Thomson Reuters

IDRAC® brings together everything you need to keep up with the ever-changing regulatory requirements in nearly 60 countries and regions, replacing the onerous and time-consuming tasks of acquiring, compiling, indexing, cross-referencing, updating and analyzing this information.

Tens of thousands of documents cover all aspects of drug development in each country or region, thematically organized for easy retrieval, with more added every week. Every document includes a title, source, abstract, comprehensive and intuitive keywords in English, and extensive hyperlinks. A powerful search engine enables you to interrogate the entire database in seconds using full text, title, and keyword searches.

A single, authoritative source of global regulatory requirements.

With IDRAC, you can:

• Access more than 50,000 documents.
• Speed up access to the information you need.
• Track changes to documents.
• Trace each step of new regulations and directives.
• Browse easily between documents.
• Receive configurable email alerts.
• Facilitate better collaboration.

Why choose IDRAC?

• Reference texts, normally in the local language (with complementary translations into English for China, Japan, Taiwan and South Korea).
• Unique explanatory documents written in English by our team of experts to explain key processes and trends in each country.
• Build the coverage that suits you by subscribing only to the countries relevant to your organization. As standard, every IDRAC subscription also includes free access to an extensive library of reference texts and explanatory documents covering international organizations such as ICH, WHO, PIC, and many others.
• Outstanding support and training from a team of global regulatory affairs professionals and database management and online development experts. Training is provided by qualified instructors who can visit your site at your convenience or host a virtual training session online.
• Comprehensive customer service through easy-to-follow product manuals, dedicated telephone and email helpdesk support and our regular IDRAC newsletter.
  

• 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 33 individual European country modules. In addition, basic information on fees is available for Cyprus, Iceland, Luxembourg and Malta. 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. 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. 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. 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.
• Other modules: Argentina, ASEAN, Australia, Brazil, Canada, Hong Kong, Israel, Latin American Malaysia, Mercosur, Mexico, Russian Federation, Singapore, South Africa, Taiwan.

• 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. PDF