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


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.


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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1. Badjatya JK, Bodla R. Drug Product Registration in Semi-Regulated Market. Int J Drug Reg Affairs [Internet]. 2018 Feb.6 [cited 2023 Apr.12];1(2):1-. Available from:
2. Sahithya KS, Kumar DS, Madhavi BL, Goli D, Shanthakumar GS. Regulatory Pathway for Registration and Approval of Indian Drug Products in Overseas Market. Journal of Pharmaceutical Sciences and Research. 2020 Sep 1;12(9):1150-61.
3. Virkar KA, Ghige T, Velhal AB, Redasani V. A Review of the Preparation of Regulatory Dossiers in CTD Format and ECTD Submissions. IJPRA. 2022 July-Aug; 7(4):808-818.
4. Government Of the Republic of The Union of Myanmar Ministry of Health and Sports Department of Food and Drug Administration A Guideline on Drug Registration Application [Internet]. FDA; 2018 Feb. 15 [cited 2023Apr.08]. Available from:
5. Godiyal S. Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format. Int J Drug Reg Affairs [Internet]. 2019Jun.16 [cited 2023Apr.08];7(2):51-. Available from:
6. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: A systematic review and meta-analysis. JAMA. American Medical Association; 2008;300:2514-26.
7. Pashikanti S, Koribilli N. Generic Drug Registration Requirements in Row Countries. Journal of Pharmaceutical Sciences and Research. 2021 Oct 1;13(10):617-22.
8. MCAZ. Guideline on Submission of Documentation For Registration of a Multisource (Generic) Finished Pharmaceutical Product (FPP): Quality Part In The Common Technical Document (CTD) Format [Internet]. MCAZ; 2012 Aug [cited 2023Apr.09]. Available from:
9. Carolyn L. Gates; Mya Than. ASEAN Enlargement: impacts and implications. Institute of Southeast Asian Studies; 2001.
10. MCAZ. A Guideline on Drug Registration Application. Alternative Submission Pathways [Internet]. MCAZ; 2013 Mar [cited 2023Apr.08]. Available from:
11. Sithole T, Mahlangu G, Salek S, Walker S. Evaluation of the regulatory review process in Zimbabwe: challenges and opportunities. Therapeutic Innovation & Regulatory Science. 2021 May;55:474-89.
12. Rathod MH, Jain PN, Jain VC, S. M. SV. Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine) in Myanmar as per ACTD. Int J Drug Reg Affairs [Internet]. 2018Apr.15 [cited 2023Apr.18]; 6(2):35-0. Available from:
13. Food and Drug Administration. A Guideline on Drug Registration Application [Internet].FDA; 2018 [cited 2023Apr.18]. Available from:
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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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