Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 101

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 101
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 medicines in these regions are falsified, affecting all therapeutic areas including vaccines. Worldwide, falsified products are an issue, due in part to an exponential rise in internet connectivity of those engaged in the manufacture, distribution and supply of substandard and falsified medical products. Similar types of competition apply to Opella. In Vaccines, there are two primary types of competition: • competition for innovation in the development of new vaccines, including breakthrough technologies (such as mRNA vaccines introduced against COVID-19) or address unmet medical needs; and • competition among different patented (or non-patented) vaccine products marketed for the same therapeutic indication. In contrast, generics and biosimilars do not directly affect vaccines, which rely on proprietary viral or bacterial strains. Competition from parallel importers remains limited due to the specific requirements for vaccines, such as the cold chain and the need for administration by healthcare professionals. B.5.3. Regulatory framework The pharmaceutical and health-related biotechnology sectors are highly regulated. National and supranational health authorities administer a vast array of legal and regulatory requirements that dictate pre-approval testing (including testing in human subjects) and quality standards to maximize the safety and efficacy of a new medical product. These authorities also regulate product labeling, manufacturing, importation/exportation, safety reporting and marketing, as well as mandatory post-approval requirements and commitments. The submission of an application to a regulatory authority does not guarantee that a license or approval to market will be granted. Furthermore, each regulatory authority may impose its own requirements during product development or during the application review. It may refuse to grant approval or require additional data before granting approval, even in circumstances in which the same product has already been approved in other countries. Regulatory authorities also have the authority to request product recalls and product withdrawals, to impose penalties for violations of regulations, and ultimately the ability to revoke product licensure or approval. Product review and approval can vary from six months or less to several years from the date of application submission depending upon the country and regulatory jurisdiction. Factors such as the quality of data and evidence, the review procedures, the nature of the product and the condition to be treated, play a major role in the length of time a product is under review, and whether or not the product is ultimately licensed or approved. In the EU , there are three main procedures for applying for marketing authorization: • the centralized procedure is mandatory for drugs derived from biotechnologies; new active substances designed for human use to treat HIV, viral diseases, cancer, neurodegenerative diseases