[ Pharmaceutical Sciences Asia - ONLINE ]
E-ISSN 2586-8470
[ Journal Abbreviation: Pharm.Sci.Asia ]
Mahidol University Journal of Pharmaceutical Sciences
  FORMER NAME   "Mahidol University Journal of Pharmaceutical Sciences" Published Since 1974

 
Abstracts

DOI: 10.29090/psa.2022.05.22.174Pharm Sci Asia 2022; 49(5), 498-505
 

Regulatory landscape analysis of Myanmar Food and Drug Administration based on the World Health Organization Global benchmarking tool

Ei Ei Chaw1,2, Leena Suntornsuk1*

1 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
2 Department of Food and Drug Administration, Ministry of Health, Nay Pyi Taw, Myanmar


Regulatory authorities play significant roles for ensuring quality, safety, and efficacy of pharmaceutical and health products. However, most of the national regulatory authorities in low- and middle-income countries encounter many challenges such as over workload and under-staff/resources to maintain the efficiency in regulatory process. To alleviate the problem, the World Health Organization (WHO)supports its member states and implements the WHO-Global Benchmarking Tool (GBT) to strengthen the capacity of the national regulatory system. In this study, the regulatory system of Myanmar was investigated using the WHO-GBT based questionnaire survey. The study aimed to assess the national regulatory system and regulatory activities with WHO-GBT indicators and sub-indicators and to provide recommendations for the future progress of Myanmar Food and Drug Administration (MFDA). The results shows that MFDA has a well-structured legal foundation for the regulatory system and regulatory activities. Interestingly, the National regulatory system is the first priority and most challenging item to be achieved. Human resource capacity is below the standard requirements to operate efficient regulatory activities. It is recommended that the MFDA should implement the guideline on complaints and appeals to regulatory decisions and published documents or channels for laboratory activities within a short to medium period (1-12 months). As a medium to long-term plan (6-12 months and above), a human resource development plan and capacity building should be immediately established to accelerate the regulatory functions. Besides, transparency and public confidence must be promoted in regulatory activities.


Keyword:

National regulatory system, Global benchmarking tool (GBT), Myanmar Food and Drug Administration (MFDA), Regulatory *GMP-Good manufacturing practice, GDP-Good distribution practice, GSP-Good storage practice, GPP-Good pharmacy practice




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