Monday, 23 September 2019
The Medicines and Allied Substances Control Act (MASCA)[15:03] and the Medicines and Allied Substances Control Regulations (MASCR) SI 150 of 1991 requires that all medicines be registered, after scientific scrutiny of quality, safety and efficacy data, before they are allowed to be used on the Zimbabwean public and/or animals. The Evaluations and Registration (EVR) Division is responsible for the evaluation of both human and veterinary pharmaceutical and biological (vaccines) products. The EVR Division reviews safety, quality and efficacy of medicines in accordance with the requirements of MASCA [15:03], MASCR SI 150 of 1991, the MCAZ Registration Guidelines, Registration Committee policies and approved internal procedures (SOPs) which are in accordance with the MCAZ Quality Management System (QMS). The technical elements in the MCAZ Registration Guideline are based on Southern African Development Community (SADC) Registration Guidelines, WHO norms and standards or equivalent. For sophisticated novel dosage forms and other new products, the EVR Division borrows concepts from WHO, ICH, USFDA, EMA and other leading regulatory agencies, as appropriate.
Approval of Registration of Medicines
The Registration Committee or the Veterinary Committee registers medicines that have met all the technical & legal requirements i.e. evaluation of dossier, analysis of samples and GMP compliance.
These successful applications will be issued with registration certificates and published in the MCAZ medicines register.
In pursuit of promoting high ethical standards, the Authority has formulated a Code of Ethics for its employees and members of the Authority .The Authority believes that high ethical...
Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization...
In line with the WHO guidelines on variations and other SRA guidelines, the EVR Division is updating the MCAZ Guidelines for submitting applications for Variations to Registered Medicines. The update...
Background The Medicines Control Authority of Zimbabwe (MCAZ) Regional Centre of Regulatory Excellence (ReCORE) in partnership with the European and Developing Countries Clinical Trials Partnership (EDCTP) is offering...
The Quality Policy of the Medicines Control Authority of Zimbabwe (MCAZ) is to ensure the provision of accurate and timeous services, continuously meet requirements of our customers and guarantee patient...
In this issue: MCAZ turns 20 years Basics of reporting Side Effects of medicines Electronic Adverse Drug Reaction Reporting For more information Please click here to download the Newsletter...
Increased Reporting from the Targeted Spontaneous Reporting (TSR) Programme Click here to download Drug Information Bulletin
Download Complementary medicines applications extension - press statement
The aims of the PV policy handbook are to firstly provide a framework for a national pharmacovigilance system in Zimbabwe. Secondly, to define the pharmacovigilance activities undertaken by the Pharmacovigilance...
The Medicines Control Authority of Zimbabwe (MCAZ) as a responsible corporate citizen runs a Scholarship Fund as part of its corporate social responsibility programmes. Click here to download the...
The approved Guidelines for Advertising and Promotion of Medicines are now available. Download the Guidelines for Advertising and Promotion of Medicines
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...
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...
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...