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:
468 ad


  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.

Leave a Comment

%d bloggers like this: