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2014-10-17 识林

正如一句俗语所说“自己动手，丰衣足食”。10月16日药品审评与研究中心（CDER）主任Janet Woodcock向全体中心工作人员发出邮件宣告在超过2年的酝酿期后新的药品质量办公室（OPQ）正式成立！看来新的“超级办公室”将在2015年1月1日开始工作（因为这天是公众假日，可能没有任何工作人员工作）。更令人意想不到的是，Woodcock本人将担任新的超级办公室的代理主任！有传言称CDER内部对这一新安排有相当大的反对，因此像我说的一样“自己动手……”。余煊强将出任副主任。

新办公室的人员详情请参见全新的OPQ网页。

新的OPQ超级办公室下有8个办公室。这对于CDER处理新药批准和产品生命周期行动是一个重大的变化。下述重大（且很可能是颠覆性的）职能变化正在发生。

• 目前在制药科学办公室的许多成员将迁往OPQ。

　　　这些人员中仿制药的关键人员均是CMC审评人员

• 合规办公室将其批准前和日常监管活动转移到OPQ。

　　　这意味着将来企业见到的检查员将来自于OPQ

• 生物等效性/生物利用度和非临床检查活动将转移到转化科学办公室

这是CDER传统上处理新药审评和批准活动方式的巨大变化，且很可能在新办公室落成之前扰乱CMC审评效率。FDA White Oak园区的办公空间严重短缺将使其很难让新同事了解彼此。我们希望这将不会进一步拖延仿制药批准，虽然我非常怀疑。令人不解的是，CDER将所有这些重大变化置于重要的新使用者付费计划GDUFA的中间时期实施。

最后一件观察到的事。新OPQ下8个办公室领导中的6个是女性，或许表明当面临适应重大变化时，女性比起男性更加不那么固执 — 也许这是真的！

北京大学药物信息与工程研究中心 - Garth Boehm博士 2014-10-17
校译：识林-椒 2014-10-17

Janet Woodcock Launches the Office of Product Quality
Written by Garth Boehm • October 17, 2014

“If you want a job done properly, do it yourself” as the saying goes. On October 16 Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) sent an email to all Center staff officially launching the new Office of Product Quality (OPQ) after a gestation period of just over 2 years! Apparently the new “Super Office” will begin working on January 1, 2015 (probably without any staff since this day is a public holiday). More unexpected is that Woodcock herself will be the Acting Director of the new Super Office! It is rumored that there is considerable opposition within CDER to this new arrangement, so like I said “if you want a job done properly …”. Laurence Yu will be the Deputy Director.

Details of the new office staffing are on the brand new OPQ web page.

There are 8 Offices in the new OPQ Super Office. This is a major change to the way CDER handles New Drug Approvals and Product Lifecycle activities. The following major (and very probably disruptive) function changes are occurring.

• Many of the personnel currently in the Office of Pharmaceutical Science will move to OPQ.

　　　Key among these staff for Generic Drugs are all the CMC review staff

• The Office of Compliance will cede its Preapproval and Routine Surveillance activities to OPQ.

　　　This means that the inspectors companies will see in future will come from OPQ

• Bioequivalence/Bioavailability and non-clinical inspectional activities will move to the Office of Transitional Sciences

This is a huge change in the way that CDER traditionally handled New Drug Review and Approval activities and is likely to be disruptive to CMC review productivity until the new office settles down. This will not be helped by the critical shortage of office space at FDA's White Oaks Campus which will make it difficult for the new co-workers to get to know each other. We hope that this will not further delay Generic Drug Approvals, but I fear that it will. It is puzzling that CDER would make all these major changes literally in the middle of a major new User Fee program, GDUFA.

One last observation. Six of the eight Office leaders within the new OPQ are women perhaps indicating that women are less stubborn than men when it comes to adapting to major change – maybe that is true!!

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