專案核准藥品安全監視義務之銜接：從藥事法第27條之3 到草案第14條
Bridging Pharmacovigilance Duties for Project-Approved Drugs: From Article 27-3 of the Pharmaceutical Affairs Act to Draft Article 14
藥事法增訂第27條之3，使主管機關於知悉具有許可證之藥品有供應不足之虞時，得不經通常查驗登記，專案核准該藥品或其替代藥品之製造或輸入。配套辦法草案第14條雖已明定基本安全監視義務，現行子法卻仍以許可證持有者及有效期間為構成要件。本文區分得直接適用、須替換許可證基準及涉及新設義務三類：共同之義務主體、期間與法效果應以法規命令規定；個案風險要求得依法以附款承載；技術執行事項則可由機關調整。
Article 27-3 of Taiwan’s Pharmaceutical Affairs Act permits the central competent health authority, upon learning that a licensed drug may face a supply shortage, to approve as a special case the manufacture or import of that drug or its substitute without ordinary registration and market approval. Although Article 14 of the draft supporting regulations establishes baseline pharmacovigilance duties, existing regulations still define duty-bearers and periods by reference to the drug license. This article distinguishes directly applicable duties, duties requiring replacement of license-based elements, and genuinely new duties. General rules governing duty-bearers, periods, and legal effects should be prescribed by legal orders; product-specific risk requirements may be imposed as incidental provisions attached to approvals under the principle of statutory reservation, while technical implementation remains within administrative operations.
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