• 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

• NEW! IDRAC LAUNCHES THREE NEW MODULES IN MIDDLE EAST

  In line with global regulatory evolution IDRAC continues its coverage of the Middle East region with three new country modules: Gulf Cooperation Council (GCC), United Arab Emirates (UAE), and Saudi Arabia.

  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. These Regulatory Summaries provide information on authorities’ organization, legal framework, registration, product information requirements, clinical research, quality assurance, pharmacovigilance, import, and export. The modules also cover prescription medicinal products, over-the-counter drugs and generics. The GCC module is a regional module that provides general information on local authorities organization and GCC centralized procedures requirements.

  Please contact your sales representative if you have questions regarding any of these country modules.
  

• Global Module: Access and Compare Global Regulatory Requirements Quickly and Simply

  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.  View PDF

• 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

46th ANNUAL DIA ANNUAL MEETING

June 13 - 17 | Washington, DC

Come listen to what our experts have to say

JUNE 14, 1:30 - 3:00PM

Improving and Changing R&D Organizations with a Knowledge Management Focus

Sougato Das, MS, Product Manager, Thomson Reuters, United States 

Recognized as the main asset of any organization, the intellectual capital is nowadays a constant worry for pharmaceutical companies, CROs, and investigator sites, and must be considered in all steps of an R&D strategy. The information related to R&D companies has being disseminated broadly, but there is no clear guidance for filtering and transforming it in knowledge and a competitive differential. This session will present some ways of knowledge management and considering human, structural, and customer capitals. Some practices currently used by leading companies to accelerate product development that will exemplify methodologies focused on processes, where the knowledge base is crucial, will also be addressed.