美國食品藥品管理局（FDA）于2022年1月發(fā)布了“參比制劑（RLD）說明書修訂后簡化新藥申請（ANDA）說明書的修訂”供企業(yè)用的指導原則草案。該指導原則提供了多種獲取RLD說明書變更信息的方法，還告知提交修改后的仿制藥說明書的具體資料。2020年11月FDA發(fā)布了“聯(lián)合方案中的抗腫瘤藥物的交叉說明書”供企業(yè)用的指導原則草案。所謂“交叉說明書”是指被批準用于聯(lián)合方案的抗腫瘤藥物的說明書納入的相關(guān)信息。該指導原則指出，其中新藥的交叉說明書“應包括有關(guān)聯(lián)合用藥安全有效的信息以及僅限于各自藥物的信息”；而其中已批準的藥物的交叉說明書，“應包括在聯(lián)合方案中該藥物與其他藥物合用的安全有效性信息”。該指導原則還對交叉說明書一些具體項目的內(nèi)容提出了建議。而我國目前尚沒有類似的指導原則。詳細介紹FDA這2個指導原則，期望對中國RLD說明書修訂后的仿制藥說明書的修訂以及聯(lián)合用藥方案中的抗腫瘤藥的“交叉說明”的實施有幫助；對這兩種情況的說明書的監(jiān)管也有所啟迪。

FDA issued the Revising ANDA Labeling Following Revision of the RLD Labeling Draft Guidance for Industry in January 2022. The guidance provides a variety of methods to obtain the information on changes to RLD labeling, and also inform the specific data of submitting the revised generic labeling. FDA issued the Cross Labeling Oncology Drugs in Combination Regimens Draft Guidance for Industry in November 2020. The so-called "cross labeling" refers to relevant information included in the labelings of oncology drugs approved for use in a combination regimens. The guidance points out that the cross labeling of new drug " should include information about the safe and effective use of the combination regimen", "as well as information that would be limited to the individual drug". The cross labeling of the approved drug" should include information on the safe and effective use of the drug in combination with the other drug or drugs in the combination regimen". The guidance also puts forward some suggestions on the contents of some specific sections in the cross labeling. At present, there is no similar guidance in China. The two guidances of FDA are introduced in detail, which is expected to be helpful to the revision of generic drug labelings after the revision of RLD labelings and the implementation of "cross labelings" of oncology drugs in the combination regimen in China, the supervision of the labelings in these two cases is also enlightening.

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