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Global Regulation of the Pharmaceutical Sector: Europe and other Foreign Countries

This guide is designed to help students in Prof. Abbott's course of the same name.

Global Regulation

Canada

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)

European Law

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

European Regulations

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

European Court of Justice


 European Medicines Agency

Other Countries

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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