1.Pharmaceutical Regulatory Affairs Committee

Established on September 1, 1948

The Pharmaceutical Regulatory Affairs Committee promotes members’ compliance with the Act on Securing Quality, Efficacy and Safety of Pharmaceutical Products and Medical Devices (the Pharmaceuticals and Medical Devices Act: 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 regulatory laws in other countries, to discuss systems related to pharmaceutical laws and regulations, and problems 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 problems related to the PMD Act.

In FY2023, the Committee will focus on the following activities:

1. Strengthening of the Committee’s Functional Activities such as Research Study and Proposals Related to Pharmaceutical Laws and Regulations
   The revised PMD Act promulgated in December 2019 (hereinafter referred to as the “2019 Revised Act”) was enacted in phases as follows: in September 2020, the legislation of the Pioneer Review Designation System and the Conditional Accelerated Approval System; in August 2021, the establishment of a legal compliance system for Pharmaceutical Marketing Authorization Holders, etc., the digitalization of package inserts, the introduction of procedures for changing approved matters through PACMP, and the review of GMP inspections for international harmonization, etc.; and in December 2022, the mandatory labeling of a code on containers to improve traceability. We will collect and study the relevant information in order to enable accurate response to the operation of the administrative ordinances, notices, etc. associated with the 2019 Revised Act that have been issued. In addition to the activities mentioned above, to solve problems faced by member companies in practicing pharmaceutical businesses in accordance with the 2019 Revised Act, the Committee will collect opinions and requests from member companies and conduct research to identify problems in pharmaceutical business practice. Based on these activities, the Committee will make requests to the relevant administrative agencies through FPMAJ to issue notifications clarifying the measures to be taken.
   In FY2023, as a review of the 2019 Revised Act will be initiated five years after its enforcement, the Committee will take into consideration the status of operation of various systems and respond to issues by submitting requests for system revision to FPMAJ and by actively participating in the consideration of revision requests at FPMAJ.
   It will also compile a proposal that summarizes requests and opinions from member companies regarding pharmaceutical and healthcare regulations and requests for support and incentive measures. It will present this proposal to the relevant public agencies in opinion exchange meetings and other occasions.
2. Proactive Proposals Regarding Measures that Will Help the Development and Growth of Member Companies and Proposals Regarding Rationalization of Regulations
   The Committee will make proposals for rationalization of regulations and systems to match the globalization of pharmaceuticals and related products. It will also conduct research and examination and make proposals regarding modification of regulations to accelerate the introduction of next-generation medical treatments such as regenerative medicines and the launch of new healthcare products.
3. Cooperation with MHLW and PMDA
   The Committee will collect opinions and requests from member companies regarding problems they have found in practicing their operations, such as the examinations for approval of drugs (approval of new drugs, partial changes), inspections (document inspection, on-site inspection, GMP compliance inspection), consulting services (face-to-face advice, simplified consulting, etc.), notification services (clinical trial plan, minor change notification, notification of manufacturing of pharmaceuticals for export/ import, etc.), export/ import procedures under the PMD Act, and research and development activities. Based on these opinions and requests, the Committee will propose 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 will keep contact with officers in the pharmaceutical regulatory affairs section of the Osaka Prefectural Government and other local governments to deepen the mutual understanding about pharmaceutical regulations and conduct activities as a local trade organization. The Committee will regularly share information, conduct surveys, review, and exchange opinions on issues and operations of the pharmaceutical affairs system through the “Information Exchange Meeting on Pharmaceutical Affairs,” etc., and make 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 will discuss and conduct research on matters (Guidelines Regarding Legal Compliance and GDP Guideline, etc.) related to business management (Pharmaceutical Marketing Authorization Holders, Manufactures, Wholesalers, etc.), matters related to GMP (Revised Administrative Ordinances on GMP, Inspection of GMP Compliance for each manufacturer, Examination of Conformity regarding Type of Manufacturing etc.) and matters related to registration application (Impurity Control, Inspection of GMP Compliance, Change procedure based on confirmation of PACMP, etc.) as topics and themes with regard to the PMD Act and related laws and subjects
   2. Approval and Authorization Sub-Committee
      1. First Working Group
         The Working group will conduct research on cases of consultation on partial and minor changes, notifications related to partial and minor changes, and PMDA consultation systems from a pharmaceutical point of view as research themes highly related to pharmaceutical affairs such as a change control of approval document (partial changes and minor changes).
         The group will also organize seminars to strive for proactive collection of knowledge and information required as a person in charge of pharmaceutical regulatory affairs.
      2. Second Working Group
         The Working Group will conduct research on pharmaceutical manufacturing method-related matters, ICH Guidelines, and online applications as research themes related to approval review, and approval and licensing, etc., including pharmaceutical manufacturing and marketing approval, investigation applications, and various notifications, etc.
      3. Third Working Group
         The Working Group will conduct research on a regulatory review of manufacturing and marketing approval applications for orphan drugs, a regulatory review of application for the designation of orphan drugs, and real-world data from a pharmaceutical point of view as research themes highly related to pharmaceutical regulatory strategy and examination and investigation for approval mainly focusing on products with new active pharmaceutical ingredients, and daily regulatory affairs for drug development in the field of application and R&D regulatory affairs
      4. Working Group for Drug Approval and Licensing Procedures
         Regarding the publication of the Drug Approval and Licensing Procedures in Japan 2024, the Working Group will review and make necessary revisions to reflect the latest regulatory contents and to further improve their business practice, by adding new regulatory requirements, administrative notifications, reporting and other necessary matters in the Guideline.
      5. Working Group for Approval/Authorization Information
         The Working Group will make proposals to improve the usability and function regarding the database of pharmaceutical-related administrative notifications provided by PRAISE-NET. It will also improve the database by identifying problems in the database for person in charge of pharmaceutical regulatory affairs currently made available via PRAISE-NET to members of the Pharmaceutical Regulatory Affairs Committee and some others.
   3. Sub-Committee for Advertisement/Promotion
      The Sub-Committee will conduct research on the PMD Act and other related laws and regulations regarding Advertisement/Promotion of pharmaceutical products (ethical and OTC) such as Standard for Adequate 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 Premiums and Representations Act, etc., focusing on case studies.
   4. Sub-Committee for Packaging/Labeling
      The Sub-Committee will conduct research on labeling for prescription and OTC drugs, packing design, digitalization of package inserts, interview forms, and distribution code of ethical drugs etc.
   5. Sub-Committee for OTC drugs
      The Sub-Committee will conduct 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 specific to OTC drugs, such as application for approval, marketing, GMP and prescription of traditional Chinese medicine, etc.
   6. Sub-Committee for Overseas Pharmaceutical Regulations
      1. Group for the U.S. and Europe
         The Group will conduct research mainly on the approval and licensing systems in the U.S. and Europe, and exchange views and share information about related topics including the U.S. GMP system, the European Pharmacopoeia Certificate of Conformity (CEP) Guidance, and the European approval and licensing system among member companies.
      2. Group for Asia
         The Group will conduct extensive research on overseas pharmaceutical regulations in Asian countries including China, exchange views and share information on daily operations among member companies.
6. Holding of Workshops and Seminars
   The Joint Pharmaceutical Regulatory Affairs Committee between KPIA and PMAT will be formed. Seminars by MHLW and PMDA representatives on the latest movements in pharmaceutical regulations and other topics will be organized by the Committee, and questions and requests in relation to pharmaceutical regulations during the seminars will be made to assist in its pharmaceutical affairs activities. The Committee will hold workshops and seminars in a timely manner as appropriate that are useful for the practical works of the Committee members and Sub-Committees’ members and related to the activities of Sub-Committees and Working Groups.

2.Technical Research Committee

Established on September 1st, 1948

The Technical Research Committee will participate in the Japanese Pharmacopoeia Expert Committee (hereinafter the “JP Expert Committee”) of PMDA as a sub-committee member and cooperate in the preparing the draft of the Japanese Pharmacopoeia and the Guidance for drafting and revision of the Japanese Pharmacopoeia. The Committee will appropriately conduct surveys on the actual conditions and requests to member companies to ensure the consistency of understanding in the method of quality evaluation, specifications and test methods for pharmaceutical products between the administrational agencies and the Pharmaceutical Industry.
The Committee will also address and solve technical issues occurred in the Japanese Pharmacopoeia and the marketing approval application for pharmaceuticals through activities by working groups organized under the Committee, provision of technical information to member companies, and cooperation/ coordination with other related committees.

In FY2023, the Committee will Focus on the Following Activities:

1. Cooperation in the Revision of the Japanese Pharmacopoeia
   The Committee will dispatch its associate members to the JP Expert Committee and working groups organized under the JP Expert Committee.
   The Committee will contribute to the maintenance and reinforcement of the Japanese Pharmacopoeia, improvement of public health, and also to the international harmonization and globalization of the Japanese Pharmacopoeia by making requests and presenting opinions to the relevant administrational agencies in accordance with the Basic Policy for Preparing the 19th edition of the revised Japanese Pharmacopoeia.
   The Committee will solve the 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 the Revision of Japanese Pharmaceutical Excipients
   Upon request from the Ministry of Health, Labor and Welfare, the Committee will dispatch representatives to the JP Expert Committees on Pharmaceutical Excipients to cooperate in the revision of the Japanese Pharmaceutical Excipients.
3. Provision of Technical Information
   The Committee will report conclusions and points of discussion in the JP Expert Committee and share the progress of the revision for the Japanese Pharmacopoeia with member companies in the whole committee, which is composed of representatives from member companies.
   The Committee will plan and hold lectures and briefings on the Japanese Pharmacopoeia to deepen understanding of the Japanese Pharmacopoeia.
   In cooperation with PMAT, the Committee will prepare and publish the　Practical Guide to the Guidance for drafting the Japanese Pharmacopoeia to supplement the Guidance for drafting the Japanese Pharmacopoeia and to assist in drafting of the Japanese Pharmacopoeia.
4. Working Group Activity
   The Bio-Pharmaceutical Product Working Group will continue its activities to research the quality evaluation method, specifications and test methods and other matters for bio-pharmaceutical products.
   The achievement will be shared with member companies by reporting the details of their activities in the whole committee.
5. Action to Technical Issues of the Japanese Pharmacopoeia and Quality Evaluation
   The Committee will solve technical issues of quality evaluation of pharmaceutical products and general test methods in the Japanese Pharmacopoeia by collaborating with related organizations and committees.

3.Quality Committee

Established on July 1, 1973

To improve the quality assurance systems for pharmaceutical products, the Quality Committee will work to collaborate with Osaka Prefectural Government and other local governments in the Kansai region and promote information exchange and mutual enlightenment regarding GQP and GMP related information with relevant business organizations and committees in pharmaceutical trade organizations such as FPMAJ, and member companies.
In recent years, quality assurance systems for pharmaceutical products have been accelerated international regulatory harmonization and convergence, and scientific and logical proposals and discussions are required on ordinances, notifications and guidelines regarding GQP and GMP (including GDP). The Committee will actively make proposals related to these matters to the administrative organizations through FPMAJ.
The Committee will identify issues in relation to the inspection/guidance of GQP/ GMP and their operation including GDP and make requests or proposals to MHLW and PMDA though FPMAJ and Osaka Prefectural Government to solve the issues and develop mutual understanding between the government and the pharmaceutical industry.
Additionally, the Committee will strive to actively plan and promote measures as an industry organization in order to recover the loss of public trust due to recent manufacturing and quality violations and repeated recalls.

In FY2023, the Committee will focus on the following activities:

1. Identification of Issues and Proposals in Relation to the Inspection/ Guidance of GQP/ GMP and their Operation Including GDP
   • Promotion of various measures after the revision of ministerial ordinance on GMP
   • Revision of PIC/S GMP Guide and these Annex
   • Other administrative notifications from MHLW or the Osaka Prefectural Government, etc. related to GQP/GMP/GDP
2. Promotion of Cooperation with Local Governments Mainly in the Kansai Region
   1. Promotion of Cooperation with the Osaka Prefectural Government
      • The Committee will ensure common understanding regarding problems related to GQP/GMP/GDP through periodical information sharing and exchange of opinions with the Osaka Prefectural Government, and work to solve the issues
      • The Committee will continue to participate in the Standard Evaluation Examination Sectional Meeting for pharmaceutical products under the Osaka Prefecture Pharmaceutical Affairs Council and provide opinions about issues of GQP/GMP
      • The Committee will participate in the “Information Exchange Meeting on Pharmaceutical Affairs” to develop mutual understanding and strive to solve any issues related to regulatory affairs, approval procedures, and inspection/compliance pertinent to pharmaceutical products
   2. Promotion of Cooperation with the GMP Team under the Pharmaceutical Affairs　Division Manager Meeting in the Kansai region
      The Committee will work to cooperate in the activities of the GMP Team comprised of the Chiefs of Pharmaceutical Affairs in the Kansai region and proactively exchange opinions to enhance the partnerships with local governments.
3. Planning and Implementation of Measures as an Industry Organization to Prevent the Recurrence of Serious Quality Problems
   With reference to opinions exchanged with the government, the Committee will consider short-, medium- and long-term measures, and promote activities on short-term measures.
4. Activities toward Problems in the Business Practice
   Three Sub-Committees (the Quality System Research Sub-Committee, the Operations Case Study Sub-Committee, and the Education Sub-Committee) will review and consult problems in the business practice to devise solutions.
   The research subjects for individual Sub-Committees in FY2023 are as follows:
   • Quality System Research Sub-Committee:
     Cleaning Validation
   • Operations Case Study Sub-Committee:
     Management of suppliers and outsourcing contractors, and coordination between marketing authorization holders and manufacturers
   • Education Sub-Committee:
     Publish of "Workbook for GMP of Pharmaceuticals (4th Edition)”

4.International Business Committee

Established on April 1, 2014

The International Business Committee supports international business activities of member companies with an aim to further promote global expansion of Japanese pharmaceutical related industries. The Committee will collaborate with the Secretariat to promote a global development of the pharmaceutical related industries by supporting overseas business development (international business activities) of member companies.

In FY2023, the Committee will focus on the following activities:

1. Strengthening of Cooperation with Overseas Partners to Achieve Improved Access Including Establishment of Pharmaceutical Related Value Chains
   Among overseas countries, Asian economies (China, India, Korea, Taiwan, ASEAN, etc.) in particular have already been becoming important manufacturers of APIs and other related products and have also been growing substantially as a market.
   Due to the high level of interest of member companies in these regions, the Committee will conduct seminars/lectures, matchmaking/net-working meetings, on-site visits, study sessions, and other events on pharmaceutical related value chains focusing on these regions and strengthen cooperation with FPMAJ and related organizations. Regarding Europe and the USA, as it is also important for member companies to understand pharmaceutical related R&D and regulatory trends in these areas, the Committee will continue to collect relevant information, hold seminars, lectures and study sessions, and strengthen 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 the Osaka Prefectural Government, other local governments, and related organizations (such as the Foundation for Biomedical Research and Innovation at Kobe, Kyoto Research Park and Senri Life Science Foundation), the Committee will hold business net-working meetings, lectures and other exchanges with overseas biotechnology clusters and start-ups.
3. Promotion of Activities in Cooperation with Local Governments and Consulate Generals, etc.
   The Committee will strengthen cooperation with overseas governmental agencies and trade organizations, the Embassies and the Consulate Generals in Osaka, MHLW/PMDA, local governments such as Osaka, Kyoto and Kobe, JETRO, the chambers of commerce and industry in Osaka, Kyoto and Kobe, the Kansai Economic Federation and international committees of FPMAJ, JPMA, JGA and the Japan Self-Medication Industry (JSMI), and Biocommunity Kansai (BiocK) and hold conferences and networking meetings aimed at overseas business expansion of member companies.
4. Promotion of Information Sharing on Healthcare Needs, Regulatory Authorities and Systems, etc.
   The Committee will share information on healthcare and medical needs, regulatory authorities/systems, and the business and investment environment in countries of interest to member companies, particularly in Asia. The committee will also hold study sessions as needed to respond to diverse needs.
5. Development of Globally Competent Human Resources
   To promote overseas business development in the pharmaceutical field, it is essential to develop and secure, retain global and foreign human resources. The Committee will identify their needs to support for developing, securing and retaining globally competent human resources, and examine and try the measures needed.
6. Strengthen the Information Distribution Function
   The Committee will strengthen efforts to disseminate the information about our activities to overseas stakeholders by reviewing and enhancing the contents of our English website which introduces our activities and some others.

5.Eye Drops Study Group

Established on July 1, 1977

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

In FY2023, the Study Group will focus on the following activities:

1. Activities Regarding Education on Proper Use of Eye Drops
   The Study Group will continue 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 Government Notifications
   The Study Group will examine matters requested by FPMAJ and JSMI. Such requests include a review of approval criteria for manufacturing of ophthalmic preparations; research on revision of the Japanese Pharmacopoeia General Provisions, the general testing method and reference information; matters related to prevention of medical accidents; publication of cases in the GMP case book, and research related to notifications issued by the government.
3. Research on Problems in Pharmaceutical Regulations and Quality of Eye Drops and Actions to Address these Problems
   The Study Group will hold plant tours and various study sessions in conjunction with questionnaire surveys and opinions exchange with member companies to identify and analyze problems in pharmaceutical regulations, production management and quality management of eye drops. It will also standardize interpretation and terminology, and consider measures to address these problems, aiming to support learning of knowledge and skills.
4. Cooperation with the Eye Drops Study Group of PMAT
   To gather opinions from the eye drops industry and facilitate making proposal to the government and trade organizations, the Study Group will cooperate with the 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 will hold workshops and study sessions, including tours to production sites of pharmaceutical products and other subjects. It will also support the learning of general knowledge and skills related pharmaceuticals among member companies of the KPIA’s or PMAT’s Study Group and conduct opinion exchange meetings leading to quality improvement of pharmaceuticals.

6.Intellectual Property Study Group

Established on February 1, 1956

The 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 conduct practical studies regarding issues in the practice of survey and search of intellectual property information and various problems of intellectual property systems including patents/trademark examinations/trials related to not only pharmaceuticals, but also healthcare worked on by pharmaceutical companies in recent years. The Study Group also has a meeting to discuss various IP issues with the Japan Patent Office (JPO) or other relevant agencies, in cooperation with the 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 FY2023, the Study Group will focus on the following activities:

1. Patent Sub-Committee
   The Sub-Committee will study various issues concerning patent systems in Japan and overseas.
   The Sub-Committee will collect and review information 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 will submit requests and offer opinions to the JPO or other relevant government organizations in cooperation with Intellectual Property Study Group of PMAT, as necessary.
   The Sub-Committee will also collect pharmaceuticals and healthcare related information as well as court precedents and theories related to the patent law in Japan and other countries, and conduct research and analysis on the information. Taking into consideration new partnerships with industries, government and academia that contribute to creation of innovations, it will identify problems to be solved in pharmaceutical industries and propose actions to address these problems.
2. Patent Information Sub-Committee
   The Sub-Committee will be suspended due to the lack of member companies wishing to participate in it.
3. Trademark Sub-Committee
   The Sub-Committee will be suspended due to the lack of member companies wishing to participate in it.

7.Medical Information Service Study Group

Established on February 1, 1995

The Medical Information Service Study Group has handled problems occurring in customer service departments of pharmaceutical companies that directly receive inquiries from medical professionals such as doctors and pharmacists, patients and general consumers. The Study Group works to improve our skills and acquire a wide range of peripheral knowledge as well as the knowledge of the company's own products and conduct study sessions and training sessions so that we can respond to a wide variety of inquiry needs.
In recent years, the Study Group also works to gather information related to IT systems installed in call centers. As a part of our contribution to society, the Study Group also explore the dissemination of information on the proper use of pharmaceuticals to general consumers.

In FY2023, the Study Group will focus on the following activities:

1. Activities of Study Group of the Whole and Individual Sub-Committee
   The Study Group of the Whole will work to promote mutual understanding among member companies by feeding back to the members the information obtained through the 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 the Pharmacovigilance Study Committee of FPMAJ.
   The Study Group will form the Information Review Study Working Group and the Case Study Working Group under the Study Group and make great efforts with mutual study as well as self-improvement through monthly regular meetings of these groups.
   The information Review Study Group will encourage self-improvement through plan, development, and management of various study groups and workshops and it will also strive to gain recognition for the attractiveness of the Study Group’s activities.
   The Case Study Working Group will work to improve the communication skills through investigation of consultation cases and feed their results back to member companies so that they can be used as educational materials for each member company.
2. Holding of Seminars and Training Sessions
   The Study Group will hold 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 will identify needs of Group members, hold timely study workshops on topics of interest to Group members in order to obtain various knowledge.
4. Cooperation with Related Organizations
   The Study Group will examine to collaborate with the related organizations regarding the corresponding to the common issues (such as a corresponding to customers).

8.Pharmacovigilance Study Group

Established on May 24, 1963

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

In FY2023, the Study Group will focus on the following activities:

1. Activities Related to New Post-Marketing Safety Management Operating Procedures The Study Group will work to collect the information in a timely manner from the government and FPMAJ (participation in the Safety Committee of FPMAJ) regarding the revision of PMD Act and new movements of pharmacovigilance, support safety measures of member companies regarding the post-marketing safety management operating procedures by feeding the information back to member companies, and make proposals to FPMAJ, etc. if necessary.
2. Activities Related to Compliance (Safety) by Marketing Authorization Holders
   The Study Group will support member companies by collecting and providing information related to on-site inspections regarding GVP conducted by local governments and compliance inspections regarding GPSP by PMDA, and other related information in a timely manner so that they can smoothly comply with regulatory requirements. The Study Group will participate in the Drug Standard Evaluation Sub-Committee and Drug Good Distribution Practice Sub-Committee under the Pharmaceutical Regulatory Council of the Osaka Prefectural Government and offer opinions. The Study Group will also feed the information back to member companies to ensure that they know necessary information.
3. Activities Related to the Drug Information Service System
   The Study Group will participate in the FPMAJ information service system project and offer opinions on PMDA’s “Pharmaceuticals and Medical Devices Information Providing Website”. The Study Group will feed the information back to member companies to ensure that they know necessary information.
4. Activities Related to Measures to Prevent Medical Accidents
   The Study Group will participate in the FPMAJ’s Safe Drug Use Review Sub-Committee and feed the information back 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 will enhance the awareness of the 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.
   The Intelligence Sub-Committee will support member companies to take proper actions without omissions by improving the abilities of their practitioners to evaluate safety management information and preparing appropriate reporting forms to the government through review of serious adverse reaction cases, research reports and action reports. By using the published pharmaceutical product RMPs, the Sub-Committee will also examine the components of these RMPs and the evidence of safety specification items and provide support to member companies to deepen their understanding of RMPs. The Study Group will work to improve the response capability of member companies through providing topics related to pharmacovigilance from the standing members and sharing of understanding of issues in safety management operations and related notifications, etc.
   The Study Group will release serious adverse reaction cases, research reports and action reports, and investigative documents for RMP prepared by the Intelligence Sub-Committee to member companies as a deliverable.

9.MR Education and Training Study Group

Established on March 3, 1980

The Medical Representatives (MR) Education and Training Study Group will support 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 Study Group will also participate in councils/committees organized by the MR Education & Accreditation Center of Japan and strive to reflect opinions and requests of member companies in the activities of these councils.

In FY2023, the Study Group will focus on the following activities:

1. Support Introductory/Continuing Education of MR based on the MR Accreditation System
   The MR Accreditation System is operated by the MR Education & Accreditation Center of Japan to realize the role^*1 and future vision^*2 of MRs. In order to enhance and strengthen the MR education and training system of its member companies, the Study Group provides support for introductory and continuing education of MR based on the MR Accreditation System.
   • To contribute to medical professionals, healthcare and society by appropriately providing and collecting scientifically based information on the proper use of pharmaceuticals as a “partner in drug treatment” from the patient’s perspective based on high ethical standards.
   • To be a trusted partner by medical professionals through activities to provide, collect, and disseminate pharmaceutical information from patient-oriented perspective.
   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 (1) the sharing of education materials and information that can be used for the MR accreditation examination, and (2) conducting last-minute lectures for the MR accreditation examination by experts in preparation for the exam to pass the MR accreditation examination.
      Practical education is defined as “acquiring the practical qualities necessary for MRs to be patient-oriented and trusted partners by medical professionals,” and since each company needs to set GIO (General Instructive Objectives) and SBO (Specific Behavioral Objectives) for the three subjects of “ethics educations,” “safety management educations,” and “skills educations,” the Study Group will share the methods for implementing education and training and checking results at the general meeting.
   2. Continuing Education
      Continuing Education is a lifelong education and training program to maintain and improve the 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. Similar to Introductory Education, the Study Group will share the methods of implementing education and training and checking results at the general meeting as well as identify common issues, discuss solutions to solve problems, and put them into practice in an education and training program of the member companies.
2. MR Educator Course
   The MR educator course will set up a curriculum related to the 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 will be selected from the member companies who are familiar with the contents of the training, and for some subjects, outside lecturers will be selected. In addition, the Study Group will make efforts to publicize this course by posting posters on KPIA’s website and in the KPIA’s bulletin.
3. Activities related to MR Accreditation Center of Japan
   In collaboration with the MR Accreditation Center of Japan, the following activities will be carried out:
   • Send a representative from the Study Group to the Education and Training Committee of the MR Accreditation Center of Japan and attend regularly scheduled meetings of the Education and Training Committee to collect appropriate information.
   • Send a representative from the Study Group to the Accreditation Examination System Reform Review Committee and cooperate in the study of the reform of the accreditation examination system.
   • Submit comments from the Study Group to the Examination Division of the MR Accreditation Center of Japan on the exam questions and its administration of the MR accreditation examination in order to further improve the quality of the MR accreditation examination.
   • Collect the latest information at MR forums, education and training promotors’ meetings, education and training system accreditation workshops, etc., and reflect it in an education and training program of the member companies.

10.Clinical Trial Promotion Study Group

Established on April 1, 2000

The Clinical Trial Promotion Study Group collects problem cases related to clinical trials from member companies and hold active opinion exchange meetings to find concrete solutions for these problems 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 FY2023, the Study Group will focus on the following activities:

1. Promotion of Working Group Activity
   The Clinical Trial Sub-Committee, the sub-sector of the Study Group, has formed working groups that examine various subjects related to clinical trials. The Sub-Committee sets up the following working groups and the group members will share the latest information, knowledge and experience related to GCP with each other and strive for mutual improvement by making effective use of Web meetings. Through these activities of the working groups, it will support for effective and efficient clinical trial activities of member companies.
   Theme 1:
   Remote Monitoring
   Theme 2:
   Consideration for future GCP Renovation
   Theme 3:
   Current Status and Future Vision of Medical Affairs
   Theme 4:
   Review of Monitoring/SDV methodology for Bioequivalence Studies of Generic Drugs
2. Support Activities for Association Business
   As in the past, the Study Group will provide 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 practitioners in member companies.
3. Cooperation with Related Parties
   The Study Group will cooperate with MHLW, PMDA, the Osaka Prefectural Government, the Clinical Trial Network Osaka, the Japan Society of Quality Assurance, the Osaka Medical Association, and other related parties, and disseminate useful information obtained from relevant organizations.
   It will also promote 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, Labor 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