Regarding the pharmaceutical regulation, ICH which was established in 1990, has played a major role in the need for international harmonisation. As results of ICH, clinical trials are conducted in accordance with GCP, and adverse drug reactions are reported electronically in Japan and overseas based upon the ICSR guidance summarized as E2B (R3), and adverse events are coded by MedDRA. Although the previous E2B (R2) specification adapted SGML format and was published in 2000, the E2B (R3) ICSR uses HL7 V3. It took more than 10 years to finalize the process with the involvement of international standardization organizations. Furthermore, a group called M5 was once established in ICH, and its purpose was to standardize drug dictionary, but this was discontinued. This shows that while there are various drug codes used domestically, it is even more difficult to standardize internationally. On the other hand, when limited to the field of clinical research, CDISC standards are progressing internationally, and even in Japan, for new drug applications, WHODrug, which CDISC has designated as Controlled Terminology, is used as drug code. Furthermore, there is a growing demand for RWD in order to activate clinical research both domestically and internationally. However, MedDRA and WHODrug are not widely used in medical institutions where RWD are accumulated. Considering the life cycle management of pharmaceuticals broadly, including drug development through clinical research and post-marketing pharmacovigilance, it is necessary to standardize drug code and medical terminology.