Regulatory Links
To better understand regulatory requirements for the manufacture and use of clinical trial products see links below.
- U.S. Food and Drug Administration (FDA) http://www.fda.gov
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) http://www.ich.org
- U.S. Pharmacopeia (USP) http://www.usp.org
- Code of Federal Regulations, Title 21 Food and Drugs (CFR 21) http://www.ecfr.gov
- European Medicines Agency (EMA) http://www.ema.europa.eu/
- The Japanese Pharmacopoeia http://jpdb.nihs.go.jp/jp14e/