What does "confidentiality" mean in regulatory affairs?

In regulatory affairs, "confidentiality" refers to the obligation to protect proprietary information. This encompasses the need to keep certain sensitive data related to products, processes, and research secret to prevent unauthorized access or disclosure. Maintaining confidentiality is essential for companies as it safeguards trade secrets, intellectual property, and sensitive business strategies, which could otherwise be exploited by competitors or malicious entities. This practice is often mandated by regulations to ensure that sensitive information is handled properly during the regulatory submission processes and while interacting with regulatory bodies.

The other options represent concepts that do not align with the principle of confidentiality. Public disclosure of product information contradicts the idea of protecting sensitive data. Enforcement of trade agreements typically relates to compliance mechanisms rather than information protection. Lastly, informing competitors about product changes would undermine a company's competitive position, as confidentiality is about restricting access to proprietary information rather than sharing it.