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IDRAC®: A single source of trusted global regulatory intelligence

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IDRAC offers the following modules

Global Module: The IDRAC Global Module is an access point for users who work with more than one IDRAC country module. Available by separate subscription, it provides content, regulatory expertise and visual enhancements to aid comparisons between the regulatory requirements in multiple countries and regions. Please contact your sales representative if you have questions regarding the Global Module. 

United States: The complete resource for FDA drug and biological advisory committee and workshop meetings. IDRAC features access to the AdCommTM, AdComm Profiles, AdComm Voting, and the FDA Workshop Bulletin.

Europe: The EU module covers all European Union Authority legislation, with specific national requirements faced by companies operating in this complex regulatory environment. We also offer 34 individual European country modules. In addition, basic information on fees is available for Cyprus, Iceland, Luxembourg and Malta.

Japan: More than 800 documents, all translated into English, keep you up to date with changes resulting from the reorganization of the Japanese system in 2002.

India: The organization and function of the Medicines Agency (CDSCO); consolidated versions of main acts and rules including the Drug and Cosmetics Act 1940 and the Drug and Cosmetics Rules 1945, with a comprehensive follow-up of amendments; the Indian Constitution, main guidelines, including GMP and GCP and government policies; and much more.

China: The organization and function of authorities, the State Food and Drug Administration (SFDA) and the Ministry of Health (MOH); the China Drug Administration Law and its regulations for implementation; Chinese guidelines including GMP, GLP, GCP, GRP, and GSP; and much more.

South Korea: The organization and function of authorities, the Korea Food and Drug Administration (KFDA); Korean legislative documents including the Pharmaceutical Affairs Act and the main guidelines; and much more.

Latin America: This module covers regulatory information for the largest markets in the region; Argentina, Brazil, Chile, Colombia and Mexico. We offer a complete set of regulatory summaries and official documents to help your Company understand the particulars of the dossier for registration or renewal; the considerations for conducting clinical trials; the type of existing business licences; the import/export barriers; and much more. With this module you will also have access to MERCOSUR (Southern Common market) major provisions regarding medicinal products and health policies.

Middle East & Africa: In line with global regulatory evolution, IDRAC continues its coverage of the Middle East & African regions with the following country modules: Gulf Cooperation Council (GCC), Israel, Saudi Arabia, South Africa, and United Arab Emirates (UAE). These modules include relevant Reference Documents for drug development, registration and marketing; and Regulatory Summaries written by local experts and aligned with IDRAC proprietary specifications.

International module: Reference texts and explanatory documents on the major international and regional organizations involved with legislating medicinal products around the world.

Medical Device Coverage: Everything you need to keep up with the ever-changing regulatory requirements for medical devices in key countries and regions around the world.

Other modules: ASEAN, Australia, Canada, Hong Kong, Malaysia, New Zealand, Singapore, and Taiwan

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