• 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.

IDRAC US Module PDF
IDRAC Adcomm Bulletin PDF
IDRAC Adcomm Solutions PDF

• 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. View PDF
• 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. View PDF
• 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. View PDF
• 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. View PDF
• 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. View PDF
• International module: Reference texts and explanatory documents on the major international and regional organizations involved with legislating medicinal products around the world. View PDF
• 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. View PDF
• Other modules: ASEAN, Australia, Canada, Hong Kong, Israel, Malaysia, Singapore, South Africa, Taiwan PDF

• Global Module: Provides IDRAC content and regulatory expertise with visual enhancements for making comparisons easier between multiple country regulatory requirements. The Global Module is a new module and access point for users who have access to more than one IDRAC country module.
• IDRAC SOP Library: Get generic SOP templates, dedicated to clinical trials, that are continuously updated to match the ongoing regulation changes. View PDF
• IDRAC Notes: An individual productivity tool and a collaboration tool that allows you to capture and store your notes on IDRAC PDF Documents and share them with colleagues.
• IDRAC Regulatory Online Learning courses View PDF

22nd Annual DIA EuroMeeting

Monaco
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