Today, IIGG releases a new policy innovation memorandum entitled “Designing a Global Coalition of Medicines Regulators.” This policy memo assesses the regulatory landscape of the global supply chain for medicines and proposes that a multilateral coalition of regulatory authorities would substantively improve the ability of public regulators to keep pace with a dynamic global marketplace. Here is an excerpt:
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.
Read the full publication here.