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美国FDA电子烟PMTA(上市前烟草制品申请)内容
美国FDA电子烟PMTA(上市前烟草制品申请)内容
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所属报告:
电子烟行业深度报告:解析电子烟全球监管体系重点关注品牌化出海机会-230206(26页).pdf
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到2040年美国FDA批准的中国原创新药占比
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2026-06-11
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美国FDA各年度批准NME药物与生物药数量
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2026-05-25
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美国FDA药物评价与研究中心受理的IND申请
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2026-04-08
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图表11FDA获批KRASG12C抑制剂的全球销售额(百万美元)
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2026-02-25
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图 26 美国食品和药物管理局(FDA)在2020年开始实施RACE法案,以确保更多癌症药物试验包括儿童人群
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2026-02-13
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**TABLE 5. FDA-approved Immunotherapeutics to Treat Pediatric Cancers (2015–2025)**
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2026-02-13
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**TABLE 4 FDA-approved Molecularly Targeted Therapies to Treat Pediatric Cancers (2015–2025)**
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2026-02-13
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表 5 FDA批准的免疫治疗药物用于治疗儿科癌症(2015–2025)
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2026-02-13
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Figure 2 FDA-approved therapeutics with CDx, including novel oncological therapies (1997-2024)
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2026-02-13
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表4 FDA批准的分子靶向疗法用于治疗儿童癌症(2015–2025)
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2026-02-13
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2018-2024年FDA批准的创新抗体药物分类(个)
fCDliIbnsbsgICB8IOaVsOmHj++8iOS4qu+8iSB8IOWNoOavlCAgIHwKfCAtLS0tLS0gfCAtLS0tLS0tLS0tIHwgLS0tLS0tIHwKfCDltYzlkIjkvZMgfCAzICAgICAgICAgIHwgNC42JSAgIHwKfCDlhajkurrmupAgfCAyMiAgICAgICAgIHwgMzMuOCUgIHwKfCDkurrmupDljJYgfCA0MCAgICAgICAgIHwgNjEuNSUgIHwKCui1hOaWmeadpea6kO+8muWFrOWPuOaLm+iCoeS5pu+8jOW8l+iLpeaWr+eJueaymeWIqeaWh++8jOWbveazsOa1t+mAmuivgeWIuOeglOeptg==
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2026-01-27
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2018-2024年FDA批准的全人源抗体制备技术分
fCDmioDmnK/nsbvliKsgICAgICAgfCDmlbDph4/vvIjkuKrvvIkgfAp8LS0tLS0tLS0tLS0tLS0tLXwtLS0tLS0tLS0tLS18Cnwg6L2s5Z+65Zug5bCP6byg5oqA5pyvIHwgOSAgICAgICAgICB8Cnwg5Zms6I+M5L2T5bGV56S65oqA5pyvIHwgNyAgICAgICAgICB8Cnwg5YW25a6D5oqA5pyvICAgICAgIHwgNiAgICAgICAgICB8CgrotYTmlpnmnaXmupDvvJrlhazlj7jmi5vogqHkuabvvIzlvJfoi6Xmlq/nibnmspnliKnmlofvvIzlm73ms7DmtbfpgJror4HliLjnoJTnqbY=
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行业数据
2026-01-27
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FDA拟禁用合成色素种类在欧盟和中国使用情况
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2026-01-15
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2018-2024各年NMPA及FDA合批准的抗
fCDlubTku70gfCDmipfkvZPoja/mlbDph4/vvIjkuKrvvIkgfAp8LS0tLS0tfC0tLS0tLS0tLS0tLS0tLS0tLXwKfCAyMDE4IHwgMjAgICAgICAgICAgICAgICB8CnwgMjAxOSB8IDE2ICAgICAgICAgICAgICAgfAp8IDIwMjAgfCAxNiAgICAgICAgICAgICAgIHwKfCAyMDIxIHwgMjEgICAgICAgICAgICAgICB8CnwgMjAyMiB8IDIxICAgICAgICAgICAgICAgfAp8IDIwMjMgfCAyMyAgICAgICAgICAgICAgIHwKfCAyMDI0IHwgMzIgICAgICAgICAgICAgICB8CgrotYTmlpnmnaXmupDvvJrnmb7lpaXotZvlm77mi5vogqHkuabvvIxGREHvvIxDREXvvIzlvJfoi6Xmlq/nibnmspnliKnmlofvvIzlm73ogZTmsJHnlJ/or4HliLg=
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2026-01-05
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2018-2024FDA批准的创新抗体药分类
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行业数据
2026-01-05
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最新数据
全球全年龄段奶粉市场规模(亿美元)
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2026-07-30
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全球酸奶及发酵乳制品市场规模(亿美元)
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2026-07-30
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全球药用级益生菌市场规模(百万美元)
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2026-07-30
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全球益生菌膳食补充剂市场规模及增速
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2026-07-30
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全球拥有AKK专利菌株的核心企业
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2026-07-30
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PMTA 申请特点为高门槛、全链条。资金壁垒和材料专业度壁垒能够在一定程度上使小厂被迫退出市场,利好龙头企业;同时 PMTA 审核促使电子烟产品回归减害性和替烟性。美国于 2016 年对电子烟纳入 FDA PMTA(上市前申请)制度。PMTA 制定的目的就是更好的将行业规范化。为获得 PMTA 审批的营销许可令,电子烟企业需要提交价值数百万美元的申请,整个申请材料或多达 10 万页,申请周期长达 2 年;PMTA 申请需与制造方绑定,提供代工制造方的全面信息(包括制造/包装工厂的详细信息,所有设施及生产步骤的描述、制造商实验室、制造/控制/质量流程)。美国 FDA 对电子烟产品的 PMTA 或是电子烟行业某种程度上的供给侧改革。另一方面,PMTA 申请需提交大量的科学研究及分析信息,包括产品减害特性的研究结果、产品与市场同类型电子烟产品及烟草制品的健康风险对比、有害成分等。通过 PMTA 认证的电子烟产品可看作获 FDA 减害背书。
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电子烟行业深度报告:解析电子烟全球监管体系重点关注品牌化出海机会-230206(26页).pdf
全球主要地区对雾化电子烟/HNB的管理分类及政策
日本、西欧、美国市场电子烟规模及渗透率,不同的监管政策造成了雾化电子烟/HNB的渗透率差异
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