Laws Information

法規資訊
Title: Regulations for Publication of Drug Information
Am Date: 2012-07-31
Legislative History: Amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1011405253, on July 31, 2012.

Transaction

Amendment

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.