Regulatory Substance Check System 'CRAIS Checker'

Currently, our regulatory substance determination software, "CRAIS Checker," is widely used by many companies in Japan and is set to make its overseas debut with a new specification following its adoption in the Pistoia Alliance CSCS Project. Even in the pharmaceutical industry, the movement towards compliance with chemical substance management regulations has become stricter, and companies have been troubled by the complex regulations that vary from country to country. In response, the Pistoia Alliance launched the Controlled Substance Check Service (CSCS) project last year, aiming to provide a global regulatory information source within a single system. Our company, in collaboration with our partner ChemAxon, applied for the development of this system, and we are pleased to announce that we have been officially selected. This recognition is based on our extensive track record and operational know-how in Japan, and we would like to express our heartfelt gratitude to all the domestic users who have helped us develop our products thus far.

As incidents related to dangerous drugs continue to occur, becoming a social issue, the Ministry of Health, Labour and Welfare has introduced "comprehensive designation," which categorizes substances with similar structural components as illegal drugs. This includes strengthening regulations on the manufacture and sale of designated drugs, as well as prohibiting possession and use. Additionally, Tokyo, which has its own drug regulations, is also strengthening penalties under the "Tokyo Ordinance on the Prevention of Drug Abuse." Pharmaceutical and chemical companies that handle various chemical substances on a daily basis must confirm the latest legal regulations regarding the chemicals they intend to handle before taking any action. However, the increasing regulatory burden raises the risk of overlooking regulatory information. The CRAIS Checker, which rapidly determines the regulatory status of chemical substances based on their structural formulas, addresses recent regulations that are difficult to manage through investigations of CAS numbers or lists of regulated substances, supporting faster and more reliable compliance responses. Furthermore, our regulatory substance check technology has been selected as a solution for regulatory drug compliance by the non-profit organization Pistoia Alliance, and we also sell the "Compliance Checker," which complies with drug regulations in North America, Europe, India, and other regions, in the global market.

Various regulations exist for chemical substances from the perspective of safety guarantees, but in legal terms, they are primarily regulated by substance names, making it difficult to determine them from chemical structural formulas. Additionally, for organizations handling chemical substances, proper management of regulated chemicals is one of the important compliance issues. However, the diversity of regulated compounds and the fact that many organizations handle a wide variety of chemicals require considerable effort to address these challenges. The regulatory compliance check system "CRAIS Checker" was developed to solve such problems and has been used by approximately 2,000 users in pharmaceutical and chemical companies, making it the largest regulatory substance check system in the country. Recently, it has been introduced to the National Institute of Health Sciences, a public institution.

Tokyo Chemical Industry Co., Ltd. and Patcore Co., Ltd. have entered into a contract for the regulatory substance check system "CRAIS Checker." The possession and proper handling of regulated substances such as narcotics, psychotropic drugs, poisons, and hazardous materials are legally required to be accurately monitored. Reagent manufacturers need to provide regulatory information about their reagents to various companies, and until now, they have conducted regulatory checks through stringent checking systems. However, in recent years, the number of regulated substances has been on the rise, and the increasing complexity of laws and regulations has necessitated more careful verification of compliance. This time, Tokyo Chemical Industry has adopted the regulatory check system "CRAIS Checker" to further strengthen its checks. Additionally, "CRAIS Checker" will be provided as a cloud service, significantly reducing hardware investment and operational efforts compared to installing the system in-house.