Africa focusing on dossier assessments and good manufacturing practice (cGMP) inspections. It was founded in October 2013 by four countries Zambia, Zimbabwe, Botswana and Namibia with the support of WHO prequalification and the Southern Africa Regional Program on Access to Medicines (SARPAM). The name ZAZIBONA is a combination of the first two letters of the name of the founding countries and coincidentally means ‘to look to the future’ in a local Zambian language, nyanja. The name ZAZIBONA has been retained even though the membership has grown from the four founding countries to all 16 SADC countries. The initiative was formally endorsed by the SADC Ministers of Health in 2014 and became part of the SADC medicines registration harmonisation (MRH) project in 2015. Â
Objectives
ZAZIBONA is a collaboration in assessments and GMP inspections for medicines registrations with objectives to:
- Reduce workload
- Reduce timelines to registrations
- Develop mutual trust and confidence in regulatory collaboration
- Establish a platform for training and collaboration in other regulatory fields
Scope of Products
Products eligible for assessment under the ZaZiBoNa initiative consist of all essential medicines and medicines used in the treatment of the SADC priority diseases or conditions listed below:
- HIV/AIDS
- Tuberculosis
- Malaria
- Acute respiratory infections
- Diarrhoea
- Diabetes
- Pneumonia
- Cardiovascular
- Cancer
- Obstetrics
- Gastroenteritis and colic
- Reproductive health products
- Products included in the list of United Nations Commission for Life-Saving Commodities for Women and Children Final UN Commission Report_14sept2012.pdf (unfpa.org)
Participating Countries
Active Member Countries
Botswana
Active (A)
D.R.C
Active (A)
Malawi
Active (A)
Mozambique
Active (A)
Namibia
Active (A)
United Republic of Tanzania
Active (A)
South Africa
Active (A)
Zambia
Active (A)
Zimbabwe
Active (A)
Non-Active Member Countries
Angola
Non-Active (N)
Comoros Islands
Non-Active (N)
Madagascar
Non-Active (N)
Seychelles
Non-Active (N)
Swaziland
Non-Active (N)
Observer Countries
Lesotho
Observer (O)
Mauritius
Observer (O)