With an increasing number of pharmaceutical products being developed for the international market, the National Regulatory Authorities (NRAs) that use VigiFlow as their pharmacovigilance database have highlighted the importance of improving the efficiency of ADR reporting from the pharma industry. UMC is always looking for new solutions and has developed an e-reporting tool that allows big and small pharma companies to submit reports directly and securely to NRAs via VigiFlow, reducing the workload for both parties and making the process more efficient. Industry e-reporting is already being tested in six countries – Brazil, Colombia, Mexico, Morocco, the Philippines and South Africa – and it should be ready for other countries in Q2 2021. It's been an interesting challenge to coordinate the efforts of UMC’s developers, the pilot countries and industry. We’ve had great feedback and all of us involved are very excited about the results so far, as this represents the transition to full electronic reporting according to the international ICH E2B(R3) standard, more efficient processes – and of course better medicines safety.
Salvador Alvarado López