双润｜资料清单 / Suncoop | Document Checklist

01概述Overview

登记资料（Dossier）是官方技术评审与行政审批的基础。欧盟 (EC) 1107/2009 附录 II/III 规定了统一的卷宗结构，各成员国可能另有补充要求；核心数据体系一致，差异主要在成员国层面的补充资料与语言。下方清单按功能模块组织，并在末尾给出"按登记类型"的资料侧重与实务提示，帮助您建立系统化的准备框架。The dossier is the basis for the authority's technical and administrative review. Markets differ in module取舍 and format — EU (EC) 1107/2009 Annex II/III sets a unified dossier structure, with possible additional requirements at member-state level — the core data system is shared, and the differences lie mainly in national supplements and language. The list below is organized by functional module, with type-specific emphasis and practical tips at the end, to help you build a systematic preparation framework.

02按登记类型看资料侧重Emphasis by Registration Type

不同登记路径所需的资料深度不同Different pathways require different data depth

新有效成分（New Active Ingredient）New Active Ingredient

需提交毒理、生态毒理、残留、环境归趋与药效全套 GLP 资料，原药与制剂卷宗齐备，周期与成本最高。Requires the full GLP battery — toxicology, ecotoxicology, residues, fate and efficacy — with both active-ingredient and formulation dossiers; highest time and cost.

制剂登记（仅制剂）Formulation-only

侧重制剂资料；原药以等同性（TE）佐证或引用已登记数据，必要时做数据桥接。Focus on formulation data; the active ingredient is supported by technical equivalence (TE) or cited data, with bridging where needed.

原药等同性 TE / 等效产品Technical Equivalence (TE)

核心为 5 批分析、杂质谱与工艺比对，证明与已登记来源等同，可省去重复毒理/生态试验。Centered on 5-batch analysis, impurity profile and process comparison to prove equivalence to a registered source — avoiding duplicate toxicology/ecotoxicology.

Me-Too / 相同产品Me-Too / Identical Product

引用已登记产品的完整数据包＋授权信（LoA），避免重复试验，重点在 LoA 与合规比对。Cite the complete data package of a registered product plus a Letter of Access (LoA); focus on LoA and compliance comparison.

03资料模块清单Document Modules

逐项核对，可打印后勾选Check item by item; printable for ticking off

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申请主体与授权Applicant & Authorization

☐当地设立主体或授权代表／代理人Local entity or authorized representative/agent多数市场要求申请人具属地资格。Most markets require a territorially qualified applicant.
☐授权书／授权委托书（Power of Attorney）Power of Attorney / Letter of Authorization部分国家需公证或海牙认证（Apostille）。Notarization or Apostille may be required.
☐公司注册与营业执照Certificate of incorporation / business license
☐生产／质量体系证书（GMP、ISO 9001 等）Manufacturing/quality certificates (GMP, ISO 9001, etc.)

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原药卷宗Active Ingredient Dossier

☐有效成分鉴别与结构确证Identity and structural confirmation
☐原药全分析 — 5 批分析（5-batch Analysis）Full AI analysis — 5-batch analysisGLP 条件下、具代表性的商业生产批次。Representative commercial batches under GLP.
☐生产工艺、反应方程式与流程图Manufacturing process, reaction equations and flow diagram
☐杂质谱：合成杂质、降解杂质与溶剂残留Impurity profile: synthetic, degradation and solvent residues含杂质界定与界定限度。With impurity identification and limits.
☐原药规格与分析方法（含验证）AI specification and analytical method (with validation)
☐理化性质全套（溶解度、pKa、分配系数等）Full phys-chem properties (solubility, pKa, partition coefficient, etc.)
☐储存稳定性Storage stability

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制剂卷宗Formulation Dossier

☐制剂组成与配方表（含助剂）Composition and formulation table (with co-formulants)
☐制剂理化性质与外观Phys-chem properties and appearance of formulation
☐储存稳定性（加速 + 长期）Storage stability (accelerated + long-term)
☐与包装材料相容性Compatibility with packaging materials
☐分析方法与验证（原药含量、杂质、助剂）Analytical method and validation (AI content, impurities, co-formulants)

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毒理学（GLP）Toxicology (GLP)

☐急性毒性（经口／经皮／吸入）Acute toxicity (oral/dermal/inhalation)
☐皮肤／眼睛刺激性、皮肤致敏性Skin/eye irritation, skin sensitization
☐亚慢性／慢性毒性Sub-chronic / chronic toxicity
☐遗传毒性（Ames、微核、染色体畸变等）Genotoxicity (Ames, micronucleus, chromosome aberration, etc.)
☐生殖与发育毒性Reproduction and developmental toxicity
☐致癌性Carcinogenicity
☐毒物代谢动力学Toxicokinetics
☐ADI / ARfD 推导依据Basis for ADI / ARfD

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生态毒理（GLP）Ecotoxicology (GLP)

☐鸟类急性／饲喂毒性Avian acute / dietary toxicity
☐鱼类急性／慢性毒性Fish acute / chronic toxicity
☐藻类生长抑制Algal growth inhibition
☐溞类急性／繁殖毒性Daphnia acute / reproduction
☐蜜蜂急性经口／接触毒性Honeybee acute oral / contact
☐蚯蚓／土壤微生物Earthworm / soil microorganisms
☐生物富集与二次中毒风险Bioaccumulation and secondary poisoning
☐非靶标植物Non-target plants

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残留（GLP）Residues (GLP)

☐田间残留试验（多地区、多季节、符合 GAP）Field residue trials (multi-region, multi-season, GAP-compliant)
☐加工因子研究（如涉及加工食品）Processing studies (if processed commodities involved)
☐代谢与饲喂／牲畜残留Metabolism and livestock residues
☐分析方法与最低检出限（LOQ）Analytical method and LOQ
☐MRL 提议与膳食风险评估Proposed MRL and dietary risk assessment

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环境归趋（GLP）Environmental Fate (GLP)

☐水解与光解Hydrolysis and photolysis
☐土壤好氧／厌氧降解Aerobic / anaerobic soil degradation
☐淋溶与吸附（Koc / Kd）Leaching and adsorption (Koc / Kd)
☐挥发性与在环境中的归趋Volatility and environmental fate
☐生物富集潜力Bioconcentration potential

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药效与作物安全Efficacy & Crop Safety

☐靶标防效田间试验（多区域）Field efficacy trials (multi-region)
☐推荐剂量、施药次数与方式Recommended dose, application frequency and method
☐作物耐受性／药害评估Crop tolerance / phytotoxicity assessment
☐轮作间隔与后茬作物安全性Rotation interval and following-crop safety

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标签与安全技术说明书Label & SDS

☐双语标签（符合目标国语言要求）Bilingual label (per target-country language)按登记成员国要求，使用该国官方语言。Per the registering member state's official language.
☐GHS 分类与象形图、信号词GHS classification, pictograms and signal words
☐安全数据单（SDS / MSDS）符合 CLP／GB／OSHASDS / MSDS compliant with CLP / GB / OSHA
☐使用说明、安全间隔期（PHI）、个人防护Use directions, Pre-Harvest Interval (PHI), PPE
☐储存与废弃处置Storage and disposal

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翻译、公证与认证Translation, Notarization & Legalization

☐译文准确性声明（译员／机构公证）Translator's accuracy affidavit
☐关键文件公证／海牙认证（Apostille）Notarization / Apostille of key documents
☐GLP 符合性声明GLP compliance statement
☐授权代表签署与盖章Authorized representative signature and seal

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数据与授权文件Data & Access Rights

☐数据补偿声明／授权信（LoA）Data compensation statement / Letter of Access (LoA)
☐数据独占期与权属确认Data exclusivity and ownership confirmation
☐引用前人数据的权利人同意Third-party data holder consent for citation

04实务提示Practical Tips

降低补正与返工风险的六条建议Six tips to cut deficiency and rework risk

提交前务必做资料差距分析（Gap Analysis），按目标市场逐国核对模块取舍。Run a Gap Analysis before filing; check module取舍 per target market.
GLP 是硬门槛：所有关键毒理、生态、残留、环境试验须由 GLP 实验室出具。GLP is a hard gate: all key tox/eco/residue/fate studies must come from GLP labs.
译件须由具资质译员／机构出具并公证，且须为目标国官方语言。Translations need a qualified, notarized translator and must be in the official language.
原药企业优先评估 TE 路径，可大幅节省试验成本与周期。AI makers should prioritize the TE route to save cost and time.
妥善管理 LoA 与数据权属证据，是合法引用受保护数据的前提。Manage LoA and data-ownership evidence well — a precondition to cite protected data.
标签与 SDS 随法规更新，建议建立版本管理与复核机制。Labels and SDS change with regulations; keep version control and review.

免责声明Disclaimer： 本页登记主管机构、流程与周期为基于公开资料的初稿，标注"以官方为准"。具体登记要求、周期与费用以各国官方主管部门最新规定为准，正式提交前请由专业顾问核实。本网站不构成法律或合规意见。The authorities, procedures and timelines on this page are a draft based on public sources, marked "subject to official rules". Exact requirements, timelines and fees are governed by each national authority's latest regulations and must be verified by a professional advisor before filing. This site is not legal or compliance advice.

资料清单Document Checklist