Download - 藥品優良安全監視規範Guidance for
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Guidance for
Good Pharmacovigilance Practice
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1.Safety Specification 2.Pharmacovigilance Plan 3. 4.Risk Minimization Plan 5. 6.
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1. ICH Topic E 2 E Pharmacovigilance Planning (PvP). European Medicines Agency. June 2005 CPMP/ICH/5716/03 2. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. Clinical Medical. March 2005. 3. VOLUME 9A of The Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use Final March 2007. 4. Pharmaceutical Administration and Regulations in Japan. March 2007. http://www.jpma.or.jp/jpmalib/0607/index.html (Japanese) http://www.jpma.or.jp/english/parj/0607.html (English) 5. Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Registered Medicines Regulated by Drug Safety and Evaluation Branch. July 2003 Amended 31 May 2005.
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Summary of PSUR for (Period covered: )
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Table ISummary by number of cases
Number Of Cases Type of Cases Taiwan Other countries Serious Non Serious Total (Serious + Non Serious Cases) (+)
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PSUR Table IITabulation of all Adverse Drug Reactions by SOC in Taiwan (Period covered: ________) SOC ( System Organ Classes)
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MedDRA System Organ Class Serious Case Non Serious Cases Total Cumulative Total MedDRA Blood and lymphatic system disorders Cardiac disorders Ear and labyrinth disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (including cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Vascular disorders Total Cumulative Total
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Table IIITabulation of all Adverse Drug Reactions by SOC in Others Countries (Period covered: ____) SOC ( System Organ Classes)
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MedDRA System Organ Class Serious Case Non Serious Cases Total Cumulative Total MedDRA Blood and lymphatic system disorders Cardiac disorders Ear and labyrinth disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders
Neoplasms benign, malignant and unspecified (including cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders Vascular disorders Total Cumulative Total
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