20180220 ECA新闻：FDA已批准申报变更报告指南草案

20.02.2018

FDA Draft Guideline onreporting Changes to an approved Application

FDA已批准申报变更报告指南草案

It was 1997 when the FDApublished their 'Guidance for Industry: Changes to an ApprovedApplication: Biological Products'. The Document was supposed to assistmarketing authorisation holders (MAHs) and manufacturers in classifying andreporting on changes in the chemistry, production and control of approvedproducts as per CFR 601.12.

1997年，FDA发布了其“行业指南：批准后申报的变更：生物制品”。该文件意在帮助在市的许可持有人（MAH）和生产商对依CFR601.12批准的药品的化学、生产和控制变更进行分类和报告。

The new document on this topicpublished on 21 December, 2017, is a revised version of the almost 20 year oldguideline and is, in its final version, supposed to replace the old guideline.

本主题的新文件于2017年12月21日发布，在定稿后是使用了近20年之久的旧版本指南的修订后版本，其意在替代旧指南。

There are various reasons whya manufacturer of biological medicinal products may be forced to change thechemical composition, production process or control strategy of an approvedproduct. This may also affect the equipment used, facilities or plants or theresponsible personnel. Manufacturers need to inform the competent authorityabout such changes. The requirements for 'Approved Biological Applications(BLA)' must be considered as well as the requirements of other regulationslike 'current good manufacturing practice (cGMP)' as per CFR Section501 while doing so.

生物制品生产商有诸多理由被迫修改已批准产品的化学成分、生产工艺或控制策略。这可能也会影响所用设备、设施或车间或负责人。生产商需要通知监管机构此类变更。在变更时必须依CFR第501部分考虑“已批准生物申报（BLA）”的要求以及其它指南如“现行优良生产规范（CGMP）”的要求。

Currently the changenotifications of the past years considering modern principles of riskassessment as per 'Guidance for Industry: Q9 Quality Risk Management (Ref.3)' are evaluated comprehensively. Then the present draft guideline issupposed to provide updated support for users. For that purpose a numberof examples for changes were added to aid the user when it comes to theclassification of post-approval changes and their submission.

目前，过去数年的变更通知是考虑了依“行业指南：Q9质量风险管理（参考文献3）”进行的风险评估的现代化原则进行全面评估的。目前的这份指南草案则意在提供更新后的用户支持。为此，加入了大量变更例子来帮助用户对批准后变更及其申报进行分类。

The following products arewithin the scope of the new guidance document:

下列产品在新指南文件范围内：

• Vaccines 疫苗

• Allergenic products 引发过敏的药品

• Plasma-derived products     (e.g., albumin, immunoglobulins, clotting factors, fibrin sealants,     proteinase inhibitors, etc.) 血浆制品（例如，血浆蛋白、免疫球蛋白、凝血因子、纤维蛋白封闭剂、蛋白酶抑制剂等）

• Antitoxins, antivenins, and venoms 抗毒素、抗蛇毒血清和毒液

• Naturally-derived protein products (e.g., enzymes, toxins, etc.) 自然生成的蛋白产品（例如，酶、毒素等）

• Cellular, gene and cell-based gene therapy products 细胞、基因和基于细胞的基因治疗产品

• In vitro diagnostics (IVDs) regulated under the PHS Act (e.g., blood donor screening assays, etc.) 受PHS法案管辖的体外诊断（IVD）（例如，血液捐献筛选测试等）

• Other biological products licensed under the PHS Act subject to exceptions listed below 依PHS法案批准的其它生物制品，下列产品除外

Comprehensive information canbe found directly in the draft guideline 'Chemistry, Manufacturing, and Controls Changes to an ApprovedApplication: Certain Biological Products'.

完整信息参见FDA官网。