Article
Regulatory Data Protection in Switzerland
IQVIA Ark Patent Intelligence
Mar 25, 2025
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Pharmaceutical research and development is a complex, expensive, and risky process, often requiring years and substantial investment. Regulatory authorities valuate a drug's quality, safety, and efficacy through extensive nonclinical and clinical trial data before granting approval. Given the high costs and risks, protections like patents and Regulatory Data Protection (RDP) are crucial to incentivize these investments. Patents alone may not be sufficient to encourage pharmaceutical innovation in a competitive market. Therefore, RDP was introduced to provide additional incentives for pharmaceutical companies. RDP consists of two main components: Data Exclusivity (DE) and Market Protection (MP). The DE period prevents generic drug manufacturers from referencing the innovator's clinical trial data to obtain marketing approval for a certain number of years. MP refers to the period during which a generic version of a drug cannot be marketed, even if it has received regulatory approval. This ensures that the innovator maintains market exclusivity and profitability for a specified time. These periods vary across countries but generally start from the market authorization date of the original product.

Ark Patent Intelligence provides the most up-to-date data on RDP for 41 countries (including 27 countries in the European Union) in its Regulatory Protection module, offering valuable insights into the varying protection periods and regulations across different jurisdictions.

Download our comprehensive article to gain valuable insights into Regulatory Data Protection (RDP) in Switzerland and enhance your pharmaceutical investment strategies. Learn how RDP provisions can benefit your business by providing crucial protections and competitive advantages in the market.

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