FDA有关仿制药和抗肿瘤药说明书的2个指导原则介绍

美国食品药品管理局（FDA）于2022年1月发布了“参比制剂（RLD）说明书修订后简化新药申请（ANDA）说明书的修订”供企业用的指导原则草案。该指导原则提供了多种获取RLD说明书变更信息的方法,还告知提交修改后的仿制药说明书的具体资料。2020年11月FDA发布了“联合方案中的抗肿瘤药物的交叉说明书”供企业用的指导原则草案。所谓“交叉说明书”是指被批准用于联合方案的抗肿瘤药物的说明书纳入的相关信息。该指导原则指出,其中新药的交叉说明书“应包括有关联合用药安全有效的信息以及仅限于各自药物的信息”;而其中已批准的药物的交叉说明书,“应包括在联合方案中该药物与其他药物合用的安全有效性信息”。该指导原则还对交叉说明书一些具体项目的内容提出了建议。而我国目前尚没有类似的指导原则。详细介绍FDA这2个指导原则,期望对中国RLD说明书修订后的仿制药说明书的修订以及联合用药方案中的抗肿瘤药的“交叉说明”的实施有帮助;对这两种情况的说明书的监管也有所启迪。

Introduction to two guidances of FDA generic drug and oncology drug labelings

FDA issued the Revising ANDA Labeling Following Revision of the RLD Labeling Draft Guidance for Industry in January 2022.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 FDA issued the Cross Labeling Oncology Drugs in Combination Regimens Draft Guidance for Industry in November 2020.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.