Technical Cooperation and Capacity Building

There is increasing recognition within FDA of the need to engage in effective, global regulatory cooperation. Such cooperation usually involves working with other regulatory agencies and development partners to strengthen regulatory capacity and provide technical and scientific expertise. Strengthening regulatory capacity is important to FDA’s ability to fulfill its mission to better monitor and ensure the safety of the supply chain for food, feed, medical products and cosmetics that enter the United States from other parts of the world. Equally important, strengthening regulatory capacity in the developing world can reap significant benefits for the health and quality of life of individuals and communities in those countries. Strong regulatory systems reinforce and secure public and private investments in new drugs and vaccines development and manufacture, as well as agriculture and food production -- all of which are vulnerable in the absence of capable, strong and effective regulatory frameworks.

Regulatory capacity is characterized as the ability of national regulatory authorities to perform regularly their core functions to ensure the availability of high quality and safe food and medical products. For the FDA, technical cooperation results in the cumulative public health footprint left by a variety of efforts related to the development, utilization, implementation, and enforcement of international scientific regulatory standards that help assure globally the efficacy, safety, and quality of products FDA regulates in the United States.

OIP has defined three program areas that contribute to this goal, and where resources have been committed:

1. Strengthening information and evidence so we can make informed decisions about how we target resources and use our expertise:
2. Transferring information, methods and practices related to regulatory processes, including identifying training efforts globally that do not require the use of FDA resources; and
3. catalyzing regional and global networks and information platforms to enable information sharing and strengthen detection, surveillance and assessment systems.

These efforts complement FDA’s work in global policy such as at the World Health Assembly and PAHO Directing Council and in international harmonization bodies like ICH and VICH – to provide the technical support that enables countries and regions to implement and utilize harmonized standards. They also help the FDA to identify strategic areas of focus, and cultivate new partnerships with multilateral organizations and development agencies to leverage FDA’s scientific expertise with others’ resources and knowledge in order to strengthen regulatory systems and achieve effective regulatory cooperation.

Key studies underway:

• A consensus study by the Institute of Medicine that will identify the core elements of needed regulatory systems development in developing economies and appropriate roles for FDA, other regulatory authorities, and, potentially, the donor community;
• A global assessment of training institutions, capacities, and approaches in regulatory affairs to enable FDA to identify gaps in training, particular niches that it can uniquely fill, and areas where collaboration and synergies with other regulatory authorities and institutions should be explored.
• With USAID’s Strengthening Pharmaceuticals Systems, a review and analysis of pharmacovigilance capacities and foci in Africa in order to inform the FDA and USAID of systems gaps/needs, existing efforts, and strategies for systems strengthening

Networks and Platforms

In the area of medical products:

• With the World Health Organization (WHO), help build a global surveillance and monitoring system for combating substandard and falsified/counterfeit medicines and supply chain threats
• With the Pan American Health Organization (PAHO), help develop a regional information hub related to medical products that promotes regional cooperation and data utilization / sharing to enable harmonized approaches, standards, and guidelines for medical products regulatory systems.

In the area of food safety:

• With the World Health Organization, help support capacity building activities through the Global Food-borne Infections Network (GFN) and its Advisory Group on Integrated Surveillance of Anti-microbial Resistance; and
• Help develop a plan for a global integrated food safety information platform that will facilitate global information sharing and strengthen capacity to address food safety problems

In the area of veterinary medical products:

• With the World Organization for Animal Health (OIE), help contribute to regulatory capacity strengthening and adoption of international standards for veterinary medical products through regional training and laboratory capacity building.