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Table 5 Status of the Quality Management System in the EAC Partner States NMRAs (2011/12–2014/15)

From: Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community

  National Medicine Regulatory Agency
Burundi Kenya Rwanda Tanzania Uganda Zanzibar
Indicator 12: Implementation of EAC QMS in the NMRA based on ISO-9001 standard No Yes (2011) No Yes (2014) Yes (2014) Yes
Indicator 13: ISO-9001 Certification of NMRA medicines regulatory system No No No Yes (2010) No No
  1. NB: Year in brackets indicates the time from which the indicator started to apply