• 發文/公布日期：2004-09-09
• 文件類別：law & regulations
• 分類：安全資訊風險溝通表
• 點閱次數：211

主旨：

Regulations Governing Safety Mornitoring of Medicines

說明：

Regulations Governing Safety Monitoring of Medicines Article 1 This set of Regulations is formulated in accordance with regulations of Paragraph 2, Article 45 of the Pharmaceutical Affairs Act. Article 2 This set of Regulations applies to the following: 1. New medicines mentioned in Article 7 of the Pharmaceutical Affairs Act; 2. Medical devices designated by announcement of the Department of Health, the Executive Yuan (hereafter referred to as the Department); 3. Other cases deemed applicable by announcement of the Department. Article 3 New medicines that have passed review for registration and market approval, and have been issued permit licenses, the safety monitoring period shall be five years from the date of the issuance of licenses. The safety monitoring period of Subparagraph 2 of the preceding Paragraph shall be three years from the date of the issuance of licenses. The safety monitoring period of Subparagraph 3 of the preceding Paragraph shall following regulations of the Department. Article 4 During the period of drug safety monitoring, pharmaceutical dealers holding permit licenses of medicines shall actively collect safety information on drug use available both domestically and abroad. In addition to making report following the Regulations Governing the Reporting of Severe Adverse Reactions of Medicines, other adverse reactions of medicines shall also be recorded and listed in the periodic safety report of drugs, and reported in the time period designated by the Department. In the case that pharmaceutical dealers fail to submit reports in accordance with regulation of the preceding Paragraph, the Department may re-evaluate the safety of the medicines. 　　　 Article 5 For new drugs that have completed clinical trials or bridging studies in country and have been approved by the Department, during the period of safety monitoring of new drugs, medical care institutions may not ask for the clinical trials or trial use of individual drug. This regulation does not apply to the laboratory testing for acceptance of products. Article 6 This set of Regulations shall be implemented on the day of announcement.