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Table 4 Medicines Registration and GMP Inspection Systems in the EAC Partner States NMRAs (2011/12–2015/16)

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 5: Availability of guidance and procedures for registration of medicines
 Legal mandate to register medicines Yes Yes Yes Yes Yes Yes
 Availability of a system for receiving applications, evaluating and providing marketing authorisation for medicines Yes Yes Yes Yes Yes Yes
Indicator 6: NMRAs using regionally harmonized guidelines for product registration
 Availability and use of EAC Harmonized guidelines for registration of medicines YesΔ YesΔ YesΔ YesΔ YesΔ YesΔ
 Year EAC Harmonized Guidelines for Registration of Medicines came into force 2015 2015 2015 2015 2015 2015
Indicator 7: Availability of a process to track product registration applications and timelines
 Availability of mechanism for tracking registration timelines No Yes (2011) No Yes (2011) No Yes (2015)
 Average timelines range attained for Fast-tracked products 3 months 4–6 months
 Average timeline range attained for normal review 12 months* 12 months* 12 months*
Indicator 8: Number of products applications with registration decisions per annum (Mean ± SD)
 Applications received per annum 70.0 ± 42.0 1030* 833* 799.7 ± 275.2 457.80 ± 148.73 16.00 ± 18.89
 Application carried over from previous reference year(s) 0.0 ± 0.0 1000* 575* 443.0 ± 301.4 0
 Medicines registered by the NMRA per annum 0.0 ± 0.0 514* 175* 463.0 ± 224.6 344.40 ± 243.87 6.20 ± 4.76
Indicator 9: Proportion of NMRAs participating in joint assessments
 Participation in EAC joint assessments Yes (2015) Yes (2015) Yes (2015) Yes (2016) Yes (2015) Yes (2015)
 Number of joint assessments participated by NMRA 1 1 1 3 1 3
 Existence of policy on abridged procedure for registration of medicines No No No Yes (2011) Yes (2016) No. It is happening but there is no written policy yet.
 Reference regulatory standard used on abridged procedure for registration of medicines None WHO-PQ EAC & WHO-PQ In-house SOP EAC, SRAs & WHO-PQ WHO-PQ
Indicator 10: Proportion of product applications jointly assessed/ reviewed at regional level
 Number of products registered based on EAC joint dossier reviewsd 1/15 13/15 9/15 15/15 7/15 1/15
 Time taken to register medicines based on joint review outcomesd
Indicator 11: Availability of a Good Manufacturing Practice (GMP) inspection guidance and procedure
 Legal mandated to conduct GMP inspection No Yes (2011) Yes (2015) Yes (2011) Yes (2011) Yes (2015)
 NMRA using EAC Harmonized guidelines for good manufacturing practice (GMP) inspections No Yes (2015) Yes (2015) Yes (2015) Yes (2015) Yes (2015)
 Year EAC GMP inspection guidelines came into force 2015 2015 2015 2015 2015
 Participating in EAC joint GMP inspections Yes (2014&16) Yes (2015) Yes (2015) Yes (2015) Yes (2012) Yes (2012)
 Availability of policy on GMP assessment of pharmaceutical manufacturing sites using document review No No Yes No Yes No (it is happening but there is no written policy yet)
 Reference regulatory standard used for GMP document review EAC, PICs & WHO-PQ EAC, WHO-PQ, US-FDA, EMA, PICS Inspection Reports EAC GMP inspection report, WHO-Prequalification GMP inspection reports-
  1. NB: Year in the bracket indicating the time from which the indicator started to apply; YesΔ = a change from No at baseline; * = only 2015/16 data (not average); − = No data available/ submitted; sd = Secondary data from the EAC MRH Project SC Meeting Report (2018)