The ZAZIBONA Collaborative Medicines Registration Procedure


Introduction

The Tanzania Medicines and Medical Devices Authority (TMDA), since March 2019 has been actively participating in the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Medicines Registration Procedure.

The ZAZIBONA process is a collaborative procedure of 14 Southern African Development Community (SADC) countries in which national regulatory authorities jointly assess medicines for registration purposes. Currently there are nine (9) of the 14 member states actively participating in ZAZIBONA namely Zambia, Zimbabwe, Botswana, Namibia, Tanzania, Democratic Republic of Congo, Malawi, Mozambique and South Africa. The remaining six (6) of 14 member states do not actively participate in dossier assessment but are involved in training programmes and information sharing on products approved through collaborative procedure. In the long term all SADC countries are expected to actively participate depending on their capacity. The ZAZIBONA process aims at:-

  1. reducing time taken to grant marketing authorization in individual participating countries
  2. utilizing efficiently resources available within the regional national regulatory authorities through sharing
  3. making available good quality medicines to all those who need them in the region
Eligibility Criteria

Any medicine meeting the criteria of being an essential medicine is invited for submission to be considered for registration via the ZAZIBONA collaborative process Special consideration may be given to medicines that are vital to effective treatment and to expanding treatment programmes, where there are currently limited options for health practitioners in the participating countries. This includes medicines identified for special regional programmes and initiatives.

The focus will however be on the 10 priority disease conditions identified by SADC (List of priority diseases) plus reproductive health products. Priority will be given to the products included in the List of UN Commission for Live-Saving Commodities for Women and Children.

Any other medicines that are important from a public health perspective may be considered on a case-by-case basis.

Other eligibility criteria

To be eligible for the ZAZIBONA collaborative process an application in CTD-format should have been lodged with at least two (2) ZAZIBONA participating countries.

Products registered by stringent regulatory authorities (SRA) are eligible for an abridged review process provided there is access to the full assessment reports on which the authorisation by the respective SRA was based.

Applications not eligible

The invited generic products exclude those which have been prequalified by the World Health Organization (WHO), for which an accelerated registration mechanism (WHO PQ Collaborative Registration Process) can be applied.

Applicants are encouraged to make pre-submission consultations on eligibility of their products with TMDA before submission is done.

For The Pharmaceutical Inspection Co-operation Scheme (PIC/S) Link: (https://picscheme.org/en/about)

For The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Link: (https://www.ich.org/)