South Korea’s rapidly expanding pharmaceutical industry and stringent regulatory requirements have established the country as a key global player in the sector. However, for pharmaceutical companies, thriving in this environment demands careful planning and expertise in compliance.
The Ministry of Food and Drug Safety (MFDS), formerly known as the Korean Food and Drug Administration, is the primary regulatory authority overseeing pharmaceuticals in South Korea. The MFDS is responsible for reviewing, approving, monitoring post-market safety, and enforcing regulations. Its goal is to ensure that medicines meet global standards while ensuring patient safety and efficacy.
South Korea presents an attractive market for both domestic and international pharmaceutical companies. However, its regulatory framework can be complex, particularly for foreign firms. Understanding and adhering to South Korea’s regulatory standards is crucial for achieving success in the market. In this blog, we will delve into South Korea’s regulatory landscape.
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