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:
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