Links

Although every effort is made to keep this website updated eCTDconsultancy can not be held responsible for linking to any obsolete or inaccurate information. 

General

• WHO Collaborating Centre for Drug Statistics Methodology
• Medical Glossary
• Internet Archive
• CIA - The World Factbook

ASEAN

• Drug Registration Guidance
• HSA -bs-HPreg

Australia

• TGA - Therapeutic Goods Administration

Canada

• e-CTD

Drugs

• ATC codes
• Medicines.org.uk
• Medscape DrugInfo Search
• Pharmaceutical related sites
• The Free Medical Journals Site

EU

• EFPIA Links
• EMEA Web sitemap
• EMEA Regulatory and Procedural Guidance
• EU Acronyms and Links
• EudraCT
• EudraLex (Legislation, NtA, Guidelines)
• EUDRALINK
• EuroInvestor.nl - WISSELKOERSEN - EURO - WISSELKOERS - DOLLAR - POND - YEN
• Europa - The European Union On-Line
• European Pharmacopoeia Online
• Heads of Agencies
• List of CPMP members wishing to receive partial or complete copies of the dossier
• News of the European Directorate for the Quality of Medicines Pharmacopoeia on the WWW
• Orphan medicinal products
• Pharmacos V4 - Pharmaceuticals - Regulatory frameworks and Market authorisations
• presub-Dossier_requirements.pdf
• TIGes

 EU - Netherlands

• CBG-MEB Home
• CCMO
• EMEA
• Gezondheidsraad

EU - UK

• MHRA Medicines Regulatory News

FDA

• CBER - Center for Biologics Evaluation & Research
• CDER Data Standards Manual
• CDER Home Page
• CDER Guidance Documents
• Electronic Common Technical Document (eCTD)
• FDA Advisory Committee
• FDA-ORA PDA Conference Summary June 2000
• International Organizations and Foreign Government Agencies
• USP-NF Online

ICH

• Health Level 7
• Glossary of CDISC terms
• ICH Main

Japan

• Jouhou Koukai Services Web Site

Switzerland

• Allgemeine Rechtsgrundlagen Recht und Normen Swissmedic

WHO

• Declaration of Helsinki

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