International Council on Harmonisation


The International Council on Harmonisation (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the biopharmaceutical and pharmaceutical industries to discuss scientific and technical aspects of medicinal product registration.  The purpose of ICH is to harmonise the approaches and testing performed during the R&D of new medicines.  They are typically used as guidelines by the US Food & Drug Administration (FDA) and European Medicines Agency (EMA).

Some of the key guidance for biopharmaceuticals can be found on www.ich.org that include:

Q1A-Q1F: Stability
Q2: Analytical Validation
Q5A-Q5E: Quality of Biotechnological Products
Q6A-Q6B: Specifications
Q7: Good Manufacturing Practice
Q8: Pharmaceutical Development
Q9: Quality Risk Management
Q10: Pharmaceutical Quality System
Q11: Development and Manufacture of Drug Substances