CIAO DATE: 09/2014
August 2014
Globalization has transformed the marketplace for medicines in recent decades, giving rise to new threats including the poor traceability of global supply chains, counterfeit and substandard medicines, and antibacterial resistance. Aware that public drug authorities must cooperate to meet the emerging challenges of modern medicines regulation, the U.S. Food and Drug Administration (FDA) has been discussing with counterpart agencies abroad creating a "global coalition of regulators." Yet a coalition alone is not enough; the devil, as always, will be in the details. In pursuit of this goal, the FDA and partner medicines regulatory agencies should design a coalition with five distinct features: narrow scope, to promote realistic goals; flexibility, to adapt to future circumstances; selective membership, to maximize likemindedness, particularly in the early stages; nongovernmental (NGO) participation, to leverage the capacities of both NGOs and for-profit corporations; and institutional partnerships, to orchestrate the activities of other regulatory organizations.
Resource link: Designing a Global Coalition of Medicines Regulators [PDF] - 82K