Regulations for Publication of Drug Information Article 2
The central competent health authority may, if necessary, publicize summary of assessment reports of drug approvals, and the data below which are submitted by pharmaceutical firms in their application for registration, holding and keeping by the authority. The health authority shall keep confidential for any trade secrets in the new drug applications:1. ingredient and instruction of the drug.2. summary of clinical trial protocols.3. information of drug risk management plan and drug safety.
中文原文 藥物資料公開辦法第2條
中央衛生主管機關必要時得公開其所為之藥物核准審查報告摘要，及持有、保管藥商申請藥物查驗登記所檢附之下列資料。
但藥商申請新藥查驗登記所檢附之營業秘密資料，應保密之：
一、藥物成分及仿單。
二、臨床試驗計畫摘要。
三、藥品風險管理計畫及藥物安全相關資訊。
但藥商申請新藥查驗登記所檢附之營業秘密資料，應保密之：
一、藥物成分及仿單。
二、臨床試驗計畫摘要。
三、藥品風險管理計畫及藥物安全相關資訊。