20.02.2018
FDA Draft Guideline onreporting Changes to an approved Application
FDA已批準申報變更報告指南草案
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發(fā)布了其“行業(yè)指南：批準后申報的變更：生物制品”。該文件意在幫助在市的許可持有人（MAH）和生產(chǎn)商對依CFR601.12批準的藥品的化學、生產(chǎn)和控制變更進行分類和報告。
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.
本主題的新文件于2017年12月21日發(fā)布，在定稿后是使用了近20年之久的舊版本指南的修訂后版本，其意在替代舊指南。
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.
生物制品生產(chǎn)商有諸多理由被迫修改已批準產(chǎn)品的化學成分、生產(chǎn)工藝或控制策略。這可能也會影響所用設備、設施或車間或負責人。生產(chǎn)商需要通知監(jiān)管機構此類變更。在變更時必須依CFR第501部分考慮“已批準生物申報（BLA）”的要求以及其它指南如“現(xiàn)行優(yōu)良生產(chǎn)規(guī)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，過去數(shù)年的變更通知是考慮了依“行業(yè)指南：Q9質(zhì)量風險管理（參考文獻3）”進行的風險評估的現(xiàn)代化原則進行全面評估的。目前的這份指南草案則意在提供更新后的用戶支持。為此，加入了大量變更例子來幫助用戶對批準后變更及其申報進行分類。
The following products arewithin the scope of the new guidance document:
下列產(chǎn)品在新指南文件范圍內(nèi)：
Vaccines 疫苗
Allergenic products 引發(fā)過敏的藥品
Plasma-derived products (e.g., albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase inhibitors, etc.) 血漿制品（例如，血漿蛋白、免疫球蛋白、凝血因子、纖維蛋白封閉劑、蛋白酶抑制劑等）
Antitoxins, antivenins, and venoms 抗毒素、抗蛇毒血清和毒液
Naturally-derived protein products (e.g., enzymes, toxins, etc.) 自然生成的蛋白產(chǎn)品（例如，酶、毒素等）
Cellular, gene and cell-based gene therapy products 細胞、基因和基于細胞的基因治療產(chǎn)品
In vitro diagnostics (IVDs) regulated under the PHS Act (e.g., blood donor screening assays, etc.) 受PHS法案管轄的體外診斷（IVD）（例如，血液捐獻篩選測試等）
Other biological products licensed under the PHS Act subject to exceptions listed below 依PHS法案批準的其它生物制品，下列產(chǎn)品除外
Comprehensive information canbe found directly in the draft guideline 'Chemistry, Manufacturing, and Controls Changes to an ApprovedApplication: Certain Biological Products'.
完整信息參見FDA官網(wǎng)。
