Links
Regulatory Agencies
- WHO – Entry page
- EMA - Entry page
- List of Human Medicines Authorities in the EU
- Swiss Agency for Therapeutic Products
- FDA – Entry page
- Health Canada
- Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
- Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
- Saudi Food and Drug Authority (SFDA)
- India’s Central Drugs Standard Control Organization (CDSCO)
- Japanese Ministry of Health, Labor and Welfare (MHLW)
- Singapore‘s Health Sciences Authority (HSA)
- China’s State Food and Drug Administration (SFDA)
- Australian Therapeutic Goods Administration (TGA)
If you are seeking rules, regulations or guidelines?
- EMAs Regulation of Human Medicines
- EudraLex, the collection of rules and regulations governing medicinal products in the European Union
- FDA Guidances
- ICH, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- The European Pharmacopeia (Ph. Eur.)
- The US Pharmacopeia (USP)
- The Japanese Pharmacopeia (JP)
- The International Pharmacopeia (Ph.Int.)
- The European Society of Gene and Cell Therapy (ESGCT)
- Gene Therapy Net – US regulations
Intelligence Databases
- THE MERCK MANUAL - according to Wikipedia the world's best-selling medical textbook
- ATC/DDD Index – The Anatomical Therapeutic Chemical Classification System including defined daily doses (DDDs) for many drugs
- EMA – authorized medicines that have a European Public Assessment Report
- Clinicaltrials.gov - database of clinical trials conducted in the United States and around the world