Patient Safety

From early discovery through drug development, as well as while a product is on the market, we prioritize the safety, integrity and effectiveness of our medicines.

This starts with the procurement of materials and continues throughout the production process. We employ comprehensive health, safety, and environment (HSE) practices with R&D materials suppliers and with contract manufacturers. We also maintain a well-established product protection program to safeguard our medicines against counterfeiting, falsification, and other threats to the legitimate supply chain.

Global Patient Safety

Beginning with the discovery of a potential new medicine, and for as long as it is available to patients, our goal is to ensure that the benefits and risks of a medication are continuously monitored and well-understood by regulators, healthcare providers and patients.

Our Global Patient Safety organization is dedicated to collecting, monitoring, evaluating, and reporting safety information. Lilly collects adverse event reports and other safety data worldwide in an adverse event database. New safety findings are communicated to patients, caregivers, healthcare professionals and regulators through product labeling, patient information, and instructions for use.

Lilly Global Patient Safety physicians collaborate with Global Manufacturing and Global Quality colleagues to ensure the safety of our medicines and devices by evaluating manufacturing specifications, changes, and potential issues. Additionally, the organization maintains a safety system spanning the development-to-end-of-life cycle that integrates risk management, complaint analysis, surveillance analytics, and periodic safety and clinical evaluation, all working together to support the safety and effectiveness of our medicines and devices.

Safety of Clinical Trial Patients

We work to find new and improved medicines through rigorous research and clinical trials. One of the primary responsibilities of our researchers and the medical professionals who conduct our clinical trials is the safety of study participants. Participant safety and well-being are monitored throughout each clinical trial. Ethics review boards, along with independent research teams, are responsible for safeguarding the rights and welfare of clinical trial participants prior to their enrollment as well as ongoing oversight over each clinical trial throughout its duration.

Before enrolling in a clinical trial, participants are given information about the study through a process called informed consent, which continues throughout the duration of the study. This document describes the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. Participants may withdraw from a study at any time for any reason. They are also informed if new safety information emerges during the study that may influence their decision to continue participation.

We sponsor clinical trials and rely on various partners to conduct them. In addition to the medical professionals at research sites, known as clinical trial investigators, we collaborate with service providers, technology providers, research monitors, and other necessary entities to effectively carry out our research. These partnerships are crucial for ensuring appropriate oversight. For example, research monitors collaborate with investigator sites to validate and confirm clinical trial data, while technology providers supply items such as electronic trial diaries or digital devices to collect biomarker data (e.g., pulse, breathing rate, body temperature). We conduct robust evaluations of these partners to ensure they meet our standards for research and data privacy, and we oversee their activities throughout the clinical trial to ensure quality and data integrity.

During the clinical trial, researchers monitor patient safety by collecting any information on adverse events that occur to identify potential safety concerns. We review these adverse events across trial participants to help inform researchers, participants and regulators how to appropriately manage the care of the research volunteers, and to inform the benefit-risk profile of our products in development.

Upholding Product Quality

Quality Systems and Governance

Product quality and patient safety are core responsibilities and central to our approach to protecting patients and ensuring compliance with regulatory expectations established by global health authorities. We support this commitment through a comprehensive quality management system and a governance structure that provides appropriate oversight, including an independent Global Quality organization that reports directly to our Chief Executive Officer.

Global Quality applies a lifecycle approach, engaging across research and development and manufacturing to provide oversight, guidance, and cross-functional collaboration. This integrated model supports the consistent application of quality standards, enables the proactive identification and management of quality risks, and promotes alignment with regulatory expectations.

The organization is responsible for the Lilly Quality System, an integrated framework of standards, business processes, organizational controls, and oversight mechanisms. This framework is designed to promote consistency in execution, strengthen operational performance, and support the reliable and sustained delivery of high-quality medicines to patients globally.

Testing and Assurance

Testing and assurance checks are performed throughout the manufacturing process, starting with testing raw materials and components, continuing through in-process testing of active pharmaceutical ingredients, and finally, testing final products to confirm compliance with regulatory and internal specifications.

Authorization and Regulation of Products

Our regulatory affairs function is responsible for the content of product submissions to regulatory authorities to request product approval and any communications with authorities related to submission, review or approval. They also manage post-approval product registrations, labeling, promotional materials and compliance with associated regulatory policies.

Quality Management Training

Employees regularly undergo training to ensure compliance with relevant enterprise quality policies. For those working in Good Manufacturing Practices (GMP) areas, we have a comprehensive Current Good Manufacturing Practices (CGMP) training program designed to prepare them to fulfill their responsibilities effectively. This program includes an annual CGMP training that addresses current quality-related topics, industry trends, and regulatory updates.

Culture of Quality

We emphasize a culture of quality with intentional leadership training and employee engagement. We perform quality culture assessments at internal manufacturing sites to reinforce cultural strengths and operational excellence, and we work to create an environment where employees are empowered to speak up and share concerns.

Medical Device Certifications

For our medical devices, we maintain certification to the current ISO 13485 standard and participate in the Medical Device Single Audit Program (MDSAP). In this program, multiple regulatory authorities can accept the audit from a notified body on their behalf.

Regulatory Inspections

We host regular inspections by global health authorities across our manufacturing facilities, marketing affiliates and clinical operations. These inspections support adherence to regulatory requirements such as Good Manufacturing Practices, Good Clinical Practices, and Good Pharmacovigilance Practices, as well as internal quality standards. They contribute to the reliable supply of medicines to patients and drive continuous improvement through the identification and implementation of corrective and preventive actions.

Product Quality Assessment and Actions

Lilly applies a systemic approach to the identification, assessment, and management of potential quality defects and safety issues, whether identified through internal testing, product complaints, or events that may impact product quality. Incidents with potential patient safety impact are promptly escalated and investigated. Outcomes from these investigations are used to strengthen processes, enhance controls, and support continuous improvement across the quality system.

If a market action, such as a product recall, is required, we execute defined procedures in coordination with relevant health authorities to enable the timely removal of affected products from the market and ensure appropriate communications. In cases involving suspected or confirmed counterfeit products within the legitimate supply chain, we collaborate with health authorities and law enforcement agencies to support investigation activities and mitigate potential risk to patients.

Manufacturing and Supply Integrity

Our mission is to provide a reliable supply of high-quality medicines. As a medicine manufacturer, we take seriously our responsibility to protect the materials and processes that patients depend on.

The Manufacturing Leadership Team oversees Lilly’s inventory of essential materials. Before these materials are received, our material and component suppliers are assessed for technical competence and their capability to supply high-quality, effective materials. We have robust processes for drug product components, including the active pharmaceutical ingredient and other materials used in manufacturing. Our manufacturing, packaging, and distribution capabilities help ensure the supply of safe and effective medicines.

Product Protection

Illegitimate, falsified, and counterfeit medicines pose a serious and growing threat to patient safety. As a medicine company, we believe that everyone who needs medicine deserves medicine they can trust, that is clinically tested and evaluated by regulators for safety and effectiveness. Our product protection program reflects a sustained, long-term approach to addressing this challenge. We work to secure the integrity of our medicines through legitimate supply channels, deter bad actors through targeted investigations, internet monitoring, and legal action, and partner with government agencies, non-government organizations, and trade associations to strengthen and enforce relevant laws and raise awareness. To further support supply chain integrity, many packages of Lilly medicine are identified with a unique serial number that can be traced. This allows a documented chain of custody to be further established as wholesalers and pharmacies record shipments and receipts of our medicines. We have invested in packaging operations, distribution centers, and IT infrastructure to deploy this technology across packaging lines.

We continue to see the production, marketing, and sale of counterfeit, misbranded, adulterated, and mass-compounded drugs, including knockoffs of our incretin medicines. Counterfeit or knockoff products may contain the wrong ingredients, incorrect dosages, no active ingredient at all, or harmful contaminants, and they may also be manufactured in insanitary conditions by unregulated entities without adequate skill or training. Compounded products, while permitted in limited circumstances to address individual patient needs, do not undergo regulatory review for safety, quality, and efficacy. We have identified compounded products that contained bacteria, high impurity levels, and different chemical structures. Knockoff products are frequently sold online, through social media, or at med-spas and wellness centers, sometimes making misleading claims about FDA approval or clinical testing.

In response, we have taken significant action. For example, we have published open letters to inform patients, families, and healthcare providers about the risks posed by counterfeit, compounded, and other unsafe knockoffs of our medicines, and we have filed legal actions against certain entities selling unapproved products. We continue to work alongside regulators and law enforcement and to call on state and federal authorities to take decisive action against those who put patients at risk.

Throughout 2025, we continued to strengthen the systems and partnerships that underpin our approach to patient safety from pharmacovigilance and quality oversight to the protection of our medicines in the supply chain. Our Global Patient Safety organization maintained its ongoing monitoring and evaluation of safety data across our portfolio, communicating new findings to regulators, healthcare providers, and patients as they emerged. We had zero product recalls in 2025.

Our product protection efforts intensified as threats from counterfeit, compounded, and knockoff drugs continued to grow. We expanded our testing of suspect products, pursued additional enforcement actions, and continued working alongside regulators and law enforcement to hold bad actors accountable. These efforts remain ongoing, and we will continue to seek to protect patients and the integrity of our medicines.

Resources

• Patient Safety

• Lilly Position Statement on Patient Safety

• Identify Real Lilly Medicine

Related Topics

• Innovate

• Approve

• Supply Chain Management

• Ethics and Compliance

• Data Privacy