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REGULATORY AGENCIES

U.S. Food and Drug Administration FDA http://www.fda.gov/
FDA Center for Drug Evaluation and Research (CDER) http://www.fda.gov/cder/index.html
FDA Center for Biologics Evaluation and Research (CBER) http://www.fda.gov/cber/index.html
FDA Center for Devices and Radiological Health (CDRH) http://www.fda.gov/cdrh/index.html
FDA Office of Combination Products  http://www.fda.gov/oc/combination/
European Medicines Agency EMEA http://www.emea.europa.eu/index/indexh1.htm and http://www.emea.europa.eu/htms/human/humanguidelines/background.htm
Health Canada  http://hc-sc.gc.ca/dhp-mps/index_e.html 
Australian TGA  http://www.tga.gov.au/
Japanese PMDA http://www.pmda.go.jp/english/about.html  

STANDARD SETTING BODIES  

US Pharmacopeia (USP) http://www.usp.org/  
EDQM (responsible for European Pharmacopeia and European biologics standardization programme) http://www.edqm.eu/site/Homepage-628.html
Japanese Pharmacopeia http://www.sjp.jp/index_e.htm 
International Organization for Standardization (ISO) http://www.iso.org/iso/home.htm   
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) (ICH) http://www.ich.org/cache/compo/276-254-1.html 
Global Harmonisation Task Force (GHTF)  http://www.ghtf.org/ 
Asian Harmonization Working Party http://www.asiahwp.org/?page=article&id=214

INDUSTRY AND ACADEMIC GROUPS AND ASSOCIATIONS

The Aerosol Society http://www.aerosol-soc.org.uk/
Biotechnology Industry Organization (BIO) http://www.bio.org/
European Federation of Pharmaceutical Industries and Associations (EFPIA) http://www.efpia.org/content/default.asp
European Pharmaceutical Aerosol Group (EPAG) http://www.epag.co.uk/
Generic Pharmaceutical Association (GPhA) http://www.gphaonline.org/AM/Template.cfm?Section=Home
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) http://www.ifpma.org
International Pharmaceutical Excipients Council (IPEC) http://www.ipec.org/
International Society for Aerosols in Medicine (ISAM) http://www.isam.org/
International Society of Pharmaceutical Engineers (ISPE) http://ispe.org/
Inhalation Technology Focus Group (AAPS) http://www.aapspharmaceutica.com/inside/focus_groups/IT/index.asp
Product Quality Research Institute (PQRI) http://pqri.org/
Pharmaceutical Research and Manufacturers of America  (PhRMA) http://www.phrma.org/
Respiratory Drug Delivery (RDD) http://www.rddonline.com/

PATIENT AND HEALTHCARE INFORMATION GROUPS

Allergy & Asthma Network Mothers of Asthmatics http://www.aanma.org/
Asthma & Allergy Foundation of America http://www.aafa.org/
American Lung Association http://www.lungusa.org/site/pp.asp?c=dvLUK9O0E&b=22542
British Lung Foundation http://www.lunguk.org/
Canadian Lung Association http://www.lung.ca/home-accueil_e.php
Cystic Fibrosis Foundation http://www.cff.org/
European Federation of Allergy and Airways Diseases Patients Associations (EFA) http://www.efanet.org/

 

 

REGULATORY AGENCIES

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