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EAC to launch project on harmonization of medicines registration 30 march 2012 / Harmonization of registration systems will ensure access to medicines of assured quality, says EAC Secretary General

By East African Community (EAC)
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ARUSHA, Tanzania, March 15, 2012/African Press Organization (APO)/ -- The East African Community will on 30 March 2012 officially launch the Medicines Registration Harmonization (EAC-MRH) Project at the Ngurdoto Mountain Lodge and Golf Club in Arusha, Tanzania.

The EAC-MRH Project aims to improve public health by increasing rapid access to good quality, safe and effective medicines through reductions in the time taken to register essential medicines for the treatment of communicable and non-communicable diseases.

Specifically, the EAC-MRH Project aims to develop and implement a harmonized system for registration of medicines in the EAC Partner States; implement a common information management system for medicines registration in each of the Partner States' National Medicines Regulatory Authorities (NMRAs); build national and regional capacity in medicines regulation; and to develop and implement a framework for mutual recognition of regulatory decisions of the Partner States, among others.

The project, to cost USD 10 million, is part of the African Medicines Regulatory Harmonization (AMRH) Programme which came into being three years ago. The AMRH Programme aims to assure quality, efficacy and safety of medicines by collaborating with nine Regional Economic Communities (RECs) and 40 National Medicines Regulatory Authorities to create a simplified and transparent regulatory system.

Assuring the quality, efficacy and safety of medicines is an important task for NMRAs and is performed through subjecting all pharmaceutical products to pre-marketing evaluation, marketing authorization/registration and post-marketing review.

Speaking ahead of the official launch, the EAC Secretary General Amb. Dr. Richard Sezibera explained that the EAC-MRH Project has been designed to support EAC Partner States to ensure the rapid availability of safe and effective medicines of assured quality, including life-saving treatments for priority diseases.

“Countries may differ regarding registration systems, as all may not have the capacity to implement a comprehensive medicine evaluation and registration system.

“It is important to note that the availability of affordable essential medicines can be improved through a simplified, open and transparent regulatory system,” Amb. Sezibera added.

Ministers of Health from the EAC Partner States will attend the launch ceremony, which will be officiated by the Chairperson of the EAC Council of Ministers. High level delegates from of the EAC Partner States, ARMH Programme Partners, the African Union, the EAC and other RECs, among others, are expected to attend.

The EAC-MRH Project is supported by the World Bank through a two-phased financing agreement with the EAC Secretariat.

Notes to Editors

• The African Medicines Regulatory Harmonization (AMRH) initiative came about three years ago and is supported by a Consortium of Partners[1].

• The initiative gave rise to the AMRH Programme, through which the New Partnership for Africa's Development (NEPAD) Agency as the technical arm of the African Union, in collaboration with Consortium partners, supports African Regional Economic Communities (RECs) towards achieving better health outcomes through improved access to new medicines and quality pharmaceuticals.

• Following successful initiation of the AMRH Programme at a NEPAD and Pan-African Parliament (PAP) consultation meeting in February 2009, the EAC-MRH Project has been designed to support countries to ensure the rapid availability of safe and effective medicines of assured quality, including life-saving treatments for priority diseases.

• Studies have shown that currently approximately 20% of countries have fully operational medicines regulation. Of the remainder, half have regulation of varying capacity, and 30% have either very limited medicines regulation or none at all.

• The reality is that many low income countries cannot ensure the safety, efficacy and quality of medicines circulating in their markets because they lack standards, systems, training facilities and are resource constrained in terms of staffing.

• These constitute some of the factors that contribute to the weaknesses of drug regulation with regards to health systems or socioeconomic development. Furthermore, problems of ineffective regulation transcend national borders and have global implications.

• The EAC-MRH Project is in line with the Millennium Development Goal (MDG) 8, target (8e)which seeks to promote a Global Partnership for Development through providing access to affordable essential medicines in developing countries.

• The launch event will mark the beginning of implementation of the Medicines Registration Harmonization Project in the East African Community. This project therefore will ultimately:

• Harmonize registration dossier format and technical requirements in the EAC region

• Increase technical capacity and efficient use of resources

• Increase applications for registration from manufacturers

• Realize cost savings

• Enable greater access to good quality and affordable medicines

• Enhance impact on efforts towards reaching the MDGs with regards to the three health-related MDGs (4, 5 and 6)