East African Community
The East African Community Headquarters will today Friday 17th October 2014, host the EAC-Africa Medicines Regulatory Harmonization Round Table Donors Conference at its headquarters Arusha, Tanzania.
The Round Table Donors Conference will be co-chaired by Hon. James W. Macharia, Cabinet Secretary for Health of the Republic of Kenya and Chairperson of the EAC Sectoral Council of Minister of Health as well as Mr. Dan Hartman, Director of integrated Development (Global Health) from Bill and Melinda Gates Foundation, USA.
The Round Table Conference aims at improving access to quality and safe drugs for African citizens and exploring ways of financing the African Medicines Regulatory Harmonization (AMRH) Initiative at a time many countries are struggling to streamline medicines registration processes and systems.
In addition, the Round Table Conference will give an overview of the AMRH, showcase exciting progress made to date in the EAC as well as future plans and expansion plans into other Regional Economic Communities.
The conference will be attended by among others donors from developed and emerging markets, Ministers of Health and Finance from Partner States, Heads of National Regulatory Authorities(NRAs),representatives from the East African Legislative Assembly(EALA) and Pan African Parliament, high level political leaders from the EAC and African Union(AU)as well as representative from Regional Economic Communities(RECs),
The Multi-Donor Trust Fund for the AMRH Programme (MDTF-AMRH) has secured funding for the East Africa Community (EAC) AMRH project, which was launched in March 2012 in Arusha, Tanzania.
The EAC MRH Project aims to streamline medicines registration processes and systems among the EAC Partner States that will ultimately pave the way for the pharmaceutical industry to lodge a single application for marketing authorization of medicines. The process will contribute to improve patient's access to quality, safe and efficacious medicines for treatment of priority diseases.
To this end, EAC MRH Project has achieved significant results with the approval of the EAC Medicines Regulation Harmonized guidelines, requirements and standards for Medicines Evaluation and Registration (MER), Good Manufacturing Practice (GMP) and Quality Management System (QMS) by the 29th Ordinary Meeting of the Council of Ministers ("the Council") on 20th September 2014.
In addition, through a demonstration pilot project initiated by WHO in July 2013 and completed in March 2014, five multi-source products were reviewed jointly by EAC Partner States and the WHO Prequalification Programme.
The products ― three (3) antimalarial and two (2) reproductive health products (under the trade names of Falcimon, Misoprost 200 and Pill 72 respectively) ― were prequalified by WHO and registered by the EAC Partner State national medicines regulatory authorities (NMRAs) in less than a year. This is faster than the average total time required for WHO prequalification of a generic medicine and 80‒90% faster than the average EAC country registration time for a generic medicine.
