How many days does a manufacturer have to report serious adverse drug reactions after becoming aware of the information?

A manufacturer is required to report serious adverse drug reactions within 15 days of becoming aware of such information. This timeline is set to ensure timely communication about potential safety concerns regarding medications, allowing health authorities and other stakeholders to respond promptly to protect public health. This standard aligns with regulatory expectations to maintain patient safety and allows for the continual assessment of the risks associated with medications as more data becomes available post-marketing.

In the context of this requirement, a shorter time frame, such as 5 or 10 days, would not provide sufficient time for a thorough evaluation of the reaction. On the other hand, a longer duration, such as 30 days, could delay critical information from reaching healthcare professionals and regulatory authorities, potentially risking patient safety. Thus, the 15-day period strikes a balance between the need for prompt action and the need for a careful review of the adverse reaction.