Business Policy and Business Plan for FY 2026

Japan Pharmaceutical Manufacturers Association

Introduction

Prime Minister Sanae Takaichi declared in her policy speech at the 219th session of the Diet in October 2025, "We will aim to realize strong growth of the Japanese economy through the flowering of advanced technologies that will contribute to solving our nation's problems." He declared, "We will aim to realize strong growth of the Japanese economy through the flowering of advanced technologies that contribute to solving our nation's problems.

In addition, "drug discovery" was selected as a strategic field for "crisis management investment" in response to risks and social issues such as health and medical security, and "growth investment" in industries that will become a new technology-driven nation and a winning force. In addition, in the "Outline of Tax Reform for FY2026," the "Strategic Technology Area" was positioned as one of the bearers of a "strong economy" and "Japan that shines globally.

As Japan's economy faces supply constraints in the midst of a declining population, the role of the pharmaceutical industry, which contributes to economic growth by improving labor productivity through the improvement and extension of health and life expectancy, as well as being high value-added, knowledge-intensive, and internationally competitive, is becoming increasingly important as a driver for Japan to shine in the world and contribute to the nation's success. In particular, R&D based in Japan and conducted internationally contributes to GDP and tax revenues through the intellectual property obtained, and also plays a spillover effect to support "Japan as a Nation of Science and Technology" by stimulating academic research in the life science field in Japan, including basic research. In addition, as stated in former Prime Minister Shigeru Ishiba's speech at the "Public-Private Consultative Meeting for Enhancing Drug Discovery Capability" held in June 2025, many of the pharmaceutical manufacturing bases are located in regional areas, playing an important role from the perspective of regional development.

On the other hand, the promotion of the pharmaceutical industry, which has high potential as a health care security and growth industry, is being addressed as a national strategy in many countries in the U.S., China, and Europe, and the industry is in a state of international competition. In this context, the U.S., in particular, is strongly inducing investment in the U.S. through its tariff policy and MFN (most-favored-nation drug pricing) policy under the U.S. first principle.

In this regard, in contrast to the semiconductor industry, etc., where more than 10 trillion yen in public support has been secured by 2030, the pharmaceutical industry has been subject to devaluation of official drug prices, etc., for nine consecutive years, while "making Japan the land of drug discovery" is being touted. Unlike other manufacturing industries, the pharmaceutical industry, which depends on profits from new products, cannot sustain its business model unless it continues to develop useful new products. Against this backdrop, the NHI drug price system makes it difficult to create new drugs in Japan, as it does not necessarily cover the costs of supporting future R&D, although some allowances are made for raw material and labor costs directly related to manufacturing in response to inflationary trends.

Now is the time for Japan's pharmaceutical industry to maintain and strengthen its revenue base to withstand the burden and risk of new drug development in an inflationary economy, based on a strong national strategy that is globally competitive, and to contribute to the security and promotion of health capital and a "strong economy" in Japan and the world. In this context, pharmaceutical organizations themselves, which represent the industry and are responsible for policy advocacy, dialogue with society, and public-private partnerships, are also facing unprecedented changes in the environment and intensifying international competition. In order to accurately respond to increasingly diverse and sophisticated policy issues and stakeholder expectations, and to draw out the full potential of the industry, it is essential for JPMA to ceaselessly strengthen its foundations, including its planning, communication, coordination, and implementation capabilities.

The "JPMA's Vision for 2035" (hereinafter referred to as "Vision"), which was announced in February 2025, is a set of goals set forth by the Takaichi Cabinet. The "Pharmaceutical Industry Vision 2035 (the "Vision")," released in February 2025, anticipates the goals of the Takaichi Cabinet and clearly states that it aims to "improve the health and wellbeing of patients and the public" as well as "health security" and "growth of the Japanese economy.

In its business policy for FY2026, based on Co-creation, which is based on trust with patients, citizens, and society, the company will work together to create the future, powered by change and challenge, and to realize its vision with continuity and consistency.

Priority issues

Basic Concept of Priority Issues

Under the national strategy of health and medical security, fostering growth industries, and becoming a nation of new technologies, the pharmaceutical industry is facing intensifying international competition at every stage of drug discovery, production, and market.
In particular, the drug discovery ecosystem and the ability to create innovations that support the creation of innovative drugs are the foundation for both ensuring competitiveness as a growth industry and ensuring health and medical security, and are core elements that will determine the future of Japan.

In addition, changes in the international environment, such as industry protection policies mainly in the U.S. and trends in drug pricing and trade policies including MFN, have a direct impact on investment decisions in Japan's pharmaceutical industry.
In light of these circumstances, JPMA has identified the following three priorities for fiscal 2026, which are consistent with the national strategy, and will focus its resources on them.

Pillar (1) Ensuring competitiveness as a growth industry - Implementation of an investment environment that will sustainably generate innovation from Japan

Priority Initiatives

-Strengthening Japan's unique drug discovery ecosystem and innovation creation capabilities

-Improvement of the institutional environment to promote R&D investment

-Improvement of the competitive environment with an eye on the global market

Pillar (2) Strengthening Health and Medical Security - Establishment of domestic infrastructure to support drug discovery, production and supply

Priority Initiatives

-Attract production functions mainly for biopharmaceuticals

-Establish a domestic infrastructure for drug discovery, production, and stable supply in times of peace, and build a system that can function in times of emergency.

Pillar (3) Strengthening JPMA's infrastructure to respond flexibly to changes in the global environment - Establishing the ability to respond quickly to protect and utilize innovation

Priority Initiatives

-Strengthening of the ability to respond flexibly to changes in the global environment and policies

-Drastic reinforcement of the foundation of the organization through transition to a general incorporated association

Policies to be implemented in line with the vision

As in 2025, the business policy and business plan for 2026 are also designed to achieve the vision, etc. Therefore, in principle, duplication of descriptions of continuing efforts should be avoided, and efforts related to "2. Priorities" should be listed by ◎ as follows.

(1) Innovation Initiatives

Discovery of knowledge from academia and other sources in Japan

◎ In 2025, the Nobel Prize in Physiology or Medicine was awarded to Specially Appointed Professor Shifumi Sakaguchi of Osaka University, demonstrating to the world Japan's potential in the field of life sciences. In order to link such potential of basic research in academia to the creation of innovative new drugs, we concluded a collaboration and cooperation agreement (AND-E) with AMED in October 2025 In FY2026, we will identify new research ideas that will contribute to practical applications from among the research projects supported by AMED. In FY2026, we will identify new research ideas that will contribute to practical applications from among research proposals supported by AMED.

◎ In order to overcome the "magic river" that is pointed out to exist between basic research and start-up budding research in academia and drug discovery research, it is necessary to develop a common understanding with academia and others on the "scientific and practical requirements for drug candidate substances targeted by companies" (TPP: Target Product Profile). It is necessary to deepen mutual understanding between industry and academia based on the materials released in September 2025, and to bridge the gap to patients.

Promote optimization of development, etc. by utilizing DX, etc.

In pharmaceutical development, efforts should be made to promote utilization of advanced technologies such as next-generation synchrotron radiation, high-performance computer systems, quantum computers, etc. in industry, academia, and government.

Based on the revision of the Medical Service Act, etc., and in line with the international trend toward the utilization of medical information, such as the European Health and Medical Data Space Act (EHDS Act) that came into effect in FY2025, we will work together to improve the environment so that medical information can be used for drug discovery, etc. in Japan. In order to promote the development of innovative new drugs for cancer and intractable diseases, we will also promote and collaborate on whole genome analysis, for which a project implementation organization will be established in FY2025, so that it can be utilized more in drug discovery.

In addition to optimizing non-clinical evaluation using DX technology, etc., the industry, academia, and government will work together to improve the environment for conducting clinical trials based on the "Clinical Trial Ecosystem Industry Declaration 2025" announced in October 2025.

Improvement of drug discovery environment and securing of human resources

With regard to the drug discovery ecosystem, JPMA will work on its realization after incorporating it into concrete measures, based on the study of the ideal state of the ecosystem.

In order to strengthen the manufacturing base, the government and private sector will collaborate to study the enhancement of facilities for innovative pharmaceuticals (biotechnology) and the application of new manufacturing technologies, such as automation.

The JPMA will closely monitor the government's project to support the development of the drug discovery ecosystem, with a view to reviewing the project three years after its implementation, to see whether it is appropriately fulfilling its original objectives and the image of its results.

◎ With the declining birthrate, there is an urgent need to secure and develop human resources with expertise in drug discovery. In addition to efforts such as fostering human resources for bio-manufacturing, in FY2025, the Center will continue to actively strengthen its efforts to secure human resources for drug discovery in general, including efforts to incorporate drug discovery into the curriculum of pharmaceutical education and the development of videos such as job placement information.

Promote PPI/E (Patient and Public Involvement) and Co-creation

In FY2025, we are organizing the efforts of each company and developing plans to encourage the participation of patient groups, based on the joint message of the "Pharmaceutical Visionary Council 2025" to further promote the participation of patients and citizens not only in clinical trials, but also in all stages from non-clinical to post-marketing. 2026 In FY2026, we will continue to conduct educational activities for member companies and patient groups to further accelerate our commitment to co-creation.

In FY2025, we will further accelerate our commitment to co-creation by continuing to conduct educational activities for member companies and patient groups, etc, In FY2026, we will continue to steadily take necessary measures while further deepening cooperation among industry, academia, government, and patients in order to achieve concrete results from these efforts.

Responding to global expansion and international pharmaceutical regulations

In order to ensure that innovative new drugs created in Japan reach Asia and the world and contribute to global health, we will strengthen our advocacy function as well as our intelligence function, and address regulatory and market access issues.

In 2026, the JPMA's approach will be appropriately reflected in the International Affairs Committee, including the development of guidelines for the use of real-world data for efficacy evaluation. In FY2026, we will continue to promote activities to establish international harmonization guidelines that appropriately reflect the Pharmaceutical Manufacturers Association of Japan (PMAJ)'s thinking, such as guidelines on the use of real-world data for efficacy evaluation.

z With regard to international profit sharing regarding genetic resources, etc., we will take appropriate measures so as not to impede R&D activities that contribute to patients and medical care through the utilization of genetic resources and digital sequence information, in preparation for the Conference of the Parties to the Convention on Biological Diversity to be held this year.

Responding to domestic pharmaceutical affairs-related policies

◎ In accordance with the "Aim" of the "Study Group on the Drug Regulation System for Strengthening Drug Discovery Capability and Securing Stable Supply," which was compiled in 2024, the next revision of the Pharmaceutical Affairs Law will be considered so that innovative drugs can be delivered to patients more quickly and efficiently, with the safety of drugs in Japan as the first priority, Discuss and make proposals, etc. on matters where further internationalization is desirable (GMP investigation system, etc.) as well as improvement of pharmaceutical affairs examination concerning manufacturing methods of pharmaceutical products (revision of the so-called "February 10 Notice").

Respond to the taxation system, intellectual property system, etc.

With regard to the R&D taxation system, which is the lifeline of the pharmaceutical industry, we will maintain that overseas contract research expenses are covered so that Japan-based pharmaceutical R&D can be possible, and at the same time, we will hold discussions, etc. to contribute to a "strong Japan" and a "Japan that shines in the world".

The need for a pharmaceutical data protection system, which has been a long-standing concern, was recognized in the "Intellectual Property Strategic Headquarters Decision in August 2025" (Intellectual Property Strategic Headquarters Decision in August 2025), and the industry will incorporate this into specific measures and make the necessary lobbying efforts.

(2) Access Initiatives

Ensure access to innovative medicines for citizens in the social security system

As mentioned above, under the current inflationary environment, member companies are working hard to provide innovative new drugs that patients are demanding, even as the current drug price system increases the burden and risk of necessary research and development costs, etc. With the National Council on Social Security Benefits and Burdens also being convened, we will continue our multifaceted advocacy activities by proposing reform of the NHI drug price system, etc., so that an attractive Japanese market can be built where the value of innovation is valued and patients in Japan can have uninterrupted access to innovative new drugs.

◎ We will also take necessary actions to ensure that appropriate evaluation of innovations is made with regard to discussions at the Chuikyo and other bodies, including verification of the cost-effectiveness system.

◎ The MFN (Most Favored Nation drug pricing policy) in the U.S. may also have a negative impact on the development and launch of new drugs in Japan, and may lead to new drug lag/drug loss. In light of this, we will compile a policy on how to respond to this issue and make necessary efforts, including making specific proposals.

Ensuring access from the perspective of health and medical security

From the perspective of health and medical security, it is necessary to take into account infectious disease contingency risks and geopolitical risks in the international supply chain with regard to access to medicines.

◎ With regard to infectious disease contingencies, public and private sectors will work together to strengthen research, development, and production systems for vaccines, therapeutic drugs, diagnostics, etc., based on discussions at the Council on Infectious Diseases of the Health and Medical Care Strategy Headquarters, etc., so that those eligible for drug administration can use necessary drugs. With regard to geopolitical risks, we will closely monitor trends in the U.S. and China, including the U.S. Biosecure Act, and will proactively address these risks based on discussions at the Japan Growth Strategy Council.

With regard to international access to pharmaceuticals, the United States is reviewing the elimination of tariffs on pharmaceuticals in the Uruguay Round from the perspective of national security, and we will continue to take measures such as domestic and international advocacy. In addition, as geopolitical risks increase, the significance of securing access to innovative new drugs in the Asian region is growing, and we will work with the PMDA Asia Office and others to deepen regional cooperation and solidarity.

(3) Trust Initiatives

Trust on social and environmental issues

In FY2025, we will continue to strengthen our efforts to secure the trust of the international community for Japan's pharmaceutical industry.

We will continue to strengthen our efforts to secure trust from the international community for Japan's pharmaceutical industry. z With regard to efforts to achieve carbon neutrality, we have been selected for a project by the Ministry of the Environment in FY2025, and we will continue to work with our member companies and related parties to promote decarbonization throughout the value chain, including medical institutions, in order to proactively address threats to human health, ensure sustainability of our business, and ensure that our business will be sustainable. By promoting decarbonization along the entire value chain, including medical institutions, we will proactively respond to threats to human health, ensure business sustainability, and enhance our presence as the industry of choice for future generations.

Trust on high corporate ethics

z Regarding the enhancement of corporate ethics, we will continue to adhere to a code of conduct based on accurate and high ethical standards for medical professionals and others, in accordance with the JPMA Charter of Corporate Behavior, the JPMA Compliance Program Guidelines, the Consensus Framework for Ethical Collaboration in Japan, and other guidelines.

Trust as an industry that promotes the proper use of pharmaceuticals

z With regard to the appropriate provision of information on pharmaceutical products, in October 2025, the JPMA Code of Practice revision will be enforced, and an environment will be created to provide accurate information to medical professionals in accordance with the Guidelines for Activities to Provide Sales Information.

We have been working for many years on pamphlet distribution, polypharmacy, drug resistance (AMR), and the elimination of drug residuals, and will continue to take possible measures this year as well.

z Based on the "Guidelines for Response to Pharmaceutical Consultations," which were fully revised in October 2025, we will substantially revise the consultations of each member company and improve the response capabilities of medical communicators of each company through the use of digital technology, with a view to using AI, to secure the trust of the medical community and others. z We will continue to make efforts to improve the response capabilities of medical communicators of each company through the use of digital technology, with a view to using AI.

Trust on stable production and supply of high quality pharmaceuticals

◎ In pharmaceutical manufacturing, which requires a high level of quality control, etc., the Task Force (TF) launched in 2025 will further promote digital transformation in commercial production to meet expectations for ensuring quality and maintaining a stable supply of pharmaceuticals.

◎ With regard to pharmaceutical distribution, we will ensure the sustainability of pharmaceutical distribution in the future and secure trust through transactions based on the value of pharmaceuticals and stable supply to patients, amidst stable supply issues, labor shortages in the transportation industry, and a shrinking gap between drug prices and delivery prices.

Fostering trust, including among the younger generation, regarding the value of new drugs and the value of the drug discovery industry

z Regarding the value of new drugs, in addition to initiatives such as media forums, etc., we will consider and implement measures that are easy to understand and appealing, such as devising methods to explain the value of new drugs.

In FY2025, we are strengthening our efforts to communicate to children and young people through hands-on events at the Science Museum targeting the younger generation, and by soliciting catchphrases for junior high and high school students under the theme of "catchphrases that express that the pharmaceutical industry is an innovative industry". In FY2026, we will continue to appeal to the younger generation.

Initiatives to strengthen the foundation of JPMA

◎ In FY2025, in order to strengthen the JPMA's foundation, the JPMA has been studying the transition to a general incorporated association, etc., including the Board of Directors and Assembly, in accordance with the implementation plan, and based on this, the JPMA shall establish a general incorporated association and take over its operations during FY2026.

In order to realize the vision and policy proposals formulated in February 2025, the JPMA's Policy Proposals for 2025, a project to strengthen JPMA was launched in July of the same year based on the committee's questionnaire. The project is working on (1) fostering a common understanding to realize the vision, (2) materializing the action plan to achieve the vision into projects (incorporating into implementation plans)/checking the progress of JPMA's Policy Proposals for 2025 (process management and updates), and (3) strengthening JPMA's functions (strengthening the executive system/integrity), which, combined with the transition to a general incorporated association, will strengthen JPMA's foundation. (2) Strengthen the foundation of the Pharmaceutical Manufacturers Association of Japan (PMAJ) through the transition to a general incorporated association.

Business Plan

In addition to constant efforts to ensure the transparency and fairness of corporate activities, the JCIA will make proposals to the government in a timely and appropriate manner in accordance with the timing of deliberations and decisions by the government on bills, the budget, the Framework Policy, the Japan Growth Strategy, the NHI drug price standards, and other related matters.

In particular, we will respond to the Japan Growth Strategy Council established in the Cabinet Secretariat, the revision of the Industrial Technology Development Law regarding R&D taxation, the Framework Policy, and discussions on the revision of medical fees, including the verification of the cost-effectiveness system, etc.

From the viewpoint of ensuring mobility and flexibility in light of various rapidly changing domestic and international circumstances, as mentioned above, specific business plans shall be left to the implementation plans of each committee and The Office of Pharmaceutical Industry Researchas in the past. As necessary, the Chairperson of each committee shall report on the committee activities to the Executive Committee and other committees, and based on their opinions, necessary changes, etc. shall be made to the implementation plans of each committee.

In FY2026, the JPMA is scheduled to review its committees in accordance with the transition to a general incorporated association and the project to strengthen the JPMA, etc. When the JPMA transfers its operations to a general incorporated association, this business policy, business plan, and implementation plans of each committee, etc. based on this policy and plan shall be transferred to the committee, etc. that is to take over such operations, together with its budget. ni、Shall be passed on with the budget。

In order to realize the objectives and vision of the association, all the committees are expected to exercise their expertise from their respective standpoints and pursue them in a systematic manner.

(1) Innovation Initiatives

(2) Access Initiatives

(3) Trust Initiatives

TOP