Safety and Efficacy Standards

Safety and efficacy standards ensure that new medicines or medical devices are both safe for patients and effective in treating or preventing health conditions. Safety standards evaluate whether the product is unlikely to cause harm or serious side effects, while efficacy standards confirm that it works as intended. Regulatory agencies review clinical data to confirm these aspects before approval, balancing the potential benefits against risks. This process helps ensure healthcare products are reliable, protecting public health while providing effective treatment options.