Regulatory Reporting

We routinely communicate safety information to regulatory authorities as a part of our expedited and periodic reporting and risk management activities.

Regulatory authorities worldwide, including the FDA, monitor the benefit/risk balance of marketed drugs, in accordance with each country's local or regional laws and regulations.

Based on these activities, regulatory authorities may take actions such as requesting that drug companies update the information in the drug's label or conduct additional risk assessment or minimization activities. This may include additional research to evaluate a safety risk or communications to health care providers/consumers to bring attention and emphasize the new information included in the updated product label.

In some instances, regulatory authorities may decide to directly communicate with the public.

Types of reports provided to regulatory authorities

By law, Lilly is required to report safety information to regulatory authorities according to specific timelines. This mandatory reporting includes:

  • Expedited Reporting
  • Periodic Reporting

Lilly is also required to promptly communicate with regulatory authorities when Lilly becomes aware of any new safety information that might influence the evaluation of a product's benefits and risks.

What is Expedited Reporting?

Worldwide regulatory authorities require expedited submission of individual safety reports received by drug companies that meet certain, specific criteria, including criteria for the seriousness of a clinical event, whether or not a report has been previously observed and an assessment of the event's relatedness to administration of the product.

The decisions on when and how to report individual case reports are based on the requirements of each country’s local law.

By U.S. law, expedited reporting is defined as submitting an individual safety report to the FDA within 15 days of Lilly receiving it for clinical events that are considered to be serious and unexpected.

What is Periodic Safety Reporting?

Periodic safety reports are submitted to regulatory agencies in accordance with government regulations.

The purpose of these periodic safety reports is to provide an aggregate review and analysis of all adverse event reports received over a defined time period.

Periodic reports provide an overall safety re-evaluation at defined time-points and contribute to the ongoing assessment of whether changes should be made to product information or the risk management plan. The timing and content of periodic reports for marketed products are based on local requirements (ie, every 6 months, every year, every 3 years, etc).

In most countries post-marketing periodic reports are referred to as a Periodic Safety Update Reports (PSURs) or Periodic Benefit Risk Evaluation Reports (PBRER)s. In the United States these reports are referred to as a Periodic Adverse Drug Experience Reports (PADERs).