Procedures for Dossier Preparation and their Marketing Authorisation in Zimbabwe Country for Complementary Drug

Authors: Nasare SO* and Pise AG

DOI: 10.23880/pdraj-16000141

Volume 6, Issue 1

Abstract

The Medicines Control Authority of Zimbabwe (MCAZ) is the authority to regulate from the Ministry of Health. It is established through an Act of Parliament which gives these bodies the `power to regulate the quality and sale of Complementary medicines. The objectives of this study were to evaluate the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate overall performance from 2017 to 2019, identify best practices in review, evaluate the quality of decision-making processes and identify challenges and opportunities for improvement. Complementary medicine has always been at the heart of most Zimbabweans. That most of the drug is located close to the African community makes it very attractive, user-friendly, cost-effective and flexible in adapting to the dynamics of modern societal trends. The aim is to understand the need for professionalization of complementary medicine. The guidelines were studied from the website. We studied the guidelines to prepare a checklist and dossier preparation to submit to the authority of Zimbabwe.

Keywords: Medicine Control Authority of Zimbabwe; Complementary Medicine; African Community; Dossier

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