would agree to work toward the priorities identified on the strategic plan, and all work would be directly related to the plan, an openly shared document (Tominaga, 2012). For many smaller countries the plan should include a strategy for sharing work and pooling resources. At the regional level, the New Partnership for Africa’s Development recently published a 5-year strategic plan for regulatory harmonization (NEPAD, 2011). This document identified the technical barriers facing African regulators, clarified the mission of the African Medicines Regulatory Harmonization (AMRH) project, and identified objectives for 2011-2015 (NEPAD, 2011).

Multilateral agencies, such as development banks, should support the development and implementation of strategic plans for compliance with international standards. The pharmaceutical market is international, and everyone has an interest in promoting global standards. There is precedent for such investment. The Bill & Melinda Gates Foundation, the British Department for International Development, the World Bank, and the WHO all support the AMRH program (AMRH, 2012). Donor agencies can do similar work, as USAID has in support of postmarket surveillance in Latin America, Southeast Asia, and Africa (Miarlles, 2011).

Regulators will welcome the strategic investments this planning would bring. Governments need to support these investments as well. Compliance with international standards will demand a wide range of activities, including research, education, supply chain management, and incentives for the private sector. The regulatory agency alone cannot effect change and will need government support to marshal the involvement of all stakeholders.

Developed country governments also need to improve support for their regulatory agencies. At the time this report was prepared, substandard injectable drugs caused a fungal meningitis outbreak in the United States, bringing the topic of drug regulatory oversight to the forefront of the U.S. political discourse.

Gaps in Regulatory Oversight

On September 21, 2012, the Tennessee Department of Health notified the Centers for Disease Control and Prevention (CDC) about an outbreak of meningitis caused by fungal infection through a contaminated epidural steroid injection from New England Compounding Pharmacy Center in Framingham, Massachusetts (CDC, 2012). By early 2013, the CDC had counted 693 illnesses and 45 deaths in 19 states from the contaminated drug (CDC, 2013). The FDA’s October 2012 inspection report indicated gross violations of good manufacturing practices, including visible contamination of equipment and drug ingredients at the New England Compounding Pharmacy (FDA, 2012b).

The outbreak brought to light a gap in the U.S. regulatory system. The



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