Fifth Steering Committee meeting of the West African Medicines Regulatory Harmonization (WA-MRH) Project

5TH STEERING COMMITTEE MEETING

Lagos, Nigeria, February 2, 2019

1. The fifth Steering Committee meeting of the West African Medicines Regulatory Harmonization (WA-MRH) Project was held on February 2, 2019 in Lagos, Nigeria. It was preceded by a preparatory Technical Meeting, from January 31 to February 1, 2019.

2. The WA-MRH Steering Committee meeting was chaired by Professor Stanley OKOLO, the Director General of WAHO, with  the participation of:

• Dr Mahamane Hamidine, Director of Health and Social Protection at the UEMOA Commission,
• Prof. Moji Christianah Adeyeye, Director General of NAFDAC,
• Heads of National Medicines Regulatory Agencies (NMRAs) of the fifteen (15) ECOWAS Member States,
• Dr Aïssatou DIACK, Task Team Leader WA-MRH at the World Bank;
• Dr David Mukanga, Bill & Melinda Gates Foundation;
• Dr Samvel Azatyan, Team Leader, WHO International, Geneva;
• Dr Petra Dorr, Deputy Director SWISSMEDIC;
• M. John Patrick Nwesigye, Senior Health Officer, in charge of Medicines Regulation in East African Community (EAC).

3. Also present were the Chairpersons of the seven (7) Experts Working Groups (EWGs), the Professional Officer in charge of the Pharmaceutical Regulatory Harmonization and Cooperation in UEMOA Commission and WAHO staff, including the Director of Public Health and Research, Professional Officer responsible for Essential Medicines and Vaccines, and the Project Management Unit team.

4. The objectives of the Steering Committee meeting were to:

• Review and approve the 2018 Project Implementing Reports of countries and the region;
• Review and approve the 2019 Annual Workplan and Budgets of countries and the region;
• Review and approve the report of the joint assessment of the dossiers of Fluconazole Infusion (Juconazole) and Chlorhexidine Gel;
• Review and approve the procedure for joint assessment of medicines and other medical products in the ECOWAS region;
• Review and approve the list of drugs that will be evaluated jointly;
• Review the level of implementation of the recommendations of the last Regional Steering Committee meeting held in Ouagadougou in July 2018.

5.  The Steering Committee approved:

• The level of implementation of the recommendations of the Regional Steering Committee Meeting of July 2018;
• The 2018 Project Implementation Report;
• The 2019 Workplan.

6. The Steering Committee reviewed and approved the proposal for the procedure of the joint assessment of medicines dossiers (Plan B) presented by the EWG on Medical Products Dossiers Evaluation and Registration (EWG-MPDER). However the Steering Committee instructed the EWG MPDER to continue to work on:

• Improving the timelines of the joint assessment procedure taking into account the nature of the products and the specificity of the legislation in force in countries;
• Taking into account the variations;
• Determining the fees to be paid for the joint assessment and allocation to the parties involved.

7. The Steering Committee directed the Secretariat to identify three (3) eligible NMRAs to play the role of coordinating NMRA, based on the results of the benchmarking exercise and criteria proposed by the EWG-MPDER.

8. The Steering Committee recommended the commencement of a pilot-phase of the joint assessment with a short list of medicines which will give the time to build the capacities and confidence of the NMRAs and to test the procedure for its improvement.

9. The Steering Committee agreed that fees be paid for Joint Inspection by the manufacturers. To this end, it instructed the EWG on GMP/Inspection to continue their work and propose the amount for these fees which should be presented during the next Steering Committee.

10. The Regional Steering Committee took note of the Presentation of the EWG on MPDER on the progress of the joint assessment of Fluconazole Infusion and Chlorhexidine gel.

11. The Steering Committee instructed the Secretariat to take all necessary steps to enable the EWG MPDER to continue and finalize the joint assessment of the Fluconazole Infusion and Chlorhexidine gel, in order to present the report at the next Steering Committee meeting.

12. The Steering Committee was informed on the progress made by the EWG on Policy, Legislation, Regulation (EWG-PLR) regarding the development of the ECOWAS Pharmaceutical Policy, Legislation and Regulation.

13. The Steering Committee instructed the EWG PLR to continue their work and submit their proposal to the NMRAs for their contribution and comments for subsequent presentation at the next Steering Committee meeting.

14. The Steering Committee was informed by WHO and the Bill and Melinda Gates Foundation (BMGF) of the key partners of the African Medicines Regulatory Harmonization Initiative and their roles.

15. The Steering Committee was impressed by the experience Share by the East African Community (EAC) on Medicines Regulatory Harmonization Initiative in EAC.

16. In order to strengthen the capacity of the Project implementation actors (WAHO, UEMOA, EWGs and WA-MRH Focal Persons in the NMRAs), the Steering Committee requested the approval of the World Bank to acquire computers.

17. In order to facilitate and accelerate the implementation of the Project, the Regional Steering Committee made the following recommendations:

To countries:

• Be more proactive and take initiatives to accelerate the implementation of the Project activity ;
• Accelerate the signing of Financing Agreements by the two countries yet to do so (Mali, Nigeria);
• Justify funds received quickly enough to speed up the disbursement process of the second tranches;
• Accelerate the development and transmission to WAHO the Terms of Reference (TOR) no later than 28 February 2019;
• Comply with WAHO procurement guidelines to expedite the procurement process and the use of consultants.

To countries:

• EWG MPDER:
  • Continue the work on Plan B, in order to improve the timelines of the joint assessment process, taking into account the nature of the products and the specificities of the legislation in place in the ECOWAS Member States ;
  • Continue the work on Plan B, taking into account the notion of variations;
  • Determine the fees to be paid for the joint assessment process and the planned allocation to the various parties.
  • Continue the process of assessing the dossiers of Fluconazole Infusion (Juconazole) and Chlorhexidine gel, with a view to finalize them within a short time.

• EWG PLR:
  • Finalize the ECOWAS Pharmaceutical Policy, Legislation and Regulation and submit them to the NMRAs for contribution and comments for subsequent presentation to the Steering Committee.

To WAHO / Technical Secretariat:

• Improve the communication with the National Medicine Regulatory Authorities (NMRAs) by using New Information, Communication and Technology (Videoconference, WhatsApp…);
• Allow the Heads of the autonomous NMRAs to sign the Financing Agreements;
• Improve the procurement process, in order to reduce the time required to process country requests;
• Conduct monitoring and supportive supervision missions in the countries;
• Include the purchase of computers in WAHO's 2019 Workplan;
• Forward to the World Bank the official copy of the request for the project’s restructuring;
• Identify the three eligible NMRAs to coordinate the joint assessment process;
• Explore the possibility to dissociate the meeting of Technical preparatory Committee meeting, to facilitate better consultation between the Technical Expert and Member of the Steering Committee.

To partners and the World Bank:

• Strengthen the technical and human resource capacity of WAHO to facilitate and accelerate the implementation of the Project;
• Study the possibility to extend the Project closing date to 31 December 2020.

Done in Lagos, 2nd February 2019