2015年4月3日讯 /生物谷BIOON/ --对于生物医药公司来讲，药物研发还不是最烦心的事情。在经历了数年的临床研究后，当研究人员将获得的珍贵数据上报相关管理部门后却迎来了一段漫长的审查期才是让公司最为抓狂的事情。众所周知，当今生物医药产业的发展日新月异，今天的新药或许在下个月就会被竞争对手所取代。因此，在新药审批层面上缩短时间是所有公司占领市场的关键！
在这方面，美国FDA已经走在了世界前面。从2013年起，FDA先后通过突破性药物疗法认证、审批绿色通道等方式为在美国上市的新药提供了多种便利途径，这也使得一些市场急需的药物能够以最快、最安全的速度到达临床治疗中。
最近欧洲医药管理部门EMA也终于在这一方面迈出了重要一步。EMA最近宣布将开展有条件优先审批计划，这一计划旨在为一些药物疗效显著的药物开辟绿色通道，帮助医药研发者们缩短审批时间。
EMA的管理人员表示，目前EMA已经接到了58个希望进入该通道的药物申请，相关管理人员将从中筛选出8个候选药物作为首批使用该通道的待审药物。虽然EMA并未透露这些药物的名称和拥有者，但是EMA的官员表示这些药物涵盖了基因治疗、细胞治疗以及组织工程等多个新型疗法领域在内，涉及到了癌症药物和罕见疾病药物等。
EMA加速审批计划主要是根据公司递交的临床研究数据对新药的使用人群进行严格的限制，随着药物使用人数的增多，在获得足够的药物有效性和安全性数据后再逐步放开对药物的限制。EMA相信，利用这种方式，管理人员将能够兼顾药物审批速度与药物安全性两方面。
详细英文报道：
The European Medicines Agency (EMA) is preparing to step up its conditional approval initiative to cut the time and data needed to bring new drugs to patients. Having received applications to enter 58 drugs into the program, EMA has selected a treatment based on genes, cells or tissue engineering as the first candidate to advance to the next stage.
EMA has so far declined to name the company or drug involved in the first meeting to discuss the second stage of the initiative, which is scheduled for April 7. What we do know is that EMA will be sitting down to discuss an advanced therapy, the umbrella term the regulator uses for medicines based on genes, cells or tissue engineering. The potential for such treatments to make a major difference to health outcomes in underserved patient populations means they are ideal candidates for EMA's program, but in the long term the regulator has broader ambitions for its initiative.
"I think this is a way of working that is applicable to many drugs," Tomas Salmonson, chairman of the EMA's Committee for Medicinal Products for Human Use (CHMP), told Reuters. The first crop of 8 products selected by EMA to advance through the program also includes experimental treatments for cancer and rare diseases. Each of the 8 drugs could win approval in restricted patient populations on the basis of unprecedentedly slim data submissions, after which the label will become less and less restrictive as more safety and efficacy information accumulates.
The shifting of the burden of evidence generation from pre to post-approval is part of a Europe-wide rethink on the balance between speed and safety. EMA is leading the agenda at the continent level, but member states, notably the United Kingdom, are pushing their own initiatives. Novartis ($NVS) became the latest company to advance to the first stage of the U.K.'s fast-track scheme this week when its lung cancer drug Zykadia was named a Promising Innovative Medicine. Receipt of the status is the first of two steps in the U.K.'s Early Access to Medicines Scheme (EAMS).