药物警戒风险评估委员会（PRAC）9月28日至10月1日会议要点
正文 · 中文译文
在其月度会议上，EMA安全委员会（PRAC）履行其广泛职责，管理药品安全性，包括评估安全信号、风险管理计划、定期安全性更新报告和上市后安全性研究。 委员会未启动或结束任何转介程序。有关进行中的安全性转介的信息见下方“进行中的转介”表。 PRAC讨论的所有议题信息可在议程中获取。 PRAC会议议程 2026年9月28日至10月1日 基于议程草案的PRAC结果月度数据。 9个安全信号：5个启动，4个进行中并已结束 85份定期安全性更新报告（PSURs）单项评估：55项建议仅针对集中授权药品，27项建议仅针对国家授权药品，3项建议针对同时包含集中和国家授权药品的PSURs 49项集中授权药品风险管理计划（RMPs）：10项针对新药审查的RMPs，39项针对已授权药品审查的RMPs 16项上市后安全性研究（PASSs）：7项审查了强制性和非强制性研究的方案，9项审查了强制性和非强制性研究的结果 程序：含铁胃肠外给药药品 - 转介 安全信号评估。安全信号是指提示药物与不良事件之间存在新的潜在因果关联，或已知关联的新方面，且需要进一步调查的信息。安全信号来源于多种途径，如自发报告、临床研究和科学文献。更多信息见“信号管理”。 定期安全性更新报告（PSUR）是由上市许可持有人编制的报告，用于描述药品在获批后特定时期内的全球安全性经验。对于含有相同活性物质或相同活性物质组合，但具有不同上市许可且在欧盟不同成员国获批的药品，其PSUR将在单一评估程序中联合评估。更多信息见“定期安全性更新报告：问答”。 风险管理计划（RMP）是旨在识别、描述、预防或最小化与药物相关风险的活动和干预措施的详细描述。公司在申请上市许可时需向欧洲药品管理局（EMA）提交RMP。随着新信息的出现，RMP在药品整个生命周期中持续更新。更多信息见“风险管理计划”。 上市后安全性研究（PASSs）是在药品获得授权后开展的研究，以获取其安全性的进一步信息，或衡量风险管理措施的有效性。药物警戒风险评估委员会（PRAC）评估研究方案（与研究组织相关的方面）以及PASSs的结果。更多信息可在“上市后安全性研究”项下找到。 转介是用于解决诸如对某种药品或某类药品的安全性或获益-风险平衡的担忧等问题的程序。在与药品安全相关的转介中，成员国或欧盟委员会要求PRAC代表欧盟对特定药品或某类药品进行科学评估。更多信息可在转介程序项下找到。 药物警戒风险评估委员会（PRAC）：2026年9月28日至10月1日 药物警戒风险评估委员会（PRAC） EMA科学委员会以及互认和分散程序协调小组（CMD）文件中使用的缩写，以及与EMA监管活动相关的缩写 电话 +31 (0)88 781 8427 电子邮箱：press@ema.europa.eu
正文 · 英文原文
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. The Committee did not start or conclude any referral procedures. Information on ongoing safety referrals is provided in the ‘Ongoing referrals’ table below. Information on all topics discussed by the PRAC is available in the agenda. Agenda of the PRAC meeting 28 September - 1 October 2026 Monthly figures for PRAC outcomes based on the draft agenda. 9 safety signals: 5 started, 4 ongoing and concluded 85 periodic safety update reports (PSURs) single assessments: 55 recommendations for centrally authorised medicines only, 27 recommendations for nationally authorised medicines only, 3 recommendations for PSURs including both centrally and nationally authorised medicines 49 risk management plans (RMPs) for centrally authorised medicines: 10 RMPs reviewed for new medicines, 39 RMPs reviewed for authorised medicines 16 post-authorisation safety studies (PASSs): 7 protocols for imposed and non-imposed studies reviewed, 9 results from imposed and non-imposed studies reviewed Procedure: Parenteral iron-containing medicinal products - referral Safety signal assessments . A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under ' Signal management '. Periodic safety update reports , abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under ' Periodic safety update reports: questions and answers '. Risk management plans , abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans '. Post-authorisation safety studies , abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under ' Post-authorisation safety studies '. Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures . Pharmacovigilance Risk Assessment Committee (PRAC): 28 September - 1 October 2026 Pharmacovigilance Risk Assessment Committee (PRAC) Abbreviations used in EMA scientific committees and Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) documents, and in relation to EMA’s regulatory activities Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu