Regulatory Agencies Around the World: An Introduction
Regulatory agencies play a critical role in ensuring the safety and efficacy of drugs worldwide. They oversee every aspect of drug development, from preclinical research to post-market surveillance, and are responsible for approving or rejecting new drugs for sale in their respective regions. This blog will introduce some of the most important regulatory agencies worldwide, including the FDA, EMA, and PMDA. 1- United States Food and Drug Administration (FDA) The United States Food and Drug Administration (FDA) is perhaps the most well-known regulatory agency in the world. The FDA is responsible for ensuring the safety, efficacy, and quality of drugs, medical devices, and other products in the US market. The FDA regulates all stages of drug development, from preclinical research to post-market surveillance, and has the authority to approve or reject new drugs for sale in the US. To receive FDA approval, drug manufacturers must conduct extensive clinical trials to demonstrate the sa...