服务资讯 2025-06-18
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仿制药参比制剂目录（第九十二批）的通告（2025年第20号）
发布时间：2025年5月13日
经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第九十二批）。
相关附件：
1. 化学仿制药参比制剂目录（第九十二批）
正文链接：
https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250513170750117.html
2. 国家药监局关于修订盐酸雷尼替丁注射制剂说明书的公告（2025年第49号）
发布时间：2025年5月16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，国家药监局决定对盐酸雷尼替丁注射制剂（包括：盐酸雷尼替丁注射液、注射用盐酸雷尼替丁、盐酸雷尼替丁氯化钠注射液）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8月12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。
相关附件：
1.盐酸雷尼替丁注射制剂说明书修订要求
正文链接：
https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypshmshxdgg/20250516090939169.html
3.国家药监局关于发布麻醉药品和精神药品实验研究管理规定的公告（2025年第51号）
发布时间：2025年5月30日
为进一步加强麻醉药品和精神药品实验研究的监督管理，根据《中华人民共和国药品管理法》《麻醉药品和精神药品管理条例》等法律法规，国家药监局组织修订了《麻醉药品和精神药品实验研究管理规定》，现予发布，自发布之日起施行。
相关附件：
1. 麻醉药品和精神药品实验研究管理规定
正文链接：
https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20250530115105182.html
1.关于公开征求ICH《Q1：原料药和制剂的稳定性试验》指导原则草案意见的通知
发布时间：2025年5月6日
ICH《Q1：原料药和制剂的稳定性试验》指导原则现进入第3阶段区域公开征求意见阶段。按照ICH相关章程要求，ICH的监管机构成员需收集本地区关于该文件草案的意见并反馈ICH。
Q1指导原则草案的英文原文和中文译文见附件，现就该指导原则内容及中文译文向社会公开征求意见。
相关附件：
1. 【英文】Q1指导原则（草案）
2. 【中文】Q1指导原则（草案）
正文链接：
https://www.cde.org.cn/main/news/viewInfoCommon/9a6ad182f5b9f52f2a71d7ec71f8fde0
2.关于公开征求《创新药研发期间风险管理计划撰写技术指导原则（征求意见稿）》意见的通知
发布时间：2025年5月6日
为指导申请人规范撰写创新药研发期间风险管理计划，药审中心组织起草了《创新药研发期间风险管理计划撰写技术指导原则》，经中心内部讨论，现形成征求意见稿。
相关附件：
1.《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》
2.《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》起草说明
3.《放射性治疗药物申报上市临床风险管理计划技术指导原则（征求意见稿）》征求意见反馈表
正文链接：
https://www.cde.org.cn/main/news/viewInfoCommon/da7d8db507357593f8b46ab2aa4752f2
3. 关于公开征求《化学仿制药参比制剂目录（第九十三批）》（征求意见稿）意见的通知
发布时间：2025年5月7日
根据国家局2019年3月28日发布的《关于发布化学仿制药参比制剂遴选与确定程序的公告》（2019年第25号），我中心组织遴选了第九十三批参比制剂（见附件），现予以公示征求意见。
相关附件：
1. 化学仿制药尚未发布参比制剂目录（第九十三批）（征求意见稿）
2. 化学仿制药参比制剂异议申请表
正文链接：
https://www.cde.org.cn/main/news/viewInfoCommon/284bf0148d21abc68ebae176e2170999
4. 关于公开征求《化学仿制药参比制剂目录（第九十四批）》（征求意见稿）意见的通知
发布时间：2025年5月19日
根据国家局2019年3月28日发布的《关于发布化学仿制药参比制剂遴选与确定程序的公告》（2019年第25号），我中心组织遴选了第九十四批参比制剂（见附件），现予以公示征求意见。
相关附件：
1.《化学仿制药参比制剂目录（第九十四批）》（征求意见稿）
2. 化学仿制药参比制剂异议申请表
正文链接：
https://www.cde.org.cn/main/news/viewInfoCommon/dca68f17e87da392efdc6a41bb2d2ba2
5. 国家药监局药审中心关于发布《已上市血液制品生产场地变更研究技术指导原则（试行）》的通告（2025年第20号）
发布时间：2025年5月29日
为指导血液制品上市许可持有人科学规范开展血液制品上市后场地变更药学研究，引导和促进血液制品持有人利用场地变更进行生产工艺升级优化和硬件系统改造，加强对已上市血液制品药学变更的管理，药审中心组织制定了《已上市血液制品生产场地变更研究技术指导原则（试行）》。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。
相关附件：
1. 已上市血液制品生产场地变更研究技术指导原则（试行）
正文链接：
https://www.cde.org.cn/main/news/viewInfoCommon/e13aa3a6b482a06e6980763617375a08
美国食品药品监督管理局批准首个用于诊断阿尔茨海默病的血液检测
发布时间：2025年5月16日
The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”
Alzheimer’s disease, a brain disorder known to slowly destroy memory and thinking skills, and, eventually, the ability to carry out the simplest tasks, is progressive, meaning that the disease gets worse over time. In most people with Alzheimer’s disease, clinical symptoms first appear later in life. Amyloid plaques in a patient’s brain are a hallmark sign of Alzheimer’s disease. While amyloid plaques can occur in other diseases, being able to detect the presence of plaque, along with other evaluations, helps the doctor determine the probable cause of the patient’s symptoms and findings. These plaques can be detected and visualized using amyloid positron emission tomography (PET) brain scans, often years before clinical symptom onset, to aid in diagnosing Alzheimer’s disease. PET scans, however, are a costly and time-consuming option and expose patients to radiation.
The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma, a component of blood, and calculates the numerical ratio of the levels of the two proteins. This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan. Similar FDA-authorized/cleared tests, one from the same company as this new test, are used with cerebrospinal fluid (CSF) samples, which are collected through an invasive lumbar puncture, also called a spinal tap. This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access.
“Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
During review of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the FDA evaluated data from a multi-center clinical study of 499 individual plasma samples from adults who were cognitively impaired. The samples were tested by the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio and compared with amyloid PET scan or CSF test results.
In this clinical study, 91.7% of individuals with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of individuals with negative results had a negative amyloid PET scan or CSF test result. Less than 20% of the 499 patients tested received an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result.
These findings indicate that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information.
The risks associated with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio are mainly the possibility of false positive and false negative test results.
False positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for, Alzheimer’s disease. This could lead to psychological distress, delay in receiving a correct diagnosis as well as expense and the risk for side effects from unnecessary treatment.
False negative results could result in additional unnecessary diagnostic tests and potential delay in effective treatment. Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options.
The FDA reviewed the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio through the 510(k) premarket notification pathway. A 510(k) notification is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. The FDA found that the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is substantially equivalent to the Lumipulse G β-amyloid Ratio (1-42/1-40), which is the previously authorized test that uses CSF samples.
The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA issued clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio to Fujirebio Diagnostics, Inc.
美国FDA批准了Lumipulse G pTau217/β-淀粉样蛋白1-42血浆比率检测，该血液检测可用于55岁以上出现症状的成年患者，检测与阿尔茨海默病相关的淀粉样斑块。这有助于更早诊断疾病，而无需昂贵PET扫描。
核心要点：
阿尔茨海默病影响超10%的65岁以上人群，预计2050年患者数量将翻倍 ；
通过测量血液中两种蛋白（pTau217和β-淀粉样蛋白1-42）的比率评估脑内斑块 ；
现有PET扫描成本高、耗时长且存在辐射风险 ；
该检测结合其他评估手段可提升诊断可及性 ；
FDA局长Martin Makary博士强调：应对日益严峻的阿尔茨海默病危机需要更优诊断工具 。
正文链接：
https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease
药物警戒风险评估委员会（PRAC）会议要点2025年5月5日至8日
发布时间：2025年5月8日
Review of medicines containing finasteride and dutasteride concluded
Finasteride and dutasteride tablets: Measures to minimise risk of suicidal thoughts
Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.
A warning about mood changes, including depression, depressed mood and suicidal ideation, is already included in the product information for finasteride medicines. Patients who experience mood changes should seek medical advice and, if taking finasteride 1 mg, should also stop treatment.
Most cases of suicidal ideation were reported in people using 1 mg finasteride to treat hair loss due to male hormones. The product information for finasteride 1 mg will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction) that have been reported to contribute to mood alterations and suicidal ideation in some patients. A patient card will be included in the 1 mg finasteride package to remind patients of these risks and to advise them about the appropriate course of action.
Although a link between suicidal ideation and dutasteride was not established based on the reviewed data, dutasteride works in the same way as finasteride. Therefore, information about the mood changes seen with finasteride will also be added to dutasteride’s product information as a precaution.
The review found no evidence linking suicidal ideation to finasteride skin sprays and no new information is being included in the product information for these sprays.
Finasteride 1 mg tablets and finasteride skin spray are used to treat early hair loss due to male hormones, while finasteride 5 mg tablets and dutasteride 0.5 mg capsules are used to treat benign prostatic hyperplasia, a condition in which the prostate is enlarged and can cause problems with urine flow.
More information is available in EMA’s public health communication.
Start of safety review of Ixchiq (live attenuated chikungunya vaccine)
EMA’s safety committee (PRAC) has started a review of Ixchiq, a live attenuated chikungunya vaccine, following reports of serious adverse events in elderly people.
Many of the people affected also had other illnesses and the exact cause of these adverse events and their relationship with the vaccine have not yet been determined.
So far, 17 serious adverse events have been reported worldwide in people aged between 62 to 89 years who received the vaccine.
Given that clinical studies on Ixchiq mainly involved people below 65 years of age and that most serious cases concerned people 65 years of age and above, PRAC recommends that Ixchiq must not be used in adults aged 65 years and above as a temporary measure while the review is underway. Ixchiq vaccination can continue in people under 65 years of age, in accordance with official recommendations.
PRAC also reminds healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatments. Persons with a weakened immune system are at greater risk of having complications from vaccines containing live attenuated viruses, regardless of age.
Ixchiq is a vaccine used to protect people in endemic areas and travellers to endemic areas against a mosquito-borne disease caused by the chikungunya virus, mostly present in tropical and subtropical regions. Symptoms include fever, painful joints, headache, muscle pain, joint swelling and rash. Most patients recover within a week, but some develop joint pain for several months or longer and a small proportion of patients may develop severe acute disease, which can lead to multiorgan failure.
Ixchiq was authorised as a single-dose vaccine for chikungunya on 28 June 2024. Around 43,400 doses are estimated to have been used worldwide.
PRAC will now review all available data to assess the benefits and risks of the vaccine. EMA will communicate further when appropriate.
More information is available in EMA’s public health communication, published on 7 May 2025.
1. 非那雄胺（Finasteride）和度他雄胺（Dutasteride）安全性审查结论
欧盟药监局（EMA）确认：1mg/5mg 非那雄胺可能引发自杀倾向（频率未知），但获益仍大于风险。
新增警告：
药品说明书需注明可能引发情绪变化（抑郁、自杀念头），患者出现症状应立即就医。
1mg剂型（治脱发）需额外提示性功能障碍（如性欲减退）可能加重心理问题，包装内将附**患者风险提示卡。
度他雄胺虽未明确关联自杀倾向，但因作用机制相似，说明书将同步增加情绪副作用警示。
外用喷雾剂未发现相关风险，无需更新说明。
2. 基孔肯雅热疫苗（Ixchiq）安全性审查启动
原因：全球报告17例62-89岁接种者出现严重不良反应（部分患基础疾病），因果关系待查。
临时措施：
65岁以上人群暂停接种**（临床试验数据不足）。
免疫功能低下者禁用**（活疫苗可能引发并发症）。
背景：该疫苗2024年6月获批，用于热带地区居民及旅行者预防蚊媒基孔肯雅病毒（症状包括发热、关节剧痛，少数可致多器官衰竭）。全球已接种约4.34万剂。
相关附件：
1. Agenda of the PRAC meeting 5-8 May 2025
正文链接：
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-may-2025
2. ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant
欧洲药管局建议更新新冠疫苗以针对新型LP.8.1变异株
发布时间：2025年5月16日
EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign.
LP.8.1 differs from the JN.1 family targeted by previous updated vaccines and has now surpassed the JN.1 variant to become the most widely circulating variant worldwide.
In making its recommendation, the ETF consulted with the World Health Organization (WHO, international partners and marketing authorisation holders for COVID-19 vaccines. The ETF also considered a wide range of data, including data on the evolution of the virus and data from animal studies on the effects of candidate vaccines targeting LP.8.1.
The evidence indicates that targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve. Vaccines targeting JN.1 or KP.2 strains could still be considered for the vaccination campaigns in 2025 until updated LP.8.1 vaccines become available.
Marketing authorisation holders should now contact EMA to discuss updates to the marketing authorisations of their vaccines. All marketing authorisation holders are expected to update the composition of their authorised vaccines in accordance with this recommendation.
Companies currently developing new COVID-19 vaccines targeting strains other than LP.8.1 are also encouraged to contact EMA to discuss strategies for changing the composition of their vaccines.
National authorities in the European Union (EU) will ultimately make decisions about vaccination campaigns for 2025 and 2026, taking into account the situation in their country.
EMA建议2025/26新冠疫苗更新为针对LP.8.1变异株
1. 最新建议
欧洲药管局紧急工作组（ETF）建议将2025/2026年度新冠疫苗更新为针对新型变异株LP.8.1
LP.8.1已超越JN.1成为全球主流流行毒株
2. 决策依据
综合世卫组织、国际合作伙伴及疫苗生产商意见
分析病毒进化数据及LP.8.1靶向疫苗的动物实验数据
现有JN.1/KP.2靶向疫苗在LP.8.1疫苗上市前可暂用
3. 执行要求
疫苗厂商需立即联系EMA更新上市许可
所有获批疫苗应按建议调整成分
非LP.8.1靶向的在研疫苗厂商也应协商调整策略
4. 后续安排
欧盟成员国将根据国情最终决定2025-2026接种计划
更新疫苗将更好应对持续进化的新冠病毒
相关附件：
1. EMA recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2025-2026
正文链接：
https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-lp81-variant
3. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025
2025年5月19日至22日，人用药品委员会（CHMP）会议亮点
发布时间：2025年5月23日
Ten new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting.
The committee recommended granting a conditional marketing authorisation for Aucatzyl* (obecabtagene autoleucel), for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukaemia, a type of cancer of the white blood cells. This medicine was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.
A positive opinion was adopted for Blenrep* (belantamab mafodotin), for the treatment of relapsed or refractory multiple myeloma, a rare and incurable disease of the plasma cells, which typically affects adults from 60 years of age.
The committee recommended granting a conditional marketing authorisation for Ezmekly* (mirdametinib), for the treatment of plexiform neurofibromas in paediatric and adult patients with neurofibromatosis type 1, an inherited disease in which the patient develops benign (non-cancerous) tumours along the nerves.
Itovebi (inavolisib) received a positive opinion from the CHMP for the treatment of adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative locally advanced and metastatic breast cancer.
The CHMP adopted a positive opinion under exceptional circumstances for Maapliv* (amino acids), for the treatment of maple syrup urine disease (MSUD) in patients from birth. MSUD is a rare genetic disorder where the body cannot break down certain amino acids found in proteins. This leads to a buildup of harmful substances in the blood and urine, which can cause serious health problems.
The CHMP recommended granting a marketing authorisation for Riulvy (tegomil fumarate), for the treatment of adults and children from 13 years of age with relapsing remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves. This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product and in part on new data.
The committee adopted positive opinions for three biosimilar medicines:
Bomyntra (denosumab), for the prevention of skeletal related events in adults with advanced malignancies involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
Conexxence (denosumab), for the treatment of osteoporosis, a disease that makes bones fragile, in postmenopausal women and in men at increased risk of fractures.
Rolcya (denosumab), for the treatment of osteoporosis and bone loss.
A generic medicine, Emtricitabine/Tenofovir alafenamide Viatris (emtricitabine / tenofovir alafenamide), received a positive opinion for the treatment of adults and adolescents infected with human immunodeficiency virus type 1 (HIV-1).
The committee recommended not granting a paediatric-use marketing authorisation for Atropine sulfate FGK (atropine), a medicine intended for treating myopia in children aged three years and older.
Kinselby* (resminostat) received a negative opinion from the CHMP for the treatment of patients with advanced stage mycosis fungoides and Sezary syndrome, two cancers of blood cells that affect mainly the skin.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
The committee recommended extensions of indication for four medicines that are already authorised in the European Union (EU): Imfinzi, Rezolsta, Saxenda and Tevimbra.
On 28 June 2024, the European Commission revoked the refusal of a marketing authorisation for Aplidin (plitidepsin), a medicine expected to be used to treat multiple myeloma. Following the adoption of this decision, the Commission has requested EMA to re-start the re-examination of the negative opinion adopted by the CHMP in December 2017.
The marketing authorisation holder for Winlevi (clascoterone), a medicine intended for treating acne vulgaris, has requested a re-examination of the negative opinion adopted during the committee’s April 2025 meeting.
Upon receipt of the grounds of these requests, the CHMP will re-examine its opinions and issue final recommendations.
An application for an initial marketing authorisation was withdrawn. Teriparatide Ascend (teriparatide) was intended for the treatment of osteoporosis.
An application to extend the therapeutic indication of Lutathera (lutetium (177Lu) oxodotreotide) in the treatment of adults with newly diagnosed tumours in the gut, known as gastroenteropancreatic neuroendocrine tumours, was also withdrawn.
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
The committee finalised its review of the use of azithromycin, an antibiotic that has been used for decades to treat a wide range of infectious diseases. The CHMP has recommended several changes, including revisions and removals of certain indications. These recommendations aim to optimise the use of this common antibiotic and minimise the development of antimicrobial resistance, the ability of microorganisms to become resistant to antimicrobials.
For more information on this recommendation see the public health communication in the grid below.
The CHMP started a review of all available information on the benefits and risks of medicines containing ipidacrine. These medicines have been authorised in several EU countries through national procedures and are used in adults to treat different conditions affecting the nervous system. The review of ipidacrine-containing medicines has been initiated at the request of the Irish medicines regulatory agency, under Article 31 of Directive 2001/83/EC.
For more information, see the public health communication in the grid below.
The agenda of the May 2025 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the May 2025 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
EMA 2025年5月会议新药审批要点总结
1. 推荐批准的10种新药
Aucatzyl（obecabtagene autoleucel）
适应症：复发/难治性B细胞前体急性淋巴细胞白血病
审批类型：有条件上市许可（PRIME计划支持）
Blenrep（belantamab mafodotin）
适应症：复发/难治性多发性骨髓瘤（60岁以上多发）
Ezmekly（mirdametinib）
适应症：1型神经纤维瘤病相关丛状神经纤维瘤（儿童及成人）
审批类型：有条件上市许可
Itovebi（inavolisib）
适应症：PIK3CA突变/ER+/HER2-局部晚期或转移性乳腺癌
Maapliv（氨基酸制剂）
适应症：枫糖尿症（MSUD，先天性代谢疾病）
审批类型：特殊情况批准
Riulvy（tegomil fumarate）
适应症：复发缓解型多发性硬化症（13岁及以上）
2. 生物类似药（Biosimilars）
Bomyntra / Conexxence / Rolcya（denosumab）
适应症：骨巨细胞瘤、骨质疏松
3. 仿制药（Generic）
Emtricitabine/Tenofovir alafenamide Viatris
适应症：HIV-1感染
4. 未获批药物
Atropine sulfate FGK（儿童近视治疗）→ 拒绝批准
Kinselby（蕈样肉芽肿/Sezary综合征治疗）→ 拒绝批准
5. 申请撤回
Teriparatide Ascend（骨质疏松）
Lutathera适应症扩展（胃肠胰神经内分泌瘤）
6. 重新审查
Aplidin（plitidepsin，多发性骨髓瘤）→ 重新评估2017年的否决决定
Winlevi（clascoterone，痤疮治疗）→ 重新评估2025年4月的否决决定
7. 药物安全性审查
阿奇霉素（Azithromycin）
调整适应症，以减少抗生素滥用和耐药性
pidacrine类药物（神经系统用药）→ 启动安全性审查
相关附件：
1. Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025
2. Overview of (invented) names reviewed in April 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 22 May 2025
3. Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 19-22 May 2025
正文链接：
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-may-2025
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