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Table 2 Status of indicators under policy and legal frameworks category (2010/11–2015/16)

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

 

National Medicines Regulatory Agency

 

Burundi

Kenya

Rwanda

Tanzania

Uganda

Zanzibar

Indicator 1: National Medicines Policy (NMP)

 Availability of a National Medicines Policy (NMP)

Yes

Yes

YesΔ

Yes

Yes

YesΔ

 Year of approval of the NMP by the Cabinet of Ministers

2012

2012

2016sd

2007

2015

2014

 Availability of a provision in the NMP for establishment of an autonomous national medicines regulatory agency (NMRA)

Yes

Yes

YesΔ

Yes

Yes

YesΔ

 Existence of a vision for the NMRA

Yes

Yes

YesΔ

Yes

Yes

YesΔ

 Policy comprehensiveness

Yes

Yes

YesΔ

Yes

Yes

YesΔ

Indicator 2: Legal framework governing the regulation of medical products

 Legal framework availability

Yes

Yes

YesΔ

Yes

Yes

YesΔ

 Availability of a Law for regulating medicines in your country

Yes

Yes

YesΔ

Yes

Yes

YesΔ

 Year of enactment of medicines law

1980

1957

(as amended in 2009)

2013

1978, (repealed 2003 and amended in 2004 & 2014)

1993

1986 (repealed in 2006 & amended in 2016)

Legislation comprehensiveness

No

YesΔ

Yes

Yes

YesΔ

  1. NB: - = No data available/submitted; sd = Secondary data from the EAC MRH Project SC Meeting Report (2018); YesΔ = a change from No at baseline