The 8th session of the East African Community (EAC) Medicines Regulatory Harmonization (MRH) joint dossier assessment has reviewed assessment reports of twelve (12) new applications, three (3) query responses and 1 variation. The review looked at product ranges from anti-cancers, Anti-Retroviral (ARVs), antifungals, products to treat urinary incontinence, urinary tract infections, pneumonia, and conjunctivitis among others and the meeting took place in Entebbe, Uganda from 19 – 24 March 2018.
Two of the query responses were recommended for approval. 1 variation for extension of shelf life was approved, 2 products were recommended for registration subject to submission of controlled specifications for the drug substance, drug product and container closure systems and 11 products required additional information. The EAC region is the pioneer in joint dossier assessments in Africa and has paved the way for other regions to also implement similar initiatives. The EAC joint dossier assessments are aimed at improving access to safe, efficacious and good quality essential medicines for the treatment of conditions of public health importance through putting up harmonized and functioning medicines registration and regulation systems within the region in accordance with the national and internationally recognized standards and best practices.
The session also reviewed joint assessment procedures to identify current challenges. During the meeting, the integrated regional Information Management System (IMS) was discussed as a shared point to enable secure information sharing of dossier applications for both medicines dossiers and GMP Inspections and other related regulatory information among the regulatory authorities participating in the process. This process is expected to enhance information exchange across countries and encourage peer-to-peer learning. The regional IMS platform is seamless and also allows for online application for registration of medicines in the NMRAs in the region. A demonstration of the regional IMS system was done.
The EAC joint dossier assessments are conducted based on the regional harmonized guidelines, requirements and standards for Medicines Evaluation and Registration (MER), Good Manufacturing Practices (GMP) and Quality Management Systems (QMS) that were approved by the 29th Ordinary meeting of the EAC Council of Ministers in 2014 through its Decision EAC/CM29/Decision 036. The Decision directed the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs) to begin domesticating and implementing the approved EAC harmonized guidelines, requirements and standards for MER, GMP and QMS from January 2015. Since this decision and subsequent joint dossier assessments being conducted, the EAC region has managed to reduce the average timelines for review of medicine registration applications from 1-2 years to a median of 7 months, representing a 40-60% reduction. This has improved patient access to essential medicines in the region.