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-LINK Federation of Pharmaceutical Manufacturers & Associations

Country Member List

United States Department of Health and Human Services: for Disease Control and Prevention (CDC):

National Institutes of Health (NIH):

Centers for Medicare and Medicaid Services (CMS):

Food and Drug Administration:

Center for Drug Evaluation and Research (CDER):

Center for Devices and Radiological Health (CDRH):

Center for Biologics Evaluation and Research (CBER):

Structured Product Labeling (SPL):

Combination Products:

The Orange Book:

FDA Advisory Committees:

User Fees:

Industry Associations
Pharmaceutical Research and Manufacturers of America (PhRMA):

Biotechnology Industry Association (BIO):

Generic Pharmaceutical Association (GPhA):

Regulatory Affairs Professional Society:

Drug Information Association (DIA):

European Medicines Agency (EMEA): Human Medicines:

Scientific Guidelines for Human Medicinal Products:

Summary of Opinions:

Opinions for Orphan Designation:

National Regulatory Agencies






United Kingdom:


Industry Associations

European Federation of Pharmaceutical Industries and Associations (EFPIA):

European Generics Medicines Association (EGA):

European Association of Bioindustries (EuropaBio):

Association of the British Pharmaceutical Industry (ABPI):

The Organisation for Professionals in Regulatory Affairs (TOPRA):

German Association of Research-Based Pharmaceutical Companies: (VFA):

Health Canada:
Therapeutic Products Directorate:

Medical Device Bureau: Health Products Directorate:

Biologics and Genetic Therapies Directorate:

Health Products and Food Branch Inspectorate:

Marketed Health Products Directorate:

Office of Regulatory and International Affairs:

Patented Medicine Prices Review Board (PMPRB):

Common Drug Review (CDR):

Provincial Drug Programs Overview:
Federal and Territorial Drug Programs Overview:
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  1. 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.

  2. 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.

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