eCTDconsultancy - The Science Of Submissions

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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

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Medicines.org.uk
Medscape DrugInfo Search
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The Free Medical Journals Site

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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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