ESG index - Quality and supply

We prioritize quality and safety at each stage of a medicine’s life cycle. During clinical trials and after launch, we monitor the use of our medicines to identify possible adverse events and minimize risks to patients. In the production phase, we ensure product quality from raw material sampling and testing to packaging, testing and distribution of finished goods. We are also committed to timely identification, authentication and reporting of falsified medicines, which can pose a serious threat to human health. Furthermore, we are committed to engaging with third parties who operate in a manner that is consistent with our values and ethical principles.

In this section: Product quality | Pharmacovigilance | Falsified medicines | External Partner Risk Management (EPRM) | Responsible promotion and marketing of products

Product quality

To ensure product quality, we maintain a robust quality management system for our medicines in full compliance with requirements from health authorities and other regulators. We have licenses and relevant International Organization for Standardization (ISO) and Good Practice (GxP) certificates for all our activities, including clinical trials, manufacturing, medical devices, supply, warehouse and distribution operations. Our facilities are regularly subject to inspections from health authorities and other regulators.

Employees and third-party personnel working in our facilities take part in comprehensive quality and safety training before executing a GxP relevant task. Regulators require employees to be qualified, through education, training or experience, to perform any assigned task which has an impact on product quality or patient safety. Our training processes are well documented and regularly audited.

See ESG Data Summary 2025 (PDF 0.1 MB) for metrics including: GxP audits; inspections; recalls; coverage of certified quality management system.

Pharmacovigilance

Pharmacovigilance involves monitoring the safety of medicines. Our approach to achieve effective pharmacovigilance relies on safety monitoring both during drug development and in the commercial setting, as well as the timely assessment and reporting of adverse events.

Falsified medicines

Falsified medicines pose significant health risks and are a growing global health problem. Our efforts to combat falsified medicines are focused on investigating all incidents and mitigating risks across four distinct areas: counterfeiting, illegal diversion, product theft and tampering.

Our strategy is focused on accelerating the timely authentication and reporting of falsified medicines by leveraging the latest innovative technologies such as Authentifield by Novartis (drug testing) and MoVe (packaging testing). We have also strengthened our supply chain security capabilities and governance to enhance our corrective and preventive measures against product theft in high-risk regions. And, we continuously work with public and private stakeholders to encourage collective enforcement, advocacy, policy and coordinated action against falsified medicines.

External Partner Risk Management (EPRM)

We are committed to working with third parties who operate in a manner that is consistent with our values and ethical principles. While interactions with third parties at Novartis are broadly defined by our Third-Party Code, we identify, assess, monitor and mitigate risk associated with suppliers through our External Partner Risk Management (EPRM) framework.

Our EPRM process promotes ethical behavior and fosters sustainability across our supply chain by addressing risk areas such as anti-bribery; labor rights; global trade sanctions; information security; data privacy; animal welfare; health, safety and environment (HSE); contractor safety; substances of concern in products; business continuity management; and raw material certification. Human rights aspects are integrated in several of these areas, including raw material certification and labor rights.

See ESG Data Summary 2025 (PDF 0.1 MB) for metrics including: external partners audited; external partner engagements stopped; human and labor rights remediation actions with external partners.

Responsible promotion and marketing of products

We have controls and policies designed to ensure we adhere to all relevant laws and industry regulations. These cover all aspects of a drug’s commercialization, including marketing. Our Doing Business Ethically Policy sets out principles for interactions with patients, customers and other third parties where there is potential risk, for example, of unethical business practice or inappropriate influence. This policy reinforces commitments outlined in the Novartis Code of Ethics.

The process requirements for engagement activities with external stakeholders have been embedded within our BeSure digital compliance platform to ensure an approach where policy, processes and systems are integrated. We have also established a comprehensive monitoring and audit framework, which includes a comprehensive external partner risk management program, local compliance risk self-assessments, local reviews conducted by an independent global compliance monitoring team, and audits performed by Internal Audit.