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Global Regulation of the Pharmaceutical Sector: Primary Sources

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

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What You Need to Know

During your research, you may need to refer to statutory and regulatory materials from the United States, European Union, and individual foreign countries.

United States

Federal Statutes (published in United States Statutes at Large, or as codified in the United States Code)

Federal Legislative History Materials, available through Thomas, HeinOnline, and LexisNexis Congressional

Federal Regulations (in the Code of Federal Regulations and the Federal Register)

 

Europe

European Directives

European Regulations

European Medicines Agency documents

Individual country legislation and regulations

 

Other Countries

This guide has information from China, Japan and Canada, together with links to various websites that have the legislation and regulations of other countries.

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This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License.