Health Canada's Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations.
Kwasi A. Nyarko, Regulatory Approach for Subsequent Biologics Entry in Canada (2009)
Eur-LEX - Access to European Law, including Directives
Outline of original European Directive (2001/83/EC) and amendments.
European Directives
2001/83/EC, on the Community code relating to medicinal products for human use
2003/63/EC, amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use
2004/24/EC, amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use
2004/27/EC, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
1901/2006, on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
Proposed Legislation concerning customs enforcement of intellectual property rights
Central Drug Standard Control Organization (with rules and regulations)
Phamaceuticals and Medical Devices Agency
Kazuyuki Motohashi, OECD/TIP Project on Biopharmaceutical National Innovation Systems National Report: Japan (March 2004)
Pharmweb List of Government and Regulatory Bodies
National Law Center for Inter-American Trade - InterAmSM Database. Most materials, including legislation, regulations, case law, and other documents, are in Spanish or Portuguese.
Margaret Clark's International and Foreign Legal Research LibGuide
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