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Posted On: May 16, 2020

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

PUBLIC NOTICE

14th May, 2020

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) initiatives through the ZAZIBONA Collaborative Medicines Registration Procedure.

The ZAZIBONA process is a collaborative procedure for 14 Southern African Development Community (SADC) countries in which national regulatory authorities jointly assess medicines for registration purposes. Currently there are 9 of the 14 member states actively participating countries which are Zambia, Zimbabwe, Botswana, Namibia, Tanzania, Democratic Republic of Congo, Malawi, Mozambique and South Africa. The remaining six 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 vision of the ZAZIBONA process is:-

  • A region in which good-quality medicines are available to all those who need them;
  • Significantly reduce time taken to grant marketing authorization (registration) in the individual countries; and
  • Efficient utilization of resources within regional national regulatory authorities through work sharing.

The process objective is to promote a collaboration model to facilitate access to good-quality medicines through work sharing in assessment of medicines and inspection of medicine manufacturing and testing facilities. Products that meet assessment criteria are then granted registration in the participating countries, in which CTD-format applications for registration would have been submitted. Where countries agree that is necessary, variations to the products which have been registered under this collaboration may be handled through the same process.

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, in order 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 queries during the registration process and in principle harmonized registration decisions, which will facilitate easier review of any post-registration variations.

It should be noted that, applications may be submitted by any person that qualifies to be an applicant in each participating country as per national requirements.

SCOPE

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 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.

Issued by:
Acting Director General,
Tanzania Medicines and Medical Devices Authority (TMDA),
PSSSF House, 10th Floor, Makole Road,
P. O. Box 1253, Dodoma Or
P. O. Box 77150, Dar es Salaam
Phone: +255 22 2452108/2450512/2450751
Fax: +255 22 2450793
Hotline: 0800110084