What does the term "regulatory pathway" refer to?

The term "regulatory pathway" specifically refers to the established route a product must follow to achieve regulatory approval from governing bodies, such as the FDA or EMA. This pathway outlines the necessary steps, requirements, and processes involved, which may include preclinical studies, clinical trials, submission of applications, and evaluation of data.

Understanding the regulatory pathway is crucial for companies developing products, as it guides them through the complexities of compliance and helps ensure that their products meet the necessary safety and efficacy standards before they can be marketed. This term encapsulates all the regulatory considerations and steps needed before a product can enter the market, distinguishing it from marketing strategies, manufacturing processes, or financial aspects related to distribution.