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Message from Chairman

Terukazu Kato,
Japan Kampo Medicines Manufacturers Association

FY2022 marks the second year of the first five year action plan for realization of the Future Vision for Kampo Medicines 2040.

The Forum: The Vision for Kampo Medicines and Public Welfare has been convened eight times to date.

One outcome of its recommendations was that “Basic Concept on Bioequivalence Evaluation for Addition of Formulations with Different Dosage Forms in Ethical Kampo Formulations” was issued as an administrative notice by the Ministry of Health, Labour and Welfare on July 19, 2021. The development of new formulations of ethical Kampo formulations was previously considered difficult but we are confident that the publication of such a guidance will benefit patients and the general public alike.

In addition, we launched a research grant to promote research into medical economics in fields in which Kampo medicines can be expected to be effective such as geriatric diseases and supportive care in cancer, with May 1, 2022 to March 31, 2023 as the research period. Grants have been provided for four research themes. We expect this project will help us identify medical economics researchers and expand the scope of research domains, and the research findings are expected to help accelerate the accumulation of evidence.

In the FY2022 drug price revision, ten Kampo products for ethical use and three crude drug ingredients were approved for re-examination for product unprofitability and upward price revisions.

Such approval was issued for ethical-use Kampo products for the first time in FY2020 (three products) and has been issued for more products this time around. Similarly in the case of ethical-use crude drugs, the 62 raw drug ingredients that were included in defined basic drugs in the FY2018 drug revision are still included in defined basic drugs. In order to maintain a stable supply of safe and reliable ethical-use Kampo products for the Japanese public, JKMA will continue to do its best to ensure that drug prices are maintained through their inclusion in defined basic drugs and approval for their re-examination for product unprofitability and upward price revisions.

Regarding promotion of the use of OTC Kampo products and crude drug products, the self-medication taxation system originally introduced as a time-limited taxation system will now be extended for a further period of five years from 2022. A further 42 ingredients that were not on the Rx-to-OTC switch list are now covered by the system, and also among OTC Kampo products/crude drug products, many products that contain the three crude drugs Ephedra, Lumbricalis and Nandian Fruit now qualify for the system. JKMA sees this as an opportunity to make Kampo and crude drug products more readily available to the Japanese public and is supporting calls for revisions such as making the taxation system permanent and making all OTC drugs qualify for the system.

We will also continue conducting awareness raising activities, including providing information to increase the rate of utilization.

Regarding the crude drugs from which Kampo products and crude drug products are made, JKMA will seek to encourage and expand the cultivation of domestically produced crude drugs to ensure stability. To maintain and develop good relations with China, the world’s largest supplier of crude drugs, we will promote exchange between Japan and China, including exchanging opinions and information in online meetings with the China Chamber of Commerce for Import & Export of Medicines & Health Products. Looking to expand production of domestically produced crude drugs, we will take advantage of the Sustainable Production Strengthening Measures Project run by the Ministry of Agriculture, Forestry and Fisheries and, in cooperation with the Ministry of Agriculture, Forestry and Fisheries, the Ministry of Health, Labour and Welfare and other agencies, we will continue holding community briefing and consultation sessions to promote the development of domestic production areas for medicinal crops, thus helping realize a stable supply of high quality crude drugs.

To improve the quality of the crude drugs for Kampo preparations, we will also promote enhancement of the content of standards including proposing listing in JP and non-JP crude drug standards. In addition, we will hold seminars and workshops for JKMA members to bolster the Kampo GMP framework, ensure thoroughgoing quality management, and stabilize the supply of high-quality Kampo products.

Recently, there has been a spate of quality violations in Japan’s pharmaceutical industry and unfortunately some of our members have also been involved in such quality violations. JKMA provides appropriate guidance and useful information to its members and holds regular study meetings for them, in the hope that the senior executives at all member companies demonstrate a policy of compliance to all their employees.

JKMA and its members will renew their efforts to raise compliance awareness and promote activities to strengthen the compliance framework of member companies.

In 2023, JKMA will celebrate the 40th anniversary of its founding. In FY2022, member companies will work as a united team to realize a sustainable society through environmentally friendly activities whilst at the same time preparing to mark this anniversary. Member companies will cooperate closely with each other as they strive to contribute to public health and medical care by maintaining a stable supply of high quality Kampo products and by ensuring even greater product safety and encouraging the proper use of products.