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