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

The specific initiatives for each issue in fiscal year 2026 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.

Searching for the latest information from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), the National Medical Products Administration (NMPA) of South Korea, the Taiwan Food and Drug Administration (TFDA),the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Swiss Agency for Therapeutic Products (Swissmedic), and the Australian Therapeutic Goods Administration (TGA), as well as information from the JPMA International Affairs Committee and individual member companies, and disseminate it to member companies without delay.In collaboration with the International Affairs Committee’s Asia Subcommittee, the organization will also conduct research and participate in public comment processes regarding GMP regulations in China, ASEAN countries, and elsewhere, providing useful information to member companies engaged in exports and change management.We will translate revised versions of GMP/GDP documents from the EU, PIC/S, and the FDA—which undergo frequent revisions—as needed, disseminate this information through GMP News and other channels, and share updates on each company’s progress regarding the regulations introduced in our projects.

(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

We will work closely with the Quality & Technology Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) and participate in JPMA projects.We will participate in projects aimed at preventing the recurrence of quality issues, responding to amendments to the Pharmaceutical and Medical Devices Act and GMP Ministerial Ordinances as well as quality-related notifications, addressing nitrosamine WT, and revising PIC/S GMP-related notifications, among others, to further ensure the reliability of pharmaceutical quality and enhance GMP as the foundation for globalization.This fiscal year, we will continue to submit requests and take other appropriate actions as part of industry-wide discussions regarding the upcoming amendments to the Pharmaceutical and Medical Devices Act.

2. Formulation Research Subcommittee

(1) Project Activities

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 fiscal years 2024 and 2025, we will work to establish and promote these standards domestically through the completion and Japanese translation of training materials for ICH Q13 (Continuous Manufacturing), Q2/Q14 (Analytical Method Development), and Q5A (Quality of Biopharmaceuticals), which are scheduled to reach Step 5.Regarding ICH Q9(R1), we will support a risk management seminar lasting approximately half a year, involving both current and former working group members, in collaboration with external organizations based on the guidelines.

3. New Project Initiatives

Regarding CMC research topics for chemical active pharmaceutical ingredients (APIs), there has been little discussion or activity to date. However, since APIs are closely related to drug formulations and there are many issues associated with them, we will launch a new project this fiscal year to address these challenges.

1) Project on Nitrosamine Risk Mitigation for Investigational Drug Substances

Since the nitrosamine-related guidelines issued by various countries all apply to commercial products, and there are no internationally coordinated guidelines other than ICH M7, it is believed that differences exist in companies’ perceptions and approaches to risk assessment, particularly during the development stage.The purpose of this initiative is to compile and publish standard guidelines for assessing the risk of nitrosamine contamination in active pharmaceutical ingredients (APIs) and their manufacturing processes during the development phase.

Project to Organize and Standardize Quality Control Issues at the Interface Between Active Pharmaceutical Ingredients and Formulation Functions

In the interface between active pharmaceutical ingredients (APIs) and formulation functions in chemical drug development, there are important characteristics—such as API particle size and crystal polymorphs—that affect formulation quality; however, the extent to which these characteristics are evaluated and the establishment of specifications vary from company to company.We aim to contribute to improved productivity, rapid market launch, and a high-quality, stable supply for each company by identifying and sharing these challenges and countermeasures.

Project for the Selection of API Starting Materials

Regarding ambiguities in the ICH Q11 guideline concerning the selection of active pharmaceutical ingredients (APIs), we aim to establish optimal interpretations and response policies to reduce the risk of approval/market launch caused by regulatory authorities redefining the API starting material as an upstream compound at the time of the approval application, and to develop backup plans to deliver medicines to patients as quickly as possible.

Other Issues and Initiatives

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.

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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