LATEST COUNTRY MODULE LAUNCH: LEBANON, NOVEMBER 28, 2011

IDRAC has extended its coverage of countries in the Middle East/ Africa region with a new Country Module covering Lebanon.

This module gives you access to relevant Reference Documents and Regulatory Summaries that provide information on the Lebanese Ministry of Public Health (MOPH).

IDRAC regulatory summaries written by a local expert include various topics in the field of pharmaceutical regulatory affairs. The topics cover the organization of the national agency in Lebanon, Legal framework for medicinal products, Registration and Maintenance processes for Marketing Authorisations, Handling of product information, Management of clinical research, Quality assurance, Pharmacovigilance, Requirements for import and export, Pricing and reimbursement as well as Basics for marketing Generic Products and Medical Devices.

Please contact your sales representative or request more information via webform if you have questions regarding this new country module.

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EXISTING MODULES:

Global Module: The IDRAC Global Module is an access point for all 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.

United States: In addition to the Reference Documents and Regulatory Summaries, this module also offers a complete resource for FDA drug and biological advisory committee and workshop meetings. IDRAC provides access to the AdCommTM, AdComm Profiles, AdComm Voting, and the FDA Workshop Bulletin.

IDRAC Adcomm Bulletin PDF
IDRAC Adcomm Solutions PDF

Many more Regulatory Intelligence Reports are also available to help you keep abreast of regulatory changes, increase your preparation for a meeting with the agencies, and to compare existing or emerging products.

Canada: In addition to Reference Documents and Regulatory Summaries, this module also contains comprehensive tables which include product approval information for new drug submissions and Class IV medical devices authorized after January 1, 2005.

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 35 individual European country modules. This module also provides a wealth of Regulatory Intelligence Reports and Comparative Tables to help support your multi-country filing in Europe.

Latin America: This module covers regulatory information for the largest markets in the region; Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela. We offer a complete set of Regulatory Summaries and Reference 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: Egypt, Gulf Cooperation Council (GCC), Israel, Lebanon, 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.

Asia Pacific: This module provides full coverage of the Asia Pacific region with the following country modules: Asean, Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam. We provide a full set of regulatory reports and reference documents to help you understand local regulatory practices and submission routes to enter these key markets.  A unique set of proprietary translations in English are available for the Japan, China, South Korea, and Taiwan country modules. The scope of the translations includes the Pharmaceutical Laws, Regulations, GMP, GCP and GLP Guidelines, Pharmacovigilance, and Administrative Notifications relating to the product registration.

International module: This module contains Reference Documents and Regulatory Summaries on major international and regional organizations involved with legislating medicinal products around the world. 

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

For further product information or to request a trial.

IDRAC Regulatory Online Learning courses View  PDF

Annual TOPRA Symposium
13 Oct - 14 Oct 2011
Crowne Plaza Hotel
Rome, Italy
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