Regulatory & Industry Links – Global / USA / EU / Canada

Posted by on Sep 25, 2012 in Blog | 2 comments

Regulatory & Industry Links – Global / USA / EU / Canada

Enclosed are some handy links related to various government, pharmaceutical, biotechnology and medical device industry sectors. All efforts are made to keep these links updated.

 

 

 

GLOBAL REG-LINKhttp://www.globepharm.org/links/resource_agencies.htmlInternational Federation of Pharmaceutical Manufacturers & Associations

http://www.ifpma.org/

Country Member List

http://www.ifpma.org/about-ifpma/members/companies.html

 USA REG-LINKS
United States Department of Health and Human Services: http://www.hhs.gov/Center for Disease Control and Prevention (CDC): http://www.cdc.gov/

National Institutes of Health (NIH): http://www.nih.gov/

Centers for Medicare and Medicaid Services (CMS): http://www.cms.hhs.gov/

Food and Drug Administration: http://www.fda.gov/

Center for Drug Evaluation and Research (CDER): http://www.fda.gov/AboutFDA/CentersOffices/CDER/default.htm

Center for Devices and Radiological Health (CDRH): http://www.fda.gov/Training/CDRHLearn/default.htm

Center for Biologics Evaluation and Research (CBER): http://www.fda.gov/BiologicsBloodVaccines/default.htm

Structured Product Labeling (SPL): http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

Combination Products: http://www.fda.gov/CombinationProducts/default.htm

The Orange Book: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

FDA Advisory Committees: http://www.fda.gov/AdvisoryCommittees/default.htm

User Fees: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm

Industry Associations
Pharmaceutical Research and Manufacturers of America (PhRMA): http://www.phrma.org/

Biotechnology Industry Association (BIO): http://www.bio.org/

Generic Pharmaceutical Association (GPhA): http://www.gphaonline.org/

Regulatory Affairs Professional Society: http://www.raps.org/personifyebusiness/

Drug Information Association (DIA): http://www.diahome.org/DIAHome/

EU LINKS
European Medicines Agency (EMEA): http://www.emea.europa.eu/EMEA Human Medicines: http://www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/landing/human_medicines_regulatory.jsp&mid=WC0b01ac058001ff89

Scientific Guidelines for Human Medicinal Products: http://www.emea.europa.eu/htms/human/humanguidelines/background.htm

Summary of Opinions: http://www.emea.europa.eu/htms/human/opinion/opinion.htm

Opinions for Orphan Designation: http://www.emea.europa.eu/htms/human/orphans/intro.htm

National Regulatory Agencies

France: http://www.afssaps.fr/

Germany: http://www.bfarm.de/EN/Home/home_node.html

Spain: http://www.msc.es/

Sweden: http://www.lakemedelsverket.se/

Switzerland: http://www.swissmedic.ch/

United Kingdom: http://www.mhra.gov.uk/index.htm

 

Industry Associations

European Federation of Pharmaceutical Industries and Associations (EFPIA): http://www.efpia.org/Content/Default.asp?

European Generics Medicines Association (EGA): http://www.egagenerics.com/

European Association of Bioindustries (EuropaBio): http://www.europa-bio.be/

Association of the British Pharmaceutical Industry (ABPI): http://www.abpi.org.uk/

The Organisation for Professionals in Regulatory Affairs (TOPRA): http://www.topra.org/

German Association of Research-Based Pharmaceutical Companies: (VFA): http://www.vfa.de/en/latest-topics

CANADA LINKS
Health Canada: http://www.hc-sc.gc.ca/ahc-asc/index-eng.php
Therapeutic Products Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/tpd-dpt/index-eng.php

Medical Device Bureau: http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.phpNatural Health Products Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.php

Biologics and Genetic Therapies Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/bgtd-dpbtg/index-eng.php

Health Products and Food Branch Inspectorate: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/hpfi-ipsa/index-eng.php

Marketed Health Products Directorate: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/mhpd-dpsc/index-eng.php

Office of Regulatory and International Affairs: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/oria-bari/index-eng.php

Patented Medicine Prices Review Board (PMPRB): http://www.pmprb-cepmb.gc.ca/english/home.asp?x=1

Common Drug Review (CDR): http://www.cadth.ca/

Provincial Drug Programs Overview: http://www.drugcoverage.ca/default.asp
Federal and Territorial Drug Programs Overview: http://www.drugcoverage.ca/default.asp
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2 Comments

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