蒲公英 - 制药技术的传播者 GMP理论的实践者

搜索
查看: 1654|回复: 7
收起左侧

[GMP相关] 良好的ANDA提交指南(草案)

[复制链接]
药士
发表于 2018-4-20 23:40:01 | 显示全部楼层 |阅读模式

欢迎您注册蒲公英

您需要 登录 才可以下载或查看,没有帐号?立即注册

x
Good Abbreviated New Drug Application Submission Practices; Draft Guidance for Industry; Availability

Good ANDA Submission Practices (DRAFT).pdf

249.56 KB, 下载次数: 47, 下载积分: 金币 -1

回复

使用道具 举报

药士
 楼主| 发表于 2018-4-20 23:51:10 | 显示全部楼层
Draft Guidance and a MaPP to Help Firms and Reviewers Get It Right the First Time (or Second Time)

By Bob Pollock | January 3, 2018 | FDA, Generics, Regulatory Affairs | 4 |


Today, the FDA issued a draft guidance entitled “Good ANDA Submission Practices” (here) along with a new Manual of Policy and Procedure (MaPPs) 5241.3, entitled “Good ANDA Assessment Practices: Manual of Policies and Procedures.” These establish good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness. (here ).
Regarding the draft guidance, the FDA says:
“This draft guidance is intended to assist applicants preparing to submit ANDAs to FDA. It highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. This draft guidance also makes recommendations to applicants on how to avoid these deficiencies so that applicants can submit ANDAs that may be approved in the first review cycle. This draft guidance has been developed as part of FDA’s “Drug Competition Action Plan,” which, in coordination with the Generic Drug User Fee Amendments (GDUFA I and II) (Pub. L. 112-144 and Pub. L. 115-52, respectively) and other FDA activities, is expected to increase competition in the market for prescription drugs, facilitate entry of high quality and affordable generic drugs, and improve public health.”
The MaPP, according to the Agency, “establishes good ANDA assessment practices for the Office of Generic Drugs and the Office of Pharmaceutical Quality to increase their operational efficiency and effectiveness.”
These two documents have been developed based upon feedback from industry during the GDUFA I term and as part of the FDA’s Drug Competition Action Plan which, along with GDUFA II and other Agency initiatives, are designed to bring generic products to market in a more expeditious manner.
The industry guidance document explores common deficiencies and how to respond to them in the following categories:
  • Patent and exclusivity deficiencies
  • Labeling deficiencies
  • Product quality deficiencies and.
  • Bioequivalence deficiencies

While the guidance does restate many of the common deficiencies that OGD has previously identified as issues that tend to create additional review cycles, they also provide additional transparency as to what OGD is actually looking for, which may make responding to the deficiencies easier or help to avoid them altogether.
The MaPP speaks to an age-old problem relative to “the nice-to-know versus the need-to-know” for approval that has been brought up by industry for years. As FDA states in the MaPP:
“Over the past several decades, ANDA review customs have evolved, and the quantity of documentation of FDA’s ANDA review has increased. During this time, supervisor expectations concerning review documentation occasionally varied within and across disciplines. For instance, reviewers sometimes evaluated ANDAs beyond what was necessary to ensure that the ANDA met the regulatory requirements for approval, worked to remediate and re-assemble poorly organized ANDAs, or generated elaborate work papers.
OGD and OPQ’s consistent and targeted focus should continue to be on evaluating whether ANDAs meet the regulatory requirements for approval. To reinforce the policy and procedural changes set forth in this MAPP, going forward, OGD and OPQ will use the term assessment in place of review. Assessment means the process of both evaluating and analyzing submitted data and information to determine whether the application meets the requirements for approval and documenting that determination.”
The document goes on to discuss the need for reviewers to:
  • Not only utilize standard and proven templates in their assessment and determine when an ANDA meets the regulatory requirements but also to explain why there are deficiencies and how to define what is needed to resolve them.
  • “Clarifies the roles and responsibilities of primary assessors, secondary assessors, and division directors (who, under this MAPP, will no longer perform the role of a typical tertiary reviewer). This clarification will reduce duplicative and unnecessary work, which will increase FDA’s efficiency and effectiveness.”
  • “Establishes that OGD and OPQ will clearly communicate to applicants what deficiencies must be corrected for their ANDAs to be approved. This communication will enable applicants to develop high-quality re-submissions and to reduce the number of subsequent cycles to approval.”

The document goes on to describe the roles and responsibilities of the assessors in the review loop (very enlightening).  Remember that a MaPP is a document that describes how the Agency staff does its job and its publication is to provide greater transparency to industry.
This is what industry has been asking for, for years.  If FDA can deliver, then the review process should greatly benefit by taking the guess work out of what FDA may be asking for in their deficiencies.  Let’s hope this works to the advantage of both the FDA and industry; after all, teamwork by all players gets the ANDAs to the finish line!




回复

使用道具 举报

药徒
发表于 2018-4-21 08:54:55 | 显示全部楼层
纯英文的。有点看不懂啊
回复

使用道具 举报

药士
发表于 2018-4-21 11:55:52 | 显示全部楼层
回复

使用道具 举报

药徒
发表于 2018-4-30 18:02:40 | 显示全部楼层
谢谢分享学习
回复

使用道具 举报

药士
 楼主| 发表于 2018-5-22 05:54:31 | 显示全部楼层
本帖最后由 beiwei5du 于 2018-5-22 06:01 编辑

APIC和AAM的comments
Good ANDA Submission Practices

Comment_from_Association_for_Accessible_Medicines_(AAM).pdf

187.87 KB, 下载次数: 1, 下载积分: 金币 -1

Comment_from_Active_Pharmaceutical_Ingredients_Committee_APIC.pdf

164 KB, 下载次数: 2, 下载积分: 金币 -1

Comment_from_International_Pharmaceutical_Excipients_Council_of_the_Americas_(IP.pdf

116.17 KB, 下载次数: 1, 下载积分: 金币 -1

回复

使用道具 举报

发表于 2020-7-23 13:37:41 | 显示全部楼层
beiwei5du 发表于 2018-4-20 23:51
Draft Guidance and a MaPP to Help Firms and Reviewers Get It Right the First Time (or Second Time)By ...

楼主好厉害!英语特好!!
回复

使用道具 举报

药圣
发表于 2022-7-15 18:30:52 | 显示全部楼层
非常感谢分享
回复

使用道具 举报

您需要登录后才可以回帖 登录 | 立即注册

本版积分规则

×发帖声明
1、本站为技术交流论坛,发帖的内容具有互动属性。您在本站发布的内容:
①在无人回复的情况下,可以通过自助删帖功能随时删除(自助删帖功能关闭期间,可以联系管理员微信:8542508 处理。)
②在有人回复和讨论的情况下,主题帖和回复内容已构成一个不可分割的整体,您将不能直接删除该帖。
2、禁止发布任何涉政、涉黄赌毒及其他违反国家相关法律、法规、及本站版规的内容,详情请参阅《蒲公英论坛总版规》。
3、您在本站发表、转载的任何作品仅代表您个人观点,不代表本站观点。不要盗用有版权要求的作品,转贴请注明来源,否则文责自负。
4、请认真阅读上述条款,您发帖即代表接受上述条款。

QQ|手机版|蒲公英|ouryao|蒲公英 ( (京)-非经营性-2014-0058 京ICP证150354号 京ICP备14042168号-1 )

GMT+8, 2024-3-28 20:06

Powered by Discuz! X3.4运维单位:苏州豚鼠科技有限公司

Copyright © 2001-2020, Tencent Cloud.

声明:蒲公英网站所涉及的原创文章、文字内容、视频图片及首发资料,版权归作者及蒲公英网站所有,转载要在显著位置标明来源“蒲公英”;禁止任何形式的商业用途。违反上述声明的,本站及作者将追究法律责任。
快速回复 返回顶部 返回列表