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首页> 外文期刊>Regulatory Affairs Journal- Devices >EMA seeks out ATfVIP manufacturers In advance of approval deadlines
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EMA seeks out ATfVIP manufacturers In advance of approval deadlines

机译：EMA在批准截止日期之前寻找ATfVIP制造商

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At least 20 advanced therapy medicinal products that are currently on the market in the EU will require formal centralised approval by the end of 2012 if they are to remain legally in use. If they fail to receive a marketing authorisation, they will have to be withdrawn. Some of the products in question have been on the market for as long as 15 years, Christian Schneider; chair of the European Medicines Agency's Committee for Advanced Therapies, told a recent regulatory science conference in London.The CAT, which is responsible for the primary evaluation of ATMP marketing authorisation applications for the EMA's Committee for Medicinal Products for Human Use, cannot "just wait and perhaps take negative decisions on all of these products", Dr Schneider said. Rather than "just be sitting there at the end of [the] road", regulators need to be prepared to help get manufacturers back on the road "if there's an accident [along the way]", he added.
机译：如果要继续合法使用，到2012年底，至少有20种在欧盟市场上出售的先进治疗药物将需要正式的集中批准。如果他们没有获得市场授权，则必须将其撤回。克里斯汀·施耐德（Christian Schneider），其中一些有问题的产品已经投放市场长达15年之久。欧洲药品管理局先进疗法委员会主席在伦敦举行的一次监管科学会议上说。负责EMA的人类用药用产品委员会对ATMP营销许可申请进行初步评估的CAT不能“只是等待并对所有这些产品做出负面决定”，施耐德博士说。他补充说，监管机构不仅要“只是坐在路的尽头”，还需要做好准备，以帮助“如果在途中发生事故，”使制造商重返道路。

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