Regulations for the Management of Drug Safety Surveillance Article 6
In any of the following situations, the pharmaceutical dealer shall report it through the online system established by the central competent health authority within three days from the day of awareness of the situation:1. Unexpected serious adverse drug reactions or serious adverse drug reactions occurs at a frequency that exceeds expectations.2. It is required to evaluate new or altered contraindications or restricting use.3. The drug is suspended or withdrawn from the market due to adverse reactions in A10 countries, which include Germany, US, UK, France, Japan, Switzerland, Canada, Australia, Belgium, and Sweden.4. It is determined that it should be reported when a drug is suspended or withdrawn from the market due to adverse reactions in countries other than those in the preceding subparagraph.Serious adverse drug reactions indicated in Subparagraph 1 of the preceding paragraph refer to those indicated in Article 4 of the Regulations for Reporting Severe Adverse Reactions of Medicaments.
中文原文 藥物安全監視管理辦法第6條
藥品有下列情形之一者，藥商應自知悉之日起三日內，至中央衛生主管機關建置之網路系統通報：
一、發現未預期或超出預期發生頻率之嚴重藥品不良反應。
二、有評估新增或變更禁忌、使用限制之必要。
三、於德國、美國、英國、法國、日本、瑞士、加拿大、澳洲、比利時、瑞典共十國（以下簡稱十大醫藥先進國家），因不良反應被暫停使用或下市。
四、於前款外其他國家，因不良反應應暫停使用或下市，經評估應通報。
前項第一款所稱嚴重藥品不良反應，指嚴重藥物不良反應通報辦法第四條規定之情形。
一、發現未預期或超出預期發生頻率之嚴重藥品不良反應。
二、有評估新增或變更禁忌、使用限制之必要。
三、於德國、美國、英國、法國、日本、瑞士、加拿大、澳洲、比利時、瑞典共十國（以下簡稱十大醫藥先進國家），因不良反應被暫停使用或下市。
四、於前款外其他國家，因不良反應應暫停使用或下市，經評估應通報。
前項第一款所稱嚴重藥品不良反應，指嚴重藥物不良反應通報辦法第四條規定之情形。