The Evaluations and Registrations (EVR) Division of the MCAZ assesses applications for medicinal products. The EVR Division reviews safety, quality and efficacy of medicines intended for marketing, sale and distribution in Zimbabwe 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). EVR is comprised of the Human Medicine , Complementary Medicine and Veterinary Medicine Units responsible for assessment and registration of human, complementary and veterinary medicines including post-registration variations.
There are four different registration pathways for registration of medicines namely Normal, WHO collaborative procedure, Zazibona and Expedited review pathways.
|Normal||The normal pathway involves assessment of full dossier reviews to check for compliance in quality, safety, and efficacy of human, complementary and veterinary medicines.|
|WHO collaborative procedure||This collaborative procedure serves to facilitate and accelerate registration of products which have already been assessed and prequalified by WHO Prequalification Team-Medicines (WHO/PQTm).|
|Zazibona||Zazibona is a SADC initiative for SADC countries. 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|
|Expedited review ‘Fast track’||Stringent Regulatory Authority (SRA) approved innovator products registered in the country of origin are eligible for this pathway. For these products the pathway is open throughout the year.
The expedited pathway for other products is opened periodically and communication through a circular is posted on the website from time to time.
Regional Collaborative Work
The Evaluation and Registration Division of MCAZ is involved in Southern African Development Community (SADC) collaborative work. This initiative also known as Zazibona, is a collaborative procedure for 16 SADC countries in which national regulatory authorities jointly assess medicines for registration purposes. 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. Currently 9 of the 16 member states are actively participating countries, these are Zambia, Zimbabwe, Botswana, Namibia, South Africa, Malawi, Tanzania, Mozambique and Democratic Republic of the Congo. The remaining 7 of 16 member states do not actively participate in dossier assessment but are involved in training programmes and information sharing on products that go through the collaborative procedure.
The Division offers training services for new and seasoned regulators from national medicines regulatory authorities (NMRAs), regulatory affairs personnel from the pharmaceutical industry, and people from academia. Moreover, the NEPAD Planning and Coordinating Agency designated the MCAZ’s Evaluations and Registration Division as a Regional Centre of Regulatory Excellence (RCORE) in product evaluation and registration under the African Medicines Regulatory Harmonization Programme (AMRH).