日本漢方生薬製剤協会

JAPAN KAMPO MEDICINESMANUFACTURERS ASSOCIATIONGUIDE 2024

（Botanical illustrations：Kochi Prefectural Makino Botanical Garden）

Our most important challenges in this fiscal year are the stable procurement of crude drugs for Kampo preparations, the stable supply of
Kampo and other products and the assurance of quality in the process from crude drugs for Kampo preparations to final products.
Regarding the stable procurement of crude drugs for Kampo preparations, which is a prerequisite for the stable supply of Kampo and otherproducts, to maintain a good relationship with China, which is responsible for 80% of the total volume of the crude drugs we procure, we havebeen engaged with the China Chamber of Commerce for the Import and Export of Medicines and Health Products which is a part of the People’s
Republic of China’s Ministry of Commerce, excluding the period when activities were suspended due to the COVID-19 pandemic.
We at the JKMA are working to resume exchange meetings between Japan and China for the first time in five years and currently planning adelegation to visit China in early November.
Additionally, we will continue to promote and expand producing areas in Japan for domestically growable crude drugs with the support of the
Ministry of Agriculture, Forestry and Fisheries and the Ministry of Health, Labour and Welfare with the Medicinal Crop Producing Area Support
Council hosting activities.
Because of a shortage of drugs such as antipyretic analgesics and antitussive medicines in the pandemic, demand for Kampo and otherproducts has been high, forcing us to limit shipments and disrupting the stable supply of these products.
We would like to again apologize for this ongoing problem and express our determination to continue to be devoted to resuming the normal
stable supply system as quickly as possible.
Following the recent drug price revisions in FY2024, product unprofitability was reexamined as a special exception as a drug price measure tosecure a stable supply of the products which are covered by insurance and for which needs are high in healthcare.
We applaud this measure. We see it as a result of understanding of our distressed condition that may interfere with the stable supply of Kampo
products, such as the recent surge in the cost of raw materials and energy, and the support by the parties concerned including the Ministry of
Health, Labour and Welfare, the Federation of Pharmaceutical Manufacturers’ Associations of Japan and the Central Social Insurance Medical
Council.
Our corporate members are committed to reinforcing the stable supply system for Kampo and other products through capital investment inproduction equipment and crude drug warehouses.
Unfortunately, one of our corporate members violated the related laws and regulations, leading to quality misconduct which resulted inadministrative sanctions. The JKMA took the reasonable actions regarding the company.
It is very regrettable that one of our corporate members caused this problem at a time when the industry is required to establish and enhance
legal compliance and manufacturing/management systems and structures to secure the proper quality and safety of pharmaceuticals.
We at the JKMA hold workshops every year and conduct a fact-finding survey of compliance activities to make our corporate members returnto the starting point of contributing to public health, which is one of our main aims, and to increase awareness of compliance.
To secure the quality in the process from crude drugs for Kampo preparations to final products, we will continue promote initiatives toenhance the Pharmaceutical Quality System (PQS) and a system and structure to enable our corporate members to implement GMP for Kampo
products and ensure thorough compliance with laws, regulations and other rules.
The JKMA holds the Forum: The Vision for Kampo Medicines and Public Welfare jointly with the Japan Society for Oriental Medicine everyyear.
In the Vision Forum in FY2023 held on February 19 of this year which was themed on post-pandemic healthcare issues and the necessity of
Kampo products, participants made presentations and discussed the necessity of Kampo products in response to the increase of frailty in theelderly and issues relating to Kampo preparations, etc.
We will share useful information to contribute to health and healthcare for Japanese people while positioning the Vision Forum as a valuable
opportunity to discuss various issues relating to Kampo products, etc.
The Self-Medication Taxation System was extended until 2026. We will continue to request that the taxation system be made permanent andthat all OTC Kampo products and crude drug products be covered by it.
Furthermore, we will continue educational activities to encourage the use of Kampo preparations containing crude drugs such as Japaneseangelica or cnidium rhizome which are expected to be used in femtech as an answer to the mental and physical health issues faced by women.
Lastly, we will strive to contribute to people’s health and medical care with the close cooperation of our members by maintaining the stablesupply of quality Kampo and other products, ensuring even greater product safety and encouraging the proper use of products.
We sincerely ask that everyone involved provide us with continued guidance and support.
Terukazu Kato, Japan Kampo Medicines Manufacturers Association

Pharmaceutical manufacturers association made up mainly of manufacturers and distributors of Kampo products and crude
drug products made from crude drugs, and crude drugs. Industrial body affiliated with the Federation of Pharmaceutical
Manufacturers’ Associations of Japan (FPMAJ).

Member companies

58 (as of July 1, 2024)

Main aims■ Stable supply of high-quality Kampo products, crude drug products, and crude drugs.

■ Disseminating and developing Kampo products, crude drug products, and crude drugs.
■ Contributing to the growth of the pharmaceutical industry and the health of the nation

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Chairman
Terukazu Kato

Vice-chairman
Tetsuya Kusayanagi

Vice-chairman
Ippei Suzuki

Vice-chairman
Vice-chairman
Kazumasa Kobayashi Daisuke Tochimoto

Vice-chairman
Shoichi Kuwano

Managing Director
Yoshio Machida

Chairman

Terukazu Kato
Tsumura & Co.

Vice-chairman

Tetsuya Kusayanagi
Kracie Pharmaceutical, Ltd.

Managing Director

Ippei Suzuki

Kazumasa Kobayashi Daisuke Tochimoto

Shoichi Kuwano

Atsuyuki Ohta

Kotaro Pharmaceutical Co., Ltd. Kobayashi Pharmaceutical Co., Ltd. Tochimoto Tenkaido Co., Ltd.

Nippon Funmatsu Yakuhin Co., Ltd.

Yoshio Machida

Japan Kampo Medicines Manufacturers Association

Director

Masaki Mizuno

Atsushi Morisawa

Osamu Ushimaru

Takashi Okusa

Masao Tsuji

Kunio Takahashi

Katsuyoshi Sakamoto Seiichi Sato

Mitsuo Murayama

Mitsuhiro Ibe

Takahiro Uchida

Takashi Shibata

Yoshitake Tatebayashi Jin Tatsuzaki

Toshiaki Yataka

Shigeo Minakata

Asgen Pharmaceutical Co., Ltd. Alinamin Pharmaceutical Co., Ltd. Alps Pharmaceutical Ind. Co., Ltd. Ohkusa Yakuhin Co., Ltd.
Ominedo Pharmaceutical Industry Co., Ltd. Zaiseido Pharmaceutical Co., Ltd. Sakamoto Kampo Pharmaceutical Inc. Sato Pharmaceutical Co., Ltd.
Sanwa Shoyaku Co., Ltd.

Zeria Pharmaceutical Co., Ltd.

Daiichi Sankyo Healthcare Co., Ltd. Taiko Pharmaceutical Co., Ltd.

Ohta's lsan Co., Ltd.

Koichi Watanabe

Sampo Pharmaceutical Co., Ltd.

Shigeru Uehara

Taisho Pharmaceutical Co., Ltd.

Hideo Tanaka

Tatebayashi Shokakudo Co., Ltd. Tokiwa Phytochemical Co., Ltd. Naganoken Pharmaceutical Co., Honso Pharmaceutical Co., Ltd. Yomeishu Seizo Co., Ltd.

Ryuta Fujii

Ryukakusan Co., Ltd.

AuditorAtsushi Hori

Kunio Yamada

Masaki Wakiyashiki

Rohto Pharmaceutical Co., Ltd. Wakanyaku Medical Institute Ltd.

Seiji Kobayashi

Kyushin Pharmaceutical Co., Ltd. JPS Pharmaceutical Co., Ltd.

Senior Executive Advisor

Hachizaemon Kazama
Tsumura & Co.

AdvisorYasuto Mitani

Hidetoshi Imaizumi

Masao Onishi

Kanebo Pharmaceutical Co., Ltd. Daiichi Sankyo Healthcare Co., Ltd. Kotaro Pharmaceutical Co., Ltd.
*Alphabetical order of company name.
*For Senior Executive Advisor and Advisors, the company name is shown at the time of their retirement.

Secretary General

Yoshiyuki Kurimura

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The Future Vision for Kampo Medicines 2040
- Responsibility for People's Health and Healthcare In May 2018, the Japanese government released the prospect for future social security in 2040. The report predicts thatJapan's elderly population will peak in 2040. To contribute to people's health and healthcare in an aging society, for instance,
extending healthy life expectancy by supplying Kampo products and others based on crude drugs, we have established "The
Future Vision for Kampo Medicines 2040 - Responsibility for People's Health and Healthcare -."We will accumulate scientific evidence under industry-government-academia cooperation andenhance the usefulness of Kampo products and others based on crude drugs in medical care.
1. Accumulation of evidence
We will encourage the establishment of methods for evaluating usefulness, the scientific elucidation of shou that is the unique concept for
Kampo, and medical economics research to contribute to the establishment of evidence-based medicine in Kampo treatment.
In addition, we will contribute to the healthy lives of many patients by accumulating evidence of new uses, including supportive therapy incancer treatment and medical care for frailty in the elderly.
2. Inclusion of Kampo products and others based on crude drugs for ethical use in these practice guidelines
We contribute to expanding the range of treatment by accumulating evidence to increase formulations listed on treatment guidelines toallow many physicians to use Kampo products and others based on crude drugs.
3. Securing of safety and promotion of proper use of Kampo products and others based on crude drugs
We at JKMA will independently prepare the materials for providing information about proper use of Kampo products and others based on
crude drugs and will disseminate information to healthcare facilities and general users via our website and other media. We will continue toraise the value of Kampo products and others based on crude drugs as pharmaceutical products and will establish the usefulness in healthcare.

We will diligently try to procure the necessary quantity of crude drugs for Kampo preparations.
1. Securing of necessary quantity of crude drugs for Kampo preparations
As for domestic cultivation, we will increase production about three times by solving many issues, for instance, securing seeds andseedlings, training cultivation technicians and instructors, founding processing/preparation facilities, and raising efficiency and ensuringcontinuity of production. Today, we import approximately 80% of crude drugs for Kampo preparations from China. In this context, we will
try to maintain a favorable relationship with the country. In addition, we will increase sources to manage the risk of delayed procurement
caused by natural calamities and abnormal weather.
2. Promotion of cultivation of crude drugs for Kampo preparations
We will conduct a survey on the ratios of cultivated forms and wild forms of crude drugs to choose preferred items and promote cultivation without limiting production areas.
3. Japan-China interchange for stable procurement of crude drugs for Kampo preparations
We are currently communicating with China and exchanging information. We will regularly interchange with China to maintain anddevelop a successful bilateral relationship and stably secure crude drugs for Kampo preparations.

Vision 3

We will strengthen the quality control process from crude drugs for Kampo preparations to finishedproducts for the stable supply of quality Kampo products and others based on crude drugs.

1. Assurance of quality of crude drugs for Kampo preparations
We will enhance surveillance and research on quality, including origin, properties, verification tests, and quantitative methods of crude
drugs, and train the crude drug managers who play a key role in good manufacturing practices for Kampo to upgrade the level of quality
control for crude drugs comprehensively.
2. Assurance of quality in the process from crude drugs for Kampo preparations to final products, and stable supply
We will ensure thorough quality control with good manufacturing practices and voluntary standards as well as the stable supply of quality
Kampo products and others based on crude drugs. Additionally, we will advocate familiarization with the JKMA version of GACP among
farmers and assure quality in the safety in crude drugs for Kampo preparations, Kampo products and others based on crude drugs, forinstance, controlling pesticide residue, heavy metal, and microorganisms.
3. Response to ISO/TC 249
We will respond to ISO/TC 249 appropriately and use information on other ISO technical committees effectively by offering new suggestions and submitting opinions about the activities associated with the quality of crude drugs for Kampo preparations.
4. Stable supply of Kampo products for ethical use
To continuously secure a stable supply of Kampo products and others based on crude drugs for ethical use, we will approach administrative bodies and related organizations.

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We will expand the development of new dosage forms and research on additional indications of
Kampo products for ethical use and support the establishment of guidelines for applications ofpharmaceuticals containing multiple ingredients, such as Kampo products.
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
We will promote the development of new dosage forms and research on additional indications of Kampo products for ethical use. In
addition, we will support the establishment of guidelines for applications for pharmaceuticals containing multiple ingredients.

We will boost the development of OTC Kampo products and crude drug products and enhance
post-marketing information provision.
1. Encouragement of self-medication
We will encourage self-medication through the development and fulfillment of OTC Kampo products that are made from crude drugs andcrude drug products.
2. Development of OTC Kampo products and crude drug products
The environment exists for approval of Kampo products and others based on crude drugs, for example, inclusion of more formulations instandards of approval. We will continue to advocate research and development of OTC Kampo products and crude drug products.
3. Enhancement of provision of information on OTC Kampo products and crude drug products
We will enhance outreach activities for consumers by sharing actual cases of consultations with consumers and providing information andmaterials via lecture meetings and leaflets.
4. Advertisements of OTC Kampo products and crude drug products
We will enhance the advertising functions in cooperation with the related organizations and promote the proper use of OTC Kampo
products and crude drug products.

We will upgrade reliability by strengthening compliance as well as quality and safety control for
Kampo products and others based on crude drugs in corporate members.
1. Fortification of compliance activities
We will promote the construction and rearrangement of the compliance system and elevation of corporate ethics, and prevent corporate
scandals to increase trust among people.
2. Fortification of the three-key-role system
To facilitate the execution of jobs in the three key roles as defined in the laws and regulations, we will request that corporate members
fortify the three-key-role system to upgrade reliability in quality and safety control for Kampo products and others based on crude drugs.

Vision 7

We will contribute to the conservation of the global environment and biological diversity, theprotection of wild plants and animals, and will proactively work toward the international expansionof crude drugs that are natural blessings.

1. Enhancement of eco-friendly activities
We will contribute to the achievement of a low carbon society, a recycling-based society, and a natural symbiosis society in considerationof global trends including the Paris Agreement and SDGs.
2. Appropriate response to international treaties including the Convention on Biological Diversity
We will observe the domestic laws of the crude drug producing countries under the principles of the Convention on Biological Diversity
and the Nagoya Protocol on Access and Benefit-sharing. We will observe the domestic laws relating to endangered species in accordancewith CITES.
3. Promotion of international expansion of Kampo products and others based on crude drugs
We will transmit the knowledge of Kampo products and others based on crude drugs from Japan to the world to contribute to the improvement of global public health and promote the international expansion of these products.

We will implement outreach activities and enhance collaboration with the related organizations,academic societies, research institutions, administrative bodies, and others.
1. Provision of information to people and fulfillment of outreach activities
We will try to popularize Kampo by providing information to effectively raise awareness. Additionally, we will fulfill outreach activities
to build trust through interactive dialogues with people.
2. Enhancement of collaboration with academic societies and universities relating to crude drugs and Kampo
We will enhance collaboration with academic societies and universities related to crude drugs and will cooperate in human resource
development, for example, organizing symposiums at academic meetings concerning crude drugs in the industry and proactively sending
lecturers to special lectures about Kampo and crude drugs at universities.
3. Enhancement of cooperation with the related organizations, academic societies, research institutions, administrative
bodies, and others
We will enhance communications with the related organizations, academic societies, research institutions, administrative bodies, andothers and solve issues under satisfactory cooperation promptly and properly.

4Five year action plan (FY2021 to FY2025)

Plan for the execution of the road map to realize the Future Vision for Kampo Medicines 2040

Vision 1:Further accumulation of evidence and establishment of usefulness
1.Accumulation of evidence(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 ofanticancer 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)
2.Inclusion of Kampo products and others based on crude drugs for ethical use in these practice guidelines(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).
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 whichmeasures 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.

Vision 2:Continuous and stable securing of crude drugs for Kampo preparations andexpansion 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 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.
2.Promotion of cultivation of 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.
3.Japan-China interchange for stable procurement of crude drugs for Kampo preparations(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.

Vision 3:Upgrade quality control from crude drugs for Kampo preparations to final
products, strengthen the product quality assurance 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)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.

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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 theopinions 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 & Exportof 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.
4.Stably supply Kampo products for ethical use and other products(1)Exchange opinions, negotiate, consult, and propose solutions to the Economic Affairs Division, and provide explanations to the members of theFederation 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.

Vision 4:Promotion of research for the development of new dosage forms and addi
tional efficacy indications for Kampo products for ethical use toward the esta
blishment of guidelines
1.Promotion of research on Kampo products and others based on crude drugs and the establishment of guidelines forapproval applications for pharmaceuticals containing multiple ingredients(1)Cooperate in the establishment of guidelines for approval applications for pharmaceuticals (to add new dosage forms), and once guidelines areissued, 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).

Vision 5: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 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
2.Development of OTC Kampo products and crude drug products(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 therealization 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.
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 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 holdadvertising workshops to ensure thorough compliance with the Standard for Adequate Advertisement of Pharmaceutical Products.(annually)(5)D evelop a website or app about Kampo products to ensure thorough compliance with the Standard for Adequate Advertisement ofPharmaceutical Products.

Vision 6: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)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

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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 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 thePharmaceutical 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.

Vision 7:Promotion of business activities in consideration of biodiversity and theglobal 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.Promotion of activities that are considerate of the global environment(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 theenvironment 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 46% 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 thepercentage of waste recycled to 60% or more.
・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 procurenecessary 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
3.Promotion of international expansion of Kampo products and others based on crude drugs
Review and revise the JKMA version of GACP with a view toward ISO standards

Vision 8:Strengthening industry-government-academia collaboration and enhancing
outreach activities
1.Provision of information to people and fulfillment of outreach activities(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 summarizedin FY2020. Regularly verify results through awareness surveys and continuously engage in public relations activities to meet the needs of thetimes.
(3)Examine and verify means of sharing information in line with the times so that a standardized system which enables effective, efficient andcontinuous 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 thecurrent 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.
2.Enhancement of collaboration with academic societies and universities relating to crude drugs and Kampo medicines(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 onrecommended items.
(4)For the six proposals of the Forum: The Vision for Kampo Medicines and Public Welfare, understand their progress in cooperation with therelevant 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.
3.Enhancement of cooperation with the related organizations, academic societies, research institutions, administrative
bodies, and others(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 withacademia, research institutes, governments, and others.

7

Business plan for FY2024

(Developed in May 2024)■On the Establishment of the Business Plan

The JKMA celebrated the 40th anniversary of its founding last year, and made a fresh start as it moves toward
the coming 50th anniversary to contribute to national healthcare by accelerating the development of Kampo
and crude drug businesses. We have prepared an interim report examining the progress of initiatives and future
initiatives for the first five-year action plan for the Future Vision for Kampo Medicines 2040. This year, we
will promote activities to solve the issues clarified by the interim report. Through the concerted efforts of its
members and cooperation with related organizations, the JKMA will solve domestic and international issues
while regarding the stable procurement of crude drugs for Kampo preparations and the stable supply of Kampo
and other products and the assurance of quality in the process from crude drugs for Kampo preparations to final
products as the most important challenges that we face.

The stable procurement of crude drugs for Kampo preparations and the stable supplyof Kampo and other products
Today, more than 80% of crude drugs for Kampo preparations are imported from China. Due to the pandemic,
bilateral exchange activities have been halted for four consecutive years since 2019 when the China Chamberof Commerce for Import and Export of Medicines and Health Products last visited Japan, and members of the
JKMA have not visited China in the period either. We will quickly restart the Japan-China exchange activities,
maintain good relationships, and aim to achieve the stable procurement of high-quality crude drugs for Kampo
preparations.
There are concerns about reduced profitability due to reasons such as the repeated reduction of the drug pricesof ethical Kampo products and the consistently high prices of crude drugs for Kampo preparations, soaring
prices and exchange rates. The JKMA will provide the necessary information to establish a universal framework
for the elimination of unprofitable operations to enhance the drug price support system while approaching thegovernment and administrative organizations, informing them of current difficulties which could possibly disrupt
the continuous stable supply of ethical Kampo formulations due to unprofitability.
The insufficient supply of pharmaceuticals for infectious diseases increased the demand for related ethicalKampo products far more than estimated as alternative prescriptions, and the aftereffects are still impacting
OTC drugs as well. Having a sense of this crisis, the JKMA will increase its efforts to ensure the stable supply of
Kampo and other products.

Assurance of quality in the process from crude drugs for Kampo preparations to final
products
There has still been a spate of quality violations in the pharmaceutical industry and the resulting suspension ofoperations and other conditions have caused supply instability. To secure the quality of products in the processfrom crude drugs for Kampo preparations to final products, the JKMA will promote its corporate members’
implementation of PQS and enhancement of systems and structures for GMP for Kampo products. Moreover,
we will hold workshops with the goal of enhancing compliance systems and structures, clarify the responsible
departments, and implement other initiatives while informing all of the people concerned of these initiatives.
We are facing many important issues and challenges, such as establishing evidence for Kampo and otherproducts, promoting and expanding the domestic production of crude drugs for Kampo preparations, promoting
self-medication and developing new products including the addition of new dosage forms to approved drugs. The
JKMA will continue to contribute to people’s health and the growth of the pharmaceutical industry in FY2024
by achieving the stable supply of high-quality Kampo products, increasing their market presence and penetration
with the close cooperation of our corporate members to realize the Future Vision for Kampo Medicines 2040.
8

FY2024 JKMA's Business Policy
the China Chamber of Commerce for Import & Export of Medicines &Health Products, and the make necessary efforts to achieve the stableprocurement of crude drugs for Kampo preparations

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 researchsupport system.
(2)P romote research for therapies supporting cancer treatment (toreduce 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)C ooperate 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)F or the thirty general prescriptions of Kampo products, aim
to expand the number of guidelines for diseases with highmedical needs.
(2)C ooperate 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)E stablish a safety management system for manufacturers anddistributors in response to the requirements of the Pharmaceuticaland Medical Device Act, and ensure that safety managementmonitoring is continuously implemented.
(2)F or implementing appropriate response for the notification ofreevaluation results of products, establish a solid structure throughwhich measures can be worked on throughout the year.
(3)Discuss responses to consultation and complaints concerning Kampo
products(4)M ake 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 makethe electronic information of the package insert, as stipulated by
the amended Pharmaceutical and Medical Device Act, which wasenacted on August 1, 2021.
(6)Prepare materials and provide information about the proper useof 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 andproper use both domestically and abroad.
(9)P romote corporate members' prompt and reliable responses torevisions of the Precautions regarding OTC Kampo products andcrude drug products.
(10)Support corporate members' promotional activities that contributeto proper use.

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 ethicaluse and other products
1.Assurance of quality of crude drugs for Kampo preparations(1)I nvestigate the situation regarding the pesticides used in thecultivation 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, andsupport 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 versionof GACP and address challenges.
(2)P ropose the listing of unlisted crude drugs in the JapanesePharmacopoeia and non-JP crude drug standards and promote therevision of listed crude drugs.
(3)Investigate and collect opinions about products not listed in theJapanese Pharmacopoeia and products that will be revised, and workon 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 ofinternational 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 theindustry'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 theopinions 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 (manufacturingmethod and quality of granules/GACP guidelines) led by JKMA.
4.Stable supply of Kampo products for ethical use and otherproducts(1)Exchange opinions, negotiate, consult, and propose solutions to the
Economic Affairs Division, and provide explanation to the membersof the Federation of Pharmaceutical Manufacturers' Associations ofJAPAN and the Central Social Insurance Medical Council so that
Kampo products and crude drug products can be included in definedbasic 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 andupward price revision for Kampo products, crude drug products,
and crude drugs which do not have any substitutes, analyze theresults, 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 pricerevisions every year and respond.
(4)Collect and analyze information on benefits, coverage and drug pricesystem 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.

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)C onduct 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 preparations(1)Implement measures to promote and expand the domestic productionof 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 promotecultivation
3.Japan-China interchange for stable procurement of crude
drugs for Kampo preparations
Exchange information at networking events through visits to and from9

of biodiversity and the global environment, including theconservation 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 ofcorporate members' environmental activities(2)A chieve the goal of reducing carbon dioxide emissions 46%
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 thepercentage 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 theConvention on Biological Diversity(1)Comply with laws and treaties on the conservation of endangered
wild animal and plant species both in Japan and overseas, andprocure necessary crude drugs.
(2)In the event of a situation that affects the stable supply, address thesituation 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 andothers 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 outreachactivities(1)D evelop public relations activities based on the new outreachstrategy 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 thetimes so that a standardized system which enables effective, efficientand continuous information transmission can be constructed.
(3)P romote committee activities with an awareness of the need tostrength 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 anduniversities 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 withthe times (infectious diseases, topics, etc.), and hold the Forumto increase the awareness that relevant organizations, academic
societies, research institutes, governments, and others have of therole of Kampo medicine, which plays a role in people's health andmedical care.
(2)Cooperate with the Japan Society for Oriental Medicine to organize
a symposium at the academic general meeting and share evidence onrecommended items.
(3)F or proposals of the Forum: The Vision for Kampo Medicines
and Public Welfare, understand their progress in cooperation withthe relevant committees, and regularly share information with themembers 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)R eport the results of the examination of the outline of productinformation 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 withacademia, research institutes, governments, and others.

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 guidelines
1.Promotion of research on Kampo products and others
based on crude drugs and the establishment of guidelines forapplications 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)C ooperate in the establishment of guidelines for approval
applications for pharmaceuticals (changes of formulations such aschanges 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 throughopen lectures and seminars for the public(3)B uild 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 establishmentof 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 tostrengthen outreach activities for OTC Kampo products.
(2)P rovide information on the efficacy and safety of crude drug
products and encourage self-regulation through the Japan SelfMedication Industry, Promotion Code Committee and otherorganizations.
(3)I n 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)S hare 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 compliancewith the Standard for Adequate Advertisement of Pharmaceutical
Products.
VI.Strengthening the compliance system and improving
reliability
1.Fortification of compliance activities(1)C onduct a fact-finding survey of the compliance activities ofcorporate members and verify the results.
(2)Organize lectures and workshops on compliance.
(3)Encourage corporate members to establish a department or have aperson in charge of compliance.
(4)Thoroughly ensure that corporate members publish transparency
guidelines before the deadline.
(5)S hare the content of the report on the monitoring of activities
providing sales information and support corporate members toestablish 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 thePharmaceutical and Medical Device Act and ensure that it is put into
practice.
(2)B uild a collaborative system for corporate members to takeappropriate measures(3)Continuously share the latest information and implement education,
training and other activities.
(4)Comply with revisions of the regulatory systems, including thesecond 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 considerate10Roles of industrial commissions, projects,
and functional committees■Common matters

1. Matters relating to corporate ethics
2. Matters relating to cooperation with, negotiations with, and information collection from administrative bodies andrelated organizations
3. Matters relating to business plans and business reports
4. Matters relating to budget

NHI Price Committee
Code Committee

Project for Realization of Recommendations of the Forum:
The Vision for Kampo Medicines and Public Welfare

11

1. Nurturing of Kampo products for ethical use and crude drug products
2. Matters relating to adherence to fair competition rules and disclosure of Transparency Guidelines
3. Matters relating to improvement of distribution
4. Matters relating to general training of medical representatives (MRs)
5. Matters relating to usefulness of Kampo products for ethical use, such as accumulation of evidence1128
Crude Drugs Committee
ChairmanYutaka Yamamoto,
Tochimoto Tenkaido Co., Ltd.

Chairman
Daisuke Tochimoto,
Tochimoto Tenkaido Co., Ltd.

1. Matters relating to quality of crude drugs
2. Matters relating to distribution of crude drugs, such as survey on actual distribution of crude drugs for Kampo
preparations
3. Matters relating to cultivation of crude drugs inside and outside Japan
4. Matters relating to revision of Japanese Pharmacopoeia and non-JP crude drug standards in connection with crude
drugs
5. Matters relating to safety of crude drugs in China, such as survey on use of pesticides
6. Matters relating to CITES

34
Chairman
Tetsuya Kusayanagi,
Kracie Pharmaceutical, Ltd.

Ryuuji Takahashi,

1. Matters relating to provision of information on OTC Kampo products to consumers
2. Matters relating to standards for approving OCT Kampo product formulations
3. Matters relating to training activities for OTC Kampo products
4. Matters relating to promotion of proper use of OTC Kampo products
5. Matters relating to cooperation on information provision and survey/research on usefulness of OTC Kampo products

24
Chairman
Kazumasa Kobayashi,
Kobayashi Pharmaceutical Co., Ltd.

Crude Drug Products Committee
Chairman
Atsunori Wada,
Kobayashi Pharmaceutical Co., Ltd.

1. Matters relating to promotion of development and quality assurance of crude drug products
2. Matters relating to information provision and promotion of proper use of crude drug products
3. Matters relating to cooperation with the groups and organizations associated with crude drug products

7

1. Matters relating to inclusion of Kampo formulations and extracts in official compendiums
2. Matters concerning the solvent for manufacturing the crude drug extract
3. Matters relating to quality of crude drug extracts
4. Matters relating to drug affairs, laws, and regulations concerning crude drug extracts

12

Future Vision Project for Kampo Medicines and Public Welfare
Project Leader
Kenji Ajioka,
Tsumura & Co.

1. Matters relating to cross-cutting)/sustainable development of industrial commissions and functional committees inconnection with Kampo products, crude drug products, and crude drugs
2. Matters relating to realization of recommendations by Forum: The Vision for Kampo Medicine and Public Welfare

ChairmanSatoshi Nagano,
Tsumura & Co.

1. Matters relating to business policies, business plans, and business reports
2. Matters relating to management of budget, account settlement and others
3. Matters relating to efficient operation of JKMA activities
4. Matters relating to promotion of admission of new members
5. Matters relating to compliance
6. Matters relating to lecture meetings
7. Matters relating to production of Kampo products and others based on crude drugs
8. Matters relating to environmental practice
9. Cooperation with the related organizations

Chairman
Makoto Kitamura,
Tsumura & Co.

1. Matters relating to PR for JKMA activities
2. Matters relating to educational activities concerning Kampo products and crude drugs
3. Matters relating to handling of inquires and interviews by news organizations and the like
4. Matters relating to handling of inquires by general consumers, medical professionals and governments
5. Matters relating to maintenance and administration of websites

Chairman
Hirokazu Koyanagi,
Tsumura & Co.

1. Matters relating to international exchange concerning Kampo products and crude drugs
2. Matters relating to discussion on responses to changes in international situations and sharing of discussion results inconnection with Kampo products and crude drugs
3. Matters relating to cooperation in the organizations associated with international issues concerning Kampo products
and crude drugs

1. Matters relating to pharmaceutical affairs systems
2. Matters relating to surveys and research on the laws, regulations, and notifications associated with Kampo products
and crude drug products
13Chairman
Yasuhiro Takasugi,
Tsumura & Co.

1. Matters relating to quality of pharmaceutical products and raw materials
2. Matters relating to listing on Japanese Pharmacopoeia and non-JP crude drug standards
3. Matters relating to impurities
4. Matters relating to GQP/GMP for pharmaceutical products
5. Matters relating to quality in international harmonization (PIC/S, FHH, ICH, and others)

Masanori Katori,
Tsumura & Co.
1. Prompt and thorough execution of safety measures such as revisions of the precautions standardized within JKMA
2. Securing of safety and promotion of proper use of Kampo products and crude drug products
3. Sharing and discussion of a variety of safety information (general situations and academic information)
4. Mutual training among members (lecture meetings and study meetings)
5. Cooperation and submission of opinions with administrative bodies and other organizations in the pharmaceuticalindustry
6. Responses to notifications on new points on statements in package inserts for ethical drugs
7. Appropriate responses to messages concerning reevaluation results of Kampo products for ethical use
8. Discussion on responses to consultation and complaints concerning Kampo products and others based on crude drugs

Code Committee

Code Review Board consists of 5 member companies participating in the Ethical Kampo Products Commission and

1. Matters relating to codes(1) Familiarization with Code of Practice(2) Promotion of improvement in promotional activities under guidelines for sales information provision
2. Matters relating to examination of outline of product information and others(1) Examination of outline of product information and others and preparation of the board of review report(2) Thoroughly disseminate the points to be noted when creating product information outlines and Revision andthorough dissemination of information to member companies(3) Reporting of opinions to and exchange of opinions with administrative bodies, etc.
3. Matters relating to Standard for Adequate Advertisement of Pharmaceutical Products

NHI Price Committee

Makoto Sakaue,
Tsumura & Co.
1. Matters relating to survey/research, proposals, and countermeasures in connection with medical insurance systems
and drug price standard systems
2. Matters relating to cooperation with FPMAJ medical insurance and drug price research council and informationcollection
3. Matters relating to holding of lecture meetings, study meetings, and others
14

Alinamin Pharmaceutical Co., Ltd.

1-8-2 Marunouchi, Chiyoda-ku, Tokyo 100-0005

Fukudaryu Co., Ltd.

1-51-11, Nishitemma, Kita-ku, Osaka 530-0047

Honzo Pharmaceutical Co., Ltd.

Kenso-Seiyaku Co., Ltd.

9-17, Nihonbasi-kobunecho, Chuo-ku, Tokyo 103-0024

KOHKAN Pharmaceutical Institute Co., Ltd.

2-1-3, Higashikanda, Chiyoda-ku, Tokyo 101-0031

Nitto Pharmaceutical Industries, Ltd.

35-3 Minamibiraki, Kamiueno-cho, Muko, Kyoto 617-0006

Ohki Pharmaceutical Co., Ltd.

3-3 Kandakaji-cho, Chiyoda-ku, Tokyo 101-0045

15

1-5-12 Meishin-cho, Amagasaki-city, Hyogo 661-0021

5-4-11 Higashiueno, Taito-ku, Tokyo 110-0015

Tokiwa Phytochemical Co., Ltd.

5-11-10 Higashi-Nippori, Arakawa-ku, Tokyo 116-0014

16

15 Industrial Organizations

16 Regional Organizations

Japan Pharmaceutical
Manufacturers Association (JPMA)

Pharmaceutical Manufacturers’
Association of TokyoJapan Generic Pharmaceutical Association

Kansai PharmaceuticalIndustries Association
Aichi Pharmaceutical
Manufacturers Association

Toyama Pharmaceutical Association

Japan Direct-Selling Pharmaceutical
Manufacturers Association (JDSPA)-Japan Ophthalmic Pharmaceutical
Manufacturers Association (JOPMA)

Nara Pharmaceutical
Manufacturers Association
Shiga Pharmaceutical
Manufacturers Association
Nagano Pharmaceutical
Manufacturers Association
Japan Blood Products Association

Gifu Pharmaceutical
Manufacturers Association

Japan Household Medicine Association

Saitama Pharmaceutical
Manufacturers Association

Japan Association of Clinical ReagentsIndustries (JACRI)
PharmaceuticalContract Manufacturers Association

Ishikawa Pharmaceutical
Manufacturers Association

Forum for Innovative Regenerative
Medicine (FIRM)

Niigata Pharmaceutical
Manufacturers Association

17

18

https://www.nikkankyo.org/

cover photo
Yushima Nakazaka-shita intersection

Japan Kampo Medicine
Manufacturers Association（4F, Oceans Five）

Yushima Station
on Tokyo Metro Chiyoda Line

Exit 5

Mikumizaka-ue
intersection

Chuo-dori Street

Mikumi-zaka-shita
intersection

Ochanomizu Campus,
Nihon Pharmaceutical
University
GS ●
●

●

National household
appliances Hall

Rensei Park●●

Tohto Bunkyo Hospital
Dora-gu Papasu●

Kuramaebashi-dori Street
Shimizuzaka-shita
intersection●

Convenience
store

Tsumakoi-zaka
intersection

Suehirocho Station
on Tokyo Metro Ginza Line

Exit 4
Soto-kanda Go-chomeintersection

The nearest stations
Four-minute walk from Exit 5 of Yushima Station on Tokyo
Metro Chiyoda LineFive-minute walk from Exit 4 (Exit 2) of Suehirocho Station
on Tokyo Metro Ginza LineCreated by Tomitaro Makino／Plant name: Waterwheel plant
Botanical illustrations: Kochi／Prefectural Makino Botanical Garden

4F Oceans Five, 3-7-7 Yushima, Bunkyo-ku,
Tokyo 113-0034
Telephone: 03-6284-2524 ; Fax: 03-6284-2534
Planned and edited by: JKMA PR Committee;
Prepared in September 2024