China legal tool China law National framework

China PSMF
& Pharmacovigilance Reporting Assessor

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

Legal assessmentPRC lawAssumption-led estimate

01Enter facts
02Get estimate
03Check assumptions
04Verify or escalate

Compliance screen

MAH has an independent pharmacovigilance system and responsible person meeting GVP requirements?

PSMF accurately describes organization, processes, quality system, databases and outsourced activities?

Serious adverse reactions are reported within the current statutory/GVP timeline (commonly 15 days where applicable)?

Signals, periodic safety reports, risk management and label/recall escalation are operational?

Overseas serious safety information affecting China products is monitored and reported as required?

Legal basis

Scope

Reporting periods differ by event category and source; 15 days should not be applied to every adverse reaction indiscriminately.

Legal authorityReview the legal-basis section and cited source before relying on the output.

Tool typeLegal assessment

ScopeNational framework first

Local checkLocal rules and authority practice may differ

Use the output safely

Verify before relying on the result.

InputsConfirm dates, amounts, classifications and assumptions.
AuthorityCheck the cited rule, effective date and territorial scope.
EscalationSeek review for disputed facts, material exposure or imminent deadlines.

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.

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