Full name: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH brings together the regulatory authorities of Europe, Japan and the U.S. and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during R&D. Also known as International Committee on Harmonization.
Stephanie Mowery, Sherri Rinker, Franklin Spriggs and Bo Kowalcyk , AIT Bioscience||June 2, 2015 Moving forward clinical studies will have to include a comparative assessment of
pharmacokinetics and immunogenicity to the original reference biologic drug