U.S. FDA Launches New Adverse Event Monitoring System

On March 11, 2026, the U.S. Food and Drug Administration (FDA) launched a new unified platform for analyzing adverse event reports, known as the FDA Adverse Event Monitoring System (AEMS). This initiative marks a significant milestone in the agency’s mission to modernize and enhance transparency regarding the safety of regulated products.

Products Covered by the New System

The new system allows for the display of adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food in a single, streamlined dashboard.

In the coming months, all remaining product centers will begin processing adverse event reports within AEMS. The agency will also migrate historical adverse event data to the new system, decommission certain legacy systems, and introduce enhanced application programming interfaces (APIs) and data analytics tools.

Legacy Systems to be Replaced by AEMS Now Include:

• FDA Adverse Event Reporting System (FAERS) – containing reports for drugs, biologics, cosmetic products, and color additives.
• Vaccine Adverse Event Reporting System (VAERS) – containing reports for vaccines. Note: The FDA will display VAERS data in AEMS. VAERS is co-managed by the FDA and Centers for Disease Control and Prevention.
• Adverse Event Reporting System (AERS) – two databases containing reports for animal drugs and animal foods.

Legacy Systems to be Replaced by AEMS in May Include:

• Manufacturer and User Facility Device Experience (MAUDE) – containing reports for medical devices.
• Human Foods Complaint System (HFCS) – containing reports for human foods and dietary supplements.
• Center for Tobacco Products Adverse Event Reporting System (CTPAE) – containing reports for Electronic Nicotine Delivery Systems (ENDS) and other tobacco products.

Why Implement the New System

Previous Outdated and Fragmented Systems

The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics.

Cost Savings and Improved Transparency

Historically, the agency processed approximately six million adverse event reports per year across a patchwork of seven databases, which were costly to maintain and featured poor user interfaces that complicated searches. Collectively, these platforms cost the agency around $37 million annually to operate.

With the efficiencies offered by AEMS, the agency anticipates saving approximately $120 million over the next five years. Additionally, the new searchable system is expected to significantly reduce Freedom of Information Act (FOIA) requests for unreleased adverse event reports, as AEMS will publish reports in real time instead of on a quarterly basis.

Our Services

• The United States Agent
• The United States FDA Cosmetic Facility Registration
• The United States FDA Cosmetic Product Listing
• The United States FDA OTC Drug Registration
• The United States Color Additive Batch Certification
• The United States Cosmetic/OTC Drug Labeling Review
• International Cosmetic Ingredient Name (INCI) Application

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

FDA