上海领康时代药“领”速递专栏：及时整理传递，帮助大家快速、准确获取国内外最新法规政策。

1. 国家药监局关于发布二代基因测序相关体外诊断试剂分类界定指导原则的通告（2025年第22号）

发布时间：2025年06月10日

为进一步加强二代基因测序相关体外诊断试剂类产品监督管理，推动产业高质量发展，国家药监局组织制定了《二代基因测序相关体外诊断试剂分类界定指导原则》（以下简称指导原则）,现予以发布并将有关事项通告如下：

  一、本指导原则自发布之日起施行。申请人应当按照指导原则确定二代基因测序相关体外诊断试剂管理属性和管理类别。
  二、测序反应通用试剂与文库构建试剂配合使用方可完成测序功能，鼓励二者组成同一注册单元，共同申报第三类体外诊断试剂注册。
  若测序反应通用试剂与文库构建试剂确需作为不同单元分别申报，则申请人应当从实现功能、技术特征、结构组成等角度，明确二者间的划分。文库构建试剂注册时应当明确适配的测序反应通用试剂。测序反应通用试剂备案时应当明确适配的仪器品牌、型号（需适配已取得医疗器械注册证的二代基因测序仪器）。
  三、本指导原则发布前已按照第一类体外诊断试剂备案的二代基因测序相关体外诊断试剂，备案人应当对照指导原则对备案信息及备案资料进行自查；涉及备案变更、取消的，应当依据《体外诊断试剂注册与备案管理办法》《国家药监局关于第一类医疗器械备案有关事项的公告》办理；根据指导原则不应作为第一类体外诊断试剂管理的，参照《国家药监局关于实施〈体外诊断试剂分类目录〉有关事项的通告》（2024年第17号）有关要求，应当向相应药品监督管理部门申请注册，自2027年1月1日起，未依法取得注册证的，不得生产、进口和销售。

1. 二代基因测序相关体外诊断试剂分类界定指导原则

正文链接：

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20250610174001191.html

2. 国家药监局关于修订相关斑蝥酸钠注射剂说明书的公告（2025年第56号）

发布时间：2025年06月19日

根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对相关斑蝥酸钠注射剂（包括：斑蝥酸钠维生素B6注射液、斑蝥酸钠注射液、注射用去甲斑蝥酸钠、去甲斑蝥酸钠注射液、去甲斑蝥酸钠氯化钠注射液）说明书内容进行统一修订。现将有关事项公告如下：
  一、所有上述药品的上市许可持有人均应当依据《药品注册管理办法》等有关规定，按照附件要求修订说明书，于2025年9月17日前报省级药品监督管理部门备案。
  修订内容涉及药品标签的，应当一并进行修订；说明书及标签其他内容应当与原批准内容一致。自备案之日起生产的药品，不得继续使用原药品说明书。药品上市许可持有人应当在备案后9个月内对已出厂的药品说明书及标签予以更换或者以其他形式将说明书更新信息告知患者。
  二、药品上市许可持有人应当对新增不良反应发生机制开展深入研究，采取有效措施做好药品使用和安全性问题的宣传培训，指导医师、药师合理用药。
  三、临床医师、药师应当仔细阅读上述药品说明书的修订内容，在选择用药时，应当根据新修订说明书进行充分的获益/风险分析。
  四、患者用药前应当仔细阅读药品说明书，使用处方药的，应当严格遵医嘱用药。
  五、省级药品监督管理部门应当督促行政区域内上述药品的上市许可持有人按要求做好相应说明书修订和标签、说明书更换及说明书更新信息的告知工作，对违法违规行为依法严厉查处。

1. 相关斑蝥酸钠注射剂说明书修订要求

正文链接：

https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypshmshxdgg/20250619143819198.html

3. 国家药监局关于发布免于进行临床试验体外诊断试剂目录（2025年）的通告（2025年第23号）

发布时间：2025年06月24日

根据《体外诊断试剂注册与备案管理办法》（国家市场监督管理总局令第48号），国家药监局组织修订了《免于进行临床试验体外诊断试剂目录》（国家药监局通告2021年第70号），形成《免于进行临床试验体外诊断试剂目录（2025年）》，现予公布，并自公布之日起施行。

相关附件：

正文链接：

https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20250624112000177.html

4. 六部门联合发布《关于将4-哌啶酮和1-叔丁氧羰基-4-哌啶酮列为易制毒化学品管理的公告》

发布时间：2025年06月25日

为严格易制毒化学品管理，严防流失用于制毒，经国务院批准，公安部、商务部、卫生健康委、应急管理部、海关总署、国家药监局于2025年6月20日联合发布公告，将4-哌啶酮和1-叔丁氧羰基-4-哌啶酮列入《易制毒化学品管理条例》附表《易制毒化学品的分类和品种目录》予以管制，公告自2025年7月20日起施行。这是中国政府积极履行联合国禁毒公约缔约国义务的举措，体现了积极参与全球毒品治理的态度和负责任大国的担当。

正文链接：

https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250625105418111.html

1. 关于发布《药物Ⅰ期临床试验管理指导原则》的通告

发布时间：2025年06月03日

为进一步提高药物Ⅰ期临床试验和生物等效性试验质量和管理水平，国家药监局核查中心组织修订了《药物Ⅰ期临床试验管理指导原则》（见附件）。经国家药品监督管理局同意，现予发布，自发布之日起施行。

相关附件：

药物Ⅰ期临床试验管理指导原则

正文链接：

https://www.cfdi.org.cn/cfdi/resource/news/16424.html

1. 关于公开征求《化学药品批准后药学变更管理方案技术指导原则（征求意见稿）》意见的通知

发布时间：2025年6月09日

为加强化学药品上市后的变更管理，促进ICH Q12在中国的实施，我中心组织起草了《化学药品批准后药学变更管理方案技术指导原则（征求意见稿）》。

相关附件：

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/1561a57261f2c01ba35e7246162d844f

2. 关于公开征求《先进治疗药品的范围、归类和释义（征求意见稿）》意见的通知

发布时间：2025年6月10日

为规范我国先进治疗药品的范围及归类，促进分级分类科学监管，助力监管与国际接轨，推动该类药品的研发申报及审评审批上市，促进产业高质量发展，更好地满足人民健康需求，我中心组织起草了《先进治疗药品的范围、归类和释义（征求意见稿）》，明确了“先进治疗药品”的范围与释义、具体归类以及类别划分的总体原则与科学逻辑，现公开征求意见。

相关附件：

1. 《先进治疗药品的范围、归类和释义（征求意见稿）》

2. 《先进治疗药品的范围、归类和释义（征求意见稿）》起草说明

3. 《先进治疗药品的范围、归类和释义（征求意见稿）》征求意见反馈表

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/0d19d9228c90f124053e92cda08331e0

3. 国家药监局药审中心发布《中国新药注册临床试验进展年度报告（2024年）》

发布时间：2025年6月19日

为展示中国新药注册临床试验现状，进一步提升临床试验的透明度，为新药研发与审评审批提供科学参考，国家药监局药品审评中心基于药物临床试验登记与信息公示平台的临床试验数据，对2024年中国新药注册临床试验情况进行系统梳理，从临床试验登记总体概况、各药物类型临床试验基本特征、实施情况及质量控制情况等方面进行汇总分析，编制了《中国新药注册临床试验进展年度报告（2024年）》。

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/d0bc4836cfc4cb7c9ecf29ddaa7be6ea

4. 关于公开征求《创新药临床试验申请申报资料要求》等相关文件（征求意见稿）意见的通知

发布时间：2025年6月19日

为落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》（国办发〔2024〕53号）及《国家药监局关于印发优化创新药临床试验审评审批试点工作方案的通知》（国药监药注〔2024〕21号）相关要求，按照《优化创新药临床试验审评审批有关事项的公告》，我中心起草了《创新药临床试验申请申报资料要求》（附件1-4）、《创新药临床试验申请评估报告》（附件5）与《创新药临床试验申请评估要点》（附件6），现公开征求意见。

1. 创新药临床试验申请申报资料要求（模块1）

2. 化学药品创新药临床试验申请申报资料要求(模块2-5)

3. 创新型治疗用生物制品临床试验申请申报资料要求（模块2-5）

4. 创新型疫苗临床试验申请申报资料要求（模块2-5）

5. 创新药临床试验申请评估报告

6. 创新药临床试验申请评估要点

7. 创新药临床试验申请申报资料要求起草说明

8. 创新药临床试验申请评估报告及评估要点起草说明

9. 征求意见反馈表

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/473b8eff798dbf9485cbbb4fec1b698f

5. 关于公开征求《带状疱疹疫苗临床研究技术指导原则（征求意见稿）》意见的通知

发布时间：2025年6月19日

随着全球人口老龄化加剧，带状疱疹已成为一个公共卫生问题，带状疱疹疫苗近年来成为研发的热点之一。针对带状疱疹疫苗的特点建立科学的评价体系，对于提高企业研发和申报的规范性，加快安全有效疫苗的上市有重要意义。

目前境内有一款重组带状疱疹疫苗和一款带状疱疹减毒活疫苗上市，并有多个企业的带状疱疹疫苗获批开展临床试验。考虑到目前暂无相关技术指导原则，结合目前境内研发及审评工作需求，我中心组织起草了《带状疱疹病毒疫苗临床试验技术指导原则（征求意见稿）》。

1. 《带状疱疹疫苗临床试验技术指导原则（征求意见稿）》

2. 《带状疱疹疫苗临床研究技术指导原则（征求意见稿）》起草说明

3. 《带状疱疹疫苗临床研究技术指导原则（征求意见稿）》征求意见反馈表

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/78d86927084c925e38308e1bbe555b33

6.  国家药监局药审中心关于发布《局部起效化学仿制药体外释放（IVRT）与体外透皮（IVPT）研究技术指导原则（试行）》的通告（2025年第22号）

发布时间：2025年6月20日

 为明确局部起效化学仿制药体外释放（IVRT）与体外透皮（IVPT）研究的技术要求，在国家药品监督管理局的部署下，药审中心组织制定了《局部起效化学仿制药体外释放（IVRT）与体外透皮（IVPT）研究技术指导原则（试行）》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。

1. 局部起效化学仿制药体外释放（IVRT）与体外透皮（IVPT）研究技术指导原则（试行）

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/114aa83096de4873146fc035b0f6f747

7.  关于再次公开征求《多联疫苗临床研究技术指导原则（征求意见稿）》意见的通知

发布时间：2025年6月30日

根据国家药监局的有关要求，我中心组织起草了《多联疫苗临床研究技术指导原则》，并于2020年11月27日首次公开征求意见。

随着近年来国内疫苗产业的发展变化、新技术路线和研发策略的出现与更迭，为加快推进国产多联疫苗研发上市，我中心对该指导原则进行了修订完善，并形成了征求意见稿，现再次公开征求意见。

1. 《多联疫苗临床研究技术指导原则（征求意见稿）》

2. 《多联疫苗临床研究技术指导原则（征求意见稿）》起草和修订说明

3. 《多联疫苗临床研究技术指导原则（征求意见稿）》意见反馈表

正文链接：

https://www.cde.org.cn/main/news/viewInfoCommon/22ab33793569a6e0b0ed71a7850658c0

1. FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies

发布时间：2025年06月27日

The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies.  

These products are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma.

“The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving CAR T therapies. REMS is a useful safety system, but reevaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks,” said FDA Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and Director, Center for Biologics Evaluation and Research. “Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.”

A REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

The FDA determined that the approved REMS for the following products should be eliminated because a REMS is no longer necessary to ensure that the benefits of the autologous CAR T cell immunotherapies outweigh their risks.  

• Abecma (idecabtagene vicleucel)
• Breyanzi (lisocabtagene maraleucel)
• Carvykti (ciltacabtagene autoleucel)
• Kymriah (tisagenlecleucel)
• Tecartus (brexucabtagene autoleucel)
• Yescarta (axicabtagene ciloleucel)

The elimination of REMS for the above products removes the requirements that hospitals and their associated clinics that dispense products must be specially certified and have on-site, immediate access to tocilizumab. The information regarding the risks for these CAR T cell immunotherapies can be conveyed adequately via the current product labeling, which includes a boxed warning for the risks of cytokine release syndrome and neurological toxicities, and medication guides.

“Physicians and institutions now have greater experience identifying and managing toxicities with the currently approved CAR T products,” said Richard Pazdur, M.D., FDA Oncology Center of Excellence Director. “This approach will potentially facilitate patient access to these treatments while continuing to prioritize safety.”

Continuous monitoring and assessment of the safety of all biological products, including the CAR T cell immunotherapies, is an FDA priority and we remain committed to informing the public when we learn new information about these products.

These products will continue to be subject to safety monitoring, through adverse event reporting requirements in accordance with regulations (21 CFR 600.80). The elimination of the REMS for these products does not change FDA requirements for manufacturers to conduct post marketing observational safety studies to assess the risk of secondary malignancies and long-term safety with follow up of patients for 15 years after product administration.

美国食品药品监督管理局（FDA）今日宣布，取消当前已获批的BCMA和CD19靶向自体CAR-T细胞免疫疗法的 风险评估与缓解策略（REMS）要求。

这些基因疗法产品目前获批用于治疗多发性骨髓瘤、某些白血病和淋巴瘤等血液癌症。

FDA生物制品评价与研究中心首席医学与科学官Vinay Prasad博士表示：

FDA大胆取消了CAR-T疗法的REMS要求。REMS虽是有用的安全体系，但定期重新评估有助于判断其是否仍有必要，以确保产品收益大于风险。取消不必要的REMS可加速患者获得潜在治愈性疗法，同时减轻医疗机构的负担。

REMS是FDA针对存在严重安全风险的药物实施的安全计划，旨在确保药物收益大于风险。

FDA认为，以下产品的REMS已无必要，因其收益风险比无需通过REMS保障：

- Abecma（idecabtagene vicleucel）

- Breyanzi（lisocabtagene maraleucel）

- Carvykti（ciltacabtagene autoleucel）

- Kymriah（tisagenlecleucel）

- Tecartus（brexucabtagene autoleucel）

- Yescarta（axicabtagene ciloleucel）

取消REMS后，医院及相关诊所不再需要特殊认证或现场备妥托珠单抗（tocilizumab）。相关风险信息将通过现有产品标签（包括细胞因子释放综合征和神经毒性的黑框警告）及用药指南充分传达。

FDA肿瘤卓越中心主任Richard Pazdur博士称：

"医生和机构对现有CAR-T产品的毒性管理已积累丰富经验。此举在保障安全的同时，有望提升患者治疗可及性。"

FDA将持续监测所有生物制品（包括CAR-T疗法）的安全性，并承诺及时公开新发现。

这些产品仍需遵守不良反应事件报告规定（21 CFR 600.80）。取消REMS不改变制造商需进行的上市后安全性研究**要求，包括评估继发恶性肿瘤风险及对患者进行15年长期随访。

核心要点提炼：

正文链接：

https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor

1. New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

发布时间：2025年06月04日

This guideline, developed jointly by global regulators and medicines developers through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), marks a change in paradigm in the development of medicines in pregnancy and breastfeeding. It highlights that in principle, including pregnant and breastfeeding people in clinical trials should be considered for all medicines intended for people who can potentially give birth to children. It lays out the principles and conditions that should be met to ensure the safety of clinical trial participants, as well as their fetuses and babies.

Currently, pregnant and breastfeeding people are often excluded from clinical trials and those who become pregnant while participating in a clinical trial are frequently discontinued from the clinical trial. Less than 0,4% of all clinical trials currently submitted in the EU include pregnant people, and this falls to 0,1% regarding lactating individuals, according to data from the Clinical Trials Information System (CTIS).

As a result, product leaflets usually lack details about the benefits and risks of a medicine specifically in pregnancy and breastfeeding, requiring patients and healthcare professionals to make treatment decisions without this essential information. This can lead to suboptimal treatment decisions and potential harm. Meanwhile, the vast majority of pregnant people take medications, for example because of chronic diseases, infections, or pregnancy complications. The situation is similar in breastfeeding populations.

The guideline outlines the scientific and regulatory principles, as well as ethical considerations, for the inclusion of pregnant and breastfeeding individuals in clinical trials, both pre- and post-authorisation. It encourages proactive planning and early consultation of medicine developers with regulatory authorities to ensure the safety and efficacy of treatments during pregnancy and breastfeeding.

建议将支持更好地了解这一人群中药物的益处和风险

欧洲药品管理局发布了一项新的指南，就如何在临床试验中纳入和/或留住孕妇和哺乳期妇女提供建议，以征求公众意见。目标是确保开发人员在这些人群中生成可靠的临床数据，以便这些人及其医疗服务提供者在使用药物时能够做出明智的、基于证据的决定。

该指南由全球监管机构和药品开发商通过国际人用药品注册技术要求协调理事会（ICH）联合制定，标志着妊娠和哺乳期药物开发范式的转变。它强调，原则上，应考虑将孕妇和母乳喂养者纳入临床试验，用于所有可能生育儿童的药物。它列出了为确保临床试验参与者及其胎儿和婴儿的安全而应满足的原则和条件。

目前，孕妇和哺乳期的人经常被排除在临床试验之外，而那些在参与临床试验时怀孕的人也经常被终止参与临床试验。根据临床试验信息系统（CTIS）的数据，目前欧盟提交的所有临床试验中，只有不到0.4%包括孕妇，而哺乳期患者的这一比例降至0.1%。

因此，产品说明书通常缺乏关于药物在怀孕和母乳喂养中的益处和风险的详细信息，要求患者和医疗保健专业人员在没有这些基本信息的情况下做出治疗决定。这可能会导致次优的治疗决策和潜在的危害。与此同时，绝大多数孕妇服用药物，例如因为慢性疾病、感染或妊娠并发症。母乳喂养人群的情况也类似。

该指南概述了在授权前后将孕妇和哺乳期个体纳入临床试验的科学和监管原则以及伦理考虑。它鼓励药物开发商积极规划并尽早与监管机构协商，以确保怀孕和哺乳期间治疗的安全性和有效性。

ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

正文链接：

https://www.ema.europa.eu/en/news/new-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials#contact-point-76937

2.Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 June 2025

发布时间：2025年06月06日

Treatment with semaglutide should be stopped if NAION occurs

EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause loss of vision. Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity (namely Ozempic, Rybelsus and Wegovy).

After reviewing all available data on NAION with semaglutide, PRAC has recommended that the product information for semaglutide medicines is updated to include NAION as a side effect with a frequency of ‘very rare’ (it may affect up to 1 in 10,000 people). If patients experience a sudden loss of vision or rapidly worsening eyesight during treatment with semaglutide, they should contact their doctor without delay. If NAION is confirmed, treatment with semaglutide should be stopped.

More information is available in EMA’s public health communication.

PRAC reviewing risk of encephalitis with varicella vaccines

EMA’s safety committee (PRAC) is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.

Varilrix and Varivax are authorised for vaccination of adults and children from 12 months of age, and in certain populations from 9 months of age, against chickenpox. They contain live attenuated (weakened) varicella virus.

Varicella is caused by the varicella-zoster virus, which also causes shingles (herpes zoster). Varicella mainly affects children aged 2-8 years where it is usually a mild disease and children recover quickly. In some cases, varicella can cause complications including bacterial infection of the skin or blood, pneumonia (infection and inflammation of the lungs) and encephalitis. Encephalitis can also be caused by other viral or bacterial infections. While most people with encephalitis recover, the condition can be life-threatening.

This review was initiated by the PRAC following a case report in Poland of a child who developed encephalitis a few days after receiving the Varilrix vaccine. The patient died of the consequences of encephalitis several days later. As a precaution, the Polish medicines agency has suspended the distribution of vaccines from the batch in question.

These vaccines are widely used across the EU, and encephalitis is listed as a side effect in their product information based on rare reports during post-marketing surveillance.

The committee will now assess all available evidence to better understand the risk of encephalitis and to determine if any regulatory action is necessary.

While EMA is investigating the issue, the vaccines can continue to be used in line with the approved product information.

相关附件：

Agenda of the PRAC meeting 2-5 June 2025

正文链接：

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-june-2025

3.Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 June 2025

欧洲兽用药品委员会（CVMP）2025年6月10-12日会议要闻

发布时间：2025年06月13日

The Committee re-elected Dr Frida Hasslung Wikström from Sweden as its Vice-chair for a further 3-year mandate.

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a marketing authorisation from Aquilón CyL S.L. for Biobhyo for the active immunisation of pigs against infections caused by Brachyspira hyodysenteriae.

The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Numelvi (atinvicitinib) for treatment of pruritus associated with allergic dermatitis including atopic dermatitis in dogs and treatment of clinical manifestations of atopic dermatitis in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for BRAVECTO CombiUNO (fluralaner/milbemycin oxime) for treatment of tick and flea infestations in dogs.

The Committee adopted by consensus a positive opinion for a marketing authorisation from Elanco GmbH for Zenrelia (ilunocitinib) for treatment of pruritus associated with allergic dermatitis in dogs and treatment of clinical manifestations of atopic dermatitis in dogs.

The Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Daxocox (enflicoxib) concerning change(s) to therapeutic indication(s) - addition of a new therapeutic indication or modification of an approved one: treatment of pain and inflammation associated with orthopaedic or soft tissue surgery and alignment of the product information with version 9.1 of the QRD template.

The Committee adopted by consensus a positive opinion for a worksharing grouping of variations requiring assessment for NexGard (afoxolaner) and NexGard Spectra (afoxolaner/milbemycin oxime) concerning change(s) to therapeutic indication(s) – addition of a new therapeutic indication or modification of an approved one: for the reduction of the risk of infection with Babesia canis canis via transmission by Dermacentor reticulatus for 28 days and for reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for 30 days.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bravecto (fluralaner) to implement the outcome of the MAH's signal management process to add new adverse events (pruritus, diarrhoea, ataxia) to the product information.

The Committee adopted by consensus a positive opinion for a workshared variation requiring assessment for Nobivac L4, Nobivac LoVo L4 (canine leptospirosis vaccine (inactivated))– addition of a new therapeutic indication or modification of an approved one and addition of associated non-mixed use with Nobivac Rabies. The procedure included a name update from L4 to L6.

The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:

The Committee adopted, by consensus, positive opinions for variations requiring assessment to align the product information with version 9.0/9.1 of the QRD template for:

The Committee adopted by consensus a negative opinion for a variation requiring assessment for Poulvac E. coli (avian colibacillosis vaccine (live)) to reflect in the product information that administration of the vaccine was shown to reduce the use of antibiotics used to treat colibacillosis in the vaccinated chicken flocks.

Union referrals and related procedures

The Committee started a procedure for veterinary medicinal products containing albendazole as a single active substance, presented as oral suspension and indicated against gastrointestinal nematodes in sheep. The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns that doses or lower dose limits of 3.75 – 5.0 mg/kg bodyweight may no longer be appropriate to ensure the effective use of these products, which could also contribute to the further development of antiparasitic resistance. The CVMP invites all stakeholders (e.g. veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure.

Re-examinations of marketing authorisations in exceptional circumstances

For Innovax-ND-H5, the Committee recommended, based on evaluation of data submitted by the marketing authorisation holder, to extend by one year the validity of the marketing authorisation under exceptional circumstances.

Scientific advice

The Committee adopted one scientific advice report for a pharmaceutical product for rats and mice.

Concept papers, guidelines

Environmental Risk Assessment

The Committee adopted a concept paper for the development of a guideline on the methodology of environmental risk assessment for parasiticidal VMPs for cats and dogs (EMA/CVMP/ERA/499198/2024) for a 4-month period of public consultation.

Quality

The Committee adopted a draft concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water (EMA/CVMP/QWP/85848/2025) for a 4-month period of public consultation.

Pharmacovigilance

The Committee adopted the following standard list and associated documents for electronic reporting of suspected adverse reactions following the yearly review and update:

The implementation of the standard VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for 1 October 2025.

兽药产品委员会（CVMP）2025年6月10-12日会议要点总结

1. 人事任命