E2B XML was a remarkable turning point in pharmacovigilance for electronic reporting of expedited adverse reactions. A standard language format was used to configure the functional case processing (Individual case safety report) aspects of product safety.
Regulatory provided us with a unified platform to transmit messages using globally acceptable electronic format ‘Extensible Markup Language’!
The journey has just begun and we are moving on to cover major milestones that would ensure technical compatibility for global conformance to expedited adverse reaction reporting, electronic submission of medicinal product information, aggregate reporting, different report formats etc.
Today all regulatory norms that are evolving address the pharmacovigilance compliance through robust support system of information technology.
It would be wise enough to quote a few norms which are existent and also those which are likely to take over in near future.
- ICH E2B (R3) electronic transmission of ICSRs
- ISO-IDMP standards
- Electronic Medical device reporting (coming into effect from mid-August 2015)
- PSUR repository esubmission already in place
- E2B (XML) reporting to Vigiflow for Adverse drug reactions due to pharmaceutical products to National Coordinating Center, PvPI as per GOI order dated 18th May 2015
Notifying the last electronic reporting change (E2B(XML) submission to NCC, PvPI), indeed is a favorable move of the Indian regulatory to ensure global ICSR submissions in the WHO-UMC database i.e., Vigiflow. This planned activity is to speed up the assessment as well as Signal detection and management.
Pharmacovigilance operational challenges sees no boundaries when developed in accordance with IT sophistication.
More so, additionally it would not be wrong to say that technology does help boost the ‘expedited’ submission maintaining ‘uniformity’ across the globe. This applies equally well to both, expedited and periodic submissions.
As stated by a Regulatory in one of the web links:
‘The Agency is moving toward an electronic submission standard, arguing that digital submission is faster, cheaper, more accurate and allows for better analysis and reporting. –
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