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Posted on: October 19th, 2012 by Romana Turina No Comments

Global medicines regulatory harmonization discussed

Bank’s Global Medicines Regulatory Harmonization

photo: UN

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Better access to medicines is a impressive challenge in the developing world, where 1,500 people die from infectious diseases every hour. Medicines to treat some of these infections are readily available but cannot be accessed, especially when regulatory requirements become too numerous among the neighbouring countries in the same sub-region, and drug manufacturers can not navigate between them. This affects the availability and price of essential medicines for the poor who need them the most.

On October 11th, 2012 the World Bank’s China Office hosted a discussion on global medicines regulatory harmonization. Participants included government officials from the State Food and Drugs Administration (SFDA), international development partners, academics, donors, embassy representatives and industry associations representing both the local and multi-national pharmaceutical companies.

The main objectives of the session were to share information on the Bank’s Global Medicines Regulatory Harmonization (GMRH) Multi-Donor Trust Fund (MDTF) and African Medicines Regulatory Harmonization project; and to understand how the Bank could play a role in regional efforts.

Participants also discussed a potential role for China in global and regional harmonization efforts, in particular contributions to the African regional projects. It was agreed that there is a role for the Chinese SFDA, the development community and the Chinese-based pharmaceutical industry in harmonization efforts in Africa. Participants agreed to further discussions within their institutions and with other partners on how best to harness the relevant contributions.

The GMRH MDTF was established in 2011 with an initial contribution of USD 12.5 million from the Bill and Melinda Gates Foundation. The overall project goal for GMRH is to promote the harmonization of medicines regulation as a means to increase patients’ access to safe, effective, and good-quality essential medicines.

The first project to be funded from the GMRH MDTF is the African Medicines Regulatory Harmonization project which focuses on the harmonization of medicines registration in the East African Community (EAC) including Burundi, Kenya, Rwanda, Tanzania, Uganda and Zanzibar. Partners in the project include WHO, World Health Organization, the New Partnership for African Development, the EAC secretariat and national regulators.


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