International Committee

Priority Issues

  1. International Expansion: Improvement of the market environment in Asia, Europe and the U.S. through public-private sector collaboration and support for activities of member companies
  2. International Cooperation: Activities to solve bilateral/multilateral issues in cooperation with governments and pharmaceutical organizations in developed countries in Europe and the U.S. as well as in Asia including Japan
  3. Contribution to global health: Activities to resolve global health issues in collaboration with IFPMA, the Japanese government and other stakeholders

The main tasks of each subcommittee based on the above basic policy are as follows

[A] Asia Subcommittee

  1. Promotion of Universal Health Coverage (UHC)
  2. Promoting international harmonization of pharmaceutical regulations and improving the efficiency, transparency, and predictability of regulatory review, and improving the clinical trial environment in Asia
  3. Ensure rapid and sustainable access to innovative medicines
  4. Identify and share policy and regulatory trends related to pharmaceutical affairs, reimbursement, intellectual property, etc. with members
  5. Strengthen collaboration with the Japanese government, diplomatic missions abroad, international organizations, research institutions, and local Japanese and R&D-based pharmaceutical organizations

[B] Europe and America Subcommittee

  1. Identification of issues to improve the business environment in the US and European markets, and lobbying of relevant ministries, agencies, and diplomatic missions overseas to resolve these issues, as well as collaboration with key industry associations in the US and Europe
  2. Contribute to the promotion of activities within the Pharmaceutical Manufacturers Association of Japan (PMAJ) through a hub role, including strengthening cooperation with other committees and subcommittees that are relevant stakeholders in major countries in Europe and the U.S.

[C] Global Health Subcommittee

  1. Strengthen collaboration with IFPMA in addressing the global health agenda and multilateral advocacy for stakeholder groups
  2. Contribution to improving access to medicines in low- and middle-income countries
  3. Strengthening efforts to combat infectious diseases

Initiatives

[A] Asia Subcommittee

The following priority countries and regions will be targeted for issue resolution.

  • China, Korea, Taiwan, ASEAN (Thailand, Indonesia, Malaysia, Vietnam, Singapore, Philippines), India

1) Promotion of Universal Health Coverage (UHC)

  1. Contribute to the realization of UHC in each country/region through the activities of the aUHC (Asian UHC) Working Group of the APAC Project of the Pharmaceutical Association of Japan.

2) Promote international harmonization of pharmaceutical regulations, improve efficiency, transparency, and predictability of regulatory review, and improve the clinical trial environment in Asia.

  1. Promote solutions to regulatory issues in each country by strengthening cooperation with MHLW and PMDA through bilateral meetings and symposiums, etc., and strengthen advocacy through support to the Asian Training Center (ATC), PMDA Asia Office, etc.
  2. Collect the latest information on the bilateral regulatory framework (Reliance), including reference country systems, and disseminate it to member companies and promote its utilization.
  3. Identify issues that hinder smooth implementation of clinical trials and regulatory harmonization in Asia, and seek solutions through collaboration with the MHLW, PMDA, and research institutions.

3) Ensure rapid and sustainable access to innovative drugs

  1. Identify trends in related systems such as insurance, drug pricing, and medical technology assessment through collaboration with pharmaceutical organizations in each country and region.
  2. Develop advocacy plans to ensure appropriate evaluation, speed, transparency, and predictability of innovative drugs.
  3. Study and promote issues and solutions in each country/region through bilateral meetings (symposiums) led by industry associations, etc.

4) Identify and share policy and regulatory trends related to pharmaceutical affairs, insurance reimbursement, intellectual property, etc. with members

  1. Share policy and regulatory trends and best practices in priority countries/regions with stakeholders inside and outside the committee.
  2. Comprehensively understand information related to pharmaceutical affairs, insurance, drug pricing, intellectual property, etc. in each country/region through participation in the APAC Project and the PMRE Task Force of the Pharmaceutical Manufacturers Association of Japan.

5) Strengthen collaboration with the Japanese government, diplomatic missions abroad, international organizations, research institutions, and local Japanese and R&D-based pharmaceutical organizations

  1. Strengthen collaboration with embassies and other diplomatic missions in each country/region, Japan External Trade Organization (JETRO), WHO and other international organizations, and domestic and foreign research institutions, including ATLAS and other projects to establish an international clinical trial network in Asia.
  2. Strengthen collaboration with Japanese pharmaceutical organizations, APAC project member pharmaceutical organizations, and global pharmaceutical organizations such as the Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), IFPMA, etc., depending on the policy theme.

[B] Europe and America Subcommittee

(1) Work to improve the business environment in the U.S. and European markets, and collaborate with pharmaceutical associations and governments in Europe, the U.S., and other countries.

  1. Identify key issues and consider solutions: hold regular meetings with PhRMA, EFPIA, ABPI, vfa, leem, etc.; interact with JETRO New York secondees; and work with the Japanese government and the Embassy of Japan in Tokyo. Exchange information with the Japanese government and embassies in Japan to identify policy, trade, regulatory, pricing, and reimbursement issues in major Western countries and consider solutions.
  2. Collaboration with domestic and foreign stakeholders for advocacy activities: To improve issues in Europe and the U.S., the committee will promote advocacy activities to the governments of Europe and the U.S., the Japanese government and related ministries and agencies, etc., in cooperation with organizations in Europe and the U.S., as necessary.
  3. Grasping the latest information in Europe and the U.S.: To grasp the latest information in Europe and the U.S. (government policies and major medical policies on healthcare, pharmaceutical regulations of FDA and EMA, drug pricing and reimbursement systems in Europe and the U.S., collaboration with patient groups, etc.), we will actively plan and implement regular information exchange meetings with external speakers and related organizations, and share this information with our member companies. and share this information with member companies.
  4. The activities and deliverables of the European and US subcommittees will be shared with relevant committees within the Pharmaceutical Manufacturers Association of Japan (PMAJ), and the possibility of utilizing them as a reference for policy recommendations to the Japanese government will be considered.
  5. Support for efforts in the U.S. and Europe to strengthen drug discovery capabilities, with a focus on the U.S.: The industry group will identify the business development, policies and issues of the member companies in the U.S. and Europe, and consider and promote solutions to these issues and support for their efforts.

2) Collaboration within the Pharmaceutical Manufacturers Association (in a hub role)

  1. Utilizing the HUB role between industry associations, embassies, JETRO, PMDA Washington D.C. office, etc. in major European and U.S. countries and other committees of the Pharmaceutical Manufacturers Association of Japan (PMMA), work together to address issues related to Japan and abroad, and consider the possibility of utilizing information from Europe and the United States as a reference for policy proposals to the Japanese government.

[C] Global Health Subcommittee

1) Strengthen collaboration with IFPMA in addressing the global health agenda and multilateral advocacy with stakeholders

  1. Participate in the activities and discussions of IFPMA's relevant committees to strengthen the Pharmaceutical Manufacturers Association's ability to disseminate information. (Collaboration with Industrial Policy Committee, Intellectual Property Committee, Vaccine Practitioners Committee, etc.)
  2. In response to global issues such as the Pandemic Convention, Convention on Biological Diversity, and the TRIPS Waiver, the Pharmaceutical Association of Japan (PAPJ) will participate in various international conferences (World Health Assembly (WHA), G7/20, United Nations General Assembly (UNGA), etc.) with the aim of maintaining the pharmaceutical industry business model based on intellectual property, promoting innovation and improving access to medicines and vaccines at the same time. The Japanese government, the Permanent Mission of Japan Abroad, and other stakeholders will be encouraged to take advantage of opportunities at various international meetings (WHA, G7/20, United Nations General Assembly (UNGA), etc.).
  3. In order to achieve the above, gather information through planning and participation in various meetings and dialogues with stakeholders, and promote evidence-based policy proposals with academia and think tanks in cooperation with IFPMA.
  4. To gain understanding and trust of the industry by communicating the global contributions of Japan's R&D-based pharmaceutical industry based on evidence.

2) Contribution to improving access to medicines in low- and middle-income countries

  1. Follow up on the capacity building project for pharmacists in Vietnam implemented in FY2024, and summarize and disseminate the results of the activities. Consider plans for the following fiscal year and beyond.

3) Strengthening efforts to combat infectious diseases

  1. Collaborate with international organizations and associations to build an ecosystem from drug discovery promotion to access to infectious diseases, which is an important issue for global health, and contribute to the solution of the issue.
  2. Contribute to appropriate pandemic preparedness and response by raising awareness of the threat of infectious diseases, including drug resistance (AMR), and the need for countermeasures, and by understanding the status of domestic and international efforts to secure infectious disease crisis response medicines (Medical Countermeasures, MCM), and participating in discussions. In collaboration with the Industrial Policy Committee, promote industry-academia-government collaboration to realize ideal domestic push and pull incentive systems that contribute to the promotion of AMR drug research and development.
  3. Promote collaboration with the Japan Agency for Medical Research and Development (AMED) to build a community to promote efforts in drug discovery for infectious diseases, including AMR, in industry, academia, and government, and at the same time, conduct activities that will contribute to the development of young researchers.
  4. Continue public awareness activities on the proper use of antimicrobial agents in collaboration with the Industrial Policy Committee's activities to promote proper use of antimicrobial agents, and disseminate information on these activities through the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
  5. While working together with domestic and international stakeholders and contributing to the development and delivery of drugs for the three major infectious diseases and neglected tropical diseases (NTDs), we will also aim to build a highly sustainable supply system for the pharmaceutical sector and promote disease awareness and understanding over the long term.

Related Information

Share this page

TOP

Site Search