the SC. Other parties have a significant interest in the International Council for Harmonisation and have been invited to nominate Observers to the SC; three current observers are the WHO, Health Canada, and the European Free Trade Association, with the International Federation of Pharmaceutical Manufacturers Association participating as a non-voting member of the SC. The Council for International Organizations of Medical Science (CIOMS) The CIOMS, a part of the WHO, is globally oriented think tank that provides guidance on drug safety related topics through its Working Groups. The CIOMS prepares reports that are used as a reference for developing future drug regulatory policy and procedures, and over the years, many of CIOMS' proposed policies have been adopted. Examples of topics these reports have covered include: Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V); Management of Safety Information from Clinical Trials (CIOMS VI); the Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials (CIOMS VII); and Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group (CIOMS VIII). The International Society of Pharmacovigilance The International Society of Pharmacovigilance is an international non-profit scientific organization, which aims to foster pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, in all countries. It was established in 1992 as the European Society of Pharmacovigilance. Society of Pharmacovigilance, India, also established in 1992, is partner member of the International Society of Pharmacovigilance. Other local societies include the Boston Society of Pharmacovigilance Physicians. Regulatory authorities Drug regulatory authorities play a key role in national or regional oversight of pharmacovigilance. Some of the agencies involved are listed below (in order of 2011 spending on pharmaceuticals, from the IMS Institute for Healthcare Informatics). United States In the U.S., with about a third of all global 2011 pharmaceutical expenditures, the drug industry is regulated by the FDA, the largest national drug regulatory authority in the world. FDA authority is exercised through enforcement of regulations derived from legislation, as published in the U.S. Code of Federal Regulations (CFR); the principal drug safety regulations are found in 21 CFR Part 312 (IND regulations) and 21 CFR Part 314 (NDA regulations). While those regulatory efforts address pre-marketing concerns, pharmaceutical manufacturers and academic/non-profit organizations such as RADAR and Public Citizen do play a role in pharmacovigilance in the US. The post-legislative rule-making process of the