|
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-
|
