Definition

WHO-supported adverse event reporting system used by PvPI for submission of ICSRs in India; MAHs may use Vigiflow or designated pathway for CDSCO.

Example

Submitting ICSRs to PvPI via Vigiflow in compliance with Indian data requirements.

Regulatory source

NCC-PvPI, CDSCO

Common mistakes

Submitting in E2B format not accepted by PvPI or missing mandatory fields.

Inspector question

How do you submit ICSRs to PvPI and which format do you use?

Related terms