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出自识林

2015-01-07 Lachman CONSULTANTS

FDA今日发布了一篇指南，题为“指南日程：CDER计划将于2015年发布的新指南和草案修订指南”。这份文件让我们了解到，在新的一年众多议题之中，可以期待哪些新议题或者变化。这份清单可能并不足够详尽到能反映将要发生的变化，但至少就FDA即将作出的变化或新建议指明了方向。 下面我将介绍即将发生变化的领域之中读者可能特别关注哪些。文件列出了FDA正在准备制订的共计8份广告、4份生物药剂学、4份生物类似物、11份临床/医学、9份临床药理、1份临床统计、3份药品安全、3份电子申报、4份仿制药、3份标签、13份质量化学生产与控制（CMC）、3份cGMP、1份药理/毒理以及26份流程指南。下文介绍了一些值得特别关注的分类：

分类-仿制药

• 支持ANDA批准的包装内置说明书草稿的可接受性
• 因印刷错误与文件位置错误拒收的ANDA申请
• GDUFA法案下II类原料药DMF的完整性审评
• GDUFA法案下II类原料药DMF的完整性审评检查清单行业指南

对仿制药分类的看法——这些议题在仿制药办公室（Office of Generic Drugs，OGD）早先发布的指南中都已讨论过；然而，OGD基于其在GDUFA项目下积累的经验，重新探讨并扩展了其中某些议题，寻求额外的质量要求。

分类-生物药剂学

• 口服给药产品新药申请（NDA）或研究用新药申请（IND）中提交的生物等效性与生物利用度研究 – 一般性考虑
• 包括生物药剂学分类为1类与3类的速释固体口服制剂药品溶出度检测与质量标准
• 食物对生物利用度的影响以及进食生物等效性研究
• 基于生物药剂学分类的速释固体口服制剂体内生物利用度与生物等效性研究的豁免

该分类的问题在FDA之前发布的指南中也讨论过，我们可以在今年上述指南发布后关注变化与差别。

分类-生物相似性

• 生物类似药：实施生物制品价格竞争与创新法案（2009）相关的附加问题与解答
• 证明与参照药具有可替换性的考虑
• 生物制品生物类似物的标签
• 证明生物相似性所用相似性数据分析评价的统计学方法。

随着FDA去年已收到大量生物类似物申请，上述部分指南对于生物类似物项目的成功、尤其是有关标签可替换性的议题相当关键。 其它可能引起特别关注的指南（以及我们希望能回答一系列重要及正在发生的问题的指南），如下：

• 质量量度与基于风险的检查
• 确立条件：需申报的已获批药品与生物制品CMC变更
• 合规政策指导：销售未获批药品（440.100节）；草案修订
• 企业考虑是否按503B节注册为合同生产设施
• 现场警示报告与生物制品偏差报告的提交

新的一年中确实会发生一些重要变化，我们应了解FDA如何继续维持严格的标准。让我们一起观望FDA将在以上议题以及其它重要议题中何去何从。

Lachman CONSULTANTS - Bob Pollock先生 2015-01-06
编译：识林-椒 2015-01-07
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New or Revised Guidances to Look for From FDA in Calendar Year 2015
Written by Bob Pollock • January 06, 2015

FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”. This document gives us an idea of what is new and what changes we can expect on various issues over the coming year. It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.

While the complete document can be found here ,I would like to point out the following areas where changes are upcoming that may be of specific interest to readers. The document outlines 8 advertising, 4 biopharmaceutics, 4 biosimilar, 11 clinical/medical, 9 clinical pharmacology, 1 clinical statistical, 3 drug safety, 3 electronic submission, 4 generic, 3 labeling, 13 quality chemistry, manufacturing,and control (CMC), 3 cGMP, 1 pharmacology/toxicology, and 26 procedural Guidances the Agency is in the process of preparing. Some of particular interest are described below:

CATEGORY —Generics

• Acceptability of Draft Package Insert Labeling to Support ANDA Approval

• ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files

• Complete Assessments for Type II API DMFs Under GDUFA

• Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs

An observation on the Generics category – Each of these issues has been previously addressed in prior guidances issued by the Office of Generic Drugs (OGD); however, it appears that some of these issues might be revisited and expanded as OGD learns from its experiences under the GDUFA program and searches for additional quality measures.

CATEGORY — Biopharmaceutics

• Bioavailability and Bioequivalence Studies Submitted in NDA's or INDs for Orally Administered Drug Products – General Considerations

• Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs

• Food Effects Bioavailability and Fed Bioequivalence Studies

• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

Here is another category where these issues have been addressed in previous Agency guidance documents, so we will look for the changes and differences when these documents issue during the year.

CATEGORY — Biosimilarity

• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

• Considerations in Demonstrating Interchangeability to a Reference Product

• Labeling for Biosimilar Biological Products

• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

With the FDA having accepted numerous biosimilar application over the last year, some of these Guidance documents are going to be key to the success of the biosimilar program especially issues regarding interchangeability of biosimilar and labeling.

Other Guidances that may be of specific interest (and that we hope may answer a number of outstanding and ongoing questions) are as follows:

• Quality Metrics and Risk-Based Inspections
• Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
• Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
• Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
• For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
• Submission of Field Alert Reports and Biological Product Deviation Reports

There are likely to be some important changes coming this year and we know how the Agency likes to keep the bar high, so let’s watch to see where FDA may be going on these and other important issues this year.