Japanese–English glossary
Investigational product
Also called investigational medicinal product (IMP)
治験薬chiken'yaku
A drug, including a comparator, administered to subjects in a clinical trial run to support a marketing approval application in Japan. Its manufacture follows the investigational product GMP standards issued as an MHLW notice (PFSB Notification No. 0709002, July 9, 2008), which MHLW's English material calls standards for manufacturing and quality control of investigational medicinal products. MHLW later introduced the PIC/S GMP Guide as guidance for sites working under those standards. For a company-sponsored trial, import of the product into Japan is tied to the clinical trial plan notification (治験計画届): once it is filed, the separate import confirmation procedure does not apply.