Regulatory Affairs

Checking a Regulation

This department is responsible for knowing the regulatory requirements for getting new products approved. They know what commitments the company has made to the regulatory agencies where the product has been approved. They also submit annual reports and supplements to the agencies. Regulatory Affairs typically communicates with one of the Centers (e.g., Center for Drug Evaluation and Research) at the FDA headquarters, rather than the FDA local district offices. GMPs do not directly apply to Regulatory Affairs, however, they must understand and evaluate changes to drug manufacturing and testing activities to determine if and when the FDA must be notified.

Example of a GMP expectation that applies to Regulatory Affairs

The GMPs do not have any specific requirements related to the Regulatory Affairs function.