原薬工業会とは活動紹介
原薬工業会は、各業界団体との連携により、原薬製造業者の要望意向を関係当局に伝え、
より良い事業環境作りに貢献いたします。
また、会員企業の事業活動の一助となるように、日本製原薬の良さを発信し、
メイドインジャパンの価値を伝えることに努めます。
- Administrative and Economic Committee
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Administrative and Economic Committee
総務経済委員会は、将来を見据えて、当工業会の運営の在り方を考え、会員各社の立場を考慮した施策を講じております。医療や社会環境の変化、内外の諸問題の動向について調査・研究し当工業会の方向性を示すと共に、業界をリードし、如何に医薬品産業に貢献するかを考え、下記事項に付き運営管理いたしております。
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Strengthening activities to
enhance our presence -
- Organizing General Assembly and Board Meetings
- Planning to vitalize and facilitate the activities of respective Committees
- Examining issues for which other Committees are not responsible
- Examining issues of common interest to our member companies
- Planning and organization of JBPMA events
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- GMP Committee
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GMP Committee
GMP委員会はGMPを遵守すると共に、GMPを効率的且つ合理的に実施していくための方策を確率することを主眼に置き、併せてGMP実施に伴う品質保証体制の在り方について究明をするため、種々の活動を行なっております。
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Promoting proper
application of GMP -
- Organizing annual seminars for GMP practitioners
- Support and information exchange for GMP activities of API manufacturing plant
- Networking with the industry organizations and participating in the dialogues
- Submitting opinions and requests related to GMP through the industry organizations and conferences
- Participating in research task forces for regulatory science by the Ministry of Health, Labour and Welfare (MHLW)
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- Regulatory Committee
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Regulatory Committee
法規委員会は原薬に関わる薬機法をはじめとした法的諸問題を調査・研究し、問題点の究明と解決のための検討を行なっております。
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Serving to solve legal issues
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- Research and studies of the Pharmaceuticals and Medical Devices Law and relevant regulations related to drug substances
- Reviewing and responding to the problem area of handling APIs
- Working group activities and research according to subject and preparation of research reports
- Exchange of opinions with the industry organizations and regulatory authorities
- Announcing notifications from the authorities to the member companies on the homepage
- Participation in the working group on regulatory science research hosted by the MHLW
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