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.

• *Strengths of Kansai for Pharmaceutical and Related Industries
  • Integrated pharmaceutical and related industries typified by Dosho-Machi
  • Integrated manufacturers having creative and advanced technologies in the variety of fields
  • Consolidated presence of universities and research institutes related life science field
  • Consolidated science and technology at the highest international level for creating new drugs
  • Consolidated agencies for supporting and consulting drug discovery performed by academia and industry
  • Proactive initiatives by Regional government for promotion of pharmaceutical and related industries
  • Regions having a long history for gathering people, goods and information, and for interacting each other with Asia, Europe and America
  • Presence of international distribution centers for import-export logistics such as Kansai International Airport
  (Including, but not limited to the above)

• Organization Chart

• Charter
• KPIA Vision 2025

Membership Benefits

1. 

   Use of PRAISE-NET^*
   *Pharmaceutical Regulatory Affairs Information Service

2. 

   Participation in Lectures/Seminars organized by KPIA

3. 

   Participation in Committees/Study Groups

4. 

   Viewing/Downloading of KPIA’s Monthly Journal on the Web

5. 

   Purchase of books published by KPIA

Percentage of Members

KPIA’s Membership: 329（as of April 24, 2025）

• Innovative pharma
• Generic pharma
• OTC
• API/Excipient/ Reagent
• CMO/CDMO
• CRO
• Diagnostics
• Others

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 members’ compliance with the PMD Act. It has formed Sub-Committees, each assigned to a specialized field, including legislation, pharmaceutical regulatory affairs, advertisement/promotion, packaging/labeling, OTC drugs, and pharmaceutical regulations in other countries, to discuss systems related to pharmaceutical laws and regulations, and issues found during the operation by member companies.
The Committee also actively participates in projects of the Pharmaceutical Regulatory Affairs Committee of FPMAJ, the upper body of KPIA, to address issues related to the PMD Act.

In FY2024, the Committee focuses on the following activities:

1. Strengthening of the Committee’s Functional Activities such as Research Study and Proposals Related to Pharmaceutical Laws and Regulations
   We collect and review information so that we may accurately response to the operation of the administrative ordinances, notices, etc. associated with the revised PMD Act promulgated in December 2019 (hereinafter referred to as the “2019 Revised Act”). In addition to the activities mentioned above, to solve issues faced by member companies in practicing pharmaceutical businesses in accordance with the 2019 Revised Act, the Committee collects opinions and requests from member companies and conduct research to identify issues in pharmaceutical business practice. Based on these activities, the Committee makes requests to relevant administrative organizations through FPMAJ to get them issue notifications which should clarify measures to be taken.

   In FY2024, the Committee takes into consideration the status of various systems operation after the enforcement of the 2019 Revised Act and responds to issues by actively participating in the consideration of the revision requests related to laws, and enforcement ordinance regulations to be complied by FPMAJ.

   It also compiles opinions and requests from member companies regarding pharmaceutical and healthcare regulations and support and incentive measures, and makes proposals through exchanges of opinions with the authorities.

2. Proactive Proposals Regarding Measures that Help the Development and Growth of Member Companies and Regarding Rationalization of Regulations
   The Committee makes proposals for rationalization of regulations and systems to match the globalization of pharmaceuticals and related products. It also conducts research and examination, and makes proposals regarding modification of regulations to accelerate the launch of next-generation medical treatments such as regenerative medicines and new healthcare products.
3. Cooperation with MHLW and PMDA
   The Committee collects opinions and requests from member companies regarding issues they have found in practicing their operations, such as the approval review of drugs (approval of new drugs, partial changes, and confirmation of change management protocol), inspections (document inspection, on-site inspection, and GMP compliance inspection), consultation services (face-to-face advice, simplified consultation), notification services (a notice of clinical trial plan, minor change notification, and manufacturing notification of pharmaceuticals for export/import), export/import procedures under the PMD Act, and research and development activities. Based on these opinions and requests, the Committee proposes improvements to MHLW and PMDA.
4. Cooperation with Officers in Charge of Pharmaceutical Regulations in the Osaka Prefectural Government and Other Local Governments
   The Committee keeps contact with officers in the Pharmaceutical Affairs Division of the Osaka Prefectural Government and other local governments to deepen mutual understanding about pharmaceutical regulations, and conducts activities as a local trade organization. The Committee regularly shares information, conducts surveys, reviews, and exchanges opinions on issues and operations of the pharmaceutical affairs system through the “Information Exchange Meeting on Pharmaceutical Affairs,” etc., and makes proposals to MHLW or PMDA in cooperation with the Pharmaceutical Affairs Division of the Osaka Prefectural Government and others.
5. Activities by Sub-Committees and Working Groups
   
   1. Regulatory Affairs Sub-Committee
      The Sub-Committee discusses and conducts research on matters (Legal Compliance Guidelines, GDP Guideline, etc.) related to business management (Pharmaceutical Marketing Authorization Holders, Manufactures, Wholesalers), matters related to GMP (Revised Administrative Ordinances on GMP, etc.) and matters related to the application for approval (Impurity Control, GMP Compliance Inspection, Change procedure based on confirmation of PACMP, etc.) as themes and topics about the PMD Act and related laws and subjects
   2. Approval and Authorization Sub-Committee
      
      1. First Working Group
         The Working Group conducts research on the subjects highly related to pharmaceutical affairs business such as a change control of approval document (partial changes and minor changes) and authorization of business from a pharmaceutical affairs point of view as research themes such subjects include cases of consultation on partial and minor changes, notifications related to partial and minor changes, and consultation systems.
         The group also organizes seminars to strive for proactive collection of knowledge and information required as a person in charge of pharmaceutical professionals.
      2. Second Working Group
         The Working Group selects and conducts research on themes related to approval review, and approval and authorization. The themes include pharmaceutical manufacturing and marketing approval, inspection applications, and various notifications.
      3. Third Working Group
         The Working Group conducts research from regulatory point of review on pharmaceutical regulatory strategy, review and inspection for approval mainly focusing on products with new active pharmaceutical ingredients the from the fields of submission and development regulatory affairs, and regulatory considerations of manufacturing and marketing approval applications for orphan drugs and real-world data as research themes highly related to daily business of development regulatory affairs.
      4. Working Group for Drug Approval and Licensing Procedures
         In preparation for the publication of “Drug Approval and Licensing Procedures”, the Working Group incorporates necessary legislations, notifications, administrative notices to reflect the latest regulatory contents, and review/revise for further improvement to operate their business practice.
      5. Working Group for Approval/Authorization Information
         The Working Group makes proposals to improve the usability and function regarding the database of pharmaceutical-related administrative notifications provided by PRAISE-NET. It also maintains and updates the database for person in charge of Approval/Authorization Information currently made available via PRAISE-NET to the Pharmaceutical Regulatory Affairs Committee members, and enhances the database by identifying issues.
   3. Sub-Committee for Advertisement/Promotion
      Sub-Committee conducts research on the PMD Act and other related laws and regulations regarding Advertisement/Promotion of pharmaceutical products (ethical and OTC) such as Standard for Fair Advertisement of Pharmaceutical Products, Guidelines for Sales Information Provision Activities for Ethical Drugs, Instruction for Outline of Product Information Brochure, Guidelines for Adequate Advertisement of OTC drugs, and Act against Unjustifiable Premiums and Misleading Representations focusing on case studies. Sub-Committee holds lecture meetings and other events to actively collect knowledge and information necessary as pharmaceutical professionals.
   4. Sub-Committee for Packaging/Labeling
      Sub-Committee conducts research on labeling for ethical and OTC drugs, package design, interview forms, and distribution code of ethical drugs etc.
   5. Sub-Committee for OTC drugs
      Sub-Committee conducts research, exchange views and share information about OTC drug inquiries and Q&A on Approval Standard, etc., as topics that are broadly related to daily operations, mainly focusing on issues such as application for approval, marketing and GMP specific to OTC drugs.
   6. Sub-Committee for Overseas Pharmaceutical Regulations
      
      1. Group for US and Europe
         The Group conducts research mainly on the approval and authorization systems in the US and Europe, and exchanges views and shares information about relevant topics including US GMP system, Certificate of Suitability to Monographs of the European Pharmacopeia (CEP) guidance, and approval and authorization system in Europe.
      2. Group for Asia
         The Group conducts extensive research on pharmaceutical regulations in Asian countries including China, and exchanges views and shares information on daily operations.
6. Holding of Workshops and Seminars
   Joint Pharmaceutical Regulatory Affairs Committee between KPIA and PMAT organizes seminars lectured by MHLW and PMDA representatives on the latest movements in pharmaceutical regulations and other topics, and gains answers for questions and requests on the pharmaceutical regulations during the seminars as a help of the pharmaceutical affairs business. The Committee holds workshops and seminars that are useful for the practical business of the Committee and Sub-Committee members, and are related to the activities of Sub-Committees and Working Groups in a timely manner as appropriate.

2.Technical Research Committee

Technical Research Committee participates in the Japanese Pharmacopoeia Expert Committee (hereinafter “JP Expert Committee”) of PMDA as a sub-committee member and cooperate in preparing the draft of the Japanese Pharmacopoeia and the Guidance for drafting and revision of the Japanese Pharmacopoeia. The Committee appropriately conducts surveys on the actual conditions and requests of member companies to ensure consistency of understanding in the method of quality evaluation, specifications, and test methods for pharmaceutical products between the administrative organizations and the pharmaceutical industry.

The Committee also addresses and solves technical issues occurred in the Japanese Pharmacopoeia and the marketing approval application for pharmaceuticals through activities by Working Group organized under the Committee, provision of technical information to member companies, and cooperation/coordination with other related committees.

In FY2024, the Committee Focuses on the Following Activities:

1. Cooperation in Revision of the Japanese Pharmacopoeia
   The Committee sends its associate members to the JP Expert Committee and working groups organized under the JP Expert Committee.
   The Committee contributes to maintenance and reinforcement of the Japanese Pharmacopoeia, improvement of public health, and also to international harmonization and globalization of the Japanese Pharmacopoeia by making requests and presenting opinions to relevant administrative organizations in accordance with the Basic Policy for Preparing the Japanese Pharmacopoeia 19th Edition.
   The Committee solves practical issues related to the Japanese Pharmacopoeia in cooperation with other related organizations and committees so that member companies can properly operate and utilize the Japanese Pharmacopoeia.
2. Cooperation in Revision of Japanese Pharmaceutical Excipients
   Upon request from MHLW, the Committee sends representatives to the Expert Committee on Japanese Pharmaceutical Excipients to cooperate in revision of the Japanese Pharmaceutical Excipients.
3. Provision of Technical Information
   The Committee reports conclusions and points of discussion in the JP Expert Committee and shares the progress of revision for the Japanese Pharmacopoeia with member companies in the general committee meeting, which is composed of representatives from member companies. The Committee holds lecture meetings on notifications/regulations, or analytical technologies at the same time as the general committee meeting to provide technological information to member companies.
   The Committee plans and holds training lectures and briefings on the Japanese Pharmacopoeia to deepen member companies’ understanding on the Japanese Pharmacopoeia.
   In cooperation with PMAT, the Committee prepares and publishes the　Practical Guide to complement the Guidance for drafting the Japanese Pharmacopoeia to serve for drafting the Japanese Pharmacopoeia.
4. Working Group Activity
   Working Group for Biopharmaceuticals continues its activities to research quality evaluation methods, specifications and test methods, and other matters of biopharmaceuticals.
   The achievement is shared with member companies by reporting the details of their activities in the general committee meeting.
5. Action to Technical Issues on the Japanese Pharmacopoeia and Quality Evaluation
   The Committee solves technical issues on Japanese Pharmacopeia General Tests and quality evaluation of pharmaceuticals by collaborating with related organizations and committees.

3.Quality Committee

The Quality Committee aims to enhance the Pharmaceutical Quality System　 by collaborating with the Osaka Prefectural Government and the other Authorities in the Kansai region. It promotes information exchange and mutual enlightenment on GQP and GMP with relevant business organizations and committees within the pharmaceutical industry including the FPMAJ and member companies.
In recent years, the Pharmaceutical Quality System have evolved from an international regulatory harmonization and convergence perspective.　　Scientific and logical proposals and discussions are essential for ordinances, notifications, and guidelines related to GQP and GMP (including GDP). The Committee actively submits proposals to administrative organizations through FPMAJ. It also identifies issues related to GQP/GMP and their operation including GDP, and presents requests or proposals to MHLW and PMDA through FPMAJ and the Osaka Prefectural Government. The goal is to address these issues and develop mutual understanding between the administrative organizations and the pharmaceutical industries.
Furthermore, the Committee proactively plans and implements industry-wide measures to regain public trust due to the recent manufacturing and quality violations and repeated recalls.

In FY2024, the Committee focuses on the following activities:

1. Identification of Issues and Proposals in Relation to the Inspection/ Guidance of GQP/ GMP and their Operation Including GDP
   
   • Requests for the revision of PMD Act
   • Promotion of various measures after the revision of the GMP Ministerial Order
   • Revision of PIC/S GMP Guideline and its Annex
   • Other administrative notifications related to GQP/GMP/GDP from MHLW or Osaka Prefectural Government, etc.
2. Promotion of Cooperation with Authorities Mainly in Kansai Region
   
   1. Promotion of Cooperation with Osaka Prefectural Government
      
      • Ensuring common understanding of issues related to GQP/GMP/GDP through regular information sharing and opinion exchange with the Osaka Prefectural Government.
      • Active participation in the “Standard Evaluation Examination Sectional Meeting for Pharmaceutical Products under the Osaka Prefecture Pharmaceutical Affairs Council”, providing the Committee’s opinions on GQP/GMP issues.
      • Participation in the “Information Exchange Meeting on Pharmaceutical Affairs” to develop mutual understanding and strives to solve any issues related to regulatory affairs, approval procedures, and inspection/compliance pertinent to pharmaceutical products
   2. Cooperation with the GMP Team under the “Pharmaceutical Affairs Division Manager Meeting in Kansai Region”
      Cooperating with the “GMP Team consisting of the Chiefs of Pharmaceutical Affairs in Kansai Region”, and proactively exchange opinions to enhance the partnerships with Authorities in the Kansai Region.
3. Planning and Implementation of Measures as an Industry Organization to Prevent Recurrence of Serious Quality Issues
   With reference to opinions exchanged with the administrative organizations, the Committee considers short-, medium- and long-term measures, and promotes activities on short-term measures.
4. Addressing Business Practice Issues:
   The Committee’s three Sub-Committees (Quality System Research, Operations Case Study, and Education) review and consult on business practice issues:
   The theme of study at each Sub-Committees in FY2024 are as follows:
   Quality System Research Sub-Committee: Digging into the practices of data integrity more deeply
   Operations Case Study Sub-Committee: Management of suppliers and outsourcing contractors, including the cooperation between Marketing Authorization Holders and Manufacturers
   Education Sub-Committee: Way of thinking, responsibility, attitude and behavior that should be taken in Manufacturing of pharmaceutical products.

4.International Business Committee

International Business Committee, in collaboration with KPIA’s secretariat, promotes further globalization of the Japanese pharmaceutical related industries by providing support for the international business activities of member companies.

In FY2024, the Committee focuses on the following activities:

1. Strengthening of Cooperation with Overseas Partners to Improve Access Including Establishment of Pharmaceutical Related Value Chains
   Among overseas countries, especially in Asian economies (China, India, Korea, Taiwan, ASEAN, etc.), Japanese companies are gradually expanding their businesses, but they are facing difficulties in making them profitable. Asian countries have been growing substantially as a market, and some Asian countries have become important manufacturers of APIs and other related products. In view of the above, the Committee conducts seminars/lectures, matchmaking/net-working meetings, on-site visits, workshops on pharmaceutical related value chains focusing on these regions, and strengthens cooperation with FPMAJ and related organizations. Regarding Europe and the US, as it is also important for member companies to understand pharmaceutical related R&D and regulatory trends, the Committee continues to collect relevant information, holds seminars, lectures and study sessions, and strengthens cooperation with other organizations to contribute to the provision of information to member companies.
2. Exchange with Bio-clusters and Start-ups in Overseas Countries
   In cooperation with Osaka Prefectural Government, other regional governments, and related organizations (such as Foundation for Biomedical Research and Innovation at Kobe, Kyoto Research Park, and Senri Life Science Foundation), the Committee holds business net-working meetings, lectures and other exchanges with overseas biotechnology clusters and start-ups.
3. Promotion of Activities in Cooperation with Regional Governments and Consulate Generals, etc.
   The Committee strengthens cooperation with overseas governmental agencies and trade organizations, Embassies and Consulate Generals in Osaka, MHLW/PMDA, regional governments such as Osaka, Kyoto, and Kobe, JETRO, Chambers of Commerce and Industry in Osaka, Kyoto, and Kobe, Kansai Economic Federation and international committees, FPMAJ, JPMA, JGA, JSMI, and BiocK to hold conferences and networking meetings aimed at overseas business expansion of pharmaceutical related industries.
4. Promotion of Information Sharing on Healthcare Needs, Regulatory Authorities/Systems.
   The Committee shares information on healthcare and medical needs, regulatory authorities/systems, and business and investment environment in countries of interest to member companies, particularly in Asia. The committee also holds workshops as needed to respond to diverse needs.
5. Development of Globally Competent Human Resources
   To promote overseas business development in pharmaceutical field, it is essential to develop, secure and retain global and foreign human resources. The Committee identifies their needs to support for developing, securing and retaining globally competent human resources, and provides support through necessary seminars and workshops.
6. Strengthen the Information Distribution
   The Committee strengthens efforts to disseminate information about our activities to overseas stakeholders by reviewing and enhancing the contents of our English website which introduces our activities.

5.Eye Drops Study Group

Eye Drops Study Group conducts research on pharmaceutical regulations and technical issues related to eye drops, and prepares and proposes measures to solve these issues. The Study Group also conducts activities requested by administration or industry organizations, such as research and examination on issues related to eye drops and proposal of solutions, aiming toward improvements of the quality of eye drops and enhancement of the level of industries. The results of its activities are made widely available not only to member companies but also to the public by posting on KPIA’s website and other methods.

In FY2024, the Study Group focuses on the following activities:

1. Activities Regarding Education on Proper Use of Eye Drops
   The Study Group continues enlightenment activities related to proper use of eye drops with educational materials created to date such as a “Handbook for Pharmacists”, a “Pamphlet for Patients/General Consumers” and a “Panel for Elementary School Children Regarding Education on Proper Use of Eye Drops”.
2. Activities to Address Official Documents and Administrative Notifications
   The Study Group examines matters requested by FPMAJ and JSMI. Such requests include a review of approval criteria for manufacturing ophthalmic preparations; research on revision of the Japanese Pharmacopoeia General Provisions, the general testing method and reference information; matters related to a prevention of medical accidents; publication of cases in the GMP case book, and research related to administrative notifications.
3. Research on Issues in Pharmaceutical Regulations and Quality of Eye Drops, and Actions to Address These Issues
   The Study Group holds plant tours and various study sessions, as well as conduct questionnaires and exchanges of opinions with the member companies of the Study Group, in order to solve issues related to pharmaceutical regulations, manufacturing control and quality control of eye drops. The Study Group also tries to standardize interpretation and terminology, and consider measures to address these issues, aiming to support learning of knowledge and skills.
4. Cooperation with Eye Drops Study Group of PMAT
   To gather opinions from eye drops industry and facilitate making proposal to the administration and industry organizations, the Study Group cooperates with Eye Drops Study Group of PMAT in conducting joint report meetings on the results of research study and joint opinion exchange meetings. The Study Group holds workshops and study sessions, including tours to production sites of pharmaceutical products and other subjects. It also supports learning of general knowledge and skills related to pharmaceuticals among member companies of KPIA’s and PMAT’s Study Group, and conduct opinion exchanges leading to quality improvement of pharmaceuticals.

6.Intellectual Property Study Group

Intellectual Property Study Group establishes each Sub-Committee in the field of patent, patent information and trademark, respectively. Each Sub-Committee selects research topics to collect information and to conduct practical studies. The topic includes various issues of intellectual property systems in terms of patents/trademark examinations/trials related to pharmaceuticals, as well as healthcare that pharmaceutical companies have worked on in recent years. Sub-Committee also addresses issues in the practice of survey and search of intellectual property information. 2) The Study Group also discusses various intellectual property issues with JPO or other relevant agencies, in cooperation with Intellectual Property Study Group of PMAT. The Study Group distributes information and results obtained by these activities to member companies in order to support their intellectual property activities.

In FY2024, the Study Group focuses on the following activities:

1. Patent Sub-Committee
   The Sub-Committee studies various issues concerning patent systems in Japan and overseas.
   The Sub-Committee collects and reviews information in Japan in a timely manner, mainly regarding practical aspects of examination and appeal by JPO as needed, with paying attention to the trends after the revision of the Patent Act or the Examination Guidelines, to provide member companies with results of these activities. Hearing opinions from member companies, the Sub-Committee submits requests and opinions to JPO or other relevant administrative organizations in cooperation with Intellectual Property Study Group of PMAT, as necessary.
   The Sub-Committee also collects pharmaceuticals and healthcare related information as well as precedents and theories related to a patent law in each overseas country, and conduct research and analysis on the information. It identifies issues that the pharmaceutical industry in Japan has been facing in recent years, and proposes actions to them.
2. Patent Information Sub-Committee
   The Sub-Committee is suspended due to the lack of member companies wishing to participate in it.
3. Trademark Sub-Committee
   The Sub-Committee is suspended due to the lack of member companies wishing to participate in it.

7.Medical Information Service Study Group

The Medical Information Service Study Group handles issues occurring in customer service departments of pharmaceutical companies that directly receive inquiries from medical professionals such as medical doctors and pharmacists, patients, and general consumers. The Study Group works to acquire not only product knowledge regarding its own products, but also a wide range of peripheral knowledge, including response skill development and skills for operator education, and holds various study sessions and workshops so that one can respond to a wide variety of inquiries.
As part of its social contribution activities, the Study Group has also been registered as a Sukoyaka Partner of Osaka City as a new initiative to disseminate information on proper use of pharmaceuticals to general consumers, and begins visiting social welfare centers in the city to give on-site lectures.

In FY2024, the Study Group focuses on the following activities:

1. Activities of Study Group of Whole and Individual Sub-Committee
   The Whole Study Group works to promote mutual understanding among member companies by feeding back to the members the information obtained through attendance of the representatives from the “Liaison Meeting for Medical Information Service Manager” hosted by PMDA and the Sub-Committee Meeting for Medical Information Service under Pharmacovigilance Study Committee of FPMAJ.
   The Study Group forms the Information Review Study Working Group and the Case Study Working Group under the Study Group, and makes great efforts with mutual development as well as self-improvement through monthly regular meetings of these groups.
   Information Review Study Group encourages self-improvement through plan, development, and management of various study groups and workshops. It also strives to gain a reputation of being attractive Study Group activities.
   Case Study Working Group works to improve communication skills through investigation of consultation cases, and feedback their results to member companies so that they can be used as educational materials in each member company
2. Holding of Seminars and Training Sessions
   The Study Group holds the following annual regular events to encourage member companies to acquire and broaden their knowledge.
   
   • Pharmaceutical Consultant Forum
   • Inquiry response skill up training
   • Site tour
3. Holding of Study Workshops to Acquire a Wide Range of Knowledge
   The Study Group identifies needs of Group members, holds timely study workshops on topics of interest to Group members in order to obtain various knowledge.
4. Cooperation with Related Organizations
   The Study Group considers to collaborate with related organizations regarding a corresponding to common issues (such as a corresponding to customers).
5. Disseminating Information on Proper Use of Pharmaceuticals to General Consumers
   The Study Group has been registered as a Sukoyaka Partner of Osaka City and begins visiting social welfare centers in the city to give on-site lectures.

8.Pharmacovigilance Study Group

Pharmacovigilance Study Group participates in discussion sessions and projects organized by administrative organizations, FPMAJ and other organizations to collect latest information on safety measures for pharmaceutical products. It also supports member companies’ safety activities by providing feedback about information to member companies in a timely and appropriate manner and distributing notifications issued by the administrative organizations. The Study Group exchanges and discusses new issues related to drug safety measures mainly through its standing committee. Based on the results of these activities, it makes proposals to administrative organizations, FPMAJ and other related organizations as necessary. It also plans and conducts workshops and training sessions as part of educational activities. Information Sub-Committee under the Study Group supports member companies to take prompt and appropriate post-marketing safety management by raising awareness of the need to improve the ability of the person in charge of operations to assess side effects of pharmaceutical products.

In FY2024, the Study Group focuses on the following activities:

1. Activities Related to New Post-Marketing Safety Management Operating Procedures
   The Study Group works to collect information in a timely manner from the administrative organizations and FPMAJ (participation in the Safety Committee of FPMAJ) regarding the revision of PMD Act and new movements of pharmacovigilance, supports safety measures of member companies regarding the post-marketing safety management operating procedures by giving feedback about information to member companies, and makes proposals to FPMAJ, etc. if necessary.
2. Activities Related to Compliance (Safety) by Marketing Authorization Holders
   The Study Group supports member companies by collecting and providing information related to on-site inspections of GVP conducted by local governments and compliance inspections of GPSP by PMDA, and other related information in a timely manner so that they can smoothly comply with regulatory requirements. The Study Group participates in Drug Standard Evaluation Sub-Committee and Drug Good Distribution Practice Sub-Committee under Pharmaceutical Regulatory Council of Osaka Prefectural Government and provides opinions. The Study Group also gives feedback about information to member companies to ensure that they learn necessary matters.
3. Activities Related to the Drug Information Service System
   The Study Group participates in FPMAJ information service system project, and provides opinions on PMDA’s “Pharmaceuticals and Medical Devices Information Providing Website”. The Study Group gives feedback about the information to member companies to ensure that they learn necessary matters.
4. Activities Related to Measures to Prevent Medical Accidents
   The Study Group participates in the Safety Committee of FPMAJ, and gives feedback about information to member companies so that they can ensure safety in the use of their pharmaceuticals from the perspective of measures to prevent medical accidents and appropriately respond to the provision of information on the safe use of pharmaceuticals.
5. Enlightenment on Drug Safety Measures
   The Study Group enhances the awareness of importance of drug safety measures through planning and holding seminars on drug safety by external lecturers as well as lecturing at the Pharmaceutical Regulatory Affairs Workshops and the General Marketing Director Study Course.
   Information Sub-Committee, regularly scheduled monthly meetings, supports member companies to take proper actions without omissions by improving the abilities of the person in charge of operations to evaluate safety management information and preparing appropriate reporting forms to the administrative organizations through reviews of serious adverse reaction cases, research reports, and action reports by group work. By using published pharmaceutical product RMPs, the Sub-Committee also examines the components of these RMPs and the evidence of safety specification items and provides support to member companies to deepen their understanding of RMPs. The Study Group works to improve the response capability of member companies through providing topics related to pharmacovigilance from standing members and sharing of understanding of issues in safety management operations and related notifications.
   The Study Group releases serious adverse reaction cases, research reports and action reports, and reference materials for RMP prepared by Information Sub-Committee to member companies as a deliverable.

9.MR Education and Training Study Group

Medical Representatives (MR) Education and Training Study Group supports member companies in conducting effective MR education and training to enhance and strengthen the contents of education and training programs of member companies, aiming to improve the quality of introductory education and continuing education of MR.
The MR Education & Accreditation Center of Japan has set up various committees to the forthcoming MR accreditation system reform in FY2026, and the Study Group also strives to reflect requests of member companies at these committees.

In FY2024, the Study Group focuses on the following activities:

1. Support for Introductory/Continuing Education of MR for the reform of MR Accreditation System
   
   1. Introductory Education
      Introductory Education is an education and training program aimed at acquiring minimum qualities (knowledge, skills, and sense of ethics) required to be an MR and is divided into basic education and practical education. Basic education includes the sharing of education materials and information that can be used for MR accreditation examination, and conducting last-minute lectures for MR accreditation examination by experts in preparation for the MR accreditation exam.
      In practical education, the Study Group shares information on the accreditation standards for ethics and safety management educations being discussed by the Practical Education Accreditation Standards Review Committee.
   2. Continuing Education
      Continuing Education is a lifelong education and training program to maintain and improve qualities required for MR activities and is divided into basic education and practical education. Continuing Education is designed to acquire the latest information, knowledge, and skills in the ever-evolving healthcare industry. Like Introductory Education, the Study Group shares the methods of implementing education and training and checking results at the general meeting as well as identifies common issues, discusses solutions to solve issues, and puts them into practice in an education and training program of the member companies.
2. MR Educator Course
   MR educator course sets up a curriculum related to MR accreditation system and MR textbooks to support an education and training program of the member companies. To provide the most up-to-date information, lecturers are selected from the member companies who are familiar with the contents of training, and for some subjects, outside lecturers are selected. In addition, the Study Group makes efforts to publicize this course by posting posters on KPIA’s website and in KPIA’s bulletin.
3. Activities related to MR Accreditation Center of Japan
   In collaboration with MR Accreditation Center of Japan, the following activities are carried out:
   
   • To send a representative from the Study Group to Education and Training Committee of MR Accreditation Center of Japan and to attend regularly scheduled meetings of Education and Training Committee to collect appropriate information.
   • To collect the latest information at MR forums, education and training promotors’ meetings, education and training system accreditation workshops and reflect it in an education and training program of the member companies.

10.Clinical Trial Promotion Study Group

Clinical Trial Promotion Study Group collects issues related to clinical trials from member companies and hold active opinion exchange meetings to find concrete solutions for these issues that match the actual conditions of clinical trials. The results of these activities are communicated to member companies. The results obtained through these opinion exchange meetings that can be shared among member companies are also compiled into publications.

In FY2024, the Study Group focuses on the following activities:

1. Promotion of Working Group Activity
   Clinical Trial Sub-Committee, the sub-sector of the Study Group, has formed working groups that examine various subjects related to clinical trials. In FY2024, The Sub-Committee sets up working groups on each of the following four (4) themes. The group members share the latest information, knowledge and experience related to GCP with each other and strives for mutual improvement by making effective use of Web meetings. Through these activities of the working groups, it supports for effective and efficient clinical trial activities of member companies.
   Theme 1: Guidance for Preparation of Quality Management Plans and Reports for Clinical Trials
   Theme 2: Considerations for Future GCP Renovation
   Theme 3: Expanding the Possibilities of Medical Affairs
   Theme 4: Bioequivalence Studies of Generic Drugs (Generics) in Response to ICH M13A Guideline “Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
2. Support Activities for the Association Business
   As in the past, the Study Group provides lecturers on GCP-related themes at the pharmaceutical regulatory affairs workshops held by KPIA according to the annual curriculum in order to contribute to improving the knowledge of the person in charge of operations in member companies.
3. Cooperation with Related Parties
   The Study Group cooperates with MHLW, PMDA, Osaka Prefectural Government, Clinical Trial Network Osaka, Japan Society of Quality Assurance, Osaka Medical Association, and other related parties, and disseminates useful information obtained from relevant organizations.
   It also promotes cooperation with other related parties, including publicity of their events at their requests.

Abbreviation

• • BiocK:
    Biocommunity Kansai
  • FPMAJ:
    Federation of Pharmaceutical Manufacturers’ Association
  • GCP:
    Good Clinical Practice
  • GDP:
    Good Distribution Practice
  • GMP:
    Good Manufacturing Practice
  • GQP:
    Good Quality Practice
  • IT:
    Information Technology
  • JETRO:
    Japan External Trade Organization
  • JGA:
    Japan Generic Medicines Association
  • JMACCT:
    Center for Clinical Trials, Japan Medical Association
  • 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
  • MRA:
    Japan-EU Mutual Recognition Agreement
  • OTC drug:
    Over-the-Counter drug
  • PACMP:
    Post-Approval Change Management Protocol
  • PIC/S:
    Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
  • 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
  • PMRJ:
    Pharmaceutical and Medical Device Regulatory Science Society of Japan
  • PRAISE-NET:
    Pharmaceutical Regulatory Affairs Information Service-Network
  • R&D:
    Research and Development
  • RMP:
    Risk Management Plan