Regulations for Reporting Serious Adverse Reactions of Medicaments Article 4

The reporting form referred to in the previous article may be filled out according to the electronic transmission standardization format of the International Council for Harmonisation (ICH).
中文原文 嚴重藥物不良反應通報辦法第4條
前條通報表之填具,得逕依國際醫藥法規協和會(TheInternationalCouncilforHarmonisation,ICH)之電子傳輸標準化格式為之。

English translation for reference only; the Chinese text prevails. Not legal advice.