The Managing Director of the Liberia Medicines and Health Products Regulatory Authority (LMHRA) Managing Director, Pharmacist Keturah C. Smith-Chineh has participated in the 11th West Africa Medicines Regulatory Harmonization (WA-MRH) Initiative Steering Committee Meeting where several issues about the regulatory harmonization of medicines were discussed.
The 11th WA-MRH Steering Committee Meeting which was held in Abidjan, the Ivory Coast, from April 29-30, 2022, brought together heads of the 15 West African Regulatory Authority on Medicines.
According to the LMHRA Managing Director, the rationale for the 11th WA-MRH Steering Committee Meeting was to capitalize on the various efforts of the 15 West African nation’s regulatory harmonization of medicines (MRH) as well as for greater collaboration and coordination, among the West African Health Organization (WAHO) and the West African Economic Monetary Union (WAEMU).
It can be recalled that both institutions agreed that the management of regulatory harmonization of medicines for the entire region be under the control of WAHO, with continued collaboration from WAEMU.
Managing Director Smith-Chineh in her briefing disclosed that the two organizations also decided to set up a Joint Steering Committee for the initiative to ensure effective and transparent implementation of the regulatory harmonization process.
Furthermore, the LMHRA Managing Director indicated that the meeting was also geared toward supportive efforts from the region about the WA-MRH Project launched on November 27, 2017, in Accra, Ghana; with funding from the Multi-Donor Trust Fund (MDTF) through technical and financial support from the World Bank, Bill & Melinda Gates Foundation (BMGF), African Union Development Agency-New Partnership for Africa Development (AUDA-NEPAD), the World Health Organization and Swissmedic.
The WA-MRH Project covered the 15 West African member states of ECOWAS and was implemented by WAH, O, UEMOA, and member countries, as a complement to the Medicines Regulatory Harmonization (MRH) component of the Sahel Women’s Empowerment and Demographic Dividend (SWEDD) project.
Accordingly, Managing Director Smith-Chineh noted that the achievements and gains of the WA-MRH Project included but were not limited to the 15 member countries agreeing to use the adopted ECOWAS harmonized Common Technical Document the (CTD), the establishment of seven Experts Working Groups (EWGs) to provide technical support to the WA-MRH Initiative, development of 133 regional harmonized Guidelines, approval of medicines through established regional procedure, Joint Assessment of medicines skiers and Joint Good Manufacture Practice (GMP) inspection of pharmaceutical companies that submitted applications for regional marketing authorization and development of ECOWAS Regional Pharmaceutical Policy and Regulations.
Pharmacist Smith-Chineh also disclosed that the 11th meeting of the WA-MRH Project Steering Committee which was held in Abidjan, from April 29-30, provided an opportunity to review events at the meeting and seek the endorsement of reports and medical products recommended by the EWGs as well as propose the next step or a way forward.
The role of the Steering Committee of the WA-MRH initiative includes: providing strategic and policy direction; approving technical documents and ensuring the proper implementation of the activities of the initiative.
Managing Director Smith-Chineh further asserted that the 11th Steering Committee Meeting was about the WA-MRH current initiatives as it relates to the operating rules which state that the Committee should meet quarterly each year (two emergency meetings and two general meetings) to decide on the implementation of the initiative and provide strategic direction on the way forward.
Hence, the outcome of the 11th SC meeting included: the assessment of the level of implementation of the recommendations made at the last SC meeting held on the 14th of December 2021; the level of implementation of the project to date as presented and discussed; available medicines applications endorsed to enable countries to take appropriate decision for in-country Market Authorizations (Mas); the e-CTD development of medical products submissions at the regional and national level be reviewed and regional and national assessment timelines matrix be adopted.
The steering committee meeting was formulated to appraise the Regulatory Harmonization-related activities in the region and provide the necessary guidance for more efficiency.
The African Medicines Regulatory Harmonization (AMRH) Initiative is an attempt by the African Union to strengthen regulatory capacity, encourage harmonization of regulatory requirements, and expedite access to good quality, safe, and effective medicines.
The initiative is implemented as part of the African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA); a policy framework to provide an enabling regulatory environment for local production and contribute to the Universal Health Care (UHC), AU Agenda 2063, and the Sustainable Development Goals (SDGs).
The AMRH initiative is as well implemented in the Economic Community of West African States (ECOWAS), Inter-governmental Authority on Development (IGAD), and Economic Community of Central African States (ECCAS). It covers more than 85% of the Sub-Saharan African countries which are at different levels of its implementation. To address the problem of non-coherent medicines laws in African countries, the AMRH Initiative developed a Model Law on medical product regulations to ensure effective regulation and promotion of harmonization.
The model law which among other things promotes the establishment of autonomous agencies; was adopted by the AU Assembly in January 2016 and has been domesticated by more than 12 of the AU Member States. Since 2014, eleven regional centers of regulatory excellence have been designated 2014 to provide coordinated and structured regulatory science training programs using the existing academic institutions in partnership with regulatory agencies.
