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

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

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

  1. Carlyn September 27, 2012

    We’re a group of volunteers and starting a new scheme in our community. Your site provided us with valuable information to work on. You’ve done a formidable job and our whole community will be grateful to you.

    Reply
  2. Hosting April 19, 2017

    Stated succinctly, the organization aims to standardize medical device regulations around the world by exchange of information. The founding members consist of regulatory authorities or industry members from the EU, USA, Japan, Australia and Canada because of their well established and high standards in medical device regulations.

    Reply

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