FDA仿制药审评新动向
出自识林
FDA仿制药审评新动向
笔记 2015-02-11 Lachman CONSULTANTS 2015美国仿制药协会（GPhA）年会于2月9日-11日在迈阿密召开，会议上FDA报告了其针对仿制药的下一步行动计划。 FDA终于为所有第3年之前的申请推出目标行动日期（Target Action Date，TAD）计划。这是现在对GDUFA第3年队列的申请已经在做的事情，至少将给第3年之前的申请者一个暗示，他们可能会收到一封完全回应函（CRL）。FDA表示他们希望这项计划顺利进行的话有望在2015日历年第一季度末完成，从而，第3年之前的ANDA可以期待尽快获得TAD。 另一举措是，FDA对于“重大”仿制药将在TAD之前3-6个月发布上市计划更新（launch planning updates）。虽然我们不是很肯定“上市计划更新”的定义，听起来像是FDA意识到，随着产品接近批准阶段，申请人需要一个前置时间准备上市，而不是让申请人因突然出乎意料地收到一封批准函而吃惊。 FDA还将在目前的审评周期下开始针对缺陷项实施迭代式的实时交流。希望这将允许审评继续和申请人回应，使得申请在本轮周期内批准而无需发布CRL，或在本轮周期达到微小增补状态，或给申请人有关申请问题的早期反馈。 另一个我听到的消息是，至少在未来两年内，FDA不期望其批准时间能有所改善。遗憾的是，关于批准时间，并没有惊喜出现。 Lachman CONSULTANTS - Bob Pollock先生 2015-02-11 Snippets from the GPhA Annual Meeting Technical Committee Meeting The GPhA Annual Meeting is being held in Miami this year. I'm sorry that I had to miss it (first time in over 20 years!) but the change in meeting dates conflicted with an already planned family trip. But the good news is that we are wired into some of the happenings behind the scenes and I have this to report. FDA is finally rolling out its Target Action Date (TAD) program for all pre-year three applications. This is something that is being done now for the year three GDUFA cohort and will give pre-year three applicants at least a hint of when they might expect to see a Complete Response Letter (CRL). Look for a TAD soon for those ANDAs,as the FDA said they hope to have this well underway by the end of the first quarter of the calendar year 2015. In another move, FDA will also be sending out launch planning updates 3-6 months before TADs for “big” generics. While we are not quite certain as to the definition of “launch planning updates”, it sounds like FDA recognizes the need to have a lead time for the applicant to prepare for launch as the product approaches the approval stage, as opposed to having the applicant being surprised by an Approval Letter that arrives out of the blue and unexpectedly. The FDA will also begin iterative real time communications for deficiencies in the current review cycle. Hopefully, it will allow the review to continue and the applicant to respond bringing the application to approval in that cycle without the need to issue a CRL, to reach minor amendment status in that cycle, or to give the applicant early feedback on application issues . Another bit of info that I heard was that FDA said that it does not expect its approval times to improve at least for the next two years. Unfortunately, there is no surprise there! |