Pharmacovigilance (PV) significance and cognizance is constantly growing amongst pharma and biotech Industry, health care segments and masses at large. The Arab countries have also gained impetus and shown incessant refinement in gearing their countries towards attaining universal Pharmacovigilance observance goals. Beholding the regulations so far, Egyptian Drug Authority (EDA), Egyptian Pharmaceutical Vigilance Center (EPVC) has guidelines and legislations defined for a robust pharmacovigilance system.
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Veterinary Pharmacovigilance – Few guidance extracts
Veterinary medicinal products (VMPs) also require safety monitoring to addresses the animal safety as well as vigilance for humans exposed to VMPs accidentally or otherwise. Several standards are applicable for reporting the adverse reactions, medication errors or events due to manufacturing/product defect.
It is indeed significant to correctly interpret these standards and reporting formats of different regions such as that of European Union (European Veterinary Pharmacovigilance Reporting Form for MAHs) and United States (Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report) which have their own reporting formats in PDF and for XML outputs.
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Pooling meaningful data from vast Pharmacovigilance database for Regulatory periodic reports
There exist regional and universal guidelines emphasizing the type and nature of data that needs to be submitted in the Periodic update reports (or so called ‘aggregate reports’). Few of those are listed below:
- EMA’s Good Pharmacovigilance Practices – Management and reporting of adverse reactions to medicinal products (Rev 1), Periodic safety update report (rev 1) & Post-authorization safety studies (Rev 1)
- USFDA 21 CFR 314.80 – Post marketing reporting of adverse drug experience; PADER/PAER are required for submission quarterly for initial 3 years and later annually. However, the period of reporting may vary if regulatory requests information for safety concerns
- As per MHRA, the PBRER is submitted every 6 months till product is placed in market, every 6 months for next two years and then annually for following 2 years
- For those globally following ICH E2C (R2) – PBRER submission is required twice in a year, annually and may be less frequently depending on different regions. The frequency of submission may change based on newer information, newer indication and/or population etc.
Mechanism to extract adverse experience reports output for US FDA
Periodic safety reports are prepared as a part of periodic adverse experience submission. It is an unceasing cycle till the product’s lifespan in market is anticipated. With emergence of changing risk-benefit ratio, the reporting period may change if regulatory needs more information for monitoring a pharmaceutical product.
Considering the United States requirements for periodic reports, there are four sections in accordance to which the format should be reported. The emphasis is placed to prepare checklist (Appendix B: Report checklist1) and ensure that all the data requested in those sections is available for final periodic report.
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Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software
The Regulatory industry is witnessing huge transformations. Some new regulations see the light of the day as we grow in the world of automation for regulatory compliance. Intervention of information technology for submission of periodic reports in pharmacovigilance is yet another required transformation.
History of PADER/PAER submission:
The Periodic adverse drug experience reports (PADER/PAER) submission was earlier performed on paper and alternatively, electronic submission was a convenient option i.e., earlier, it was voluntary to utilize the electronic submission method for submitting this periodic report. However, the recent mandate has discontinued the paper format and submissions are now allowed only via eCTD.
Pharmacovigilance discipline merger with IT would witness major electronic transformation
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.
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