Global Medicines Regulatory Harmonization Discussed

October 18, 2012


Strengthening governance, regulations and accountability in the pharmaceutical sector is an important segment of health systems strengthening.  Improved medicines regulatory policy and harmonization efforts can lead to more competitive markets, economic growth, improved access to new medicines, better quality of pharmaceuticals in circulation and ultimately better health outcomes.

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; to share information on the activities of the Asia-Pacific Economic Community Regulatory Harmonization Steering Committee; to obtain stakeholder feedback on ideas for a Bank-supported regional program for East Asia and the Pacific; and to understand how the Bank could play a role in regional efforts. 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, the New Partnership for African Development, the EAC secretariat and national regulators.

Participants 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.