首页 > 资讯 > OGD关于稳定性要求的新决定

出自识林

2014-07-25 识林

【注意：以2014年6月20日为界，在这之前提交的ANDA原始申请，即使后来被拒收（RTR），后续也无需按3批、6个月的要求提交稳定性数据，按1批、3个月即可】

据FDA内部消息证明：ANDA的原始提交日期决定稳定性的要求。也就是说，即使申请在2014年6月20日之后收到拒绝接受（RTR）函，该申请仅需依照原始提交之时的稳定性要求。因此，FDA已决定划一条清晰的界限，以2014年6月20日作为起始日期，对首次提交的申请要求3批6个月室温和6个月加速稳定性。
这对6月20日之前首次提交到仿制药办公室且仍处于完整性和可接收性审评阶段的大约700-800件ANDA 无疑是好消息。据我们了解，有相当多关于此问题的讨论，划出明确界限决定的推断似乎是最合理和最容易执行的。OGD不需要一个复杂的，有争议的，可能导致其它旷日持久的辩论甚至是法庭质疑的决策过程。最后，OGD已决定这种简单易懂的方法符合OGD和行业的最大利益。
因此，籍于此消息，关于OGD政策的一个篇章告一段落。所有人快乐的一天！
Lachman CONSULTANTS - Bob Pollock先生 2014-07-24

作为一个附带的问题，据我所知OGD的决定对于那些递交失败的研究以赶上6月19日期限的企业来说是个“福利”。OGD的问题是他们的RTR决定有些武断，他们面对联邦法院的挑战极有可能会失败，所以不如干脆放弃并保持灵活性，而不是去冒法院下令严格RTR系统的风险。
北京大学药物信息与工程研究中心 - Garth Boehm博士 2014-07-25
校译：识林-椒 2014-07-25

Phew! Pre-June 20, 2014, ANDA Applicants Can Rest Easy, Regarding Stability!
Written by Bob Pollock • July 24, 2014

In previous post earlier this week (here), we were hoping to discover the Agency position on this particularly important issue. But now sources within the Agency have confirmed that the date of an ANDA original submission determines the stability requirements. That is, even if the application receives a Refuse-to-Receive (RTR) letter after June 20, 2014, the application will be held only to the stability requirements at the time of the original submission. Thus, the Agency has decided to make a bright line of June 20, 2014 as the start date for the requirement for 3 batches with 6 months room temperature and 6 months of accelerated stability at time of original submission.

This is good news for any of the approximately 700-800 ANDAs still in the completeness and acceptability review process that were originally submitted to the Office of Generic Drugs (OGD) prior to June 20, 2014. We understand that there was quite a bit of discussion on this issue, but the reasons for making a bright line determination appeared to be the most reasonable and easiest to enforce. The one thing OGD does not need is a complicated, contentious decision-making process that could lead to either protracted debates with applicants or even court challenges. In the end, OGD has decided that this straightforward approach was in the best interest of both OGD and industry.

So with this information, one more chapter on OGD policy is now closed. A happy day for all!

Garth Boehm • July 25, 2014

As a side issue, while I understand the OGD decision, this will be a "reward" for companies that filed failing studies in order to get the ANDA in by June 19. The problem for OGD is that their RTR decisions are somewhat arbitrary and they might very well lose a Federal Court Challenge, so better to just give in and keep their flexibility rather than risk a court-ordered, rigid system for RTR.

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