U.S. and European Health Organizations

United States Food and Drug Administration
http://www.fda.gov

The FDA is the agency of the United States Department of Health and Human Services responsible for regulating human and animal food, dietary supplements, drugs, cosmetics, medical devices and radiation emitting devices (including non-medical devices), biologics, and blood products in the United States.

21 CFR 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States.  Title 21 of the CFR is reserved for rules of the Food and Drug Administration.  Each title (or volume) of the CFR is revised once each calendar year.  A revised Title 21 is issued on approximately April 1st of each year.

European Medicines Agency
http://www.emea.eu.int/

EMEA is a European agency for the evaluation of medicinal products.  Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.

Roughly parallel to the FDA, but without FDA-style centralization, the EMEA was set up in 1995 with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, in an attempt to harmonize (but not replace) the work of existing national medicine regulatory bodies.

International Conference on Harmonisation
http://www.ich.org

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

The objective of such harmonization is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.

ICH Guidance for Industry – E6 Good Clinical Practice:  Consolidated Practice     
http://www.fda.gov/cder/guidance/959fnl.pdf

This guidance, prepared under the auspices of the ICH, provides a unified standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.