Leveraging the use of Real-World Data (RWD) for Real World Evidence (RWE) has been discussed in various fields, and efforts have been made around the world. Use of RWD, that is the data collected on a daily basis from a variety of sources about patient conditions and care delivery, for observational and/or epidemiological studies, drug-related information is indispensable. However, the standardization of drug codes at the site of healthcare delivery has not progressed in Japan, which is one of the major obstacles to the use of RWD. Revision of the Pharmaceuticals and Medical Devices Law has been enacted, the digitization of package inserts for drugs has started, and GTIN (Global Trade Item Number) and package insert information are to be linked. We will discuss the impact of linking package inserts and GTIN, including integrated management of various drug codes, a mechanism for smooth distribution of standard code, a pathway toward the national master, and the use of RWD for clinical research.