FDA仿制药办公室新进展及重要消息
出自识林
FDA仿制药办公室新进展及重要消息
笔记 2015-10-17 Lachman CONSULTANTS 随着GDUFA进程愈演愈烈，仿制药办公室（OGD）正在逐渐变化，关于审评协调的各个碎片已经拼凑起来，审评效率和批准流程随之改善。下面是可以证明OGD以上当前状态的一些来自于OGD的有趣的事实。 一位FDA官员最近表示：“在GDUFA I期最开始时，FDA未决递交和企业未决递交的比率大约是5:1或4:1。现在是2.3:1，并且正在加快推进。因为我们确实已经建立了审评机器，并真正使它运转起来，CR（完全回应）和IR（信息请求）的量已开始向企业施加压力。”这样的观察是独特的，我们还无法获得过去几个月中签发的CR和IR的数量，尽管我们已经看到批准量的增长。但是，关于CR和IR的数量“正向企业施压”的评论并不令人吃惊。许多CR已令企业等待长达3到5年，然后一下子凭空出现在企业面前，而企业并没有完全准备好处理这些CR。随着目标行动日期（TAD）的公布，企业应该更好的了解他们何时应从FDA收到交流，以便更好地准备及时应对回复这些交流。现在，企业院子里可能有一些FDA CR和IR的“积压”，而企业通过准备回复以处理这些积压。对于FDA来说暂时有些好处，但是这些回复终将返回OGD，并且回到FDA接收的时钟上。希望新的流程能够依照与回复分类相关的GDUFA目标有效处理这些回复。 另一个有趣的新闻是OGD表示，计划在GDUFA I期末对所有第3年前的递交（包括GDUFA前积压）采取行动。OGD指出，他们会提前开始，肯定会满足或超过90%的GDUFA积压审评目标。此外，OGD表示，他们正努力将ANDA推向批准，而不是仅仅签发完全回应函。 对于第3队列年的递交，备案审评平均为31天。对于所有第3年前的递交，2014年涌进的大量ANDA积压中仍有100件需要处理。 OGD之前没有解决而企业非常感兴趣的一个问题是，第3年前递交的额外审评周期如何及时？问题已被回答，OGD指出，将发布针对第3年前回复的TAD如下：重大增补回复将收到10个月的TAD（加速审评申请为7个月），微小增补回复将收到5个月的TAD（加速审评ANDA为3个月），ECD（易更正缺陷）和IR将收到3个月的TAD。这些披露显示OGD有足够的信心在审评过程中公开这些TAD目标。（请注意，TAD不是强制GDUFA目标，是额外的OGD所做的促进更好的交流的行动。） 我们可能会在11月初的仿制药协会秋季技术会议上听到更多消息，让我们保持关注。 Lachman CONSULTANTS - Bob Pollock先生 2015-10-07 New Information on OGD Progress and Important Information The Office of Generic Drugs (OGD) is evolving as the GDUFA process is gaining steam, and the pieces are coming together regarding coordination of reviews, and as efficiency in the review and approval process improves. Here are some interesting facts that have come out of OGD recently that may prove the above states are an accurate assessment of OGD’s current state. One FDA official recently stated: “At the very beginning of GDUFA I, the ratio of submissions pending FDA vs. submissions pending industry was roughly 5:1 or 4:1. Now it’s about 2.3:1 and accelerating. Because we truly have built the machine and truly are cranking it up, the volume of CRs and IRs may be starting to press industry.” This observation is unique in that we have not had access to the number of CRs (Complete Responses) or IRs (Information Requests) that have been issued over the last few months, even though we have seen the number of approvals increase. But the comment about the number of CRs and IRs “pressing industry” does not surprise me. Firms have been waiting for many CRs for 3 to up to 5 years, then-poof! – they appear out of thin air and the firms just are not quite prepared to begin work on them. Now with the issuance of Target Action Dates (TADs), firms should know better about when they would be receiving communications from FDA and may be better prepared to deal with responding to those communications in a timelier manner. So now a “backlog” of FDA CRs and IRs may be building in industry’s court, while industry works through formulating their responses. This may be good for FDA on a temporary basis, but those responses will be coming back in to OGD and will go back on the Agency’s clock upon receipt. Hopefully, the new process will perform well in turning those responses around, in accordance with the GDUFA goals associated with the classification of the response. Another interesting tidbit is that OGD has stated that it intends to take action on all pre-year 3 submissions by the end of GDUFA 1. That also includes the pre-GDUFA backlog, and OGD notes that they are ahead of schedule and will definitely meet or exceed the 90% GDUFA backlog review goal. In addition, OGD indicates that they are striving to move ANDA towards approval, rather than just to issue a CRL action. For Year 3 cohort submission, the filing review is at an average of 31 days. For the pre-year 3 submissions, there are still about 100 left to address from the huge backlog of ANDAs that came in in FY 2014. One very interesting question that has previously not been addressed by OGD and is of great interest to the industry is, how will additional cycles be timed for review for pre-year 3 submissions? That question has been answered, as OGD notes that it will issue TADs for pre-year 3 responses as follows – major amendment responses will receive a 10-month TAD (7 months for an expedited review application), minor amendment responses will be on a 5-month TAD (3 months for an expedited review ANDA), and ECDs (Easily Correctable Deficiencies) and IRs will receive a TAD of 3 months. These revelations make it clear to me that OGD is confident enough in the review process to make these TAD goals public. (Remember that a TAD is not a mandated GDUFA goal and is something extra that OGD is doing to promote better communication.) We will likely hear more at the GPhA Fall Technical meeting in early November and we will keep you posted on the latest developments. |