ホーム >> JKMA Guide >> English Guide >> Business plan for FY2023

Business plan for FY2023

■On the Establishment of the Business Plan

JKMA will celebrate the 40th anniversary of its founding on July 21, 2023. To develop the Kampo and crude drug business, we have overcome many difficulties surrounding the JKMA to establish our long history. Having positioned 2023 as the year in which we provide the best opportunity to enable the public, medical personnel, government, related organizations, etc. to again recognize the existential value of the JKMA, we have prepared to hold a ceremony and lectures as well as compiled a history of the association as part of the 40th anniversary project. As stated in the JKMA's constitution, we will work together to solve domestic and international problems by leveraging our achievements and experience accumulated over the past 40 years, so that we can realize the development and stable supple of high-quality Kampo products, crude drug products, and crude drugs and disseminate information about them, as well as contribute to the growth of the pharmaceutical industry and to people's health.


Stable supply of high quality Kampo products, etc.

As more than 80% of crude drugs for Kampo preparations are procured from China, we will establish an online forum for exchanging opinions and information when it is difficult to meet in person on a regular basis and to communicate with the China Chamber of Commerce for Import & Export of Medicines & Health Products, which serves as a bridge between Japan and China, so that we can maintain a good relationship with China.
Meanwhile, to ensure a continuous and stable supply of crude drugs for Kampo preparations, wherever possible, efforts should be made to diversify the production areas from which crude drugs are sourced. For this purpose, we will expand the domestic production of crude drugs for the stable procurement of high quality crude drugs for Kampo preparations with the aid of governments and related organizations.
In addition, there has still been a spate of quality violations in the pharmaceutical industry and the resulting suspension of operations and other conditions have caused supply instability. To ensure the quality of crude drugs for Kampo preparations, we will maintain a compliance system that is the JKMA's version of GACP, strengthen the Kampo GMP framework, and thoroughly implement quality control to ensure a stable supply of highquality Kampo preparations, etc.
Going forward, JKMA will provide the necessary information to establish a universal framework for the elimination of unprofitable operations, while approaching the government and administrative bodies, informing them about the current difficulties which could possibly disrupt the continuous stable supply of ethical Kampo formulations, which has been unprofitable due to the reduction of drug price and the consistently high prices of crude drugs for Kampo preparations.
Following the adjustment of shipments of antipyretic analgesics and other products due to the explosive spread of the Omicron variant of the COVID-19 virus, demand for Kampo products for cold treatments as an alternative to prescriptions has far exceeded expectations. To prioritize the supply of these products to patients and doctors using them for treatments, some member companies are implementing measures, including limited shipping.
Considering this to be the most difficult situation it has ever experienced, the JKMA will further strengthen its efforts to ensure the stable supply of Kampo and other products.


Dissemination of information about and development of Kampo products, etc.

Toward the continuing accumulation of evidence and the establishment of the efficacy of Kampo products and others, we will promote medical economics research grant programs in the fields where Kampo medicines can be expected to be effective, such as geriatric diseases and supportive care in cancer. Through this project, we will accelerate the accumulation of evidence by identifying medical economics researchers, expanding the scope of research, and enabling research results to be presented and published at JKMA's conferences and leading academic meetings.

Regarding our efforts to promote the use of OTC Kampo products and crude drug products, the Self-Medication Taxation System has been extended for the second year, and the number of products covered by the system has increased to include Kampo crude drug preparations containing ephedra, lumbricalis and nandian fruit. In addition, we will conduct educational activities to encourage the use of Kampo products and crude drug products containing Japanese angelica or cnidium rhizome, which can contribute to women's health, as a means of further promoting self-medication.


Contributing to the growth of the pharmaceutical industry and to people's health

In our view, people are not sufficiently aware of Kampo. As exemplified by informative open seminars on Kampo for the public, video distribution, and regularly held forum, The Forum: The Vision for Kampo Medicines and Public Welfare jointly with the Japan Society for Oriental Medicine, we will strengthen our cooperation with related organizations, academic societies, research institutions and government agencies, and enhance our public outreach activities.
We will promote the construction and redevelopment of the compliance system and elevate corporate ethics to prevent corporate scandals among our member companies, as well as request that member companies fortify the three-key-role system to increase the reliability of their quality and safety control for Kampo products and others.
Further, we will increase our awareness that we are an organization contributing to people's health through medicines composed of crude drugs that are the blessing of nature, and contribute to the realization of a decarbonized recycling-based society that coexists with nature against the backdrop of the social environment which includes matters such as the Paris Agreement and the SDGs.

In closing
FY2023 is the 40th anniversary of the founding of the JKMA and the middle year of the first five-year action plan for realization of the Future Vision for Kampo Medicines 2040. Each organization will confirm the progress of its activities to date and push forward with activities to realize the ideal vision of the JKMA.

FY2023 JKMA's Business Policy

Ⅰ.Further accumulation of evidence and establishment of usefulness

  1. Accumulation of evidence
    1. Continue and expand the Kampo medicine-related subsidy projects by working with relevant organizations to establish a research support system.
    2. Promote research for therapies supporting cancer treatment (to reduce the side effects of anticancer drugs).
    3. Promote research for the usefulness of Kampo medicine to address physical frailty.
    4. Implement subsidized projects to accelerate medical economics research
    5. Cooperate with the Committee for EBM, the Japan Society for Oriental Medicine to promote the publication of Kampo Treatment Evidence Reports (EKAT)
  2. Inclusion of Kampo products and others based on crude drugs for ethical use in these practice guidelines
    1. For the thirty general prescriptions of Kampo products, aim to expand the number of guidelines for diseases with high medical needs.
    2. Cooperate with the Committee for EBM, the Japan Society for Oriental Medicine to promote the publication of the Clinical Practice Guidelines For Kampo Medicine-Containing Products in Japan (KCPG).
  3. Securing of safety and promotion of proper use of Kampo products and others based on crude drugs
    1. Establish a safety management system for manufacturers and distributors in response to the requirements of the Pharmaceutical and Medical Device Act, and ensure that safety management monitoring is continuously implemented.
    2. For implementing appropriate response for the notification of reevaluation results of products, establish a solid structure through which measures can be worked on throughout the year.
    3. Discuss responses to consultation and complaints concerning Kampo products
    4. Make sure that the corporate members comply with the new guidelines regarding statements on package inserts by the end of March 2024, i.e., the end of the grace period.
    5. Within the two-year grace period, observe the principle to make the electronic information of the package insert, as stipulated by the amended Pharmaceutical and Medical Device Act, which was enacted on August 1, 2021.
    6. Prepare materials and provide information about the proper use of Kampo products and other products based on crude drugs specifically for each stakeholder (healthcare workers, patients, general consumers, the media, and other stakeholders).
    7. Strengthen the support system for research into the safety of OTC Kampo products and the activities of the study group, resulting in the enhancement of the provision of safety information.
    8. To promote the proper use, exchange information on safety and proper use both domestically and abroad.
    9. Promote corporate members' prompt and reliable responses to revisions of the Precautions regarding OTC Kampo products and crude drug products.
    10. Support corporate members' promotional activities that contribute to proper use.

Ⅱ. Continuous and stable securing of crude drugs for Kampo preparations and expansion of domestic production of crude drugs

  1. Securing of necessary quantity of crude drugs for Kampo preparations
    1. Take appropriate measures to secure the required amount of crude drugs for Kampo preparations
    2. Conduct surveys on the consumption amounts of crude drugs for Kampo preparations and others to understand actual status of distribution and take appropriate measures
  2. Promotion of the cultivation of crude drugs for Kampo pre parations
    1. Implement measures to promote and expand the domestic production of crude drugs for Kampo preparations
    2. Conduct a survey on the production volumes of crude drugs for Kampo preparations (wild forms) and other products, and promote cultivation
  3. Japan-China interchange for stable procurement of crude drugs for Kampo preparations

    4. Exchange information at networking events through visits to and from the China Chamber of Commerce for Import & Export of Medicines & Health Products, and the make necessary efforts to achieve the stable procurement of crude drugs for Kampo preparations


Ⅲ. Upgrade quality control from crude drugs for Kampo prepa rations to final products, strengthen the product quality assu rance system, and stably supply Kampo products for ethical use and other products

  1. Assurance of quality of crude drugs for Kampo preparations
    1. Investigate the situation regarding the pesticides used in the cultivation of medicinal plants in China and respond appropriately.
    2. Investigate the situation regarding the training of people responsible for the management of crude drugs, understand the challenges, and support training.
    3. Clarify the relationship between GMP and GACP and reflect it in GMP for Kampo.
  2. Assurance of quality in the process from crude drugs for Kampo preparations to final products, and stable supply
    1. Investigate corporate members’ compliance with the JKMA version of GACP and address challenges.
    2. Propose the listing of unlisted crude drugs in the Japanese Pharmacopoeia and non-JP crude drug standards and promote the revision of listed crude drugs.
    3. Investigate and collect opinions about products not listed in the Japanese Pharmacopoeia and products that will be revised, and work on the preparation for for revisions.
    4. Appropriately respond to the establishment of crude drug extract specifications and study methods
    5. Improve the quality system through continuous training activities in response to notifications issued by regulatory authorities.
    6. Work to collect information on new evaluation systems for quality control, including as they relate to impurities, aim to advanced quality control, and strengthen the product quality assurance system.
    7. Provide guidelines by identifying trends from the perspective of international harmonization, such as PIC/S GMP ANNEX7 and WHO GMP Guide, and take appropriate measures.
  3. Response to ISO/TC 249
    1. Dispatch experts for various domestic and international ISO/TC249 activities to use the ISO standard as a foothold for international expansion. Based on proposals from each country, put together the industry's attitudes related to each committee at the International Committee Expansion Conference, and work to establish ISO standards that are advantageous to JKMA.
    2. Dispatch two industry representatives to the JLOM-sponsored chief examiner's meeting and express the industry's opinions to reflect the opinions and voting attitudes of the general public in Japan.
    3. Develop and publish new international standards related to GACP in collaboration with the China Chamber of Commerce for Import & Export of Medicines & Health Products and the Traditional Chinese Medicine Resource Center of China Academy of Chinese Medical Sciences.
    4. Continue to develop two international standards (manufacturing method and quality of granules/GACP guidelines) led by JKMA.
  4. Stable supply of Kampo products for ethical use and other products
    1. Exchange opinions, negotiate, consult, and propose solutions to the Economic Affairs Division, and provide explanation to the members of the Federation of Pharmaceutical Manufacturers' Associations of JAPAN and the Central Social Insurance Medical Council so that Kampo products and crude drug products can be included in defined basic drugs and the number of crude drugs included in defined basic drugs can be expanded.
    2. In preparation for a re-examination of product unprofitability and upward price revision for Kampo products, crude drug products, and crude drugs which do not have any substitutes, analyze the results, consider new countermeasures, summarize desired items, set priorities, submit calculation tables regarding the desired items (corporate members), and hold hearings.
    3. Collect and analyze information on discussions related to drug price revisions every year and respond.
    4. Collect and analyze information on benefits, coverage and drug price system reforms from the Social Security Council, the Central Social Insurance Medical Council, the Council on Economic and Fiscal Policy and others, and prepare appropriate materials as necessary.

Ⅳ. Promotion of research for the development of new dosage forms and additional efficacy indications for Kampo products for ethical use toward the establishment of guide lines

  1. Promotion of research on Kampo products and others based on crude drugs and the establishment of guidelines for applications for pharmaceuticals containing multiple ingredients
    1. Raise awareness of the approval application guidelines (addition of formulations with different dosage forms) published in July 2021 and encourage product development by member companies.
    2. Cooperate in the establishment of guidelines for approval applications for pharmaceuticals (changes of formulations such as changes of additives).

Ⅴ. Promotion of the development of OTC Kampo products and crude drug products and strengthening the information provision system

  1. Encourage self-medication using OTC Kampo products
    1. Promote and review the tax system in collaboration with OTCrelated organizations and promote JKMA's own promotion activities for self-medication
    2. Conduct educational activities to promote self-medication through open lectures and seminars for the public
    3. Build relationships with key opinion leaders to promote selfmedication
  2. Development of OTC Kampo products and crude drug products
    1. Study for new attractive prescriptions and conduct literature research to review the efficacy of OTC Kampo products.
    2. Promote investigation and coordination toward the establishment of approval standards for Tokisenkyu preparations to contribute to the realization of a society that includes the active participation of women.
  3. Strengthen the information provision for and advertising of OTC Kampo products and crude drug products
    1. Consult with experts from public institutions and collect advice to strengthen outreach activities for OTC Kampo products.
    2. Provide information on the efficacy and safety of crude drug products and encourage self-regulation through the Japan Self- Medication Industry, Promotion Code Committee and other organizations.
    3. In cooperation with relevant organizations, collect and share information on the proper advertising of OTC Kampo products, crude drug products, and other products. In addition, make proposals and strengthen the feedback system within JKMA.
    4. Share information on the content published by the Advertising Review Board of the Japan Federation of Self-Medication Industries, and hold advertising workshops to ensure thorough compliance with the Standard for Adequate Advertisement of Pharmaceutical Products.

Ⅵ. Strengthening the compliance system and improving reliability

  1. Fortification of compliance activities
    1. Conduct a fact-finding survey of the compliance activities of corporate members and verify the results.
    2. Organize lectures and workshops on compliance.
    3. Encourage corporate members to establish a department or have a person in charge of compliance.
    4. Thoroughly ensure that corporate members publish transparency guidelines before the deadline.
    5. Share the content of the report on the monitoring of activities providing sales information and support corporate members to establish a system for activities providing sales information.
  2. Fortification of the three-key-role system
    1. Establish a three-key-role system that meets the requirements of the Pharmaceutical and Medical Device Act and ensure that it is put into practice.
    2. Build a collaborative system for corporate members to take appropriate measures
    3. Continuously share the latest information and implement education, training and other activities.
    4. Comply with revisions of the regulatory systems, including the second year (2021) compliance system for the 2019 amendments to the Pharmaceutical and Medical Device Act, general exception provisions, and others.
    5. Promote the operation of appropriate quality management systems and improve reliability by strengthening cooperation between manufacturers and distributors.

Ⅶ. Promotion of business activities that are considerate of biodiversity and the global environment, including the conservation of the natural environment, the protection of crude drug resources and other issues, and the international expansion of Kampo products and other products based on crude drugs

  1. Enhancement of eco-friendly activities
    1. Conduct a fact-finding survey and understand the conditions of corporate members' environmental activities
    2. Achieve the goal of reducing carbon dioxide emissions 25% compared to FY2013 by FY2030.
    3. Work toward a 75% reduction of final disposal of industrial waste by FY2025 compared with the amount in FY2000, and an increase the percentage of waste recycled to 60% or more.
    4. Work toward increasing the percentage of waste plastic recycled to 65% or more by FY2030.
  2. Appropriate response to international treaties including the Convention on Biological Diversity
    1. Comply with laws and treaties on the conservation of endangered wild animal and plant species both in Japan and overseas, and procure necessary crude drugs.
    2. In the event of a situation that affects the stable supply, address the situation in cooperation with the FPMAJ Washington Conventionrelated Liaison Committee.
    3. Comply with the domestic laws of crude drug exporting countries and respond appropriately based on the Convention on Biological Diversity
  3. Promotion of international expansion of Kampo products and others based on crude drugs
    1. Review and revise the JKMA version of GACP with a view toward ISO standards

Ⅷ. Strengthening industry-government-academia collabo ration and enhancing outreach activities

  1. Provision of information to people and fulfillment of outreach activities
    1. Develop public relations activities based on the new outreach strategy developed from the results of the survey of people's awareness of and experiences with Kampo products.
    2. Examine and verify means of sharing information in line with the times so that a standardized system which enables effective, efficient and continuous information transmission can be constructed.
    3. Promote committee activities with an awareness of the need to strength and increase the specialization of public relations functions.
    4. Lectures on the right themes at the right times in consideration of measures to acquire more viewers, based on the results of the online open lecture on Kampo medicine which was held for the first time via YouTube in FY 2020.
  2. Enhancement of collaboration with academic societies and universities relating to crude drugs and Kampo
    1. Incorporate the content and recommendations of the Forum: The Vision for Kampo Medicines and Public Welfare in line with the times (infectious diseases, topics, etc.), and hold the Forum to increase the awareness that relevant organizations, academic societies, research institutes, governments, and others have of the role of Kampo medicine, which plays a role in people's health and medical care.
    2. Cooperate with the Japan Society for Oriental Medicine to organize a symposium at the academic general meeting and share evidence on recommended items.
    3. For proposals of the Forum: The Vision for Kampo Medicines and Public Welfare, understand their progress in cooperation with the relevant committees, and regularly share information with the members of the Forum and relevant organizations.
    4. Enhance collaboration with academic societies and universities relating to crude drugs and Kampo medicine.
  3. Enhancement of cooperation with the related organizations, academic societies, research institutions, administrative bodies, and others
    1. Collaborate with the Japan Society for Oriental Medicine to achieve the assignment of official administrative officers related to Kampo medicine.
    2. Report the results of the examination of the outline of product information to the Ministry of Health, Labour and Welfare.
    3. Through the development of approval standards for new crude drug products, such as Tokisenkyu preparations, expand cooperation with academia, research institutes, governments, and others.