• ESG 永續報告書

    2020年 企業永續報告書

    2019年 企業社會責任報告書

  • 公司年報

      • Topic: Safety of Clinical Trial Participants
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-210a.1 Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials 本公司針對臨床試驗之風險評估,由委外研究機構(CRO)執行,並以內部標準作業程序《Vendor Selection and Management》為主,規定執行臨床試驗中的品質保證及品質管理活動。目前沒有因違反GCP而與委外研究機構(CRO)中途中止的臨床試驗案件。每個臨床開發階段我們都有稽核(Audit)和查核(Inspection)的機制,並謹遵《赫爾辛基宣言》、《國際醫藥法規協和會藥品優良臨床試驗規範(ICH-GCP)》。在醫院正式啟動臨床試驗前,必須取得受試者的書面知情同意,並依照試驗計劃書的納入與排除條件嚴格篩選合適的受試者 1.3 生物新藥的研究發展

        27

        HC-BP-210a.2 Number of FDA Sponsor Inspections related to clinical trial management and pharmacovigilance that resulted in: (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI) 藥華醫藥目前未有此情事
        HC-BP-210a.3 Total amount of monetary losses as a result of legal proceedings associated with clinical trials in developing countries 藥華醫藥目前未有此情事
      • Topic: Access to Medicines
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-240a.1 Description of actions and initiatives to promote access to health care products for priority diseases and in priority countries as defined by the Access to Medicine Index 本公司的4大聚焦疾病領域之一為罕見血液疾病截至本報告書出具前,用於治療真性紅血球增多症(PV)的藥品Besremi®已於歐洲18個國家銷售約13,000針。我們也自2016年開始,連續6年贊助舉辦亞洲骨髓增生性腫瘤國際研討會(MPN Asia),讓世界各地關注骨髓增生性腫瘤(MPN)疾病的醫師及學者們,都能夠持續獲得最新的研究及治療方式。本報告書第6章各小節,則詳細說明了我們依循Access to Medicine Index, 2020的框架所制定的「藥物近用」策略、執行計畫與其年度成果以及未來目標 1.5 積極佈局全球行銷策略 第6章

        30

        116~130

        HC-BP-240a.2 List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP) 藥華醫藥目前未有此類藥品
      • Topic: Affordability & Pricing
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-240b.1 Number of settlements of Abbreviated New Drug Application (ANDA) litigation that involved payments and/or provisions to delay bringing an authorized generic product to market for a defined time period 藥華醫藥目前未有此情事
        HC-BP-240b.2 Percentage change in: (1) average list price and (2) average net price across U.S. product portfolio compared to previous year 藥華醫藥目前尚未有於美國境內販售之藥品
        HC-BP-240b.3 Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous year 本公司的訂價策略是依各國的醫療費用可負擔能力(affordability),並參考世界衛生組織(World Health Organization, WHO)發布的《WHO Guideline on Country Pharmaceutical Pricing Policies》來制訂合理公平之價格。未來也將持續追蹤藥品價格於世界各國的訂定,以確保病人的可負擔性 6.4 穩定、安全、高品質的藥品供應鏈

        127

      • Topic: Drug Safety
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-250a.1 List of products listed in the Food and Drug Administration’s (FDA) MedWatch Safety Alerts for Human Medical Products database 本公司已完成建置總公司藥物安全監視機制,子公司及其他藥品供應所在國家或地區依各地法規及藥品上市時程建置完成。我們將持續對上市後之新藥進行安全性監視及風險管控。目前尚未有於美國境內販售之藥品;已於全球銷售之藥品亦未有任何藥品不良反應通報、回收藥品等情事 3.6 有效的藥物安全監視與回收

        80

        HC-BP-250a.2 Number of fatalities associated with products as reported in the FDA Adverse Event Reporting System
        HC-BP-250a.3 Number of recalls issued; total units recalled
        HC-BP-250a.4 Total amount of product accepted for takeback, reuse, or disposal
        HC-BP-250a.5 Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practalsoices (cGMP), by type
      • Topic: Counterfeit Drugs
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-260a.1 Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting 本公司已建立每批藥品的料號、批號與出廠活動紀錄確保批次流向與溯源性,以《產品代號及批號編碼程序書》等標準作業程序進行管理與追蹤。我們也訂有《產品二級包裝及序列化批次紀錄》,規範國外的委外加工廠進行產品商業化包裝和序列化的操作流程。預計於美國市場販售的Besremi®,也已於2020年完成藥品序列化的導入 3.1 建構完善的供應鏈體系
        3.6 有效的藥物安全監視與回收

        64

        83

        HC-BP-260a.2 Discussion of process for alerting customers and business partners of potential or known risks associated with counterfeit products 當獲報藥品有已知或可能的製造瑕疵、變質、仿冒品或任何其他嚴重的品質問題時,本公司 QA 部門將開展調查及啟動產品回收程序與回收行動。並依藥物危害等級,於一定期限之內將產品從使用端移除,並妥善處理回收品,主動通報當地主管機關 3.6 有效的藥物安全監視與回收

        84

        HC-BP-260a.3 Number of actions that led to raids, seizure, arrests, and/or filing of criminal charges related to counterfeit products 藥華醫藥目前未有此情事
      • Topic: Ethical Marketing
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-270a.1 Total amount of monetary losses as a result of legal proceedings associated with false marketing claims 藥華醫藥目前未有此情事
        HC-BP-270a.2 Description of code of ethics governing promotion of off-label use of products 在藥品行銷與標示方面,我們嚴格遵循WHO與各國藥業行銷倫理規範,且為確保藥華醫藥同仁在與醫護人員互動合於合理規範以及相關的藥物與醫療法規,也都接受過內部教育訓練與法令宣導的藥品行銷倫理規範。更多說明詳見2.3 法遵與誠信經營 2.3 法遵與誠信經營

        48

      • Topic: Employee Recruitment, Developing & Retention
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-330a.1 Discussion of talent recruitment and retention efforts for scientists and research and development personnel 本公司透過薪酬福利、友善環境、人性化管理、暢通內部輪調及訓練發展等方式,塑造穩定留才的工作環境。我們深入各專業領域延攬生物醫藥及研發人才,積極招募醫學臨床及全球化管理專才。2020年台灣總部及全球共招募超過30名研發及醫學研究專才,佔總員工人數之10% 4.1 幸福職場

        90

        HC-BP-330a.2 (1) Voluntary and (2) involuntary turnover rate for: (a) executives/senior managers, (b) midlevel managers, (c) professionals, and (d) all others 2020年度主管職留任率高達93.94%,且近3年藥華醫藥的全體人員成長率皆持續穩定地成長。有關本公司新進與留任率等相關說明與計算,詳見4.1 幸福職場 4.1 幸福職場

        90

      • Topic: Supply Chain Management
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-430a.1 Percentage of (1) entity's facilities and (2) Tier I suppliers' facilities participating in the Rx-360 International Pharmaceutical Supply Chain Consortium audit program or equivalent third-party audit programs for integrity of supply chain and ingredients 藥華醫藥目前雖未針對上游供應鏈進行外部稽核,但我們仍透過內部嚴謹的程序,嚴格監控原料、物料、儀器/設備供應商的篩選、評鑑與核准。我們每年也會定期進行供應商/承攬商考核,採取內部考核審查與實地稽核兩大制度併行。連續2年度,內部考核審查與實地稽核皆100%完成 3.2 當責的供應商管理

        69

      • Topic: Business Ethics
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-510a.1 Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery 藥華醫藥目前未有此情事
        HC-BP-510a.2 Description of code of ethics governing interactions with health care professionals
      • Activity Metrics
        Code Accounting Metric Disclosure 參考章節 對應的 SDGs 頁次
        HC-BP-000.A Number of patients treated 累計至2021年第1季,Besremi®於歐洲18個國家銷售約13,000針,提供近千名病患使用 1.5 積極佈局全球行銷策略

        30

        HC-BP-000.B Number of drugs (1) in portfolio and (2) in research and development (Phases 1-3) 本公司已在全球啟動多國、多中心臨床試驗,累計全球超過19件的臨床試驗案,造福病患達千名以上 1.3 生物新藥的研究發展
        6.2 創新藥物 解決未被滿足的疾病需求

        26

        122