Regulatory Substance Check System 'CRAIS Checker'

As incidents related to dangerous drugs continue to emerge as 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." For pharmaceutical and chemical companies that handle various chemical substances daily, it has become essential to verify the latest legal regulations concerning 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, thereby supporting quicker 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 offer a "Compliance Checker" that complies with drug regulations in North America, various European countries, and India, which is available in the global market.

Currently, our regulatory substance assessment 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. In the global arena, the movement towards compliance with chemical substance management regulations has become increasingly stringent, and pharmaceutical companies have been struggling with the complex regulations that vary by 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 has now been officially selected for adoption. This recognition is based on our extensive track record and operational know-how in Japan, and we sincerely thank all the domestic users who have helped us develop our products thus far.

There are various regulations regarding 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 structures. 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 issues. 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 required by law to be accurately monitored. Reagent manufacturers need to provide regulatory information about their reagents to various companies, and they have been conducting regulatory checks through a stringent check system. However, in recent years, the number of regulated substances has been increasing year by year, and the complexity of laws and regulations has necessitated more careful verification of regulatory compliance. This time, Tokyo Chemical Industry has adopted the regulatory check system "CRAIS Checker" to further enhance its checking processes. Additionally, "CRAIS Checker" will be provided as a cloud service, significantly reducing hardware investment and operational burdens compared to installing the system in-house.