Quality & Technology Committee

Basic Policy

In FY2026, the GMP Subcommittee, Formulation Research Subcommittee, and ICH Quality Group will continue their activities. In its activities, the GMP Subcommittee will provide and disseminate useful information and solutions to various issues to member companies and other organizations, including the authorities, while maintaining close cooperation within and outside the Quality & Technology Committee, including related committees and projects within various organizations and the JPMA.
The committee will continue to respond to the Pharmaceutical Affairs Law and the revised GMP Ministerial Ordinance, which were revised in the last fiscal year, by addressing issues and other matters. In addition, we will support the achievement of a stable supply of pharmaceuticals, which is attracting attention from society, from a quality perspective. With regard to ensuring pharmaceutical quality, we will consider measures to further foster and disseminate a quality culture based on a high level of compliance awareness, and we will also consider the application of new technologies such as machine learning and AI, with a focus on DX with a view to developing innovative technologies.

Initiatives for Priority Issues

Specific efforts in FY2026 to address each issue are as follows.

1. GMP Subcommittee

(1) New project initiatives

In response to the recent changes in the environment surrounding GMP, we will plan and manage activities to address quality assurance of new pharmaceutical products based on innovation, as well as further progress in the field of ICH quality and the restoration of trust in quality.

(2) Support for Asian collaboration such as the Asian Pharmaceutical Associations Cooperation Conference (APAC)

As part of the activities to respond to Asian collaboration, in addition to further fostering inspection skills (human resource development) of inspectors in Asia and other countries, we will also develop quality assurance activities in the areas of Manufacturing, Quality Control and Supply in APAC in order to provide new drugs to Asian countries as quickly as possible. In addition, in order to provide new drugs to Asian countries more quickly, we will lead Asian countries in APAC in quality issues in the areas of manufacturing, quality control and supply, and strengthen cooperation with related countries.

3) Understanding regulatory trends related to GMP overseas and communicating them to member companies through activities such as overseas Guidance Watchers and translation of GMP guidelines.

Collect and distribute information to member companies without delay, including the latest information from the U.S. FDA, EMA, WHO, China (NMPA), Korea (MFDS), Taiwan (TFDA), UK (MHRA), Swissmedic, Australia (TGA), etc., and individual information from the JPMA International Affairs Committee and each company. In cooperation with the International Affairs Committee's Asia Subcommittee, the committee also conducts surveys and public comments on GMP regulations in China, ASEAN countries, etc., and provides useful information to member companies involved in export and change management. Translate, as necessary, revised GMP/GDP documents of the EU, PIC/S, and FDA, which are undergoing significant revision, and disseminate them using GMP News and other media, as well as share the status of each company's efforts to comply with the regulations introduced in the project.

(4) Support for ICH GMP-related issues

Examine activities such as review of guidelines in the area of ICH quality and translation of training materials, and provide support for ICH Project-related activities from a quality perspective to ensure that the guidelines are established in Japan.

5）Continuous Production Project

Regarding quality issues in continuous production, collect information on approvals overseas and in Japan, information on PAT monitoring technology, etc., and compile the rationale for issues related to the introduction of continuous production, and propose the details of such issues.

6）Quality Culture Project

Many pharmaceutical companies manufacture and sell pharmaceutical products under contractual relationships with contract manufacturing organizations (hereinafter referred to as CMOs). In order to ensure a stable supply of high-quality drugs to patients, it is essential for CMOs to understand and practice the quality culture that each pharmaceutical company believes in, and to this end, it is important to build a good relationship of trust between pharmaceutical companies and CMOs. In this regard, it is important to build a good relationship of trust between pharmaceutical companies and CMOs. Based on this, we will continue to study the theme of communication and strengthening the commissioning relationship with a focus on psychological safety.

7) Commercial Production DX Promotion TF

As a measure to address stable supply issues and human resource shortage, we are working to promote implementation of DX technologies including AI and robotics in commercial production, aiming to build a robust production and quality infrastructure. In addition, we will participate in the AMED study. Furthermore, through participation in the AMED study, the committee will examine points to be considered when applying AI and standardization of materials for approval applications.

(8) Addressing issues related to the Pharmaceuticals and Medical Devices Act and making proposals in cooperation with the JFPI

To work closely with the Quality & Technology Committee of the JFRA and participate in the JFRA's projects. Participate in projects such as studies on prevention of recurrence of quality problems, response to the revised Pharmaceutical Affairs Law and GMP Ministerial Ordinance and quality-related notifications, response to nitrosamine WT, and revision of PIC/S GMP-related notifications, etc., to ensure further reliability of pharmaceutical quality and to enhance GMP as a foundation for globalization. In the current fiscal year, we will continue to submit requests and take other actions in discussions within the industry toward the next revision of the Pharmaceutical Affairs Act.

2. Formulation Research Subcommittee

(1) Project Activities

  • Project for utilization and implementation of digital tools in the field of pharmaceutical formulation

    To improve the quality and development capability of pharmaceutical products (increase efficiency and speed) by effectively utilizing and implementing digital tools. This year, based on the results of the questionnaire obtained last year, proposals for standardization of the LA/RPA implementation process will be discussed. In addition, studies will be conducted on the practical application of digital technology in technology transfer.

  • Lipid Nanoparticle (LNP) formulation development promotion project

    With the aim of accelerating the development of LNP products from Japan and strengthening competitiveness overseas, we will conduct mock quality consultations on mRNA-LNP formulations for the following case studies. This year, we will compile a research report on Case Study A/B and present it externally. In addition, we will explore opportunities to exchange opinions and share information with PMDA to promote practical application.
    Case Study A: Comparability Protocol for Passive Targeting LNP Manufacturing Process Changes
    Case Study B: Quality requirements for initiation of clinical trials for active targeting LNP formulations conjugated with Fab ligands

  • Project to study the description of Established Condition (EC)/Manufacturing Method

    Based on the domestic implementation of ICH Q12 and the current issues of manufacturing method description from the viewpoint of CMC development and manufacturing, we will review and propose how the manufacturing method description (including change categories to the description) should be from a technical viewpoint. This year, we will complete a technical white paper on EC and change category setting, including discussions with the AMED Chemicals Subcommittee. In addition, in cooperation with the Regulatory Affairs Committee, we will examine change guidance and change management issues for Japan.

  • Outsourced Problem Solving Project

    To avoid problems at the time of outsourcing of formulation manufacturing in the later stages of development, mainly from the technical perspective, and to resolve issues. Based on the examples of contractor selection and investigational new drug shipment extracted from each company's experience, finalize the deliverables (checklist, information list) based on the results of questionnaires (Japan Pharmaceutical Manufacturers Association, Japan CMO Association) this fiscal year.

  • Bioequivalence Project

    The impact of the issuance of ICH M13 on the current GLs will be examined, and the implementation of ICH M13 in Japan will contribute to reducing the burden of BE studies in new drug development as well as speeding up drug development in Japan. In the current fiscal year, the Sub-Committee will continue to discuss the revision of the current GL for the implementation of M13 in Japan, and analyze the gap between the Japanese, U.S., and European guidelines and make recommendations for M13B, which is currently under consideration, and M13C, which is scheduled to be implemented in the future.

(2) Collaboration with other organizations

  • Collaboration with the Pediatric Formulation FG of the Pharmaceutical Society of Japan

    A Pediatric Drug Formulation Study Group was established within the Subcommittee. This year, the group aims to create a document on "Classification and name of mini-tablet dosage forms" so that pharmaceutical companies and healthcare professionals can share a common understanding.

3. ICH Quality Group

1) Ongoing discussion and response to active topics

Regarding ICH Q1/Q5 (stability studies), we will continue to support the work to revise the stability study guideline to be conducted at the time of application or modification. 2026 fiscal year will see the finalization of the revised guideline after public comment.
ICH M4Q(R1) (CTD - Guidelines for the preparation of quality-related documents) Started discussions on SPQS (Structured Product Quality Submissions) with the goal of international digitization of application forms regarding
ICH Q6(R1) (Standards and Test Methods), stability testing. In parallel with the guideline revision, consultation on guidelines for specifications and test methods for new drug products will be conducted. The focus is on technical discussions such as ICH Q3E (leachables and extractables), ICH Q3C (residual solvents), and nitrosamine-related discussions, which are being discussed in parallel. We will provide support to ensure that the discussions proceed with consistent content as multiple guidelines are discussed.

2) JPMA opinions on new topics

We will support the activities of the EWG for ICH M18 (framework for determining the usefulness of efficacy comparative studies in the development of biosimilars), for which new discussions have started in 2025.
We will also actively register support staff to identify and train personnel related to JPMA's quality issues. In parallel, the EWG will also examine new topics in cooperation with those who have experience in the working loop, making proposals and evaluating them.

3) Preparation of ICH training materials

In FY2024 and FY2025, we will complete and translate into Japanese the training materials for ICH Q13 (Serial Production), Q2/Q14 (Analytical Method Development), and Q5A (Quality of Biopharmaceuticals), which reached Step 5, in order to establish and disseminate these materials in Japan. In collaboration with external organizations, provide support for risk management seminars for about six months with new and old WG members.

Other Issues and Efforts

1. GMP Subcommittee

Examine and make recommendations on technical and operational management issues (including specific application of various guidelines) in order to further ensure the reliability of pharmaceutical product quality and to enhance GMP as a basis for globalization.

  1. Holding of GMP case study meeting (September)
  2. Holding of GMP Roundtable Meeting (June)
  3. Publish GMP News (twice a year in PDF format); provide member companies with information on GMP in Japan and overseas in GMP News.
  4. Maintain the glossary of terms related to the pharmaceutical industry and GM(D)P as needed, including the addition of new terms.
  5. Continue to exchange opinions with EFPIA on administrative inspections.
  6. Strengthen cooperation with the Regulatory Affairs Committee. First, work with the Pharmaceutical Affairs Subcommittee to address issues related to category conformity surveys and standard confirmation letters.

2. Formulation Research Subcommittee

Participate in various research groups, external projects, etc., to make recommendations as an industry, and develop activities to ensure that these recommendations are appropriately reflected in guidelines, etc. In addition, through project activities, etc., the committee will engage in activities in greater collaboration with other organizations.

3. ICH Quality Group

To support the guideline consultation process from Step 1 to Step 3 in 2026-2027, the opinions of experts across the JPMA committees and other active topics will be collected and fed back to the guideline consultation process. The current status report will be presented through
As discussions on new topics in the Quality area will resume, the current issues will be identified for review, evaluation of new topics, and proposals. In addition, the activities of the ICH Quality area are not limited to ICH guideline development, and as a member of the JPMA ICH Project, I will represent the ICH Project to the international organizations such as PIC/S, ICMRA, etc., in addition to ICH guideline development, and since the cooperation with international organizations is getting stronger, I will be one of the founding organizations of the ICH As one of the founding organizations of ICH, we will participate in these meetings as a member of the ICH project.

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