Smarter collection and reporting of safety reports of suspected adverse reactions, measurement of on-market performance of medicines, and improved engagement between regulators, patients and healthcare professionals will be key elements of pharmacovigilance in 2030.
These predictions are made in an article from Guido Rasi, the European Medicines Agency’s (EMA) executive director, Sabine Straus, the chairperson of EMA's safety committee (PRAC) and Peter Arlett, the Agency's head of pharmacovigilance and epidemiology, published in Clinical Pharmacology and Therapeutics.
Medicines prevent, diagnose or treat diseases, but they also can have side effects. Therefore, their risks need to be balanced against their benefits and only medicines with a positive benefit-risk balance are authorized for marketing in the EU. The European medicines regulatory network has established a robust system for monitoring and managing the risks of medicines on the market. Coordinated by EMA, this pharmacovigilance system is designed to enable patients to benefit from medicines while making them as safe as possible.
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