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Human
Medicines - International
and National Agencies - Rules and Regulations
 International
Conference for Harmonization
ICH GUIDELINES
ICH Guidelines: Quality
ICH Guidelines: Efficacy
ICH Guidelines: Safety
ICH Guidelines: Common Technical
Document
ICH
News: News
 Danish
Medicines Agency
 US
Food and Drug Administration
FDA Web Site Index | FDA Web Site Map | Search Page
| Warning Letters |FDA Manuals and Publications
FDA Dockets
FEDERAL REGISTER NOTICES
FOR DRAFT GUIDANCES
- SINCE JANUARY 1999
CDER (Drugs) What's new at CDER
CBER (Biologics) What's New at CBER
CDRH (Devices) New Items in CDRH | FDA Compliance Program
Guidance Manual Startpage
FDA/ORA on FDA Web (Office of Regulatory
Affairs) |ORA Pages Updates and
Changes |FDA/ORA Inspection
References
FDA
ADVISORY COMMITTEES
GCP
- Good Clinical Practices
FDA Regulated
Clinical Trials
European
Regulatory Agencies about Mutual Recognition
- a bad site
due to very poor readability...........Links to national agencies
EMEA |Emea site map | Emea What´s
new
European
Commission DG 3 Enterprise and Industry -
Directorate F - Consumer Goods
F2
Pharmaceuticals |
Latest
news (Pharmacos) |
Pharmacos GMP doc
EudraLex Index - The Rules Governing Medicinal
Products in the European Union (Adobe PDF
files)
EudraLex - Download - available
languages
F3
Comtetitiveness of pharmaceutical industry, medical devices
and cosmetics Biotechnology - Human Tissue Engineering -
Pharmaceuticals - Cosmetics
G10
Medicines
News
| Site Map | Documents Recent legislation, Commission
Documents - Studies - Reports, Case Law, GMP,
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Other links re.
Medical Devices
EUR
US - FDA
US-FDA CDRH
Center for Devices and Radiological Health
DA
Bekg.89 af 4 feb 2000:
Medicinsk udstyr til in-vitro diagnostik (incl. IVD-direktivet)
ISO
ISO Online
ISO TC/176/SC2 Home
Page
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