Five year action plan (FY2021 to FY2025)
Plan for the execution of the road map to realize the Future Vision for Kampo Medicines 2040

（1）Encourage relevant organizations to establish a research support system

（2）Accumulate high-quality evidence through research into supportive therapy in cancer treatment (for the reduction of the side effects of anticancer drugs)

（3）Promote research on Kampo medicine's usefulness in addressing 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)

（1）Increase the number of guidelines including the 30 general-purpose prescriptions of Kampo products for ethical use

（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).

（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 consultations and complaints concerning Kampo products

（4）Make sure that corporate members comply with the new guidelines on statements in package inserts for ethical drugs by the end of March 2024, i.e., the end of the grace period.

（5）Create and publish an updated version of the Precautions for Kampo products for ethical use standardized within JKMA, which covers the responses to new guidelines on statements.

（6）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.

（7）Prepare materials and provide information about proper use of Kampo products and others specifically for each stakeholder (healthcare workers, patients, general consumers, the media, and other stakeholders).

（8）Strengthen the support system for research for the safety of OTC Kampo products and the activities of the study group (MHLW grants system), resulting in the enhancement of the provision of safety information.

（9）To promote proper use, exchange information on safety and proper use both domestically and abroad.

（10）Build relationships with key opinion leaders to promote the proper use.

（11）Promote corporate members' prompt and reliable responses to revisions of the Precautions of OTC Kampo products and crude drug products.

（12）Support corporate members promotional activities that contribute to proper use.

（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 other products to understand actual status of distribution and take appropriate measures.

（3）Investigate and analyze production volumes, prices, and other matters to expand the volume of domestically produced crude drugs for Kampo preparations.

（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.

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

（2）Organize problem-solving-type networking events with specific themes and strengthen the foundation for the stable securing of crude drugs.

（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.

（1）Investigate corporate members' compliance with the JKMA version of GACP and address challenges.

（2）Promote the listing of unlisted crude drugs in the Japanese Pharmacopoeia, non-JP crude drug standards, and 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 those relating to impurities, aim to achieve advanced quality control, and strengthen the product quality assurance system.

（7）Provide guidelines by identifying the trends from the perspective of international harmonization, such as PIC/S GMP ANNEX7 and WHO GMP Guide, and take appropriate measures.

（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 the China Academy of Chinese Medical Sciences.

（4）Continue to develop two international standards (manufacturing method and quality of granules/GACP guidelines)led by JKMA.

（1）Exchange opinions, negotiate, consult, and propose solutions to the Economic Affairs Division, and provide explanations 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 drug can be expanded.

（2）In preparation for re-examination for product unprofitability and upward price revision for Kampo products, crude drug products, and crude drugs which do not have any substitutes, analyze 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）Prepare to set minimum drug prices for Kampo products for ethical use and other products.

（5）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.

（1）Cooperate in the establishment of guidelines for approval applications for pharmaceuticals (to add new dosage forms), and once guidelines are issued, promote our corporate members' product development.

（2）Cooperate in the establishment of guidelines for approval applications for pharmaceuticals(change of formulations such as change of additives).

（1）Promote and review the tax system in collaboration with OTC-related organizations and promote JKMA's own promotion activities for selfmedication

（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 self-medication

（1）Study new attractive prescriptions and conduct literature research to review the efficacy of OTC Kampo products.

（2）Collect information from other organizations and public institutions to consider new attractive prescriptions and review the efficacy of OTC Kampo products.

（3）Promote relationships with key opinion leaders to consider new attractive prescriptions and review the efficacy of OTC Kampo products.

（4）Provide support for the publicization of attractive new prescriptions, the review of the efficacy of OTC Kampo products and the revision of approval criteria for OTC Kampo products.

（5）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.

（6）Continue searching for materials to establish approval standards for new crude drug products that contribute to extending healthy life expectancy.

（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 others.

（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.(annually)

（5）Develop a website or app about Kampo products to ensure thorough compliance with the Standard for Adequate Advertisement of Pharmaceutical Products.

（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）Create a model for compliance-related norms

（5）Review the JKMA Code of Practice as necessary and revise it according to the situation.

（6）Thoroughly ensure that corporate members publish transparency guidelines before the deadline.

（7）Publish corporate members' transparency guidelines on the JKMA website

（8）Share the content of the report on the project for monitoring sales information provision activities and ensure that the promotional activities conducted by corporate members are appropriate.

（9）Support corporate members to establish a sales information provision activity 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 it 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.

（1）Follow-up with corporate members

• ・Conduct a fact-finding survey and understand the conditions of corporate members' environmental activities
• ・Increase the number of organizations which are participating in the achievement of the FPMAJ's goals and solicit participation in the environment subcommittee
• ・Share information, including the results of activities to achieve the FPMAJ's goals and environment-related seminars organized by the FPMAJ

（2）Contribution to the realization of the action plan for low carbon society (CO2)

• ・Achieve the goal of reducing carbon dioxide emissions by 25% compared to FY2013 by 2030

（3）Contribution to the realization of a plan for the establishment of a recycling-based society (waste)

• ・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.
• ・Work toward increasing the percentage of waste plastic recycled to 65% or more by FY2030.

（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 stability of supply, address the situation in cooperation with the FPMAJ Washington Convention Liaison Committee.

（3）Comply with the domestic laws of crude drug exporting countries and respond appropriately based on the Convention on Biological Diversity

Review and revise the JKMA version of GACP with a view toward ISO standards

（1）Organize open lectures for the public that are responsive to the new normal created by the COVID-19 pandemic, while building a system for public hearings.

（2）Work on the implementation of a new outreach strategy based on the Survey on Awareness and Experiences of Kampo products summarized in FY2020. Regularly verify results through awareness surveys and continuously engage in public relations activities to meet the needs of the times.

（3）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.

（4）Promote the strengthening and specialization of public relations functions to share information related to JKMA's activities in ways that develop support and the understanding of internal and external stakeholders.

（5）Build an efficient information sharing system within JKMA so that information can be disseminated externally and provided to corporate members in a more timely manner in order to further promote understanding of JKMA's activities both internally and externally.

（6）When holding a open seminar on Kampo medicine, examine and verify both the software and hardware that will be used according to the current social environment, and effectively organize the seminar with optimal content in an appropriate way.

（7）Promote the marketability of OTC Kampo products and crude drug products according to their applicable scopes and product characteristics and advertise them at public relations opportunities.

（8）Investigate and examine people's awareness and usage of Kampo products and other products based on crude drugs for ethical use.

（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）Organize symposiums and other events based on the results of the forum, The Vision for Kampo Medicines and Public Welfare.

（3）Cooperate with the Japan Society for Oriental Medicine to organize a symposium at the academic general meeting and share evidence on recommended items.

（4）For the six 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.

（5）Enhance collaboration with academic societies and universities relating to crude drugs and Kampo

（6）Identify and address issues related to the regulation of OTC Kampo products together with other organizations.

（1）Assign official administrative officers in charge of Kampo medicine in collaboration with academic societies and other organizations.

（2）Exchange opinions with the Japan Society for Oriental Medicine on the ideal ways to promote the activities of corporate members

（3）Regularly report the results of the examination of outline of product information to the Ministry of Health, Labour and Welfare.

（4）Through the development of approval standards for new crude drug products, such as Tokisenkyu preparations, expand cooperation with academia, research institutes, governments, and others.