The approved Guidelines for Advertising and Promotion of Medicines are now available.
The Medicines Control Authority of Zimbabwe is responsible for the evaluation of safety, efficacy and quality and registration of complementary medicines destined for use in Zimbabwe. Please see the documents below for more details.
The MCAZ Chemistry and Medical Devices laboratories are now accredited to the ISO/IEC 17025 standard through the Southern African Development Community Accreditation Service (SADCAS).
The Chemistry laboratory is accredited for Quantitative and Qualitative analysis of pharmaceutical formulations by High Performance Liquid Chromatography (HPLC) and UV-Vis Spectrophotometry. The Medical Devices laboratory is accredited for Dimensions Testing, Freedom from Holes Test, Package Seal Integrity Test and Airburst testing of male Condoms. . This is a five year accreditation cycle starting from August 2015 to August 2020.
The two laboratories were previously accredited through South African National Accreditation System (SANAS). SADCAS a subsidiarity organization of the Southern African Development Community (SADC) is a non-profit, multi-economy accreditation body whose mission is to provide credible, cost-effective accreditation services. In line with the SADC push to have a regional accreditation system which supports regional and international trade, MCAZ as a participant in regional cooperation issues enlisted for accreditation through the new body.
SADCAS, has signatory status in both International Laboratory Accreditation Cooperation (ILAC) and African Accreditation Cooperation (AFRAC) thus MCAZ accreditation is recognised both regionally and internationally. As the National Regulatory Authority, this opens up our laboratories for business at international level entrenching our vision of being an effective medicines regulator in Zimbabwe and a leading regulatory authority in the world through our accredited quality testing facilities.
The ZAZIBONA process is a collaboration between national medicines regulatory authorities (NMRAs) in Botswana, Namibia, Zambia, and Zimbabwe.
These are four neighbouring countries in Southern Africa which have a combined population of around 34 million. This process may be extended to include participation by other interested SADC Member States.
The vision of the ZAZIBONA process is:
The process objective is to promote a collaboration model to facilitate access to good-quality medicines through worksharing 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 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.