2022 年 7 月，ICMRA 启动了两项试点：一是针对化学、生产和控制（CMC）相关上市后经变更（PAC）的协作评估；二是为 CMC 评估提供依据的协作混合检查。除最大限度利用资源、推动更富成效和更加高效的审评之外，每项协作试点的总体目标都是在参与监管辖区的生产生命周期管理背景下，识别审评与检查活动中的不一致之处、差异以及可能走向一致或协调的领域。更好地了解可能趋于一致与存在差异的领域，是协调特定 CMC 相关和检查相关监管程序的重要第一步，有助于在不同地区及时实施适当的监管行动。本着透明与开放的原则，ICMRA 将定期通报每项协作试点的状态，并提供关于各试点所收到并被选中的申请类型的更多信息，以帮助业界利用这一参与机会。
In July 2022, ICMRA initiated two pilot programs focusing on i) collaborative assessment of chemistry, manufacturing, and control (CMC) related post-approval changes (PACs) and ii) collaborative hybrid inspections to inform CMC assessment. In addition to maximising resources and facilitating more effective and efficient reviews, the overarching goal of each collaborative pilot is the identification of misalignments, differences, and potential areas for alignment or harmonization in assessment and inspection activities across participating regulatory regions in the context of manufacturing lifecycle management. A better understanding of areas of potential alignment and difference is an important first step to harmonising specific CMC- and inspection-related regulatory procedures to facilitate the timely implementation of appropriate regulatory actions across different regions. In the interests of transparency and openness, ICMRA will provide regular updates on the status of each collaborative pilot and include further information on the types of applications received and selected for each pilot to help industry take advantage of this opportunity to participate.