One of the main roles of regulatory agencies is to review and approve applications for generic medicines before they can be sold to the public. This process involves a thorough review of data on the generic product’s quality, safety, and effectiveness, as well as a comparison to the brand-name drug. Only after this review is complete and the generic product is found to be the same as the brand-name drug in all relevant regards will the regulatory agency grant approval for the product to be sold.
In addition to the approval process, regulatory agencies also set standards for the manufacturing, labeling, and advertising of generic medicines. These standards help to ensure that the products are consistently of high quality and that patients are provided with accurate and relevant information about the medications they are taking.
Overall, regulations play a crucial role in the development of generic medicines, as they help to ensure that these products are safe and effective for patients to use. Without proper regulation, it would be difficult to trust the quality and effectiveness of generic medications, and the public’s health could be at risk.