Pharmacovigilance Reporting Obligations Across Five Major Regulatory Authorities

A narrative review compares adverse event reporting frameworks for five major regulatory authorities: Health Canada, the U.S. FDA, the European Medicines Agency, Japan's PMDA, and China's NMPA. The analysis synthesizes comparative summary tables and decision algorithms from primary legislation, guidance documents, and ICH guidelines. The document was authored by Carlos G. Bernaus and published on figshare in May 2026.

Use Cases

• Design compliance workflows based on expedited reporting timelines for fatal or life-threatening events.
• Compare jurisdictional obligations based on differences in post-marketing death reporting timelines.
• Analyze regulatory convergence trends based on the global adoption of the Development Safety Update Report format.
• Map reporting requirements for medical devices based on device vigilance timelines.
• Structure decision-tree systems for multi-authority obligations based on synthesized algorithms.

Strengths

• Focuses on five major authorities representing the majority of global pharmaceutical market value.
• Synthesizes information from primary regulatory legislation, guidance documents, and ICH guidelines.
• Includes specific jurisdictional differences, such as China's 24-hour obligation for post-marketing deaths.
• Covers multiple contexts: clinical trial, post-marketing, medical device, vaccine, and special-population reporting.

Limitations

• The dataset is a single 298 KB PDF document, offering limited scope and no raw tabular data.
• Column-level documentation is absent; field semantics must be inferred from the narrative text.
• Row count is unknown, which may limit suitability assessment for quantitative analysis.

Provenance

Source

Carlos G. Bernaus

Collection Method

Narrative review of primary regulatory legislation, guidance documents, peer-reviewed literature, and ICH guidelines.

Freshness

Last updated 2026-05-07 04:44:01.

Geography

Global, focusing on Canada, United States, European Union, Japan, and China.