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 | Eastern Africa | Health, Nutrition & Population Global Practice | Recipient Executed Activities | Specific Investment Loan | FY 2011 | Seq No: 10 | ARCHIVED on 30-Jun-2017 | ISR28838 | Implementing Agencies: NEPAD, East African Community, World Health Organization, NEPAD Agency, EAC Secretariat, NEPAD Agency 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:30-Jun-2017 Revised Closing Date:29-Dec-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 Unsatisfactory Overall Risk Rating  Substantial  Substantial Implementation Status and Key Decisions 6/30/2017 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 PDO is to harmonize medicines registration systems and to improve efficiency and enhance transparency in medicines registration among the East African Community Partner States. This will be achieved through regional coordination and capacity building for medicines regulatory harmonization, and institutional development and strengthening of National Medicines Regulatory Authorities (NMRAs). With the Additional Financing, the project was previously extended to June 30, 2017 and in May 2017 was granted a no cost extension of the implementation period from June to December 2017. To date, 65.6% of the Additional Financing funds have been disbursed. Even with the recently approved no cost extension, more effort will be needed to implement the remaining project activities if the funds are to be fully utilized. The EAC was advised to plan and implement activities concurrently/in parallel in order to complete the remaining activities on schedule. 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 medicine registration based on internationally recognized policies and standards (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 6.00 3.00 Date 12-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments Additional Harmonized guidelines for Biosimilars, Biotherapeutics, Variations and Vaccines have been developed and will be approved. A 6/30/2017 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) training workshop has been organized in conjunction with WHO and has been scheduled to take place during August 28- September 8, 2017. PHINDPDOTBL  NMRAS started piloting the electronic submission of applications for registering medicines (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 1.00 1.00 3.00 Date 12-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments An Information management system catering for 6 functions/modules has been developed by Trade Mark East Africa and installed in the NMRAs of Uganda, Rwanda and Zanzibar. The solution for Burundi will be installed at a later date in consultation with the NMRA. Only Kenya PPB uses a true electronic Common Technical Document. In other words, Applicants can only go onto the Kenya PPB NMRA website/portal and make electronic submissions. PHINDPDOTBL  NMRAs sharing regulatory policies, legislation, guidelines and information on registered medicines (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 0.00 3.00 Date 12-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments The NMRAs of Uganda, Kenya, and Tanzania and Zanzibar have functioning websites. Those of Rwanda and South Sudan can be accessed through their respective ministries of health. There is no functional web portal/platform for medicine regulatory activities (MRH) that EAC NMRAs can use to work and share regulatory decisions. Kenya and Uganda are currently using the IGAD portal which was developed separately, with Bank support. S. Sudan is also able to use the IGAD portal but this may not be used for measurement as the country was not in the original or additional financing design due to their accession to EAC membership in August 2016. PHINDPDOTBL  NMRAs received ISO 9001:2015 certification (Number, Custom) 6/30/2017 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) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 1.00 1.00 3.00 Date 11-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments The NMRAs are now considering to apply directly for ISO 9001:2015 certification rather than ISO 9001: 2008 certification (the objective in the original project RF). This is expected to take more time. TFDA, which was the only country certified under ISO 9001:2008, is still within the grace period until June 2018 to transition certification to ISO 9001:2015. TFDA has applied for this and the recertification process for ISO 9001:2015 will commence in July 2017. Uganda NDA, Kenya PPB, and Zanzibar ZFDB are working towards ISO certification and likely to attain certification before December 2017. Overall Comments 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 0.00 5.00 3.00 Date 12-Jul-2012 30-Apr-2014 31-May-2017 29-Dec-2017 Comments The harmonized guidelines were developed and they are being used and are constantly updated as needed, based on international standards. 6/30/2017 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 medicine registration developed by the regional technical working group (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 5.00 3.00 Date 12-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments The NMRAs of Uganda, Rwanda and Zanzibar have a common/generic version of the TMEA-developed information management system. This will be the case for Burundi when it has completed installation. In the case of Tanzania TFDA, they upgraded their IMS system while Kenya PPB has completely reengineered theirs. It is hoped that the system will have interoperability properties to enable the 6 NMRAs to share with each other publicly available information. PHINDIRITBL  Staff trained in medicine regulation (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 169.00 75.00 Date 11-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments This has been on going. An additional 40 NMRA staff were trained in Kampala and 20 NMRA staff were trained in Nairobi with the support of WHO, USP and PTB in Advanced GMP and Data integrity. 4 more NMRA inspectors were trained through WHO and Swissmedic in Montreux, Switzerland. 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 12-Jul-2012 03-Apr-2014 31-May-2017 29-Dec-2017 Comments QMS requirements, manual, and guidelines and standards prepared under the previous ISO standard have been reviewed and updated to reflect the current ISO 9001:2015 requirements. Training and internal audits have been ongoing in all NMRAs in preparation for ISO certification. TFDA is the only one currently implementing QMS under ISO 9001:2008. The rest NDA, PPB & ZFDB are in preparation for ISO 9001:2015. TFDA, NDA, PPB and ZFDB are expected to be certified by December 2017. 6/30/2017 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) 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 -- 31-May-2017 29-Dec-2017 Comments Gap analysis in PV systems in the EAC NMRAs was completed in February 2017 and discussed in March 2017. Findings have been used to inform development of a regional PV business plan which is expected to be ready by September 2017. Overall Comments Data on Financial Performance 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% P128332 TF-12036 Effective USD 1.50 1.50 0.00 1.20 0.30 80% P128332 TF-A2289 Effective USD 3.40 3.40 0.00 2.36 1.04 70% Key Dates (by loan) Project Loan/Credit/TF Status Approval Date Signing Date Effectiveness Date Orig. Closing Date Rev. Closing Date 6/30/2017 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) P128332 TF-10846 Effective 21-Mar-2012 21-Mar-2012 13-Jul-2012 31-Dec-2014 29-Dec-2017 P128332 TF-12036 Effective 28-Sep-2012 15-Oct-2012 15-Oct-2012 31-Dec-2014 29-Dec-2017 P128332 TF-A2289 Effective 11-May-2016 11-May-2016 13-Jun-2016 30-Jun-2017 29-Dec-2017 Cumulative Disbursements Restructuring History Level 2 Approved on 11-May-2017 Related Project(s) P155163-Africa Medicine Regulatory Harmonization Project 6/30/2017 Page 7 of 7 Public Disclosure Copy