Skip to main content

China-related matters · Research first

For lawyers/Contact/Log in
China Legal PortalResearch · Routes · Counsel
Ask a lawyer

Search the portal

China legal tool Healthcare & life sciences National framework

China Cell Therapy
/ Biomedical New Technology Clinical Research Filing Tool

Interactive China legal orientation tool. Review the result with the relevant legal guide and qualified counsel where facts or local implementation matter.

Free calculatorPRC lawAssumption-led estimate
  1. 01Enter facts
  2. 02Get estimate
  3. 03Check assumptions
  4. 04Verify or escalate

Compliance screen

Legal basis

Scope

From 1 May 2026, State Council Order 818 governs biomedical-new-technology clinical research and clinical translation. Clinical research requires prior nonclinical evidence, academic and ethics approval, and NHC filing within 5 working days after those approvals. Drug/device clinical trials remain under their separate regulatory regimes; use the NHC/NMPA boundary guidance rather than a legacy universal dual-filing model.

Legal authorityReview the legal-basis section and cited source before relying on the output.
Tool typeCalculator
ScopeNational framework first
Local checkLocal rules and authority practice may differ
National framework → matter-specific file
Context note

The tool organizes the issue.
The facts determine the route.

China legal rules often begin with a national framework, while the operational answer can depend on location, dates, documents, status and authority practice. Use this result to structure the next verification step.

  • Check the inputs. Confirm dates, amounts, classifications and assumptions.
  • Read the authority. Verify the cited legal basis and effective version.
  • Localize the answer. Test relevant provincial, municipal or agency practice.
Working notes

Understanding this result

Use these checks before treating an automated output as a legal conclusion.

What does this tool provide?+

It provides a structured calculation, screening result or drafting aid based on the facts entered and the assumptions stated on this page.

What should be verified?+

Verify the legal authority, effective date, input data, territorial scope and any exclusions identified in the result.

Why can the operational answer differ?+

Documents, disputed facts, local implementation and authority discretion can affect the practical outcome.

When should the issue be escalated?+

Escalate material exposure, disputed facts, imminent deadlines, formal notices or any issue requiring representation or a legal opinion.

When the file needs review

Move from the tool to a verified legal route.

Use the output to organize the facts, then confirm the source, evidence, local implementation and available remedy before acting.