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IDRAC Database: Complete
Complete, up-to-date and enriched information you can trust.
With over 34,000 documents available at your fingertips, IDRAC is a complete and unique collection of national and international texts.
Seeking the latest GCP guideline? How do you know that it's the very latest, and that it hasn't been superseded by another?
Wouldn't it be nice to know that the critical documents you need are complete, including information about their history and publication?
Our team of experts, assisted by an internationally recognized network of consultants and partners, is dedicated to ensuring that information
contained in IDRAC is 100% accurate and safe.
We compile all the regulatory information from more than 50 different authorities, organized by country modules so that your subscription is tailored
to only the modules you need.
Collectively, these modules cover 41 countries/regions:
Full European Module
European Union, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Netherlands, Poland, Portugal, Russia, Slovenia, Slovakia ,Spain, Sweden, Switzerland, United Kingdom.
Within the most complex regulatory environment
in our industry, the European Module highlights the impact of EU legislation on each national registration system and explains all national
requirements.
Insight
Council regulations, directives (e.g. council directive for Clinical Trial 2001/20/EC), Commission regulations, directives, proposals, Notice to
Applicants.
From the EMEA: EPARs, EMEA SOP, EMEA press releases from the CPMP guidelines (final, draft and concept papers).
National laws e.g.: Code de la Santé Publique, Artzneilmittelgesetz, Medicines Acts 1968, Statutory Instruments, MALs, etc.
At national levels, Explanatory Documents - available from the “IDRAC Explanatory” section and written with our network of Consultants
- will enable you to make country to country comparisons.
USA Module
To face the world's toughest and most challenging regulatory agency, the USA Module provides a unique perspective on America's regulatory system - focusing
particularly on the biologics and drug industries.
Insight
The Food, Drug & Cosmetic Act as amended, the Prescription Drug User Act (Oct. 29, 1992), The Code of Federal Regulations - Title 21 (weekly
updated), the main Federal Register Announcements.
FDA Guidelines (CDER and CBER), FDA internal manuals.
Comprehensive and fully catalogued listing of Warning Letters/Untitled Letters as well as case studies with EIR/FORM FDA 483 and Correspondence
issued by the FDA.
Advisory committees including briefing information, transcripts and drug approval packages.
Japan Module
Japan is the second largest pharmaceutical market in the world. Yet for many companies, registration and clinical work in Japan is unchartered territory.
Why? Because information on regulatory practices in Japan has been hitherto veiled in mystique. No longer!
The Japan Module provides penetrating insight into the currently evolving Japanese regulatory system.
Insight
Apart from the IDRAC Explanatory documents, which elucidate many of the more inaccessible areas of the Japanese system, this Module also contains
the largest number of translated Japanese texts available anywhere.
The full text of the Pharmaceutical Affairs Law is updated as amended.
Thanks to the 'Information Disclosure Act,' we provide you with some Evaluation Reports (SBA or DAP)
The English translation of Japanese regulatory texts is reproduced by kind permission of Yakuji Nippo Co. Ltd., Yakugyo Jiho Co. Ltd. and other
copyright holders.
Canada Module
Developed with the Canadian consultant, CanReg Inc., the Canada Module covers regulations at both federal and provincial level, and tracks recent organization
changes in the Agency.
Insight
The Health Products and Food Branch (HPFB) of Health Canada includes the following divisions:
- Therapeutic Products Directorate (TPD)
- Biologics and Genetic Therapies Directorate (BGTD)
- Marketed Health Products Directorate (MHPD)
- Natural Health Products Directorate (NHPD)
- The Inspectorate
They are described in detail in the Explanatory sections of the Canadian Module. Sections are updated as soon as organizational/regulatory changes
occur.
Texts available:
- Foods And Drugs Acts & Regulations
- Patented Medicines Regulations
- Guidelines, Policies and Procedures
- Ready to use Forms (Word and WordPerfect)
- TPD, BGTD, NHPD Advisory Committees information
- Adverse Reaction Information (DDL, HC Advisories)
- Minutes from pharma industry associations/ Health Authority meetings
South Africa Module
The South African Module contains over one hundred documents relating to regulatory intelligence in the country
Insight
- Explanatory documents written by our in-house team of experts to explain key processes across the Republic and give practical
explanations about all the Regulatory Affairs topics
- Reference texts section including key South African legislative framework
Latin America Module
Brazil, Argentina, Mexico and Mercosur.
The Latin America Module provides a comprehensive view of the medicines regulatory environment in this changing and dynamic market.
Insight
- Comprehensive and detailed Explanatory Documents in English.
- Current versions of reference texts incorporating amendments directly into the texts.
- Ready-to-use forms.
- Clearly-written abstracts to guide you though the texts.
- Practical knowledge provided by experienced local Consultants.
International Module
'International texts' have been assembled together to create a separate International Texts Module available through IDRAC's 'Region' menu.
Insight
A Reference Texts section has been created presenting all international texts classified by the organization which released each text (ICH Guidelines,
WHO Therapeutics Guidelines, ATC Classification, PICS, CIOMS Reports, CADREAC...).
The IDRAC Explanatory presents the role, organization and activities of those international organizations in the section 'Authorities/Organizations'
- since no registration is possible at international level.
The new International Texts Module includes every major 'international text.' However, some texts covering specific subjects of interest might
not be included in IDRAC yet. They can be integrated in the Module on request from clients.
Australia Module
The Australia Module contains complete and detailed information to guide you through the sophisticated Australian regulatory system and is organized
to facilitate comparison with other IDRAC Modules.
Insight
As with any IDRAC Module, you will find comprehensive Explanatory Documents dealing with:
- Authorities/Organizations
- Legal Framework
- Format and Content of Applications
- Assembly and Submission of Applications
- Marketing Authorization Procedures
- Fees
- Product Information.
Asia Mini-Modules
The Asia Mini-Modules contain information from Hong-Kong, Singapore, Malaysia and South Korea.
Insight
The Mini-Modules give you key and succinct information on Authorities / Organizations, Marketing Authorization Procedures, Fees, Clinical Research,
Quality Assurance, Import / Export, etc. Detailed Explanatory Documents are already available, and the Reference Texts will be completed in due
course.
China Module (Jan 05)
A country with one of the biggest Pharmaceutical market growth is opening its doors to foreign investors! The China module is designed to help you accelerate
your product's entrance in this huge market!...
Insight
- Over 50 Explanatory documents providing all the necessary information on the Regulatory environment in China
- Reference Texts consists of the lists of key documents and the selected English translations including Chinese legislative documents with Law,
Regulations, Provisions and Order
Taiwan Module (March 05)
Taiwan will edge closer to third place in Asian market. The Taiwan module contains a comprehensive guide on the regulatory in Taiwan.
Insight
- Over 50 Explanatory documents providing concise information on the regulatory in Taiwan
- Reference Texts consists of the lists of key documents and the selected English translations covering Law, Enrocement rules, Guidelines/Guidance
and Standards
IDRAC now covers 39 countries and regions giving you unparalled access to regulatory intelligence worldwide! With the launch of
China and Taiwan early 2005, we will soon be 41!
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