Helping to Strengthen Regulatory Systems Globally
CBER’s International Program facilitates the Center’s efforts in foreign regulatory systems strengthening for those products it regulates. CBER employs multiple modalities and engages with multiple partners and initiatives in its efforts, notably with the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Pharmaceutical Regulators Programme (IPRP) and the Asia-Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC).
CBER offers a Quick Guide as a helpful navigational tool for foreign counterparts to locate FDA’s regulatory information on its webpages.
In 2011, CBER developed a web-based training program for foreign regulatory counterparts as an introduction to CBER’s regulatory processes, with the convenience of online training. The training material was updated in 2019 to stay abreast of legislative and organizational changes that occurred since the program was first developed.