关于2026年I类变更“年终”提交日期的建议
正文 · 中文译文
希望在2026年获得审评结果的上市许可持有人应不迟于2026年11月20日提交IA型年度更新、单项IA型和IA IN型变更以及超级组合。该截止日期使EMA能够在欧盟委员会第1234/2008号条例第14条规定的30天时限内，且在本机构于2026年12月22日至2027年1月4日关闭之前，确认提交的有效性。11月20日之后收到的提交仍将被处理，但结果可能要到2027年1月才能发出。 建议上市许可持有人在2026年11月30日前提交任何IB型变更或IB型与IA型变更的组合，以便在2026年启动程序。对于2026年12月1日或之后收到的提交，程序可能要到2027年1月才能启动。 本机构预计2026年第四季度将有大量IA型年度更新提交。这可能会影响我们所有I型变更（IA和IB）的验证和查询回复的常规时间表。建议申请人尽可能提前提交任何IB型程序，以确保在2026年启动程序。上述日期为暂定日期，将取决于收到的提交数量及其复杂性。 对于与人用药品程序相关的程序性或监管性查询，上市许可持有人可以通过EMA服务台提交工单，选择“商业服务”选项卡和“人类监管”类别。需要选择的子类别是“上市后-人类”，然后是子选项“IA类变更查询”、“IB类A&B范围查询”或“IB类C范围查询”。 为支持变更提交的准备，请参阅下方“相关内容”和“相关文件”部分提供的指南。 包括上市许可扩展在内的变更 IA类变更：问答：参见1. 我何时应提交我的IA/IAIN类变更？修订版2025年3月 欧洲药品管理局关于集中型IA和IB变更申请表的实用指南 IA/IAIN变更的预通知检查 电话：+31 (0)88 781 8427 电子邮件：press@ema.europa.eu
正文 · 英文原文
Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IA IN variations, and super-groupings no later than 20 November 2026. This deadline allows EMA to acknowledge the validity of submissions within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008 and before the Agency closes from 22 December 2026 to 4 January 2027. Submissions received after 20 November will still be processed, but the outcome may not be issued until January 2027. Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 30 November 2026 for a start of procedure in 2026. For submissions received on or after 1 December 2026, the procedure may not start until January 2027. The Agency is expecting a high number of type IA annual updates in the last quarter of 2026. This may impact our usual timelines for validation and responses to queries for all type I variations (IA and IB). Applicants are advised to submit any type IB procedure as far in advance as possible to ensure the start of the procedure in 2026. The dates given above are tentative and will depend on the number and complexity of the submissions received. For procedural or regulatory queries related to these procedures for human medicines, marketing authorisation holders can raise a ticket via the EMA Service Desk, selecting the tab “Business Services” and category “Human Regulatory”. The subcategory to be selected is “Post-authorisation - Human”, followed by the sub-option “Variation IA queries”, “Variation IB A&B scopes queries” or “Variation IB C scopes queries”. In support of the preparation of the variation(s) submission, please consult the guidance available below in the 'Related content' and 'Related documents' sections. Variations including extensions of marketing authorisations Type-IA variations: questions and answers: See 1. When shall I submit my Type IA/IAIN variations(s)? Rev. Mar 2025 European Medicines Agency practical guidance on the application form for centralised type IA and IB variations Pre-notification check for type IA/IAIN variations Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu