Another significant change in the pharmacovigilance system is the tightening of reporting requirements. Regulatory authorities such as the FDA (United States) and EMA (European Medicines Agency) have shortened the deadlines for submitting data on adverse effects. Pharmaceutical companies are now required to report serious adverse reactions within 7 days, compared to the previous 15-day timeframe.
This change aims to accelerate the risk signal analysis process. Drug manufacturers are being compelled to revise their internal procedures to comply with the new standards. This not only requires organizational changes but also the implementation of new technologies to automate processes. For instance, companies are actively utilizing electronic document management systems, which enable faster processing and submission of data to regulatory authorities.
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