With over 60,000 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 How do you know that it's the very latest, and that it hasn't been superseded by another?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 regulatory information from authorities worldwide, organized by country modules so that your subscription is tailored to only the modules you need.
Collectively, these modules cover nearly 60 countries/regions:
International Module
'International texts' have been assembled together to create a separate International Texts Module available through the IDRAC '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.
Full European Module
European Union, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovenia, Slovakia ,Spain, Sweden, Switzerland, Turkey, 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. European Parliament and Council directive for Clinical Trial 2001/20/EC), Commission regulations, directives, proposals, Notice to Applicants.
- From the EMEA: EPARs, EMEA SOP, EMEA press releases, CHMP 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, drug and medical devices 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, CBER, CDRH), 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.
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.
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.
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.
China Module
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.
Asia Mini-Modules
The Asia Mini-Modules contain information from ASEAN, Hong-Kong and Malaysia.
Insight
The Mini-Modules give you key and succinct information on Authorities / Organizations, Marketing Authorization Procedures, Fees, Clinical Research, Quality Assurance, Import / Export, etc. The reference texts of ASEAN include the harmonized ASEAN requirements on safety, quality and efficacy.
Singapore Module
The Singapore Module highlights key issues in the regulatory environment for the pharmaceutical industry in this region.
Insight
- Explanatory documents provide information on the legal background to regulatory affairs, registration system, clinical research and marketing activities.
- Reference texts, including key guidelines and forms issued by the Health Sciences Authority
Taiwan Module
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.
Thailand Module
As a member state of ASEAN, the Thai pharmaceutical market has grown with the increase in domestic demand for pharmaceuticals. The country is attracting multinational companies to manufacture international branded products.
Insight
The Explanatory texts provide an overview of the country's pharmaceutical regulatory environment, enriched by local experts. The main legal documents made of Drug Act B.E. 2510 and other relevant acts are provided.
Vietnam Module
Vietnam is experiencing growth in the pharmaceutical market as a member state of ASEAN. Imported pharmaceutical products are currently required to fulfill the increased demand from the reformed health care system.
Insight
The Explanatory texts provide concise information for registration, manufacturing, clinical trials and post marketing activities. The Reference texts section includes main laws and relevant guidelines.
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.
India Module
India is fast emerging as a preferred destination for pharmaceutical industry activities.
- Consolidated versions of the main Acts and Rules, including the 1940 Drugs and Cosmetics Act, and the 1945 Drug and Cosmetics Rule.
- Comprehensive follow up of Drug and Cosmetics Act and Rules Amendments.
- Main Guidelines and Government Polices.
Israel Module
The Israeli pharmaceutical market is rapidly expanding; Israeli generic companies are operating globally. There is also a growing interest in conducting clinical trials in Israel, as the regulatory process for multi-center international studies is not too complicated and there are quite a few world renowned doctors who are willing to participate and conduct the studies to GCP.
Insight
In this module, you can find the current or consolidated versions of the main texts ruling the pharmaceutical profession in Israel, such as "The pharmacists' Ordinance from 1981" and "The Pharmacists' Regulation from 1986", as well as the main guidelines. The texts are included in Hebrew and abstracts are in English.
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
South Korea Module
South Korea ranks as one of Asia's leading pharmaceutical markets. The South Korea module provides concise information on marketing pharmaceutical products in South Korea.
Insight
- Explanatory texts written by the local experts detail information on marketing pharmaceuticals in South Korea. Selected reference texts including the Pharmaceutical Affairs Act are translated into English.
