加拿大人類藥品規管活動費用

1. 概覽

加拿大衛生部收取人類藥品相關規管活動費用，包括處方及非處方藥品、生物製品、消毒劑及帶消毒聲明之消毒劑。這些費用支持銷售授權前之安全、有效性及品質評估，以及上市後監視及合規。費用依《藥品及醫療器械費用令》及《管制藥品及麻醉品授權經銷商費用規章》管轄。 來源：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

2. 評估人類藥品提交費用

此費用於藥品銷售授權前收取。加拿大衛生部評估提交及申請之安全、有效性及品質。藥品提交及申請管理指引，以及消毒劑藥品申請管理指引可用。 來源：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

相關連結

• 藥品提交及申請審查費用：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/fees-review-drug-submissions-applications.html
• 人類藥品提交/申請審查費用：https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/pharmaceutical-submission-application-review-funding-fees-drugs-health-products.html
• 藥品提交及申請管理指引：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html
• 消毒劑藥品申請管理指引：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/disinfectants/management-disinfectant-drug-applications-2019/document.html

3. 主檔費用

主檔包含製造、加工或包裝流程及組件之機密資訊。它們依《資訊取得法》及《食品及藥品法》保護機密商業資訊。當資訊不可用於劑型製造商或藥品提交、DIN申請或臨床試驗申請（CTA）贊助商時有用。主檔程序及行政要求載於指引。 來源：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

相關連結

• 主檔程序及行政要求指引：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/master-files-procedures-administrative-requirements.html
• 人類藥品主檔費用：https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/fees-master-files-human-drugs.html

4. 機構執照申請審查費用

此費用適用於評估藥品生產、進口、測試及分銷規管要求合規之機構檢查。藥品機構執照指引、申請表格及申請及性能管理提供。 來源：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

相關連結

• 藥品機構執照費用：https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/drug-establishment-licence-funding-fees-drugs-health-products.html
• 人類及獸醫藥品機構執照申請審查費用指引：https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-drug-establishment-licence.html
• 藥品機構執照及藥品機構執照費用指引（GUI-0002）：https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002.html
• 藥品機構執照申請：指示（FRM-0033）：https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033.html
• 藥品機構執照申請及性能管理（GUI-0127）：https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/management-applications-performance-drug-establishment-licences-0127/document.html

5. 銷售藥品權利費用

這是產業每年支付之費用，用於在加拿大市場銷售及維持人類藥品之權利。它支持上市後監視及合規及執法活動。銷售藥品權利費用指引及藥品公司聯絡及財務帳戶資訊管理資訊表可用。 來源：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html

相關連結

• 銷售藥品權利費用：https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/right-sell-drugs-funding-fees-drugs-health-products.html
• 銷售藥品權利費用指引：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/right-to-sell-drugs-2019/document.html
• 資訊表：藥品公司聯絡及財務帳戶資訊管理：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees/information-sheet-management-drug-company-contact-financial-account-information.html

6. 額外資訊

• 費用設定方式：基於《藥品及醫療器械費用令》及《管制藥品及麻醉品授權經銷商費用規章》。
• 發票支付：支付費用一般指引可用。
• 相關費用：補充保護證書（CSP）費用。
• 更廣資源：申請及提交指引文件、表格及機構執照概覽。
• 頁面更新：最後更新2024年6月17日。 來源：https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fees.html