Regulatory News - July

EMA’s newsletter and highlights

The monthly Newsletter "Human Medicines Highlights" includes decisions by the EMA’s Scientific Committees and updates on medicines safety. The latest edition of the newsletter can be accessed by clicking here. Previous editions can also be found on this page.

Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.

This guidance provides recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.