FURTHER INFORMATION

EUROPE

European Medicines Agency (EMA)

EudraLex - The Rules Governing Medicinal Products in the European Union

European Directorate for the Quality of Medicines & HealthCare (EDQM)

European Pharmacopoeia (Ph. Eur.)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

USA

US Food and Drug Administration (FDA)

Code of Federal Regulations (CFR)

US Pharmacopeia (USP)

Pharmaceutical Research and Manufacturers of America (PhRMA)

Biotechnology Innovation Organization (BIO)

CANADA

Health Canada

JAPAN

Ministry of Health, Labour and Welfare (MHLW Japan)

Japan Pharmaceutical Manufacturers Association (JPMA)

AUSTRALIA

Therapeutic Goods Administration (TGA Australia)

INTERNATIONAL

World Health Organization (WHO) - Expert Committee on Specifications for Pharmaceutical Preparations

International Council for Harmonisation (ICH)

International Clinical Trials Registry Platform (ICTRP)

International Nonproprietary Names (INN)

Anatomical Therapeutic Chemical classification system and Defined Daily Dose (ATC/DDD)

International Classification of Diseases (ICD)

Orphanet - The portal for rare diseases and orphan drugs