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

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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/

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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

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