Regulatory Services in South Korea

The Ministry of Food and Drug Safety (MFDS) regulates the registration, manufacturing, and distribution processes in South Korea for pharmaceutical products and medical devices . It is responsible for enforcing Good Manufacturing Practices (GMP), strengthening safety control systems, and activities relating to regulatory affairs. The National Institute of Food and Drug Safety Evaluation (NIFDS), the Medical Device Information and Technology Assistance Center (MDITAC), and the Pharmaceutical Safety and Medical Device Safety Bureaus synergistically work under the MFDS to regulate and monitor the approval of pharmaceutical products and medical devices.

Pharmaceutical products are governed by the Pharmaceutical Affairs Act of South Korea that classifies the products into drugs and pharmaceutical ingredients. Pharmaceutical drugs are further classified into new drugs, generic drugs, and pharmaceuticals requiring data submission. The latter may not necessarily be new drugs but are required to have safety and efficacy data submitted before they can obtain market approval. These could include medicines that require changes in administration route, for example.

As a leading global contender, DDReg’s regulatory services in South Korea provide ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high-quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.