Recommendation 4-4: Governments in low- and middle-income countries should support their regulatory agencies to develop strategic plans for compliance with international manufacturing and quality-control standards. In the least developed countries, international organizations should support their efforts.
International quality standards for drug manufacture depend on the competence of the national regulatory authority. Regulators in low- and middle-income countries need training, equipment, technology, and reference standards (IOM, 2012). The agencies’ budgets do not allow for improvements in all these areas, and the scope of the needs can overwhelm the agencies, leading to inaction. It is important for regulators to make strategic decisions about what to invest in first. A strategic plan can help identify an organization’s priorities and guide activities that advance these priorities (Tominaga, 2012).
The committee believes that making a strategic plan is feasible for almost all poor countries. The process of making the plan helps regulators advocate for better support from their ministers and identify places for donors to contribute. At a strategic planning workshop in 2010, for example, the Namibian health minister asked the regulatory authority to propose ways to build capacity in the agency and to advance harmonized regulatory systems in southern Africa (TIPC, 2010).
Agencies in the poorest countries should first enforce standards in manufacturing, wholesale, and retail. The WHO and more developed regulatory agencies should support these improvements. There is good precedent for such collaboration. The WHO prequalification program has a capacity-building function. As part of the program, regulators from low- and middle-income countries serve 3-month rotations at WHO headquarters (WHO, 2010b). Their rotations require close work with prequalification assessors and allow for sharing ideas about how to monitor manufactures (WHO, 2010b). A similar partnership among regulators could also be useful. Some regulatory agencies in emerging economies have made great progress in a relatively short time. These agencies are well positioned to help their counterparts in other developing countries set out their goals. For example, experts from the Brazilian drug regulatory agency, Anvisa, could work with their counterparts in Mozambique or Angola to help develop realistic plans.
A strategic plan for compliance with international standards can help reduce redundant work and fragmentation. Both industry and regulators