1999 Volume 1 Issue 1 Pages 18-35
Harmonization of requirements for the regulation of drugs in the world is essential in order to make newly developed pharmaceuticals available all over the world as quickly as possible. For such purpose, ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) has been organized and actively promoted by 6 parties from three regions (Japan: MHW & JPMA, USA: FAD & PhRMA, EU: CPMP & EFPIA). Quality topics on “Stability Testing, ” “Validation of Analytical Procedures” and “Impurities Testing” has already been finalized among three regions and implemented as the domestic guidelines by the regulatory authority of each member country. Other quality topics on “Specifications,” “GMP on Active Pharmaceutical Ingredients” and “Common Technical Documents” are now under discussion in ICH. In Japan, Revision of General Notices in Japanese Pharmacopoeia is proposed to cope with the concepts of “periodical/skip testing, ” in-process testing” and “parametric release” included in the Step 2 Draft of ICH Speicification Guideline. This article describes the concepts of ICH quality guidelines and their impacts on the regulation for drugs in Japan.