Tomomi Kawamata
President
Japan Generic Medicines Association
(President and Representative Director, Nissin Pharmaceutical Co., Ltd.)

The Japan Generic Medicines Association (JGA) is an association representing the generic medicines industry in Japan. Our mission is to contribute to the improvement and optimization of the healthcare system in Japan through the stable supply of high-quality generic drugs.

The generic medicines industry, as a member of the life-related industry that is directly linked to people's lives and contributes to the improvement of health and hygiene, has a social responsibility to continue to provide a stable supply of effective and safe pharmaceutical products with guaranteed quality to the market.

Currently, generic drugs account for approximately half of all pharmaceutical products in terms of trade volume, and the usage ratio of generic drugs to the total number of pharmaceutical products for which they are available exceeds 80%, playing an important role in supporting Japanese universal healthcare insurance system.

However, regarding drug supply status have been suspended or limited drug supply due to malpractice by generic medicine companies, creating an unfortunate situation in terms of access to generic drugs.

To date, the JGA has implemented measures to prevent recurrence and restore trust, including,

• ・Strengthen compliance, governance, and risk management
• ・Strengthen a system to prioritize quality
• ・Strive to ensure stable supply
• ・Proactively provide and disclose information
• ・Enhancing activities in the JGA, cooperate with the government, and so on.

We recognize that the urgent matter facing the generic medicines industry today is the resolution of instable supply.

The JGA member companies have also been trying to increase supply by capital investments, acquiring factories, and improving production efficiency to improve their production capacity, but they have been hindered by various challenges, including the industrial structure, and have not yet been able to resolve instable supply.

May 2024, the Ministry of Health, Labour and Welfare's "Study Group on the Industrial Structure for a Realization of a Stable Supply of Generic Drugs" compiled a report on achieving a stable supply of generic drugs.

• ・What the generic medicines industry should be like
• ・Direction of measures
  
  • 　　Ensuring manufacturing and quality control systems
  • 　　Ensuring stable supply capabilities
  • 　　Sustainable industrial structure
  • 　　Promotion of collaboration and cooperation between companies
  • 　　(Note) Excerpt from the report of the Study Group on the Industrial Structure for the Realization of a Stable Supply of Generic Drugs

Going forward, JGA will steadily implement what we can do in accordance with the recommendations outlined in the report.

With the ongoing understanding and cooperation of medical associations, insurance associations, and other relevant industry associations, we hope to continue working to ensure that the generic medicines industry can continue to play a part in providing stable, high-quality medical care in the future.

We would appreciate your continued understanding and support for the activities of JGA.