常见问题Frequently Asked Questions

当前覆盖巴西、阿根廷、智利、美国、欧盟（含各成员国）及英国六个市场，并由对应区域的本地办公室与法规顾问对接。我们也在持续扩展至加拿大、墨西哥及其他欧盟/非欧盟国家，可按需提前排期。We currently cover Brazil, Argentina, Chile, the United States, the EU (all member states) and the UK, each served by a local office and regulatory advisors. Coverage is expanding to Canada, Mexico and other EU/non-EU markets on request.

我们的核心服务是农药登记与合规代理（含资料编制、翻译公证、官方跟进与补正应对）。进口、分销与销售可由您指定的当地主体负责，我们也可在合规层面提供衔接建议，但不替代贸易主体。Our core is registration and compliance agency work (dossier prep, translation/notarization, authority follow-up and deficiency handling). Import, distribution and sales are handled by your local entity; we advise on the compliance interface but do not replace the trading party.

主要聚焦农药（含生物农药）登记。肥料、生物刺激素等邻类产品的登记规则差异较大，可单聊评估可行性。We focus on (bio)pesticide registration. Fertilizers and biostimulants follow different rules — talk to us case by case.

周期因国家与登记类型差异很大：引用数据或走原药等同性(TE)的制剂登记通常 12–30 个月；全新有效成分全套 GLP 资料可能 3–5 年。更准确的时间线请参见各国家页面的"登记周期"模块，且实际以主管机构评审进度为准。It varies widely by country and type: formulation registrations citing data or using Technical Equivalence (TE) typically take 12–30 months; a brand-new active ingredient with the full GLP package can take 3–5 years. See each country page's "Timeline" module, and ultimately the authority's pace governs.

没有统一价目。费用由目标国、登记类型、是否需要新生成 GLP 数据、是否引用他人数据（涉及授权信 LoA 与数据补偿费）等多因素决定。我们会在资料差距分析后给出分项预算；官方规费、翻译公证、GLP 试验通常单独列项，透明可核。There is no flat fee. Cost depends on the target market, registration type, whether new GLP studies are needed, and whether third-party data is cited (Letter of Access and compensation fees). We provide an itemized budget after a Gap Analysis; official fees, translation/notarization and GLP studies are line-itemed transparently.

不会。除约定的服务费外，主要涉及第三方刚性支出：官方规费、GLP 试验费、翻译与公证/海牙认证费、必要的数据授权(LoA)费用。这些会在预算中预先列明，执行中如有新增会事先确认。No. Beyond our service fee, the main costs are third-party hard costs: official fees, GLP study fees, translation and notarization/Apostille, and any data-access (LoA) fees. These are listed up front; new items are confirmed before they are incurred.

请参见本站"资料清单"页面——系统归纳了申请主体与授权、原药/制剂卷宗、毒理、生态毒理、残留、环境归趋、药效与作物安全、标签与 SDS、翻译公证、数据与授权文件共 11 个模块，可逐项核对勾选。See our "Document Checklist" page — it systematically lists 11 modules: applicant & authorization, active-ingredient and formulation dossiers, toxicology, ecotoxicology, residues, environmental fate, efficacy & crop safety, label & SDS, translation/notarization, and data & access rights. Check item by item.

关键毒理、生态毒理、残留与环境归趋试验通常须由 GLP（良好实验室规范）实验室出具，这是多数市场的硬性门槛；而授权书、公司资质等行政性文件一般不要求 GLP。Key toxicology, ecotoxicology, residue and environmental-fate studies generally must come from GLP labs — a hard gate in most markets. Administrative documents such as POA and company credentials do not require GLP.

TE 通过 5 批分析、杂质谱与生产工艺比对，证明您的原药与已登记来源"等同"。若获主管机构认可，可免去重复且昂贵的毒理、生态毒理全套试验，大幅降低成本与周期——原药企业通常应优先评估此路径。TE uses 5-batch analysis, impurity profiling and process comparison to prove your active ingredient is "equivalent" to a registered source. If accepted, it waives the costly, duplicated toxicology and ecotoxicology batteries — cutting cost and time substantially. AI makers should evaluate TE first.

首研者为登记新有效成分所生成的数据享有一定年限的独占保护（如欧盟一般 10 年、部分情形 15 年；美国对首次残留限量亦设独占保护；英国 HSE、巴西等亦设数据保护期）。他人引用须取得授权信(LoA)，并可能支付数据补偿。我们协助评估数据权属、获取 LoA 与合规引用。The originator's data for a new active ingredient enjoys a period of exclusivity (e.g., generally 10 years in the EU, 15 in some cases; the US grants exclusivity for first tolerances; the UK HSE and Brazil also set data-protection periods). Citing such data requires a Letter of Access (LoA) and may involve compensation. We help assess data rights, obtain LoAs and cite compliantly.

标签须使用目标国官方语言（如巴西葡语、阿根廷/智利西语、欧盟各成员国语言），并符合 GHS/CLP 等分类与象形图规范；安全数据单(SDS/MSDS)须符合当地法规（CLP/GB/OSHA 等）。法规更新时需版本管理与复核。Labels must be in the target country's official language (e.g., Portuguese for Brazil, Spanish for Argentina/Chile, member-state languages in the EU) and follow GHS/CLP classification and pictograms; the SDS/MSDS must comply with local rules (CLP/GB/OSHA). Version control is needed as rules evolve.

① 初步沟通与资料差距分析(Gap Analysis) → ② 制定国别策略与分项预算 → ③ 资料收集/缺口补试验 → ④ 翻译公证与卷宗编制 → ⑤ 官方提交与跟进 → ⑥ 应对补正直至获证。全程由对应市场顾问与主理团队协同。① Initial consultation and Gap Analysis → ② Country strategy and itemized budget → ③ Data collection / gap studies → ④ Translation, notarization and dossier assembly → ⑤ Submission and follow-up → ⑥ Deficiency handling until approval. A dedicated market advisor and core team work throughout.

多数市场要求申请人为当地设立主体或经授权的本地代理/代表。我们可在覆盖市场提供本地办公室与授权代理支持，通常无需您自建境外实体即可启动登记。Most markets require the applicant to be a local entity or an authorized local agent/representative. In our covered markets we can provide a local office and authorized representation, so you usually don't need to establish your own overseas entity to start.

能。提交后主管机构常发补正通知（Deficiency Letter），要求补充或澄清资料。我们协调技术团队与当地顾问逐条回应，直至满足评审要求、推进至获证。Yes. Authorities often issue Deficiency Letters after submission. We coordinate the technical team and local advisors to respond point by point until the dossier meets requirements and proceeds to approval.

我们协调具备资质的译员出具译文准确性声明，并按目标国要求完成公证或海牙认证(Apostille)，确保文件被官方接受。多语言、多市场的一致性由我们统一管理。We coordinate qualified translators for accuracy affidavits and complete notarization or Apostille per target-country requirements, ensuring acceptance. Multi-language, multi-market consistency is centrally managed.

是。我们与客户签署保密协议(NDA)，资料仅用于约定用途，并实行分级管理与授权访问，杜绝未经授权的对外披露。Yes. We sign an NDA with every client; data is used only for the agreed purpose and is subject to tiered access control, preventing any unauthorized disclosure.

通过页脚联系方式或各市场办公室与我们沟通，提供目标国、产品（有效成分/制剂）与初步计划，我们将安排免费的初步评估与差距分析。Contact us via the footer or the relevant market office with your target country, product (AI/formulation) and preliminary plan; we'll arrange a free initial assessment and Gap Analysis.