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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