SMD Programme: Japan

Japan volunteered to be the first Non-European country to implement the SMD programme.

The implementation of the SMD programme in Japan


The first IMI-Train deliverable has been the implementation of the SMD concept in Japan,
as a pilot run which further has paved the way for a global roll out.

The first Non-EU SMD Programme

In 2016, Japan, the Japanese Society of Pharmaceutical Medicine, the Japan ACRP, and the European Federation of Pharmaceutical Manufacturers and Associations jointly participated in the project under the auspices of the Japanese Society of Clinical Pharmacology (in Europe, Italy started the introduction at the same time). After a trial introduction, the system has been in operation at the corporation since August 2020, and continues to be supported by the Japanese Society of Pharmaceutical Medicine, ACRP Japan, and the European Federation of Pharmaceutical Manufacturers and Associations.

In particular, those who have completed the new PharmaTrain educational course offered by the Japanese Society of Pharmaceutical Medicine and Osaka University are expected to obtain SMD certification by having their competency assessed in the workplace.

In June 2023, Mr. Haruki Kusaka, certified Specialist in Medicines Development, has been celebrated at Health 2.0 Conference (held in Dubai, UAE) for his outstanding leadership: Original Publication (external)

External Links:

The SMD Japan Website (English): Click Here
The SMD Japan Website (Japanese): Click Here