The U.S. Food and Drug Administration’s (FDA) mission, as amended in the Food and Drug Administration Modernization Act of 1997, includes the mandate to, “participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.” In support of this mission element, the FDA’s Center for Biologics Evaluation and Research (CBER) exchanges critical regulatory information on an on-going basis with foreign regulatory counterparts using a range of mechanisms. CBER undertakes information exchanges with counterparts in the Americas, Europe, Africa, Asia and Australia, as well as with international organizations such as the World Health Organization and the Pan American Health Organization. These information exchanges enhance CBER’s ability to meet its responsibilities of ensuring the safety and effectiveness of the products it regulates, and earning the public’s trust. CBER accomplishes this by expanding the pool of expertise and information sources from which it can draw in order to produce comprehensive, informed decisions.
CBER undertakes a number of structured scientific and policy discussions under confidentiality commitments with foreign regulatory counterparts. Some of the most vital regulatory discussions that occur throughout the year are known as “Clusters.” These Clusters are established, routine discussions around specific subject matter areas that involve experts from CBER, other FDA components as appropriate, the European Medicines Agency (EMA), the Health Products and Food Branch (HPFB) of Health Canada (HC), Government of Japan’s Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency, and the Therapeutic Goods Administration of Australia. CBER is a principal participant in the Clusters for Blood Products, Advanced Therapy Medicinal Products, and Vaccines; it additionally participates as appropriate in the Agency Oncology, Pediatric, Pharmacovigilance, Biosimilar and Pharmacogenomic Clusters.
CBER’s information exchanges may consist of publicly available information, or may be of a non-public nature when conducted under the Agency’s Confidentiality Commitments, Memoranda of Understanding and other Cooperative Arrangements. CBER both initiates and responds to ad hoc requests for information exchanges with foreign regulatory counterparts on a range of issues, including:
- product manufacturing issues
- potential product shortages
- inspectional issues
- data interpretation
- post-marketing surveillance signals
- preapproval considerations
CBER also undertakes Parallel Scientific Advice (PSA) with the EMA. The PSA process is one in which a sponsor seeks joint scientific advice from FDA and EMA on issues related to the development phase of a new product. The benefits of these interactions include the following:
- an increased dialogue between the two agencies and sponsors at various points of the lifecycle of a new product
- a deeper understanding of the bases of scientific advice, and an opportunity to optimize product development
- the avoidance of unnecessary testing replication or unnecessary diverse testing methodologies
In addition, CBER frequently hosts short-term (no longer than 30-days) visits by foreign regulatory counterparts and scientists who can come from as nearby as Canada, or as far away as Singapore. These visits may span from one hour to several days to several weeks in length. Similarly, long-term visits (longer than 30 days) of researchers and scientists as fellows under several different programs routinely take place. These visits require background checks by FDA Security and can take as long as 6-months to obtain FDA clearance.