International Conference on Harmonisation

• Quality  http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
• Safety   http://www.ich.org/products/guidelines/safety/article/safety-guidelines.html
• Efficacy  http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
• Multidisciplinary  http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html

• Food and Drug Administration (FDA, USA)   http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
• European Medicines Agency (EMA, EU) http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp&mid=WC0b01ac05800240cb
• Pharmaceuticals and Medical Devices Agency (PDMA, Japan)  http://www.pmda.go.jp/english/service/regulation.html

• Medicines and Healthcare Products Regulatory Agency (MHRA, UK) http://www.mhra.gov.uk/Pharmaceuticalindustry/LegislationGuidanceandPolicy/index.htm
• Therapeutic Goods Administration (TGA, Australia)  http://www.tga.gov.au/industry/pm-sgp.htm
• Heads of Medicines Agencies (HMA, links to Competent Authorities of the EU) http://www.hma.eu/hdirectory.html