Product Evaluation and Registration
The Zazibona process is a collaboration between national medicines regulatory authorities (NMRAs) in Zambia, Zimbabwe, Botswana, Namibia, South Africa, Tanzania, Malawi, DRC, Mozambique and Malawi (active countries) as well as Eswatini, Angola, Seychelles and Madagascar (non-active).
BoMRA invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications through the Zazibona collaborative process.
Vision of Zazibona
The process objective is to promote a collaboration model to facilitate access to good-quality medicines through work-sharing in the assessment of medicines and inspection of medicine manufacturing and testing facilities. Products that meet assessment criteria are then granted marketing authorization in the participating countries, in which registration applications would have been submitted.
Frequently Asked Questions
The Zazibona collaboration does not represent the replacement of the need to submit applications for registration in participating countries in line with national requirements. However, as described in this document, to facilitate cooperation among Zazibona authorities, certain modifications are expected. Although there is close collaboration on assessments and inspections, final national registration decisions are the responsibility of individual participating authorities.
It is envisaged that manufacturers of needed medicines will benefit from accelerated registration processes, a single set of questions during the registration process and in principle harmonized registration decisions, which will facilitate easier review of any post-registration variations. Applications may be submitted by any person that qualifies to be an applicant in each participating country as per national requirements.
Who Prequalification Of Medicines Programme
The Collaborative Registration Procedure (CRP) for WHO-prequalified products is one of the registration pathways that applicants can utilise when submitting registration applications. The link below directs interested parties to the WHO website for more information on the procedure: https://extranet.who.int/prequal/content/collaborative-registration-faster-registration
To qualify for an Emergency Assessment Pathway (EAP), the use of the product must meet the following criteria:
The disease for which the product is intended has been declared by the WHO to be a Public Health Emergency of International Concern (PHEIC) and there is no licensed product for this disease.
The disease for which the product is intended has been declared by the Ministry of Health and Wellness to be a Public Health Emergency (PHE) and there is no licensed product for this disease.
The product is manufactured in compliance with current Good Manufacturing Practices (GMP).
The applicant attests that it intends to complete the development of the product. In the ideal situation, the remaining clinical trials and other requisite testing will already be underway at the time of the application.
Products meeting the criteria will be prioritised for assessment. Screening and assessment will be conducted simultaneously. The assessment will be conducted by the WHO Emergency Use Listing procedure and BoMRA registration guidelines.
Submitting an Application
For more information contact: firstname.lastname@example.org
Applicants should consult BoMRA to confirm eligibility and for applicable fees/ payment arrangements for EAP products.
Please see the WHO Emergency Use Listing for further guidance https://www.who.int/teams/regulation-prequalification/eul