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首页> 外文期刊>Controlled Environments Magazine >REGULATORY FORUM: Time for a New Game Plan
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REGULATORY FORUM: Time for a New Game Plan

机译：监管论坛：制定新游戏计划的时间

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Over the years I have been writing about the indicators of change both within the FDA and the industry. Few can argue with the fact that in today's society, change is inevitable. The organizations that embrace it and integrate it as part of their strategic thinking usually end up in the best position to leverage new opportunities as they arise or, more importantly, as they are created. As we wrap up 2011, we see that it has been another difficult year for the industry. The marketplace watched complacently as nearly 30 billion dollars of products came off patent. Amidst rising payer pressure and ever increasing public and government enthusiasm for generic products, the near term projections for industry growth are not rosy, to say the least. The last six years have been dubbed the Era of Scarcity as the industry has struggled to bring on average 22 New Molecular Entities (NME) to the marketplace compared to the previous eight years--dubbed the Era of Abundance--which averaged nearly 36 NMEs. More noticeable has been the lack of block-buster products, driving the average value of a new drug cohort down by nearly 50percent over the previous era.
机译：多年来，我一直在撰写有关FDA和行业内变化指标的文章。在当今社会，变革是不可避免的，这一点几乎没有人可以争论。接受并将其整合为战略思想一部分的组织通常最终处于最佳位置，以利用新的机会，当它们出现时，或更重要的是，随着它们的创造而来。在总结2011年时，我们看到对于行业来说又是艰难的一年。市场欣喜地看到近300亿美元的产品获得了专利。至少可以说，在付款人压力不断增加以及公众和政府对仿制药产品的热情不断提高的情况下，对行业增长的近期预测并不乐观。过去六年被称为稀缺时代，因为与前八年（被称为丰盛时代）相比，该行业平均难以将平均22种新分子实体（NME）推向市场，因为平均近36个NME 。更加引人注目的是缺乏重磅炸弹产品，这使得新药群组的平均价值比上一个时代下降了近50％。

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