首例中草药产品获英国官方批准2015年03月03日 08:56 来源：39健康网 据英国《每日邮报》报道，英国知名创新生物医药产品企业"凡诺华"（Phynova）日前宣布，其Phynova Joint and Muscle Relief Tablets（凡诺华缓解关节肌肉疼痛片）成为首个获英国药品及保健品管理署（MHRA）批准发售的中药产品。预计该药品将于下月上市销售。该药片的活性成分为豨莶，这种在中国被称为"猪膏草"的植物，味苦性寒，在临床中主要用于治疗包括类风湿关节炎引起的疼痛。"现在，英国人也可以从高质量、规范的中草药中受益。"凡诺华首席执行官罗伯特·米勒（Robert Miller）表示，他感到非常自豪，但"这离不开众多中国同事的功劳"。同时，公司正计划申请第二例传统中成药产品，该产品用于治疗感冒和流感。中药因为安全质量问题在英国已多次遭到过警告和封杀。2004年，欧盟颁布《传统植物药注册程序指令》，这个指令被业内人士称作2004/24EC指令。指令规定，药企若能够在申请日之前提供至少30年的药用历史，其中包括在欧盟地区至少15年的使用历史的，才可以通过简易注册后以药品身份正式登陆欧盟市场。英国从2011年开始实施欧盟规定，中成药产品必须要拿到产品的注册执照才能上市，没有注册执照的中成药库存销完、保质期结束后不能再进货。2013年，英国药品及保健品管理署宣布，为了进一步帮助人们购买和使用安全的草药制品，从2014年4月30日起将全面禁售未注册的草药制品。许多草药制品为了获得授权，花了数以百万计的成本来证明其成分安全性。但迄今为止，唯一获得批准的中草药产品只有凡诺华缓解关节肌肉疼痛片。根据益普索·莫里调查机构（MORI Ipsos）的数据显示，在过去的两年中，至少有六百万英国人咨询过西式或者中国传统草药师。这也说明，传统草药在英国大有市场。近年来，中草药产品几乎在欧盟消失，许多人因此转向互联网购买无证产品，但这也意味着药品安全性无法得到保证。对于凡诺华产品的获批，英国国内也有着不同的声音。西式草药医生克利斯·埃瑟里奇（Chris Etheridge）博士认为这是一个好消息。"豨莶草在西方是不常用的药材，它为那些不愿意服用非甾体抗炎药来对抗肌肉和关节疼痛的患者提供了新的替代品。"而在欧洲草药和传统医学从业者协会主席迈克尔·麦金太尔（Michael McIntyre）看来，中草药几乎不可能满足欧盟的许可条件。他警告称，这一新产品证明了执行欧盟指令保证中草药产品对公众安全的难度。
Phynova receives MHRA approval for the first Chinese Traditional Herbal Registration 02 March 2015 Phynova team unviels the OTC product at the GREAT Festival of Creativity. L-R Zhong Zhong, CEO Phynova (Beijing); Hongwen Yu, Executive VP Phynova (UK) ; Dominic Jeremy, the CEO of UKTI; Robert Miller, CEO Phynova (UK) 2nd March, Shanghai, China: Phynova, the innovative life science company based in Oxford, today announces at The GREAT Festival of Creativity in Shanghai, that it has received the first ever market approval for a traditional Chinese medicine (TCM) from the Medicines and Healthcare Products Regulatory Agency ("MHRA") for its product, Phynova Joint and Muscle Relief Tablets™(www.phynovajointrelief.com). This approval marks a significant development in MHRA policy, as this is the first time that the EU's Traditional Herbal Medicinal Product ("THMP") Directive, which was introduced in April 2004, has been successfully used to register a TCM product within the UK. This proves Phynova's diligence in bringing efficacious traditional herbal medicines to the UK and Europe. Chinese medicine is a high growth market, with ever expanding demand amongst European audiences. Phynova Joint and Muscle Relief Tablets™ is manufactured to Western pharmaceutical standards providing consumers peace of mind and offers a natural alternative treatment to medications such as non-steroidal anti-inflammatory drugs (NSAIDs). The GREAT Festival of Creativity in Shanghai is a trade mission led by HRH the Duke of Cambridge, sponsored by the British government and is showcasing the best of British innovation. The purpose of this mission is to strengthen bilateral trade links between China and Britain, with a focus on fashion, luxury goods, healthcare, technology and entertainment. Commenting on receiving MHRA approval, Robert Miller, Chief Executive Officer of Phynova, said: "I am exceedingly proud that Phynova is the first company to successfully bring a traditional Chinese medicine, in a modernised dosage form, through Western regulatory procedures and to receive marketing approval in the UK from the MHRA. This has come from years of working with our Chinese colleagues, and proves that Sino-British collaboration can have major benefits for both parties. The Great Festival of Creativity is a particularly fitting venue for announcing this cross-cultural first in healthcare. Britain can now benefit from having access to high quality, regulated Chinese medicines, and will continue to benefit from the strengthening ties we have with our partners in China as we look to introduce more TCM products into the UK market."
About Phynova Joint and Muscle Relief Tablets™ A traditional herbal medicinal product used for the relief of backache, minor sports injuries, rheumatic or muscular pains, general aches and pains in the muscles and joints. The OTC is derived from Sigesbeckia which is an annual herb that has been used traditionally in oriental medicine to treat the symptoms of all forms of arthritis and other musculoskeletal pains. Scientific literature reports it has anti-inflammatory, analgesic and anti-oxidant activity.
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