V. Implementing the pathway to global product safety and quality
Implementing the pathway will require a concerted effort involving all parts of FDA and multiple external stakeholders (global regulators, industry, states, White House, etc). For implementation of the strategy to be successful, FDA will undergo a paradigm shift to become a global agency. Implementing an effort of this nature will be complex and take multiple years; however, it is important to establish early momentum and support for the effort, to ensure that it launches with a critical mass of resources and attention from key stakeholders. To achieve this, FDA will focus on two areas in the coming year.
A. Establishing the framework and approach for broader data sharing and use of third parties
It will be essential for FDA’s broader product safety efforts that the agency be able to aggregate multiple sources of information as inputs to intelligence analysis to proactively identify threats. In order to share information efficiently with both domestic and foreign counterparts, the agency needs to develop or identify systems, capabilities, and processes to manage this exchange. Building the appropriate IT infrastructure will be critical.
Furthermore, scaling the current model for regulatory operations is simply not viable from a resource standpoint. FDA instead must shift to a model which more aggressively utilizes reliable public and private third parties to conduct inspections and other oversight activities. While making this shift will be a multi-year effort for FDA, it will be essential to quickly establish the framework and approach for capturing this opportunity.
B. Establishing the Global Coalitions of Regulators
Over the next 12 months FDA aims to partner with foreign counterparts to create global coalitions of regulators. Effective and well-functioning coalitions are critical to the successful implementation of the Pathway to Global Product Safety and Quality. Key activities will include:
- Determining the governance structure for the coalitions (roles, mandates,
operating model, funding mechanism, etc.)
- Identifying initial partners, with a goal of expanding over time
- Conducting discussions with key emerging economies that may not be
part of the initial group
- Identifying early high priority topics for agreement