MSD Europe Inc, Clos du Lynx 5, 1200, Brussels, Belgium.
MSD, Oss, The Netherlands.
Ther Innov Regul Sci. 2021 Sep;55(5):1036-1044. doi: 10.1007/s43441-021-00303-x. Epub 2021 May 26.
The oral explanation (OE) is a critical event during new marketing authorisation procedures in the European Union (EU). The primary objective of the present study was to investigate how many procedures, having an OE in front of the Committee for Medicinal Products for Human Use (CHMP), resulted in a regulatory approval for oncology products.
Procedures for new marketing authorisation applications (MAAs) and Type II variations (new indication) for oncology products with at least one OE (with or without a Scientific Advisory Group (SAG) meeting) and for which the outcome took place between 31 January 2016 to 31 January 2020 were included in the analysis. Publicly available agendas/meeting minutes and assessment reports were used to obtain information on the products.
An OE occurred in about 20% of procedures (n = 28/150) for oncology products during the review period. The majority of procedures having an OE (61%), with or without any SAG meeting, led to MAA/Type II variation approval in the Centralised Procedure. It was also observed that in 41% of the cases a successful outcome was contingent upon willingness of the applicant to restrict the indication.
A majority of oncology procedures that had an OE resulted in a positive outcome suggesting that such agency interaction is an important opportunity for the applicant to have a last chance to resolve any outstanding issues at the final stage of the procedure.
在欧盟（EU）的新营销授权程序中，口头解释（OE）是一个关键事件。本研究的主要目的是调查在人用药物委员会（CHMP）前进行 OE 的程序中有多少导致了肿瘤学产品的监管批准。
分析了在 2016 年 1 月 31 日至 2020 年 1 月 31 日期间，至少有一次 OE（有或没有科学咨询小组（SAG）会议）且结果发生的新营销授权申请（MAA）和肿瘤学产品的 II 类变更（新适应症）的程序。公共议程/会议记录和评估报告用于获取有关产品的信息。
在审查期间，OE 发生在约 20%的肿瘤学产品程序中（n=28/150）。大多数有 OE 的程序（61%，无论是否有任何 SAG 会议）都导致集中程序中的 MAA/II 类变更批准。还观察到，在 41%的情况下，成功的结果取决于申请人愿意限制适应症。
大多数进行 OE 的肿瘤学程序都取得了积极的结果，这表明这种机构互动是申请人在程序的最后阶段解决任何未决问题的重要机会。
