Consulting services to meet GxP CSV requirements
for Pharmaceuticals and Medical devices
REFERENCE
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The Technical Guidelines for Clinical Safety Evaluation of New Drugs
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The Technical Guidelines for Clinical Safety Evaluation of New Drugs
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Guidelines for the Summary Analysis and Reporting of Safety Information during Clinical Study (Trial)
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Guidelines for the Summary Analysis and Reporting of Safety Information during Clinical Study (Trial)
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(Portuguese Original) : ANVISA Dispõe sobre a obrigatoriedade de execução e notificação de ações de campo por detentores de registro de produtos para a saúde no Brasil.
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(Japanese/ English: Portuguese Original) : ANVISA Establishes mandatory execution and notification of field actions by medical device registration holders in Brazil
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(Portuguese Original) : ANVISA Dispõe sobre normas de tecnovigilância aplicáveis aos detentores de registro de produtos para saúde no Brasil.
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(Japanese/ English: from Portuguese Original) : ANVISA Provisions regarding post-market surveillance applicable to registration holders of health product in Brazil
DOWNLOAD
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The Technical Guidelines for Clinical Safety Evaluation of New Drugs
新药临床安全性评价技术指导原则
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The Technical Guidelines for Clinical Safety Evaluation of New Drugs
新薬臨床安全性評価技術指導原則
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Guidelines for the Summary Analysis and Reporting of Safety Information during Clinical Study (Trial)
1. 《药物临床试验期间安全性信息汇总分析和报告指导原则（试行）》
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Guidelines for the Summary Analysis and Reporting of Safety Information during Clinical Study (Trial)
1. 薬物臨床試験期間安全性情要約分析報告指導原則
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(Portuguese Original) : ANVISA Dispõe sobre a obrigatoriedade de execução e notificação de ações de campo por detentores de registro de produtos para a saúde no Brasil.
(Portuguese Original) : ANVISA Dispõe sobre a obrigatoriedade de execução e notificação de ações de campo por detentores de registro de produtos para a saúde no Brasil.
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(Japanese/ English: Portuguese Original) : ANVISA Establishes mandatory execution and notification of field actions by medical device registration holders in Brazil
（日・英翻訳版：原本ポルトガル語）：ANVISA ブラジルにおける医療機器登録保有者による現地活動の必須実施要件
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(Portuguese Original) : ANVISA Dispõe sobre normas de tecnovigilância aplicáveis aos detentores de registro de produtos para saúde no Brasil.
(Japanese/ English: refer from Portuguese Original) : ANVISA Provisions regarding post-market surveillance applicable to registration holders of health product in Brazil
-
(Japanese/ English: from Portuguese Original) : ANVISA Provisions regarding post-market surveillance applicable to registration holders of health product in Brazil
（日・英翻訳版：原本ポルトガル語）：ANVISA ブラジルにおける健康製品の登録保有者に適用される市販後調査に関する規定