IN a bid to ensure quality, safety and efficacy of medical products imported or manufactured in East African community member states, the regional body, with the help from various development partners, is implementing special program of Medical Regulatory Harmonization Program (EAC-MRH).
The EAC-MRH program is part of the African Medicines Registration Harmonization (AMRH) Programme which was established to support African countries and their regional bodies to address challenges facing medicines registration.
The importance of medicines regulatory harmonization cannot be over emphasized given the fact that most African countries including EAC member states were using or some still use different laws and regulations.
According to various studies done, the region imports about 80 per cent of its medical products requirements. By harmonizing regulations, the regional market will be assured of same quality and standard products regardless of port of entry.
As it is in all member states, the National Medicines Regulatory Authorities (NMRAs), among their functions, are mandated to conduct pre-marketing assessments of medicines applications to ensure they meet standards of quality, safety and effectiveness.
It has been mentioned, time and again, that lack of expertise to assess medicinal products as one of the challenges facing many African countries including EAC member states in their endeavor to ensuring greater access to medicines of assured quality, safety and efficacious.
That is why one of the main focus of the program is equipping with necessary theoretical and practical expertise and knowledge to National Medicines Regulatory Authorities (NMRAs) on how to conduct medicinal products assessment and registration.
As conducting training for NMRAs staff is part of the EAC-MRH program, in May, 2014, Advisory committee of the African Medicines Regulatory Harmonization Program (AMRH) appointed a consortium of TFDA and School of Pharmacy of Muhimbili University of Health and Allied Sciences as Regional Centre of Regulatory Excellence (RCORE) in Medicines Evaluation and Registration (MER).
Speaking during the opening of Bioequivalence Training Course for Assessors held last month at the centre, acting Vice Chancellor of MUHAS said that the primary goal of the centre was to assist NMRAs in the region to build up national and regional capacity in pre-approval scientific evaluation of medicines so that public can access those medicines and be assured that they meet acceptable standard of quality.
So far, the centre has conducted two training session on assessment of quality, safety and efficacy of medicinal products. The first was held in 2015 and the recent one held in September this year.
The two-week September session which focused on Bioequivalence covered theory and practical of food and drug assessment. On the other hand, EAC secretariat also appointed Tanzania Food and Drug Authority (TFDA) as a lead agency in medicines evaluation and registration. In this regard, TDFA receives applications on behalf of NMRAs of partner states and coordinates joint assessments.
When opening the tenth Steering Committee Meeting of the EAC Medical Regulatory Harmonization Program held in Dar es Salaam recently, the Principal Secretary Ministry of Health, Community Development, Gender, Elderly and Children, Dr. Ulisubisya Mpoki revealed that EAC partners states have set a target that by the end of December this year all medicines and medical equipment entering into any member state must be of the same quality as per agreed regulations by the region.
He said that the Medicine Harmonization Program under review which began in 2012 has recorded good results as it has managed to put in place harmonization systems, setting up guidelines and procedures.
Through EAC MRH Programme which was inugurated in 30th March, 2012, five programs have been approved and are now in use in all partner states since 1st January, 2015.
Those programs are EAC Guidelines on Medicines Evaluation and Registration),EAC Procedure for Marketing Authorization of Medicinal Product Dossiers, EAC Guidelines on Good Manufacturing Practice (GMP), EAC Procedure for Conducting GMP Inspections) and EAC Quality Management Manual.
According to TFDA Director General Hiiti Sello, EAC harmonization guidelines for registration became effective in 1st January, 2015 and since October that year, six joint assessments have been conducted where 38 medical products applications were assessed among them, 8 were registered.
At the national level, the EAC harmonized guidelines became effective in August 2015 and up to July 2017; TFDA has registered 109 products which surpassed national target of 75 products by the end of the program implementation.
Notwithstanding those achievements, the level of operationalization of the program results vary among partner states due to different reasons.
Commenting on the program, Dr. Mawien Atem, Secretary General of South Sudan Drug and Food Control Authority who was attending the committee meeting said the program was very important to his country as it helps to bridge the gap in technical, financial and human resources.
He explained that after successful cessation from Sudan in 2011, the following year South Sudan established the authority with strong foundation from Sudan but a major challenge it was and still facing was lack of adequate human resource. “We are benefiting from EAC in various ways including training our staff and exchange of experience with our counterparts in the community.
To be precise, our staffs were with TFDA here sometime in July for training” said Dr. Atem adding that his country was also accorded some benefits free of charge which was very important because the country saves some money and use it in other pressing development issues” He said.