What are the differences in adverse event reporting across countries?

What are the differences in adverse event reporting across countries?

Adverse event reporting varies significantly by country. For instance, the US has the FDA's MedWatch system, while the EU uses EHRs and EudraVigilance. Would you like to know more about a specific country?

Yes, can you explain how it works in the EU?

In the EU, adverse events are reported through the EudraVigilance system, which collects data from member states. Healthcare professionals and companies must report serious adverse events within 15 days.

What about reporting in Japan?

In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) oversees adverse event reporting. Reports must be submitted within 3 days for serious events and 30 days for non-serious ones.

Are there any penalties for not reporting?

Yes, failure to report adverse events can lead to penalties, including fines and sanctions against the responsible parties, depending on the country's regulations.