Comparative study of regulatory requirements and marketing authorization for medicinal products in european union and zimbabwe

Abstract

The aim of this study is to evaluate the requirements for marketing authorization procedures of new drugs, generic medicines in developed countries such as Europe and to compare these procedures with those in developing countries such as Zimbabwe. Medicines control authority of Zimbabwe (MCAZ) grants the marketing authorization for medicinal products in Zimbabwe. However, there are still some gaps which need to be filled by the MCAZ to reach other bigger markets in the world. A comparative study of current MCAZ regulatory administration and practices with those of stringent regulators such as European Union will assist in the identification of these loopholes. It also provides the need for improvement with regard to pharmaceutical industries compliance with the relevant standards. This study will give a tremendous reassurance that the MCAZ regulatory affairs acquiescence is being met and gap analysis will systematically challenge the MCAZ regulatory requirements and procedures by comparing them to the European medicines agency regulatory guidelines, which will provide MCAZ with an insight into areas that have room for improvement. The study provides MCAZ with an insight into areas that have room for improvement. Current GMP Supervision of Manufactures and Inspections need to be upgraded; however, currently in Zimbabwe, there is inadequate internal audits, inadequate quality departments to do the validation and self-inspection in pharmaceutical industries. The comparison results obtained showed grey areas needed to be enhanced by MCAZ.