SinoReg is an independent post-market compliance advisor for overseas Marketing Authorization Holders (MAH). We monitor public NMPA data for your re-registration windows and assess your readiness under China’s Domestic Responsible Person (境内责任人) rules — at the lowest viable cost, every conclusion traced to primary regulation. SinoReg 是面向境外持有人（MAH）的独立上市后合规顾问。我们监测 NMPA 公开数据中的再注册窗口，并依据中国境内责任人（Domestic Responsible Person）新规评估你的就绪度——以最低可行成本，每一条结论可溯源至一手法规。
Built from public data only. We never ask for your confidential filings to start. 仅基于公开数据，启动无需提供任何机密材料。
Neither is negotiable, and both run on a clock. Missing them is not a fine — it is losing the registration, or carrying liability you never agreed to.两条都不可商量，且都在倒计时。错过的代价不是罚款，而是丢掉注册，或背上你从未同意的责任。
Since 1 July 2025, every imported drug must have a qualified Domestic Responsible Person (境内责任人) who is jointly and severally liable with you. A registration agent or distributor is not the same thing — and the gap is where the risk sits.自 2025 年 7 月 1 日起，每个进口药品都须有合格境内责任人，与你承担连带责任。注册代理或经销商并不等于境内责任人——错配之处，正是风险所在。
NMPA Announcement No. 137 (2024) · 国家药监局 2024 年第 137 号A drug registration certificate is valid for a fixed term. Re-registration must be filed 6 months before it expires; for overseas-produced drugs, with the CDE. Miss the window and the certificate is time-barred — not extended.药品注册证书有固定有效期。再注册须于届满前 6 个月提出，境外生产药品向 CDE 提出。错过窗口，证书将因逾期而失效，不予延续。
Provisions for Drug Registration (药品注册管理办法), Art. 82《药品注册管理办法》第八十二条In this phase we advise: we assess, monitor, translate, and coordinate. We do not take on regulatory roles for you.现阶段我们做咨询：评估、监测、翻译、协调。我们不替你承担任何法规主体角色。
From a free public-data snapshot to a full, audit-ready DRP Readiness Memo: where you stand on re-registration timing and Domestic Responsible Person (境内责任人) compliance, every finding sourced to primary regulation.从免费的公开数据速检，到完整、可审计的 DRP 就绪度备忘录：你在再注册时点与境内责任人合规上的真实状态，每条发现可溯源至一手法规。
We track your products in public NMPA records and flag re-registration windows 12–18 months out — enough runway to act, well before the statutory 6-month filing line.我们在 NMPA 公开数据中追踪你的品种，提前 12–18 个月标出再注册窗口——在法定 6 个月时限前留足应对空间。
A controlled English–Chinese glossary so nothing is lost in translation. Proprietary terms always shown as EN (中文), never improvised, so your team and ours read the same rule.受控的中英术语词典，避免翻译走样。专有术语恒以 EN（中文）呈现、绝不即兴翻译，让你我两边读到同一条规则。
We assess, coordinate, and refer to vetted DRP / pharmacovigilance / legal partners. We do not act as your Domestic Responsible Person and accept no joint-and-several liability — so the advice stays conflict-free.我们评估、协调，并转介经核验的 DRP／药物警戒／律所伙伴。我们不充当你的境内责任人、不承担连带责任——因此建议无利益冲突。
A Tier-0 snapshot built from public data only. No confidential information required to begin.基于公开数据的 Tier-0 速检，启动无需任何机密信息。
Three questions: do you have a qualified DRP? Who owns re-registration? Are you across Announcement No. 137?三个问题：你有合格的境内责任人吗？谁负责再注册？你了解第 137 号公告吗？
Fixed-fee, audit-ready, versioned and frozen — every regulatory claim traceable to its source.固定费用、可审计、版本化并冻结——每条监管结论都可追溯到来源。
We help you close the gaps and connect you to vetted execution partners — staying independent throughout.我们帮你补齐缺口，并对接经核验的执行伙伴——全程保持独立。
That independence is the point. Because we never take the regulatory role ourselves, we carry no liability conflict and no incentive to sell you execution you don’t need. You get a clear read and a plan — and you stay in control of who holds the role.这种独立正是关键。我们从不自任法规主体，因此没有利益冲突，也没有动机向你兜售并不需要的执行服务。你得到的是清晰的判断与方案——而谁担任主体，始终由你决定。
Send us a product name or approval number and we’ll prepare a preliminary readiness snapshot from public data. No confidential filings, no commitment.把产品名或批准文号发给我们，我们将据公开数据为你准备一份初步就绪度速检。无需机密材料，无需承诺。