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.  

Objectives

ZAZIBONA is a collaboration in assessments and GMP inspections for medicines registrations with objectives to:

  1. Reduce workload
  2. Reduce timelines to registrations
  3. Develop mutual trust and confidence in regulatory collaboration
  4. 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:

 

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)

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)