[4-A-1-01] The next steps after introducing the obligation of e-labeling and barcoding
- Considering the improvement of Japanese health utilizing the obligation -
e-labeling, barcoding, amendment of the Law, data health, e-prescription
In recent years, along with the advancement of science and technology, the drug discovery environment has changed significantly. Development through alliances with ventures and academia and drug discovery targeting unmet medical needs through bio-products are increasing. With such products, it is difficult to conduct large-scale clinical trials prior to marketing, and there is a demand for development from the pre-marketing development stage with an eye on post-marketing drug development.
“Ikuyaku” is about developing pharmaceuticals to be safer, more effective, and easier to use. In order to maximize the value of pharmaceuticals, it is necessary to continuously investigate and collect the data on actual clinical use even after approval. There is a need to maximize and optimize the value of pharmaceuticals based on medical information that is the result of actual practice in medical settings for individual patients who need pharmaceuticals.
In December 2019, the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145 of 1960) was amended to establish e-labeling that is digitization of package inserts, and also obligate bar code display. Furthermore, the promotion of data health is extremely important, and an intensive reform plan for data health has been issued. It is said that the operation of e-prescription system will be started in 2022 after taking various legal measures.
In this lecture, I will give an overview of the current status of the e-labeling, and the barcode labeling which is scheduled to become obligatory in December 2022. I would like to express my thoughts on how things should be progressed in the future, including my own personal views. In addition, I would like to introduce about the general status of the promotion of data health, and also mention the ideal form based on it.
“Ikuyaku” is about developing pharmaceuticals to be safer, more effective, and easier to use. In order to maximize the value of pharmaceuticals, it is necessary to continuously investigate and collect the data on actual clinical use even after approval. There is a need to maximize and optimize the value of pharmaceuticals based on medical information that is the result of actual practice in medical settings for individual patients who need pharmaceuticals.
In December 2019, the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145 of 1960) was amended to establish e-labeling that is digitization of package inserts, and also obligate bar code display. Furthermore, the promotion of data health is extremely important, and an intensive reform plan for data health has been issued. It is said that the operation of e-prescription system will be started in 2022 after taking various legal measures.
In this lecture, I will give an overview of the current status of the e-labeling, and the barcode labeling which is scheduled to become obligatory in December 2022. I would like to express my thoughts on how things should be progressed in the future, including my own personal views. In addition, I would like to introduce about the general status of the promotion of data health, and also mention the ideal form based on it.