Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) AFRICA | Africa | Health, Nutrition & Population Global Practice | Recipient Executed Activities | Specific Investment Loan | FY 2011 | Seq No: 8 | ARCHIVED on 13-Jun-2016 | ISR22300 | Implementing Agencies: NEPAD Key Dates Key Project Dates Bank Approval Date:21-Mar-2011 Effectiveness Date:13-Jul-2012 Planned Mid Term Review Date:31-Mar-2014 Actual Mid-Term Review Date:16-May-2014 Original Closing Date:31-Dec-2014 Revised Closing Date:30-Jun-2017 Project Development Objectives Project Development Objective (from Project Appraisal Document) To harmonize medicines registration systems and to improve efficiency and enhance transparency in medicines registration among the East African Community Partner States. Has the Project Development Objective been changed since Board Approval of the Project Objective? No PHRPDODEL Components Name Regional Coordination and Capacity Building for Medicines Regulatory Harmonization:(Cost $4.48 M) Institutional Development and Strengthening of National Medicines Regulatory Authorities (NMRAs):(Cost $4.96 M) Overall Ratings Name Previous Rating Current Rating Progress towards achievement of PDO  Moderately Satisfactory  Moderately Satisfactory Overall Implementation Progress (IP)  Moderately Satisfactory  Moderately Satisfactory Overall Risk Rating  Substantial  Substantial Implementation Status and Key Decisions 6/13/2016 Page 1 of 7 Public Disclosure Copy Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) The Additional Financing was approved on April 21, 2016 and the Restated and Amended Grant Agreement for EAC and Amendment Letter for NEPAD have both been signed; the project should be declared effective and disbursing prior to the end of June 2016. The closing date of the project has been extended to June 30, 2017. The original project has disbursed all committed funds and both EAC and NEPAD are awaiting disbursement to ramp up project activities that slowed down since December 2015 due to a lack of funds. Under the AF, the risk related to the institutional capacity for implementation and sustainability was upgraded to reflect challenges in the NMRAs of Burundi and Rwanda which include limited capacity, understaffing and lack of recurrent budgets. It is expected that a separate study being conducted by the Bank on financial sustainability can shed further light on post-implementation strategies for continuation of activities once the project is completed. 6/13/2016 Page 2 of 7 Public Disclosure Copy Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) Risks Systematic Operations Risk-rating Tool Risk Category Rating at Approval Previous Rating Current Rating Political and Governance  --  Substantial  Substantial Macroeconomic  --  Moderate  Moderate Sector Strategies and Policies  --  Substantial  Substantial Technical Design of Project or Program  --  Moderate  Moderate Institutional Capacity for Implementation and Sustainability  --  Substantial  Substantial Fiduciary  --  Moderate  Moderate Environment and Social  --  Low  Low Stakeholders  --  Substantial  Substantial Other  --  --  -- Overall  --  Substantial  Substantial Results Project Development Objective Indicators PHINDPDOTBL  NMRAs participating in the harmonized medicines registration based on internationally recognized policies and standards (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 3.00 3.00 Date -- 24-Oct-2015 04-Jun-2016 30-Jun-2017 PHINDPDOTBL  NMRAs started piloting the electronic submission of applications for registering medicines (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target 6/13/2016 Page 3 of 7 Public Disclosure Copy Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) Value 0.00 1.00 3.00 3.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 PHINDPDOTBL  NMRAs sharing regulatory policies, legislation, guidelines and information on registered medicines on their websites (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 0.00 3.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 PHINDPDOTBL  NMRAs received ISO 9001 certification on quality management system (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 1.00 1.00 3.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 Overall Comments The NMRAs of Kenya, Uganda, and Tanzania are receiving electronic submission of Dossiers for Marketing Authorization. Evaluation of the dossiers, review by the second assessor as well as monitoring the progress of evaluation can all be done electronically. NMRAs are not yet sharing policies, guidelines and laws because sharing agreements are still under discussion and the IMS platform is also still under development. With regard, to ISO certification, Kenya PPB and Uganda NDA are currently conducting internal reviews and assessments with a view to invite external assessors in the near future. Intermediate Results Indicators PHINDIRITBL  Harmonized guidelines including SOPs and manuals for registration of medicines and GMP inspection developed based on internationally recognized policies and standards (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 2.00 3.00 3.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 6/13/2016 Page 4 of 7 Public Disclosure Copy Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) PHINDIRITBL  NMRAs operationalizing common information management system for medicines registration developed by the regional technical working group (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 0.00 3.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 PHINDIRITBL  Staff trained in medicines regulation (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 105.00 105.00 75.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 PHINDIRITBL  NMRAs implementing quality management systems (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 1.00 1.00 3.00 Date 11-Jul-2012 24-Oct-2015 04-Jun-2016 30-Jun-2017 PHINDIRITBL  Gap analysis report and a strategy for pharmacovigilance formulated and ready for implementation (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value N -- N Y Date 17-May-2016 -- 04-Jun-2016 30-Jun-2017 Overall Comments Data on Financial Performance 6/13/2016 Page 5 of 7 Public Disclosure Copy Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) Disbursements (by loan) Project Loan/Credit/TF Status Currency Original Revised Cancelled Disbursed Undisbursed Disbursed P128332 TF-10846 Effective USD 5.55 5.55 0.00 5.55 0.00 100% Key Dates (by loan) Project Loan/Credit/TF Status Approval Date Signing Date Effectiveness Date Orig. Closing Date Rev. Closing Date P128332 TF-10846 Effective 21-Mar-2012 21-Mar-2012 13-Jul-2012 31-Dec-2014 30-Jun-2017 Cumulative Disbursements Restructuring History There has been no restructuring to date. Related Project(s) P155163-Africa Medicine Regulatory Harmonization Project 6/13/2016 Page 6 of 7 Public Disclosure Copy Public Disclosure Copy The World Bank Implementation Status & Results Report AFCC2/RI-African Medicines Regulatory Harmonization Project (P128332) 6/13/2016 Page 7 of 7 Public Disclosure Copy