International
Website for EU Study
European Commission site
http://www.europa.eu.int/eur-lex/en/index.html
Europa – the European Union Online
http://europa.eu.int/
Eur-lex home
http://europa.eu.int/eur-lex/en/index.html
Enterprise Medical Devices Guidelines
http://europa.eu.int/comm/enterprise/medical_devices/guidelinesmed/baseguidelines.htm
Belgian Competent Authority (CA)
http://health.fgov.be/
UK CA, devices
http://www.medical-devices.gov.uk
UK CA, drugs – has very good links to other EU CAs websites
http://www.mca.gov.uk
German CA, drugs and devices
http://www.bfarm.de/gb_ver/
Irish CA
http://www.cenorm.be
EMEA welcome Page
http://www.eudra.org/emea.html
French CA, drugs and devices
http://agmed.sante.gouv.fr/
Regulatory Affairs Professionals Society
http://www.raps.org
Association of British Healthcare Industries
http://www.abhi.co.uk
European Confederation of Medical Device Associations
http://www.eucomed.be
European Diagnostic Manufacturers’ Association
http://www.edma-ivd.be
International Standards Organisation
http://www.iso.ch
British Standards Institution – good search function
http://www.bsi-global.com
French Standards body
http://www.afnor.fr
New Approach home page
http://www.newapproach.org
List of all New Approach directives and related harmonised standards
and standards activity at
http://www.newapproach.org/directiveList.asp
International Conference on Harmonization-drug and biologics standards
http://www.ich.org/
Global Harmonization Task Force – Device Standards and guidelines
http://www.ghtf.org/
International Federation of Pharmaceutical Associations – has links
to many national pharma trade associations, including US
http://www.ifpma.org/
Reg source EU page – many links
http://www.RegSource.com/European_Page/european_page.html
CEN standards site
http://www.cenorm.be
Cenelec standards site
http://www.cenelec.org
IEC standards site
http://www.iec.ch
TNO site (Notified Body)
http://www.cenorm.be
Medicinal sites, EU
1. EU. Rules and regs
http://pharmacos.eudra.org/F2/eudralex/index.htm
http://dg3.eudra.org/F2/eudralex/index.htm
2. Clinical Trials
http://pharmacos.eudra.org/F2/pharmacos/dir200120ec.htm
3. National agencies. (the links section also has links to ICH, EMEA,
etc. )
http://heads.medagencies.org/
4. Industry orgs, this links page has most. Scroll down to industry
orgs. also has links to most EU agencies and worldwide agencies. TOPRA
home is also interesting.
http://www.topra.org:80/Resource.phx/links/list.htx
5. ICH
http://www.ich.org/
and
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
6. Vigilance
http://www.eudravigilance.org
7. Guidances
http://eudract.emea.eu.int/document.html
8. EMEA
http://eudract.emea.eu.int/
Device and Medicinal
1. European Commission site:
http://www.europa.eu.int/eur-lex/en/index.html
2. Europa-the European Union Online:
http://europa.eu.int/
3. Eur-lex home:
http://www.eur-lex/en/index.html
4. Enterprise Medical Devices Guidelines:
http://europa.eu.int/comm/enterprise/medical_devices/guidelinesmed/baseguidelines.htm
5. Belgian Competent Authority (CA):
http://health.fgov.be/
6. UK CA, -has very good links to other EU CAs websites:
http://www.MHRA.gov.uk
7. German CA, drugs and devices:
http://www.bfarm.de/gb_ver/
8. EMEA welcome Page:
http://www.eudra.org/emea.html
9. French CA, drugs and devices:
http://agmed.sante.gouv.fr/
10. Regulatory Affairs Professionals Society:
http://www.raps.org
11. Association of British Healthcare Industries:
http://www.abhi.co.uk
12. European Confederation of Medical Device Associations:
http://www.eucomed.be
13. European Diagnostic Manufacturers’ Association:
http://www.edma-ivd.be
14. International Standards Organization:
http://www.iso.ch
15. British Standards Institution – good search function:
http://www.bsi-global.com
16. French Standards body:
http://www.afnor.fr
17. List of all new approach directives:
http://www.newapproach.org
18. Related harmonised standards and standards activity:
http://www.newapproach.org/directiveList.asp
19. Global Harmonization Task Force-Device Standards and guidelines:
http://www.ghtf.org/
20. International Federation of Pharmaceutical Associations-has links
to many national pharma trade associations, including US:
http://www.ifpma.org/
21. Reg source EU page-many links:
http://www.RegSource.com/European_Page/european_page.html
