歐盟SA和PA日常事務
歐盟科學諮詢/建議和方案協助日常事務
本篇文章同樣源自EMEA/267187/2005/Rev. 1，介紹了EMEA/科學諮詢工作組（SAWP）負責處理的日常事務，以及不屬於他們管轄的事務範圍。
According to the new Regulation, in addition to the above-mentioned provision, the EMEA/SAWP may deal with the following new aspects:
根據新法規，除了上述規定的內容外，EMEA/SAWP還負責處理以下事務：
Broader and more general advice for specific types of medicinal products or treatments, in collaboration with the relevant Working Parties.
和有關工作組合作，就特定類型的藥品或治療提供更廣泛、更基礎的建議；
Products intended for the new mandatory centralised procedure, i.e. acquired immune deficiency syndrome, cancer, neurodegenerative disorders, diabetes and, as of 20 May 2008, auto-immunediseases and other immune dysfunctions and viral diseases.
適用於集中審評程序的產品，例如，獲得免疫缺陷綜合症、癌症、神經退行性疾病、糖尿病，以及截至2008年5月20日，自身免疫性疾病和其他免疫功能障礙和病毒性疾病；
Emerging and new therapies, by maximising the involvement of all EU expertise available.
對於新興的和新療法，爭取最大限度地涉及所有歐盟現有的專業知識；
Safety aspects of scientific advice, including review of pharmacovigilance plans (pre-authorisation/post-authorisationphase) and risk-management programmes.
科學諮詢安全性方面，包括審核藥物警戒計劃（批准前/批准後階段）及風險管理計劃；
Advice about the justification on whether a specific medicinal product being developed for a specific therapeutic indication falls within one of the categories set out in Article 2 and fulfils the condition laid down in Article 4(1)(c) of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004.
關於是否為特定適應症而開發的特定藥品證據方面的建議，屬於2006年3月29日法規EC No507/2006第2條的範疇，並且滿足第4(1)條規定的條件。該法規中關於人用藥條件批准的規定，落在法規EC No726/2004的範圍內；
SA requests on acceptability of the development programme for conditional marketing authorisation, which are defined in Article 14(7) of Regulation (EC) No 726/2004.
關於條件上市批准開發計劃可接受性的SA申請，法規EC No726/2004第14(7)條進行了定義。
Advice about the justification for applying for a marketing authorisation under exceptional circumstances (Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14(8) of Regulation (EC) No 726/2004; EMEA/357981/2005).
提供適用特殊情況下上市申請理由的諮詢（符合法規EC No 726/2004第14(8)條規定，EMEA/357981/2005 特殊情況下上市申請獲批程序指導原則）；
SA requests on acceptability of the development programme for marketing authorisation application under exceptional circumstances, which are defined in article 14(8) of Regulation (EC) No 726/2004.
關於特殊情況下上市申請開發計劃可接受性的SA申請，法規EC No 726/2004第14(8)條進行了定義。
SA requests on the design of trials toassess safety and efficacy in a new indication expected to bring significant clinical benefit compared to existing therapies as defined in Article 14(11) of Regulation (EC) No 726/2004 or Article 10(1) fourth subparagraph of Directive 2001/83/EC.
和現有療法相比，期望會帶來顯著的臨床收益，並且用於評估一個新適應症安全性和有效性的臨床試驗設計SA申請。法規EC No 726/2004第14(11)條，或指令2001/83/EC第10(1)條第四段，對此進行了定義。
SA requests on the design of trials to assess safety and efficacy in a new indication for a well established substancein accordance with Article 10(5) of Directive 2001/83/EC as amended as by Directive 2004/27/EC.
根據指令2001/83/EC第10(5)條（後來修訂為指令2004/27/EC）的規定，評估一個確定化合物新適應症安全性和有效性的臨床試驗設計SA申請。
SA requests for medicinal products intended to be marketed exclusively outside the Community, in the context of WHO collaboration as defined in Article 58(2) of Regulation (EC) No 726/2004.
法規EC No 726/2004第58(2)條中所定義的WHO合作背景下，僅限於共同體以外市場上銷售藥品的SA申請。
SA requests on paediatric developments. In addition, specific needs of small and medium-sized enterprises (SMEs) will be taken into account.
兒科藥物開發方面的SA申請。此外，還將考慮中小型企業的特定需求。
The following remain outside of the scope of the scientific advice procedure:
以下內容不屬於SA程序的範疇：
Pre-assessment of data that will be used to support future marketing authorisation applications.
對用於上市申請的數據進行預審；
Compassionate use as defined in Article 83 of Regulation (EC) No 726/2004.
法規EC No 726/2004第83條規定的同情用藥；
EMEA advice prior to submission for qualification of a request for an accelerated assessment procedure [Guidelineon the Procedure for Accelerated Assessment Pursuant to Article 14(9) of Regulation (EC) No 726/2004 (EMEA/419127/05)].
提供加速審批程序資格確認遞交之前的諮詢［法規EC No 726/2004第14(9)條規定的，加速審批程序指南（EMEA/419127/05）］；
Paediatric Investigational Plans as defined in the Regulation on medicines for children when implemented.
《兒童用藥條例》中定義的兒科研究計劃；
Regulatory aspects which are handled by the EMEA Secretariat.
EMEA秘書處負責處理的法規事務。
下圖來源於EMA的另外一份文件SOP/H/3037：Scientific Advice and Protocol Assistance procedure（科學諮詢和方案協助操作規程），是EMA內部的一份SOP，從EMA/SAWP的角度看看歐盟SA的流程。
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