Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 10

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 10
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. Regulatory authorities are increasingly strengthening their requirements on product safety and risk/benefit profiles. All these requirements, including post-marketing requirements, have increased the costs associated with maintaining marketing authorizations (see “Item 4. Information on the Company — B. Business Overview — B.5. Markets — B.5.3. Regulatory framework”). Moreover, to monitor our compliance with applicable regulations, the FDA, EMA, WHO and comparable national agencies in other jurisdictions routinely conduct regulatory inspections of our facilities, distribution centers, commercial activities and development centers (including hospitals), and may identify potential deficiencies which we must adequately address. More generally, if we fail to adequately respond to regulatory inspection observations identified during an inspection or fail to comply with applicable regulatory requirements at all or within the targeted timeline, we could be subject to enforcement, remedial and/or punitive actions by the FDA (such as a Warning Letter, injunction, seizure or cease and desist order), the EMA or other regulatory authorities. For example, in January 2025 , the FDA issued a warning letter related to certain GMP practices at our Framingham facility. In addition, we have an obligation to monitor and report adverse events and safety signals. To comply with these duties, we must regularly train our employees and certain third parties (such as external sales forces and distributor employees) on regulatory matters, including on pharmacovigilance. If we fail to train these people, or fail to train them appropriately, or if they do not comply with contractual requirements, we may be exposed to the risk that safety events are not reported or not reported in a timely manner in breach of our reporting obligations. Due to regulatory or geopolitical constraints, we may face delays in our clinical studies due, for example, to the new EU Clinical Trials Regulation review process for approvals of new studies or for the transition of ongoing studies under such new regulation, and/or restrictions imposed on clinical study sites, and/or delays in the supply chain for investigational products and/or the initiation and enrollment of patients in our clinical studies, and/or disruptions related to regulatory approvals, for instance due to the inability of health authorities to perform inspections in other countries and/or delays in label expansions for existing products, and/or delays due to the complexities of the review processes for clinical studies which involve an investigational device or diagnostic combined with the investigational product. We may not be able to fully mitigate these delays, which could negatively impact the timing of our pipeline development programs and may have a negative impact on our product development and launches and hence on future product