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Association
Activities
Overview of KPIA
The association was originally founded in 1948 as the Osaka Pharmaceutical Manufacturers Association (OPMA) and the name of OPMA was changed to the Kansai Pharmaceutical Industries Association (KPIA) on January 1st, 2018.
KPIA is a Regional organization aiming at enhancing common benefits for members and contributing to the realization of “Society of Health and Longevity” by making use of the strengths of Kansai*, and through strengthening joint collaboration, mutual understanding, and enlightenment of stakeholders including members, and through the sound development of the pharmaceutical and related industries.
The KPIA comprises over 300 pharmaceutical marketing authorization holders/ manufacturers and companies engaged in associated businesses, headquartered mainly in the Kansai Area. KPIA is a member of the Federation of Pharmaceutical Manufacturers’ Associations of JAPAN (FPMAJ) as a regional organization.
KPIA conducts its activities through four (4) committees and six (6) study groups and the secretariat, under the direction of the Board of Directors to address problems that operators in the pharmaceutical industries are facing. Specifically, KPIA keeps close contact and cooperation with, and promote mutual understanding with, the Ministry of Health, Labour and Welfare (MHLW), the Osaka Prefectural Government and other Regional authorities in the Kansai Area governing pharmaceutical industries to collect, examine, analyze, and compile information related to pharmaceutical-related laws and regulations and the pharmaceutical industries.
The results of these activities are communicated to members through seminars, newsletters, information network and other events and media to provide information and improve the knowledge of members. KPIA also makes various proposals related to pharmaceutical industries to the national and Regional governments and other public organizations.
Membership Benefits
Use of PRAISE-NET*
*Pharmaceutical Regulatory Affairs Information Service
Participation in Lectures/Seminars organized by KPIA
Participation in Committees/Study Groups
Viewing/Downloading of KPIA’s Monthly Journal on the Web
Purchase of books published by KPIA
Percentage of Members
KPIA’s Membership: 328（as of July 2, 2026）
Business type of KPIA members
- Innovative pharma
- Generic pharma
- OTC
- API/Excipient/ Reagent
- CMO/CDMO
- CRO
- Diagnostics
- Others
Headquarters location of KPIA members
Activities of Committees and Study Groups
Committees and study groups are formed according to specialized fields and actively work on projects to find solutions for various issues and problems up to which operators in the pharmaceutical industries face. Member companies can join any committees and study groups they are interested in and take part in their activities. Currently, KPIA has the following four (4) committees and six (6) study groups:
1.Pharmaceutical Regulatory Affairs Committee
The Pharmaceutical Regulatory Affairs Committee promotes compliance with the PMD Act. It has established Sub-committees for specific areas—such as laws and regulations, licensing/approvals, advertising/promotion, packaging/labeling, OTC drugs, and overseas pharmaceutical regulations—to examine regulatory systems and practical issues related to pharmaceutical regulatory affairs. The Committee also actively participates in projects of the superior body, the FPMAJ’s Pharmaceutical Regulatory Committee, to address issues related to the PMD Act.
The priority items to be addressed in FY2026 are as follows:
(1) Survey/Research and Proposals Regarding the Pharmaceutical Regulatory System
The revised PMD Act was promulgated in May 2025, and the provisions scheduled to take effect within six months of promulgation came into force in November 2025. While further implementation is scheduled in phases within one, two, and three years of the promulgation, the Committee collects information and conducts examinations so that member companies can respond appropriately to the implementation of existing and future cabinet/ministerial ordinances and notifications. In addition, to resolve practical issues under the PMD Act, the Committee collects opinions and requests from member companies and conducts surveys and research on operational issues. For matters where operational issues are identified, the Committee submits proposals to the authorities through FPMAJ.
The Committee also compiles opinions and requests from member companies regarding pharmaceutical/medical regulations as well as support and promotion measures and submits proposals through exchanges of views with the authorities.
(2) Proactive Proposals for Measures Aimed at the Development and Growth of Member Companies, and for Regulatory Streamlining
The Committee conducts surveys and elaborates proposals for streamlining regulations and systems to accommodate the globalization of pharmaceutical-related products, as well as on regulatory measures to accelerate the market launch of next-generation medical care—including regenerative medicines—and new healthcare products, and makes proposals as appropriate.
(3) Proposals to MHLW and PMDA
The Committee collects opinions and requests from member companies regarding issues in executing operations such as:
・review/approval processes for pharmaceuticals (new applications, partial changes, and confirmation of change management plans),
・inspections (document-based inspections, on-site inspections, and GMP compliance inspections),
・consultation services (face-to-face consultations, brief consultations),
・filing/notification operations (clinical trial notifications, minor change notifications, and notifications for manufacture/import of export-only pharmaceuticals),
・import/export procedures under the PMD Act, and
・promotion of R&D.
Based on the collected opinions and requests, the Committee submits proposals for improvement measures to MHLW and PMDA.
(4) Activities in Sub-committees and Working Groups
1) Regulatory Affairs Sub-committee
The Sub-committee conducts surveys and research, and exchanges views on the PMD Act and related topics including:
– matters related to business management (marketing authorization holders, wholesale distributors) (e.g., the guidelines on legal compliance and the GDP guideline), and
– GMP-related matters (legal revisions regarding GMP compliance inspections, GMP case study collection, and impurity management).
2) Authorization/Approval Sub-committee
① First Working Group
The First Working Group selects subjects focused on topics closely related to regulatory operations, such as change control of approval documents (partial /minor changes) and GMP compliance inspections, and conduct surveys and research. The Working Group also holds lectures and other events and proactively collects knowledge and information necessary for pharmaceutical professionals.
② Second Working Group
The Second Working Group selects research subjects related to approval reviews and licensing—such as marketing authorization approval, inspection applications, as well as various notifications, and conducts surveys and research on these subjects.
③ Third Working Group
From a perspective of marketing authorization applications and drug development, the Third Working Group identifies findings of the MHLW’s expert panel and reviews of CTD M1 content as themes highly relevant to regulatory strategies and to approval reviews—particularly for new active ingredients—as well as day-to-day developmental operations, and conducts surveys and research from a regulatory viewpoint.
④ Working Group for Drug Approval and Licensing Procedures in Japan 2026
In preparation for publishing the “Drug Approval and Licensing Procedures in Japan 2026”, the Working Group reviews and revises the content to incorporate additional laws, notifications and administrative communications necessary to reflect the latest regulatory requirements, with the aim of further enhancing practical usability.
⑤ Authorization/Approval Information Working Group
The Authorization/Approval Working Group delivers proposals to improve usability and to enhance functions of the Pharmaceutical Administrative Notification Database provided via PRAISE-NET. In addition, the Working Group examines issues related to maintaining and updating the database for authorization/approval personnel currently provided via PRAISE-NET to committee members and others and enhances the database. Regarding preparation of licensing information summaries, the Working Group plans to pursue its further efficiency improvements (through outsourcing and the use of generative AI).
3) Advertising and Promotion Sub-committee
The Advertising and Promotion Sub-committee conducts case-based surveys and research on the PMD Act and other relevant laws and regulations related to advertising and promotion of pharmaceuticals (prescription and OTC drugs), including the Standards for Fair Advertisement of Pharmaceuticals, the Guidelines for Sales Information Provision Activities, the Rules for Preparing Product Information Summaries, the Guidelines for Appropriate Advertisement of OTC Drugs, and the Act against Unjustifiable Premiums and Misleading Representations. The Sub-committee also holds relevant seminars and other events and proactively collects knowledge and information necessary for pharmaceutical professionals.
4) Packaging/Labeling Sub-committee
The Packaging/Labeling Sub-committee conducts surveys and research on labeling, package design, electronic package inserts, identification codes (specified symbols), interview forms, and related topics for prescription and OTC drugs.
5) OTC Drugs Sub-committee
Focusing on issues specific to OTC drugs—such as approval applications, sales operations, and GMP—the OTC Drug Sub-committee exchanges opinions, shares information, and conducts surveys and research on themes broadly related to daily operations, including inquiry cases on OTC drugs.
6) Overseas Regulatory Affairs Sub-committee
① The US/Europe Group
The US/Europe Group conducts surveys and research mainly on authorization/approval systems in the US and Europe. As related themes, the Group compiles systems that promote new drug development in the US and Europe as well as procedures for factory and product registration in the US, while also exchanges opinions and shares information.
② Asia Group
The Asia Group conducts broad surveys and research on pharmaceutical regulations in Asian countries including China, and exchanges opinions and shares information related to daily operations. The Group also selects notifications and guidelines closely related to operations from both China’s regulations and those outside China (e.g., ASEAN countries’ regulations), deepens understanding through Japanese translations, and fosters opinion exchanges and information sharing.
(５) Holding Seminars and Lectures
KPIA co-hosts the Joint East–West Pharmaceutical Regulatory Affairs Committee with PMAT and invites speakers from the MHLW’s Pharmaceutical Affairs Bureau and PMDA to present the latest regulatory trends. In addition, by obtaining answers to questions and requests collected from both the East and West committees, KPIA supports practical regulatory operations.
KPIA also holds seminars and lectures as appropriate that are useful for the practical work of Committee members and Sub-committee members and are related to Sub-committee and Working-Group activities.
2.Technical Research Committee
The Technical Research Committee contributes to the revisions of the Japanese Pharmacopoeia (JP), the Guideline for Drafting Monographs for the JP, and the Standards for Pharmaceutical Excipients through the preparation and review of draft proposals. In addition, the Committee works to resolve technical issues related to the JP and marketing authorization applications through surveys of member companies, the provision of technical information via lectures and other programs, Working Group activities, and collaboration with related organizations and committees. The Committee also provides technical and practical support to member companies for the appropriate implementation and use of the JP and Standards for Pharmaceutical Excipients. Furthermore, the Committee strives to contribute to the development and enhancement of the JP, the advancement of public health, international harmonization and globalization, and the assurance of pharmaceutical quality and stable supply.
The priority items to be addressed in FY2026 are as follows:
(1) Cooperation on the Revision of the JP
The Committee sends associate members to the Draft Review Committee and its working groups and submits requests and comments to administrative bodies such as PMDA and NIHS. Through these activities, the Committee contributes to the drafting revisions to (i) the Guideline for Drafting Monographs for the JP, (ii) the Basic Policy for Preparing the 20th Edition of the JP, and (iii) the First Supplement to the 19th Edition of the JP.
(2) Cooperation on the Revision of Standards for Pharmaceutical Excipients
In response to requests from MHLW, the Committee sends representatives from among its members to the Expert Committee on the Japanese Pharmaceutical Excipients to cooperate in revising the Standards.
(3) Provision of Technical Information
To promote member companies’ understanding of the revision to the 19th Edition of the JP and related implementation notifications, the Committee holds training seminars with experts involved in the revision process serving as lecturers.
At the Plenary Meeting of the Committee (hereinafter referred to as the “Plenary Meeting”), the Committee reports to member companies on the outcomes of deliberations conducted by the Draft Review Committee, its Working Groups, and the Expert Committee on the Japanese Pharmaceutical Excipients. The Committee also provides member companies with the latest updates on the revisions to the JP and Standards for Pharmaceutical Excipients, while facilitating the exchange of views.
In addition, the Committee organizes training seminars—as agenda items within the Plenary Meeting—on the latest information regarding notifications/regulations on pharmaceutical quality, as well as the latest trends in analytical technologies to provide useful technical information directly relevant to the practical work of member companies.
Moreover, to supplement the Guideline for Drafting Monographs for the JP, the Committee cooperates with PMAT to prepare and publish the Practical Guide to the Guideline for Drafting Monographs for the JP, thereby supporting the drafting of the JP Monographs and the development of test methods.
(4) Enhancement of the JP and Addressing Technical Issues in Quality Evaluation
In cooperation with related organizations, the Committee examines proposals and measures to address the diversification of pharmaceuticals in the JP, to promote international harmonization of monographs, enhance the JP, and to improve the efficiency of drafting the JP Monographs.
The Committee also explores solutions—together with related organizations—to technical issues regarding the quality evaluation of pharmaceuticals in the JP and marketing authorization applications. In particular, the Committee works with related organizations to address technical issues concerning reagents and test solutions used in general tests of the JP.
(5) Working Group Activities
The Biopharmaceuticals Working Group addresses the following three themes and compiles its findings into an activity report. The Working Group also holds seminars and related events to support research activities on these themes.
1.Specifications and test methods for biopharmaceuticals
2.Issues related to impurity testing
3.Survey on the latest trends in biopharmaceuticals
3.Quality Committee
The Quality Committee aims to enhance pharmaceutical quality systems by fostering collaboration with Osaka Prefectural Government and other prefectural governments in the Kansai-region, while also striving to promote mutual learning through the exchange of GQP/GMP-related information among industry associations such as FPMAJ, KPIA‘s Committees, and member companies.
In recent years, pharmaceutical quality systems have been further developed and enhanced from the perspective of international harmonization, and there is a growing need for scientific and logical proposals and discussions regarding ministerial ordinances, notifications, and various guidelines related to GQP/GMP. The Committee proactively submits opinions and proposals through FPMAJ.
In addition, the Committee identifies operational issues related to GQP/GMP, and through Osaka Prefectural Government and FPMAJ, submits requests/opinions to MHLW and PMDA, thereby deepening shared understanding between the authorities and the industry, and working toward solutions.
Furthermore, although some improvements have been observed in response to recent quality-related incidents, the Committee, as an industry association, continues to support ongoing improvement activities and further quality enhancement.
The priority items to be addressed in FY2026 are as follows:
(1) Identifying Operational Issues and Submitting Opinions Regarding GQP/GMP
・Working on the phased enforcement of the revised PMD Act, and tackling issues arising after implementation,
・Identifying issues and submitting opinions regarding the next revision of the GMP case study collection,
・Identifying issues and submitting opinions regarding notifications and other materials related to GQP, GMP, and GDP issued by MHLW, Osaka Prefectural Government, and others.
(2) Promoting Collaboration with Local Government Authorities, Primarily in the Kansai-region
1) Collaboration with Osaka Prefectural Government
・Through regular information sharing and exchanges of views with the Osaka Prefectural Pharmaceutical Affairs Division on issues related to GQP/GMP, the Committee builds a shared understanding and works toward resolving these issues.
・The Committee participates in the “Osaka Prefectural Pharmaceutical Affairs Council’s Sub-committee on Standards Evaluation for Pharmaceuticals” to submit opinions on issues related to GQP/GMP and provides feedback to member companies to raise their awareness.
2) Collaboration with the GMP Team of the Pharmaceutical Affairs Division Directors’ Meeting in the Kansai-region
The Committee cooperates with the activities of the GMP Team of the Pharmaceutical Affairs Division Directors’ Meeting in the Kansai-region and proactively exchanges views to strengthen collaboration with local authorities.
(3) Planning and Implementing Measures, as an Industries Association, to Prevent the Recurrence of Serious Quality Issues
・Based on exchanges of views with the authorities and other inputs, the Committee is examining both short-term and medium-to-long-term measures and promoting these initiatives.
(4) Addressing Practical Issues
The three Sub-committees—the Quality System Research Sub-committee, the Operations Case Study Sub-committee, and the Education Sub-committee—are discussing and examining how to address practical issues and work toward their solutions.
The study themes for each Sub-committee in FY2026 are as follows:
・The Quality System Research Sub-committee: Approaches to change control, deviations, and CAPA,
・The Operations Case Study Sub-committee: Proposing KPIs tailored to corporate challenges,
・The Education Sub-committee: Human resource development related to GMP/GQP.
(5) Holding Lectures and Briefings
At twice-yearly Plenary Committee meetings, the Committee reports primarily on the activities of the FPMAJ Quality Committee and this Committee, focusing primarily on recent topics related to Committee activities. The Committee also plans special lectures by the Osaka Prefectural Pharmaceutical Affairs Division and other administrative bodies. In addition, through factory tours and other events, the Committee collects information on other companies’ production efficiency, quality control, and improvement efforts, while promoting information exchange and mutual learning regarding GQP/GMP. The Committee also cooperates with the Association’s Pharmaceutical Regulatory Affairs Training Programs and the annual training course for the Pharmaceuticals General Marketing Directors.
4.International Business Committee
The International Business Committee, in collaboration with KPIA’s secretariat, promotes further global expansion of the pharmaceutical-related industry by supporting the international business activities of member companies.
The priority items to be addressed in FY2026 are as follows:
(1) Promoting the Collection and Sharing of Information on Overseas Pharmaceutical Value Chains, R&D, and Regulatory Trends
While Japanese companies are gradually expanding their business operations overseas particularly in Asian countries (China, India, South Korea, Taiwan, and ASEAN countries), they are facing difficulties in achieving profitability. Given that these markets are experiencing significant growth and serve as key manufacturing hubs for active pharmaceutical ingredients (APIs) and other products, the Committee strengthens initiatives related to the pharmaceutical value chains, including seminars and lectures, business networking events, on-site visits, study sessions, and information sharing. In addition, it is important to monitor pharmaceutical-related R&D and regulatory trends in the US/Europe. Moreover, in addition to Asia and the West, the Committee continues to collect and share information through seminars and online resources on regions including Middle East, Africa, and South America, where member companies’ interest has been growing in recent years.
(2) Exchanges with Overseas Bio-clusters and Venture Companies
In cooperation with relevant administrative bodies (including Osaka Prefectural Government) and related organizations (e.g., Biocommunity Kansai (BiocK), the Foundation for Biomedical Research and Innovation at Kobe, Kyoto Research Park, and Senri Life Science Foundation), the Committee conducts business networking events and lectures with overseas bio-clusters and venture companies.
(3) Promoting Activities in Collaboration with Stakeholders
The Committee strengthens collaboration with authorities and organizations in partner countries; embassies and consulates-general in Osaka; MHLW and PMDA; local governments such as Osaka Prefecture, Osaka City, and Kobe City; JETRO; the Osaka, Kyoto, and Kobe Chambers of Commerce and Industry; the Kansai Economic Federation; international committees of FPMAJ/JPMA/JGMA/JSMI; as well as local Japanese embassies and Japanese corporate/industry associations in host countries—in order to support international expansion of the pharmaceutical-related industry through conferences and networking events.
(4) Developing Global Talent
To promote overseas expansion of the pharmaceutical-related sector, it is essential to develop, recruit, retain, and ensure the successful integration of global talent and foreign employees. Accordingly, the Committee identifies needs related to support for human resource development, recruitment, and retention, and provides aids by holding relevant seminars and workshops.
(5) Project Kansai
In connection with KPIA’s “Project Kansai,” a new framework designed to contribute to strengthening drug discovery capabilities in the Kansai-region and to foster innovation, the Committee works in coordination with the R&D Promotion Council to advance initiatives in global-related domains.
(6) Strengthening Overseas Communication
The Committee reviews and enhances the content of the English-language website that introduces KPIA’s activities and other information, to strengthen communication efforts to overseas audiences.
5.Eye Drops Study Group
The Eye-drops Study Group conducts surveys and research on regulatory and technical issues related to the quality of eye-drops and works to formulate and propose improvement measures. In addition, in response to requests from administrative bodies and pharmaceutical-related organizations, the Study Group investigates, examines, and makes proposals regarding issues related to eye-drops, with the aim of improving the quality of eye-drops and raising the overall standards of the industry. The results of these efforts are published on KPIA’s website and other channels, providing information not only to member companies but to the broader public as well.
The priority items to be addressed in FY2026 are as follows:
(1) Awareness-raising Activities regarding the Proper Use of Eye-drops
To ensure the proper use of eye-drops, the Study Group continues awareness-raising activities on the proper use of eye-drops using educational materials prepared to date, such as the “Handbook for Pharmacists,” “Pamphlets for Patients and General Consumers,” and “Posters on the Proper Use of Eye-drops for Elementary and Junior High School Students.”
(2) Responses to the JP and Administrative Notifications
The Study Group examines matters requested for review by FPMAJ and JSMI, such as the revision of the Manufacturing Approval Standards for Ophthalmic Products, the revisions of the General Rules for Preparations, General Test Methods, and Reference Information in the JP; matters related to the prevention of medical accidents; inclusion of cases in the GMP case study collection; and surveys related to administrative notifications.
(3) Research on Regulatory and Quality-Related Issues for Eye-drops and Corresponding Actions
Regarding regulatory and manufacturing/quality control issues for eye-drops, the Study Group holds factory tours and various study sessions, and works toward resolving these issues through questionnaire surveys and exchanges of views with the group members. In addition, the Study Group supports the acquisition of knowledge and technical skills by striving to standardize interpretations and terminology and by examining countermeasures accordingly.
(4) Collaboration with the PMAT Eye-drops Study Group
To consolidate opinions of the eye-drop industries and promptly make proposals to administrative bodies and industry organizations, the Study Group collaborates with the PMAT Eye-drops Study Group to hold joint East–West meetings to report on survey/research findings and exchange opinions. In addition, through training programs and study sessions, including tours of pharmaceutical and related manufacturing facilities, the Study Group supports learning in broad pharmaceutical-related knowledge and skills for members of both East and West Study Groups and to facilitate opinion exchanges leading to quality improvement.
6.Intellectual Property Study Group
The Intellectual Property Study Group 1) establishes Sub-committees for each field—patents, patent information, and trademarks. Each Sub-committee sets its own research themes to address various issues related to intellectual property systems–such as patent and trademark examinations and appeals–not only in the pharmaceutical field but also in the healthcare sector, which pharmaceutical companies have been actively pursuing in recent years, as well as practical challenges such as the investigation and retrieving of intellectual property information and conducts information gathering and practical deliberations. In addition, 2) in collaboration with the Intellectual Property Study Group of PMAT, the Study Group disseminates information obtained through exchanges with the Japan Patent Office (JPO) and other relevant organizations, and results of its examinations to member companies to support their intellectual property activities.
The priority items to be addressed in FY2026 are as follows:
(1) Patent Sub-committee
The Sub-committee examines various issues concerning patent systems in Japan and overseas.
In Japan, the Sub-committee collects and examines information with a focus on the practical aspects of examination and appeal by the JPO, with paying close attention to the trends after amendments to the Patent Act and revisions to examination guidelines and provides the outcomes to member companies. In addition, based on the opinions of member companies, the Sub-committee submits requests and opinions to the JPO and other administrative bodies in cooperation with the PMAT Intellectual Property Study Group as necessary. Furthermore, the Sub-committee collects and analyzes case law related to patent laws in various countries, as well as information on pharmaceuticals and healthcare, to identify challenges that the pharmaceutical industry has been facing in recent years and proposes appropriate countermeasures.
(2) Patent Information Sub-committee
The Patent Information Sub-committee is suspended due to a lack of member companies wishing to participate in.
(3) Trademark Sub-committee
The Trademark Sub-committee is suspended due to a lack of member companies wishing to participate in.
7.Medical Information Service Study Group
he Medical Information Service Study Group addresses various issues faced by customer service departments that respond to inquiries from healthcare professionals such as physicians and pharmacists, as well as from general consumers and patients. In addition, to respond to a wide variety of inquirers and inquiry topics, the Study Group holds lectures and training seminars to help staff acquire skills, including telephone response skills, harassment response skills, call center operation know-how, and knowledge on related laws and regulations, as well as on AI technologies.
As part of its social contribution activities, the Study Group is registered as an “Osaka City Sukoyaka Partner” and holds outreach seminars titled “How to Take Medicines Properly” for general consumers to deepen their understanding of the proper use of pharmaceuticals. Going forward, the Study Group plans to sequentially release educational videos using materials from these seminars on the KPIA YouTube channel and is continuing these activities in FY2026.
The priority items to be addressed in FY2026 are as follows:
(1) Plenary Study Group and Sub-committee Activities
At the Plenary Study Group Meeting, the Study Group supports medical information service activities of member companies by sharing with members the latest information obtained through representatives of the Study Group who attend the “Liaison Meeting for Medical Information Service Managers” hosted by PMDA and the Medical Information Service Sub-committee of the FPMAJ Safety Committee. The Study Group also submits proposals to FPMAJ and other organizations as necessary.
The Study Group has two Sub-committees as its subordinate bodies: the Information Review Sub-committee and the Case Review Sub-committee, both of which hold regular monthly meetings.
The Information Review Sub-committee strives to enhance the attractiveness of the Study Group’s activities by planning and management of lectures, training sessions, and other programs.
The Case Review Sub-committee works to improve communication skills by reviewing medication consultation cases and shares the results of these reviews with member companies so that they can be utilized as educational materials within each company.
(2) Holding Lectures and Training Seminars
The Study Group holds the following events to provide opportunities for members to acquire broad knowledge and improve their skills:
– Medication Consultation Forum
– Skill-Building Training Sessions
– Facility Tours
(3) Holding Various Study Sessions
Based on identified needs of the Study Group members, the Study Group holds study sessions, as appropriate, on topics of high interest to provide opportunities for gaining new insights.
(4) Collaboration with Related Organizations
The Study Group explores collaboration with related organizations or other committees and study groups within KPIA to address common issues (such as customer facing).
8.Pharmacovigilance Study Group
Pharmacovigilance Study Group supports the safety measures of its member companies by collecting the latest information on pharmacovigilance and other safety measures through the participation in review meetings, projects, and other initiatives hosted by administrative bodies and industry organizations including FPMAJ, sharing such information with member companies in a timely and appropriate manner, and ensuring the thorough dissemination of notifications and other information. In addition, the Study Group, with the Standing Committee playing a central role, exchanges views and deliberates emerging issues related to drug safety measures, and makes proposals to administrative bodies, FPMAJ, and other relevant organizations as necessary. Furthermore, the Study Group supports member companies in implementing prompt and appropriate post-marketing safety measures by planning and conducting training courses and educational seminars as awareness-raising initiatives, and in bringing out operational personnel’s assessment capability of adverse drug reactions through the Information Sub-committee.
The priority items to be addressed in FY2026 are as follows:
(1) Responding to New Post-marketing Safety Measures
The Study Group collects information in a timely manner—through administrative bodies and FPMAJ (including participation in the FPMAJ Safety Committee)—on changes in safety monitoring methods and other new developments in safety measures resulting from the amendments to the PMD Act and related regulations promulgated in FY2025. The Study Group shares this information with member companies to support their post-marketing safety activities and, as necessary, submit proposals to FPMAJ and other relevant bodies.
(2) Addressing Safety-Related Compliance Requirements for Marketing Authorization Holders
The Study Group collects and provides relevant information—such as the status of prefectural GVP inspections and PMDA GPSP compliance inspections—in a timely manner so that member companies can respond to them smoothly.
(3) Engagement with Local Pharmaceutical Administration
The Study Group assigns its representative to the Osaka Prefecture’s Pharmaceutical Affairs Council Sub-committees (the Pharmaceutical Standards Evaluation Sub-committee and the Proper Sales of Pharmaceuticals Sub-committee), submits opinions, and feedbacks information to member companies to ensure their awareness and understanding.
(4) Awareness-Raising on Drug Safety Measures
The Study Group raises awareness of the importance of drug safety measures by planning and conducting Pharmaceutical Safety Seminars delivered by external lecturers, and by serving as instructors for Pharmaceutical Regulatory Affairs Training Programs and the annual training course for the Pharmaceuticals General Marketing Directors. In the Information Sub-committee (held monthly), it supports operational personnel in improving their ability to evaluate safety management information and in taking comprehensive and error-free measures, including the proper preparation of reporting formats for administrative bodies, through group work and other activities to review cases of serious adverse drug reactions, research reports, and action reports. In addition, using published RMPs as case materials, the Sub-committee supports member companies in deepening their understanding of RMPs by examining the structure of RMPs and the evidence underlying safety specifications. Moreover, through “topic presentations by Standing Committee members” and sharing understanding of issues in safety management operations and the interpretation of relevant notifications, the Sub-committee enhances the response capabilities of its members and supports member companies in strengthen their GVP/GPSP systems.
The Study Group also publishes the materials reviewed by the Information Sub-committee, such as case reports of serious adverse drug reactions, research reports, action reports, and RMPs, to its member companies.
9.MR Education and Training Study Group
The MR Education and Training Study Group aims to improve the quality of introductory and continuing education for MRs and supports member companies in enhancing and strengthening their education and training programs. In addition, toward the implementation of the new MR accreditation system starting in FY2026, the Study Group submits various proposals to the committees of the MR Education & Accreditation Center of Japan to ensure that member companies’ requests are reflected in the system.
The priority items to be addressed in FY2026 are as follows:
(1) Operation of the Practical Training Accreditation Standards
Starting in FY2026, the MR accreditation system will transition to a “two-tier” lifelong education system in which basic education and practical training are separated.
– Basic Education:
Individual learning (the first tier) aims to acquire and maintain the basic knowledge required to provide, collect, and communicate information on the proper use of pharmaceuticals. The MR Basic Examination consists of the following subjects: “Pharmaceutical Information,” “Diseases and Treatments,” and “The Pharmaceutical Industry, Ethics, Laws, and Regulations” (formerly “General MR Studies”). The exam is conducted twice a year using computer-based testing (CBT), and a passing certificate is awarded to those who achieve a score of 650 or higher. In addition, participants receive a certificate of completion by passing the Basic Education Learning and Certification Program each fiscal year.
– Practical Education:
This is training conducted under the responsibility of companies (the second tier), designed to cultivate the practical competencies necessary for MRs to adopt a patient-centered approach and become trusted partners of healthcare professionals. Evaluation is conducted based on the Practical Training Accreditation Standards (ethics and safety management) and company-specific criteria (skills and other subjects).
Among the practical training subjects, ethics and safety management have been established as common mandatory requirements across companies under the “Practical Training Accreditation Standards,” which will come into effect in FY2026. It is important to correctly understand the “Explanatory Guide to the Practical Training Accreditation Standards,” which has been prepared to supplement the items set forth in the standards, emphasize key perspectives, and clarify areas prone to misunderstanding.
The Study Group appropriately shares information on these new systems and standards among its members to facilitate smooth implementation and promote understanding.
(2) Education and Training Study Group Seminar
The Education and Training Study Group Seminar provides courses designed to enhance knowledge among MRs, MR education and training personnel, and departments involved in MR education by establishing curricula related to introductory and continuing education. Lecturers are selected from member companies of the Study Group who are well versed in the respective training content, and for certain subjects, external lecturers are also invited to provide the latest information.
This seminar had been conducted under the name of “MR Education Personnel Course.” until FY2025. However, based on the member’s opinion that the former name gave the impression that the target audience was limited to education personnel, the name has been changed to “Education and Training Study Group Seminar” starting in FY2026.
(3) Activities Related to the MR Accreditation Center of Japan
In cooperation with the MR Accreditation Center of Japan, the Study Group carries out the following activities:
Sends representatives from the Study Group to the MR Accreditation Center’s Education and Training Committee to attend regularly held meetings and collects information appropriately.
Collects the latest information from events such as the MR Forum, the Education and Training Promoters’ Conference, and the Education and Training System Accreditation Sessions, and reflects it in the education and training programs of member companies.
10.Clinical Trial Promotion Study Group
The Clinical Trial Promotion Study Group conducts its activities with the aim of identifying concrete solutions tailored to the realities of clinical trial sites by bringing together actual cases related to clinical trials from member companies and engaging in lively exchanges of views, to provide feedback on these solutions to member companies. In addition, through these exchanges, the Study Group compiles matters that can be shared among member companies as deliverables.
The priority items to be addressed in FY2026 are as follows:
(1) Promotion of Working Group Activities
The Clinical Trial Sub-committee, a subordinate body of the Study Group, has established Working Groups to examine various topics related to clinical trials. In FY2026, the Working Groups address each of the following four themes, and the group members share the latest information, knowledge, and experience related to GCP with each other and strive for mutual learning and improvement. Through these activities, the Study Group supports the efficient and effective conduct of clinical trials at member companies.
– Theme 1: Preparing the “How to Conduct Clinical Trials in Accordance with GCP (Model) – 5th Edition –”
– Theme 2: Understanding the revised GCP ministerial ordinance and examining necessary measures
– Theme 3: Examining ways to eliminate drug lag/loss using Real World Data (RWD）— Co-creating new utilization models for the marketing authorization application and clinical development —
– Theme 4: Examining the selection of medical institutions and practical measures by sponsors to improve the quality of bioequivalence studies for generic drugs
(2) Support Activities for Association Programs
As in previous years, the Study Group serves as lecturers on GCP-related topics at the Pharmaceutical Regulatory Affairs Training Programs held by KPIA as part of its annual curriculum, thereby contributing to the enhancement of knowledge among practitioners at member companies.
(3) Collaboration with Relevant Organizations
The Study Group collaborates with MHLW, PMDA, Osaka Prefectural Government, the Clinical Trial Network Osaka Promotion Council, Japan Society of Quality Assurance, Osaka Medical Association, and other relevant organizations, and strives to disseminate useful information obtained from these sources. In addition, the Study Group engages in collaborative activities such as publicizing various events, in response to requests from relevant organizations.
Abbreviation
API: Active Pharmaceutical Ingredient
BiocK: Biocommunity Kansai
CBT: Computer-based testing
FPMAJ: Federation of Pharmaceutical Manufacturers’ Association
FY: Fiscal Year
GCP: Good Clinical Practice
GDP: Good Distribution Practice
GMP: Good Manufacturing Practice
GQP: Good Quality Practice
JGMA: Japan Generic Medicines Association
JETRO: Japan External Trade Organization
JP: Japanese Pharmacopoeia
JPMA: Japan Pharmaceutical Manufacturers Association
JPO: Japan Patent Office
JSMI: Japan Self-Medication Industry
KPIA: Kansai Pharmaceutical Industries Association
MHLW: Ministry of Health, Labour and Welfare
MR: Medical Representative
NIHS: National Institute of Health Sciences
OTC drug: Over-the-Counter drug
PMAT: Pharmaceutical Manufacturers’ Association of Tokyo
PMD Act: Act on Securing Quality, Efficacy and Safety of Pharmaceutical Products and Medical Devices (Pharmaceuticals and Medical Devices Act)
PMDA: Pharmaceuticals and Medical Devices Agency
PRAISE-NET: Pharmaceutical Regulatory Affairs Information Service-Network
R&D: Research and Development
RMP: Risk Management Plan
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