Regulatory and Pharmacovigilance services in South Korea
Regulatory and pharmacovigilance services in South Korea are essential components of the pharmaceutical and healthcare industry. South Korea has a well-established regulatory framework and agencies responsible for overseeing the safety and efficacy of drugs and medical devices. Here are some key aspects of regulatory and pharmacovigilance services in South Korea: Regulatory Authorities: The primary regulatory services authority responsible for pharmaceuticals and medical devices in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA). The MFDS plays a pivotal role in approving and regulating drugs, medical devices, and biologics in South Korea. It ensures that products meet safety, efficacy, and quality standards. Drug Approval Process: South Korea follows a thorough and rigorous drug approval process. Companies must submit applications for new drugs or variations to existing products. The MFDS reviews clini