Regulatory Reference Page
IPEC'S REGULATORY REFERENCE GUIDANCE
Section 4-Regulatory Information Compendia/Regulations
USP/NF Food Chemical Codex EUROPEAN PHARMACOPOEIA EDQM Certificate of Suitability Chinese Pharmacopoeia
The International Pharmacopoeia British Pharmacopoeia Japanese Pharmacopoeia JPE Japanese Pharmacopoeia 15 21CFR
United States: Drug Master Files FDA CDER Inactive Ingredient Search
FDA's Guidance for Industry: Testing of Glycerin for Diethylene Glycol
United States European Union
European Union
December 2006 Amendment
Residual Solvents (ICH Q3C) Residual Solvents Tables and List Kosher OU Kosher Star-K Halal ifanca-Islamic Food and Nutritional Council of America National Organic Standards Board
EMEA/ICH California Proposition 65
Kosher Certification
Muslim Consumer Group
REACH - European Registration/Classification of Chemicals
IPEC-PQG GMP Guide for Pharmaceutical Excipients
ISO International Organization for Standardization IPEA International Pharmaceutical Excipients Auditing
AIB American Institute of Baking GMA Grocery Manufacturers Association
IPEC-PQG GMP Audit Guide for Pharmaceutical Excipients
HAACP
Statistical Process Control/Process Analytical Technology (PAT)
[Top]
Bio-Terrorism Act
C-TPAT Customs - Trade Partnership Against Terrorism
HM232 Hazardous Materials
ISO 14000 ISO Standards ACC RESPONSIBLE CARE
Australia Therapeutic Goods Administration Australia - Medicines Regulation Belgium - Ministry of Social Affairs, Public Health and Environmental Brazil - Ministry of Health Bulgaria - National Drug Institute Canada (Drug and Health Products) China State Food and Drug Administration Czech Republic - State Institute for Drug Control Denmark: National Board of Health Estonia - Ravimiamet State Agency of Medicines EU Agency for Evaluation of Medicinal Products European Department for the Quality of Medicines-EP Finland: National Agency for Medicines Germany - Federal Institute for Drug and Medicinal Devices Greece - National Drug Organization Hong Kong - Department of Health Hungary - National Institute of Pharmacy International Conference on Harmonization Ireland - Irish Medicines Board Italy - Ministero della Salute Japan MHW - links to International sites Latin America - Panamerican Health Organization Latvia - State Agency of Medicines Luxembourg - Ministere de la Sante Lithuania - State Medicines Control Agency Malta - Ministry of Health The Netherlands - Medicines Evaluation Board New Zealand - Medicine Standard New Zealand Ministry of Health Poland - Drug Institute Portugal-National Institute for Pharmaceutics and Medicinal Products Singapore - Ministry of Health Slovak Republic - State Institute for Drug Control Spain - Ministerio Sanidad y Consumo Direction Sweden - Medicinal Products Agency Taiwan-Pharmaceutical Affair Act Thailand - Thailand FDA United Kingdom - Medicines Control Agency United States-Food and Drug Administration WHO
Comments? Suggestions? Contact info@ipecamericas.org
