Comparative Study of regulatory requirement for preparation of Dossier for Registration of Oral Solid Dosage form in Zimbabwe and Myanmar

  • Pankaj Nerkar R C Patel Institute of Pharmaceutical Education and Research, Shirpur
  • Atul Patil R C Patel Institute of Pharmaceutical Education and Research Shirpur
  • Gaurav Shaha
  • Vikrant Deshmukh

Abstract

The purpose of this research is to assess the requirements for generic medicine marketing approval procedures in developed nations such as Zimbabwe and Myanmar. The regulatory standards of many countries throughout the world differ. The regulatory agencies' work is to assure the quality, safety, and efficacy of medications in their respective countries. The Medicines Control Authority Zimbabwe (MCAZ) and Food and Drug Administration Myanmar (FDA) give marketing permission for healthcare products in Zimbabwe and Myanmar. The gap analysis will comprehensively assess the MCAZ and FDA regulatory requirements and procedures through comparison of them to the provided recommendations for guidance, and this study will give tremendous confidence that the MCAZ and FDA regulatory affairs agreement is being fulfilled.


Conclusions


Through this study it can be concluded that the drug registration procedure in any country is not similar and minor details cannot be missed. In detail knowledge is important of Drug Agency, its legislation, Approval pathways, dossier preparation process and dossier formats and other requirements which are required for dossier preparation and submission. This will make it easy for any drug to pass regulators eye with ease and fast. In this article will provide in depth knowledge about regulatory market and status for drug filling in given countries so that importance of drug registration in above countries can be understood. This study aims at making one understand the format and details of dossier preparation with important documentations needed. This will create impact for filling of drugs in above countries in future.

Keywords: Medicines Control Authority Zimbabwe (MCAZ), Food and Drug Administration (FDA), Certificate of pharmaceutical Product (COPP), Common Technical Document (CTD), Asian Common technical Document (ACTD), Summary of product characteristics (SmPC), Quality information summary (QIS)

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How to Cite
Nerkar, P., A. Patil, G. Shaha, and V. Deshmukh. “Comparative Study of Regulatory Requirement for Preparation of Dossier for Registration of Oral Solid Dosage Form in Zimbabwe and Myanmar”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 68-74, doi:10.22270/ijdra.v11i2.602.

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