Introduction to the "Guideline on the Use of Near-infrared Spectroscopy by Pharmaceutical Industry and Data Requirements for New Submissions and Variations (Draft)"
欧盟制药工业近红外光谱技术应用、申报和变更资料要求指南(草案)

This paper was aimed to introduce a draft guideline newly issued by the European Agency for the Evaluation of Medicinal Products (EMEA) which is intended to provide guidance to pharmaceutical industry in the process of calibration, validation and maintenance of a near-infrared spectroscopy (NIRS) method when used for quantitative/qualitative analysis and process monitoring and the type of data requirements for new submissions and variations.