2014-03-23 Lachman CONSULTANTS

修订的ANDA清单—新要求络绎不绝

在2014年1月修订的ANDA清单（上次修订是2013年10月第三季度）中，有一些FDA在ANDA完整性与可接受性审评中需要检查的新内容。如若缺少这些资料，将导致收到拒收函，并被处以占ANDA使用者付费25%的罚金。

修订后的清单包含下列新的资料要求，或至少更为准确地清楚说出了仿制药办公室审评员所希望得到的：

• 仿制药办公室现要求申请者在附函中确认该申请是否受风险评估与降低策略（Risk Evaluation and Mitigation Strategy）管制。
• 重点事项—对于药房用大包装（医院与配剂药房所使用的注射用容器，通常并未留存和包含针对具体患者的不同剂量，而是在一个规定短时间内于无菌环境下取出具体剂量），仿制药办公室希望看到 — 至少应包含清单所及的内容；然而，点击网站链接我们可以看到，在此类申请的立卷审评中有一系列问题必须评估。我们希望这一解释是全面的（参见清单的1.14.1.4部分）。
• 仿制药办公室建议原料药编制新的鉴定表（参见清单的3.2.S.3部分），提供化学名、编码、化学结构、工艺/降解杂质，以及杂质或降解产物的来源或机理（参见清单的3.2.S.3部分）。
• 仿制药办公室也希望以表格形式给出证明拟定质量合理性的信息（参见清单的3.2.S.4.5部分）。
• 对药品的杂质信息也要求同样的表格格式（参见清单3.2.P.5.5部分）。

现在，请赶紧着手调整尚未提交的ANDA， 以避免仿制药办公室责问仿制药企业一错再错。对于已经提交、但还在长达六个月的排队期内等待完整性与可接受性审查的30多份ANDA—希望它们不会收到拒收函。

Lachman CONSULTANTS - Bob Pollock先生 2014-03-13
校译：识林-Kapok 2014-03-22

Revised ANDA Checklist – The New Requirements Keep on Coming
Written by Bob Pollock • March 13, 2014

For those of you that may have missed the January 2014 revision of the ANDA Checklist (last revised was 3rd quarter, October 2013), there are some new items that FDA will be looking for in its initial Completeness and Acceptability Review of ANDAs. Failure to include this information could result in a Refuse-to-Receive letter and a penalty of 25% of your ANDA user fee.

The revised checklist includes the following new informational requirements, or at least spells out more precisely what the Office of Generic Drug (OGD) reviewers will be looking for:

• OGD is now asking for the applicant to identify in the cover letter of the application whether the product is subject to a Risk Evaluation and Mitigation Strategy (REMS).
• Here is a big one – for Pharmacy Bulk Packages (injectable containers that are usually used in hospitals or admixture pharmacies that are typically not preserved and contain multiple doses of drug from which individual patient doses are extracted under aseptic conditions ,usually within a defined short period of time), OGD will now expect to see a Label Comprehension Study – at least that is what the listing in the checklist says; however, when accessing the web link, there is a series of questions that must be evaluated in the filing review of such an application. Let's hope that is all that this means (see 1.14.1.4 in the checklist).
• OGD is proposing a new characterization table for drug substances (see 3.2.S.3 in the checklist) to provide chemical name, Code #, chemical structure, process/degradation impurity, and the source/mechanism of the impurity or degradation product (see 3.2.S.3 of the checklist).
• OGD also wants information on the justification of proposed specification provided in tabular form (see 3.2.S.4.5 of the checklist).
• The same tabular format is being requested for impurity information for the drug product (see 3.2.P.5.5 of the checklist).

That's it for now – so begin updating your yet-to-be-submitted ANDAs so OGD won't question how generic firms keep getting it wrong time after time! And for those 30 ANDAs you submitted that are still in a 6+ month queue for Completeness and Acceptability Review – Just hope you don't get an R-T-R letter!