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  北京4月23日电(赵方园)时隔二十多年,国家药监局再次启动牛黄进口试点,北京、天津等12个省市被纳入试点区域。

  天然牛黄是稀缺的中药材,也是核心中药产品安宫牛黄丸的重要原料。近年来,受其稀缺性影响,天然牛黄价格持续上涨,各大中药企业也因此承压。

  在业内人士看来,公告正式落地后,天然牛黄供需格局有望得到改善,从而对价格起到一定的平抑作用。

  京津冀等12地将开展进口牛黄用于中成药生产试点

  日前,国家药监局和海关总署联合发布公告,允许进口牛黄试点用于中成药生产。公告明确了牛黄进口涉及药材来源、进口检疫、通关、进口检验以及首次进口药材审批等方面相关要求。

  试点区域包括:北京、天津、河北、上海、浙江、江西、山东、湖南、广东、四川、福建、广西等12省份。

  公告指出,对于来自不存在疯牛病疫情禁令国家(地区),且符合我国海关检疫要求和药品质量检验要求的牛黄,允许其试点用于中成药生产。试点时限设定为自本公告发布之日起2年,到期后根据试点工作情况,逐步在全国范围内推进牛黄进口使用相关工作。

  哪些企业有资格申报?公告介绍,牛黄进口申请人应当为试点区域内处方含牛黄的中成药品种的药品上市许可持有人。进口的牛黄除进口申请人自用于相关中成药的生产外,同一集团公司试点区域内的控股企业也可使用已进口的牛黄。集团内部应当明确界定各企业在牛黄进口及使用过程中的责任和义务,确保进口的牛黄仅用于集团内部指定企业相关中成药的生产,不得对外销售。

  事实上,进口天然牛黄并非新鲜事。在2000年之前,进口牛黄一直是中国牛黄药材的重要来源。而后,疯牛病疫情在全球蔓延,进口牛黄被查出携带疯牛病病毒。为控制疯牛病传播风险,原国家药监局在2000-2002年期间先后发布了一系列文件,明确要求“禁止使用进口牛源性材料制备中成药,如天然牛黄、牛胆膏、牛骨粉等”。此后,中国未再批准牛黄进口。

  供需格局有望改善

  中国传统名方名药中大量使用牛黄。公开报道显示,在4500余种方剂中大约有650余种方剂采用了牛黄,现代中成药中如“安宫牛黄丸”“片仔癀”“牛黄清心丸”等都是以牛黄为主要原料。据国家中药材标准化与质量评估创新联盟动物药专委会主任委员李宜平教授介绍,一般10年以上的老牛,才可能有牛黄;而牛得胆结石的几率只有1-2‰,100万头牛才能得3-4公斤牛黄。

  而因其稀少珍贵,牛黄堪称中药界的”黄金”。康美中药网显示,今年1月,市场天然牛黄走动畅快,有商家寻货,市场货源紧缺,价格继续走高,现在市场天然牛黄价格在160万-170万元/公斤。

  天然牛黄价格持续上涨也助推企业对旗下产品不断提价。其中,片仔癀对提价策略的运用更为积极。根据片仔癀公告,以天然牛黄为核心原料的片仔癀产品,在过去二十年内经历13次价格调整,单价由2005年的125元/粒逐渐提升至2023年的760元/粒,提价幅度高达508%。

  同仁堂品牌的安宫牛黄丸售价,从2012年的350元/丸逐步调整至2021年的860元/丸,累计提价幅度达145.71%。港版安宫牛黄丸于2024年6月12日再次调整价格,新售价为1189元/丸,较之前价格上浮20.71%。

  北京中医药大学卫生健康法治研究与创新转化中心主任邓勇教授告诉中新健康,“此次允许进口牛黄用于中成药生产则有助于增加牛黄的供应,满足中成药生产的需求,保障相关药品的稳定生产和供应。”

  邓勇进一步解释道,增加天然牛黄的供应可以改善供需关系,减轻原料短缺导致的成本上升压力,从而对价格起到一定的平抑作用,但价格的走势还受到市场供需、生产成本、政策执行效果等多种因素的综合影响。(完) 艳姆1到5,开启美食新境界的相关文章 老板悄悄将消防员餐食换成超大份的相关文章
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