The World Bank Report No: ISR12487 Implementation Status & Results Africa African Medicine Regulatory Harmonization Project (P128332) Public Disclosure Copy Operation Name: African Medicine Regulatory Harmonization Project Project Stage: Implementation Seq.No: 3 Status: ARCHIVED Archive Date: 30-Dec-2013 (P128332) Country: Africa Approval FY: 2012 Product Line: Recipient Executed Activities Region: AFRICA Lending Instrument: Specific Investment Loan Implementing Agency(ies): Key Dates Board Approval Date 06-Oct-2011 Original Closing Date 31-Dec-2014 Planned Mid Term Review Date 31-Mar-2014 Last Archived ISR Date 17-May-2013 Effectiveness Date 13-Jul-2012 Revised Closing Date 31-Dec-2014 Actual Mid Term Review Date 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? Yes No Component(s) Component Name Component Cost Regional Coordination and Capacity Building for Medicines Regulatory Harmonization 2.40 Institutional Development and Strengthening of National Medicines Regulatory Authorities (NMRAs) 3.10 Overall Ratings Previous Rating Current Rating Public Disclosure Copy Progress towards achievement of PDO Satisfactory Satisfactory Overall Implementation Progress (IP) Moderately Satisfactory Moderately Satisfactory Overall Risk Rating Moderate Moderate Implementation Status Overview The project is the first regional operation being supported under the African Medicine Regulatory Harmonization (AMRH) initiative. The project is jointly implemented by the East African Community (EAC) and its partner states (Burundi, Kenya, Tanzania and Uganda) and became effective in July 2012. The EAC signed memorandum of understanding (MOU) with the World Health Organization (WHO) and with New Partnerships for Africa's Development (NEPAD Agency) for providing technical assistance and for advocacy and coordination with other regional economic communities respectively. All the planned project staff at regional and country level are now in place and are actively supporting project implementation. Despite the delay in recruitment of project staff, the EAC team pro-actively facilitated implementation of regional activities. Page 1 of 5 The World Bank Report No: ISR12487 During the past six months, considerable progress has been made by the project. The four Technical Working Groups (TWGs) developed most guidelines and standard operating procedures for medicine regulatory harmonization by the EAC Partner States with technical support from WHO and the World Bank. The Project Steering Committee has approved these draft guidelines in its recent meeting held in Bujumbura from September 2-3, 2013. National stakeholder consultations were completed in all countries and regional consultation Public Disclosure Copy is planned soon. In addition, a project implementation workshop was held in October 2013 where operational bottlenecks were discussed and actions to further accelerate implementation were agreed. The NEPAD Agency has continued coordination and advocacy efforts with other Regional Economic Communities and has sustained high level policy dialogue. A draft model law to improve medicine regulatory harmonization has also been prepared. An assessment of Information Management Systems (IMS) of all six National Medicine Regulatory Authorities (NMRAs) and the EAC secretariat has been completed with support from WHO and the project steering committee approved the preliminary technical specifications. The EAC is currently reviewing the IMS developed and being used in Kenya to make a final decision on the IT solution. Locations No Location data has been entered Results Project Development Objective Indicators Indicator Name Core Unit of Measure Baseline Current End Target NMRAs participating in the harmonized Number Value 0.00 0.00 3.00 medicine registration based on internationally Date 31-Oct-2013 31-Dec-2014 recognized policies and standards Comments The NMRAs finalized the draft common technical document. The training and piloting will start during later FY 2014 NMRAS started piloting the electronic Number Value 0.00 1.00 3.00 submission of applications for registering Date 31-Oct-2013 31-Dec-2014 medicines Comments Kenya has started to receive electronic submissions. Public Disclosure Copy NMRAs sharing regulatory policies, legislation, Number Value 0.00 0.00 3.00 guidelines and information on registered Date 31-Oct-2013 31-Dec-2014 medicines Comments The technical working groups actively shared the information on policies and developed draft guidelines that were discussed with the national stakeholders. NMRAs received ISO 9001 certification Number Value 0.00 1.00 3.00 Page 2 of 5 The World Bank Report No: ISR12487 Date 31-Oct-2013 Comments Tanzania FDA has received ISO 9001 certification. Public Disclosure Copy Intermediate Results Indicators Indicator Name Core Unit of Measure Baseline Current End Target Harmonized guidelines including SOPs and Number Value 0.00 0.00 2.00 manuals for registration of medicines and GMP Date 31-Oct-2013 31-Dec-2014 inspection developed based on internationally Comments Draft modules and structures recognized policies and standards for Common Technical Document and Good Manufacturing Practices have been developed and national consultations concluded. NMRAs operationalizing common information Number Value 0.00 0.00 3.00 management system for medicine registration Date 31-Oct-2013 31-Dec-2014 developed by the regional technical working Comments WHO concluded the IMS group assessment and EAC is consulting with partner states. Procurement for the VC equipment is in progress while that of InformationManagment System Solution will begin during the financial year 2014. Staff trained in medicine regulation Number Value 0.00 0.00 48.00 Date 31-Oct-2013 31-Dec-2014 Comments Training modules (Medicines evaluation and conducting GMO inspections) will be ready by December 2013 with Public Disclosure Copy WHO technical support and training will begin thereafter. NMRAs implementing quality management Number Value 0.00 1.00 3.00 systems Date 31-Oct-2013 Comments EAC Quality Management Requirements, Guidelines and Standard Operating procedures have been developed and Quality Page 3 of 5 The World Bank Report No: ISR12487 Managers in partner states NMRAs trained. Staff in NMRAs will next be trained in QMS to be followed by Public Disclosure Copy continual improvement and eventually ISO 9000Certification. Data on Financial Performance (as of 15-Oct-2013) Financial Agreement(s) Key Dates Project Ln/Cr/Tf Status Approval Date Signing Date Effectiveness Date Original Closing Date Revised Closing Date P128332 TF-10846 Effective 21-Mar-2012 21-Mar-2012 13-Jul-2012 31-Dec-2014 31-Dec-2014 P128332 TF-12036 Effective 28-Sep-2012 15-Oct-2012 15-Oct-2012 31-Dec-2014 31-Dec-2014 Disbursements (in Millions) Project Ln/Cr/Tf Status Currency Original Revised Cancelled Disbursed Undisbursed % Disbursed P128332 TF-10846 Effective USD 5.55 5.55 0.00 1.49 4.06 27.00 P128332 TF-12036 Effective USD 1.00 1.00 0.00 0.00 1.00 0.00 Disbursement Graph Public Disclosure Copy Key Decisions Regarding Implementation Page 4 of 5 The World Bank Report No: ISR12487 Sustaining the accelerated implementation of project activities by the EAC and its partner states remains critical to catch-up time lost. Lessons from the EAC will inform similar harmonization initiatives among other regional economic communities contributing to improved access for essential medicines. Public Disclosure Copy Restructuring History There has been no restructuring to date. Related Projects There are no related projects. Public Disclosure Copy Page 5 of 5