1. Board of Directors The Board of Directors consists of a chairperson, up to ten vice chairpersons, a president and other 26 members. 2. Committee 1) General Affairs Committee   The committee supports the JSMI Board of Directors meetings and deals with JSMI budgets, operational plans, and membership issues. 2) Pharmaceutical Affairs Committee   The committee deals with OTC drug regulatory issues such as product registration, business licenses, approval standards, Rx-to-OTC switch products and GMP. 3) Pharmacovigilance Committee   The committee deals with issues related to drug information on the efficacy and safety of OTC drugs; reevaluation, GVP, labeling and package inserts. In addition, the committee co works other related committees on the issues related to GLP, GCP and product liability. 4) Herbal Medicinal Products Committee   The committee deals with all issues with related to traditional medicines, working closely with WHO and WSMI in its activities. 5) GMP Committee   The committee deals with matters related to collection of information on GMP, and those related to GMP software and validations as requirements for manufacturing licenses. 6) Pharmaceutical Technology Committee   The committee deals with issues related to specifications and analysis of OTC drugs in pharmaceutical technology. It cooperates with MHLW in establishing the guidelines for OTC drug specifications and testing methods. 7) International Affairs Committee   The committee deals with international issues related to OTC drugs. It acts as a liaison of JSMI to communicate with WSMI or its member associations abroad. The committee regularly introduces OTC news from abroad to JSMI member firms through the publication of "Information Services", a Japanese newsletter. The committee also quarterly publishes "JSMI NEWSLETTER", an English newsletter, and introduces major events in the Japanese OTC sector, both industrial and regulatory, to the international community. 8) Advertising Committee   The committee deals with various advertising for OTC drug products in public media. It conducts preliminary reviews of advertisements and reports to the Advertising Review Board (ARB), a self-regulatory body for the control of OTC drug advertising, for their review and judgment. 9) Public Affairs Committee   The committee deals with the annual public campaign on the self-medication and rational use of OTC drugs. It publishes a series of booklets on the rational use of OTC drugs. Some 200,000 copies are annually distributed to the consumer groups, schools, mass media, government health offices, etc. 10) Promotion Code Committee   The committee deals with issues related to the marketing, promotion, and distribution of OTC drugs, including business ethics. 11) Environment Affairs Council 12) Deregulation Affairs Council 13) Risk Management Council 14) OTC ENCYCLOPEDIA Committee JSMI-affiliated Organization   This special organization, affiliated with but financially independent from JSMI, publishes every two years the "OTC Encyclopedia in Japan", a compendium of OTC products of JSMI member firms. The book also assists pharmacies in meeting the requirements of the 1988 revision of the "MHLW Regulation for Pharmacy Structure and Equipment". The ninth edition was published in April 2004. Next 10th edition is in progress and expected in April 2006.