Pharmaceutical Regulatory Affairs and IPR

Penalties for Regulatory Non-compliance

Non-compliance costs are costs which result from a failure to comply with regulation. These costs are not considered to be part of the regulatory burden for the purposes of the Risk Based Monitoring. This includes penalties and activities associated with those penalties that are required to be undertaken because of noncompliance with regulation. Regulatory impacts that arise, up to the point that action is taken to respond to the suspicion of a specific instance of noncompliance, are included in RBM framework. This includes risk based frameworks that may target certain populations without a specific instance of suspicion. Failure to comply with the law can lead to enforcement action including one or more of the following: on-the-spot fines, prosecution, which carries a maximum fine of $12,110, disciplinary action, ranging from fines to cancellation of the license.