The World Bank Implementation Status & Results Report West African Medicines Regulatory Harmonization (P158363) West African Medicines Regulatory Harmonization (P158363) AFRICA | Western Africa | Health, Nutrition & Population Global Practice | Recipient Executed Activities | Investment Project Financing | FY 2017 | Seq No: 3 | ARCHIVED on 18-Nov-2019 | ISR38453 | Implementing Agencies: Guinea Bissau Laboratório e Medicamento -Direcção-Geral de Estabelecimentos de Cuidados de Saúde, Mali Directeur de la Pharmacie et du Médicament, Cape Verde Agência de Regulação e Supervisãode Produtos Farmacêuticos e Alimentares (ARFA), Benin Pharmacy of Medicines and Diagnostiques (DPMED), West Africa Health Organization (WAHO), Ghana Food and Drugs Authority (FDA), Liberia Medicine & Health Products Regulation Authority (LMHRA), Nigeria National Agency for Food and Drug Administration and Control (NAFDAC), Guinea National de la Pharmacie et des Laboratoires Ministère de la Santé, Burkina Faso Directeur général de la pharmacie du médicament et des laboratoires, Directrice de la Pharmacie et du Médicament de la Côte d'Ivoire, Niger Ministry of Health, Pharmacy, Gambia Medicines Control Agency, Pharmacy Board of Sierra Leone, la Pharmacie et duMédicament du Sénégal, Togo Departement de la Pharmacie, du Médicament et des Laboratoires, West African Health Organization Key Dates Key Project Dates Bank Approval Date: 12-May-2017 Effectiveness Date: 25-Sep-2017 Original Closing Date: 14-May-2020 Revised Closing Date: 14-May-2020 pdoTable Project Development Objectives Project Development Objective (from Project Appraisal Document) To improve the availability of quality and safe medicines and vaccines in the Economic Community of West African States pharmaceutical market by strengthening and harmonizing regulatory systems, improving efficiency and enhancing transparency in medicines and vaccines registration Has the Project Development Objective been changed since Board Approval of the Project Objective? No Overall Ratings Name Previous Rating Current Rating Progress towards achievement of PDO Satisfactory Moderately Unsatisfactory Overall Implementation Progress (IP) Satisfactory Moderately Satisfactory Implementation Status and Key Decisions The project was declared effective on September 25, 2017, launched on November 27, 2017 and the first disbursement was completed on November 28, 2017. The project is currently scheduled to close on May 14, 2020. The project has reached several milestones in the MRH harmonization process in West Africa. While the flagship activity has been the Joint Assessment Sessions on Medical Products, Dossier Evaluation and Registration, several other activities have also been completed, including the finalization and validation of the harmonized ECOWAS Common Technical Document, development of Regional Harmonized Guidelines, standards and Manuals by the seven Expert Working Groups. Two Steering Committee (SC) Meetings preceded by technical meetings were organized in February and July 2019 and thoroughly discussed the status of project implementation and the establishment of a regional medicines agency for ECOWAS. Under Component 2, activities have been completed in some of the countries (Burkina Faso, Niger, and Ghana), and preparations are under way in other countries. Notable achievements of the project so far include:  Rise in project disbursement rate: Despite the implementation delays, three countries (i.e. Ghana, Burkina Faso, and Niger) have almost or fully completed the implementation of their Action Plans, contributing to raising the overall project disbursement rate from 26.4% in December 2018 to 48.8% in July 2019. 11/18/2019 Page 1 of 5 The World Bank Implementation Status & Results Report West African Medicines Regulatory Harmonization (P158363)  Improvement in Country-ownership: WAHO’s WA-MRH project team led implementation support visits to 4 countries in early 2019 and regular coordination meetings have taken place between the WAHO pharmaceutical team and MRH focal points in the NMRAs.  5 countries- Ghana, Nigeria, Liberia, Sierra Leone and The Gambia- have obtained ISO 9001-2015 certification and strengthened their Quality Management System. Risks Overall Risk Rating Risk Category Rating at Approval Previous Rating Current Rating Overall -- Moderate Substantial 5. Results Project Development Objective Indicators IN00740779 ►At least 6 NMRAs participating in a joint assessment of submitted application(s) for registration of medicines/vaccines and taking the outcome as a basis for their regulatory decision (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 0.00 6.00 Date 24-Apr-2016 04-Sep-2018 22-Jul-2019 31-Mar-2020 15 NMRAs participated in the Joint Assessment. Countries would be followed up to confirm usage of the JA outcome in their regulatory decisions after validation of the report at the WA-MRH SCM scheduled from July 25 to 26, 2019. Since no final recommendation on the products assessed, 0.0 NMRAs have taken the outcomes for Comments: regulatory decision. Going forward, the SC should also reach a decision on the procedure on joint assessment of medicines dossiers (Plan B) presented by the EWG-MPDER in February 2019. This new procedure will allow to designate “Coordinating Countries” that should receive the application. IN00740780 ►2 or more products have been registered by NMRAs in the region as a result of the joint dossier assessment (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 0.00 2.00 Date 24-Oct-2016 04-Sep-2018 22-Jul-2019 31-Mar-2020 Assessment concluded on 2 products (Chlorhexidine and Fluconazole) & outcome would be presented at the upcoming steering committee meeting for validation and action. No product is registered by NMRAs since no Comments: Joint Assessment recommendation was provided by the SCM yet. IN00740781 ►4 or more NMRAs in the ECOWAS region have applied for International Standards Organization (ISO-9001) certification on quality management system for at least one (1) department (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 1.00 1.00 5.00 4.00 11/18/2019 Page 2 of 5 The World Bank Implementation Status & Results Report West African Medicines Regulatory Harmonization (P158363) Date 22-Apr-2016 04-Sep-2018 22-Jul-2019 31-Mar-2020 Overall Comments PDO Five (5) NMRAs have obtained ISO 9001:2015 (Ghana, Liberia, Nigeria, Sierra Leone & Gambia). Intermediate Results Indicators IN00740778 ►Health personnel receiving training (number) (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 80.00 329.00 150.00 Date 24-Oct-2016 18-Jul-2018 22-Jul-2019 31-Dec-2018 Comments: IN00740787 4 CTD Trainings conducted (Number, Custom Breakdown) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 2.00 4.00 4.00 Date 24-Oct-2016 04-Sep-2018 22-Jul-2019 30-Jun-2018 IN00740782 ►NMRAs implementing quality management systems (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 1.00 1.00 5.00 3.00 Date 22-Apr-2016 04-Sep-2018 22-Jul-2019 31-Dec-2018 Comments: IN00740785 ►Joint registration documents (guidelines and Common Technical Document format) are developed with WHO support and approved by ECOWAS MRH Steering Committee (Yes/No, Custom) Baseline Actual (Previous) Actual (Current) End Target Value No Yes Yes Yes Date 25-Apr-2016 04-Sep-2018 22-Jul-2019 30-Sep-2017 IN00740784 ►Joint inspections conducted and countries sharing of reports (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target 11/18/2019 Page 3 of 5 The World Bank Implementation Status & Results Report West African Medicines Regulatory Harmonization (P158363) Value 0.00 0.00 2.00 2.00 Date 24-Oct-2016 28-Jul-2017 22-Jul-2019 29-Jun-2018 Comments: IN00740786 ►6 or more NMRAs have functional websites and are sharing regulatory policies, legislation, guidelines and information on registered medicines and vaccines (Number, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 5.00 7.00 6.00 Date 25-Apr-2016 04-Sep-2018 22-Jul-2019 29-Jun-2018 Comments: IN00740783 ►Countries using harmonized documents for registration, inspections, QMS and IMS (Percentage, Custom) Baseline Actual (Previous) Actual (Current) End Target Value 0.00 0.00 5.00 20.00 Date 24-Oct-2016 04-Sep-2018 22-Jul-2019 31-Oct-2018 Comments: Data on Financial Performance Disbursements (by loan) Project Loan/Credit/TF Status Currency Original Revised Cancelled Disbursed Undisbursed % Disbursed P158363 TF-A4885 Effective USD 3.00 3.00 0.00 2.13 0.87 71% Key Dates (by loan) Project Loan/Credit/TF Status Approval Date Signing Date Effectiveness Date Orig. Closing Date Rev. Closing Date P158363 TF-A4885 Effective 05-Jul-2017 20-Jul-2017 25-Sep-2017 14-May-2020 14-May-2020 Cumulative Disbursements 11/18/2019 Page 4 of 5 The World Bank Implementation Status & Results Report West African Medicines Regulatory Harmonization (P158363) Restructuring History There has been no restructuring to date. Related Project(s) There are no related projects. 11/18/2019 Page 5 of 5