Understanding Korea’s Drug Regulatory Requirements

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Venturing into a new market is akin to navigating uncharted waters, and the Korean pharmaceutical market is no exception. Here, the compass that guides international drug companies toward success is the understanding of the regulations set forth by the Ministry of Food and Drug Safety (MFDS). These regulations serve as the beacon that lights up the path to drug classification, reimbursement, registration, etc.

This blog post aims to unravel the intricacies of the Korean drug registration process and drug regulatory processes of the Korean MFDS. Whether your interests lie in registering your drug in Korea or general Korean pharmaceutical market entry, this comprehensive guide will illuminate the regulatory terrain of drug approval in Korea, ensuring a successful journey from pre-clinical testing to post-market surveillance.

Unveiling the MFDS of Korea

Established to ensure the safety and efficacy of food and drugs in South Korea, the Ministry of Food and Drug Safety (MFDS) performs a pivotal role. Recognizing the South Korean MFDS as a regulatory authority is essential for international drug companies aiming to introduce pharmaceutical products in this large East Asian market.

MFDS: The Pillar of Drug Safety

The Ministry of Food and Drug Safety (MFDS) in Korea shoulders the primary responsibility of ensuring public health by diligently regulating food and drugs. As South Korea’s dedicated drug safety watchdog, the MFDS plays a pivotal role as the gatekeeper for drug approval. Consequently, understanding the agency’s processes and policies becomes paramount for businesses operating in the Korean pharmaceutical industry. Adhering to the MFDS’s stringent regulations and guidelines is crucial in navigating the complex landscape of drug approval in Korea.

By acquiring a comprehensive understanding of the MFDS’s expectations and requirements, international pharmaceutical companies can proactively meet regulatory standards, foster trust, and contribute to the overall protection and well-being of Korean patients. Keeping abreast of the MFDS’s evolving guidelines and maintaining compliance is vital for international drug companies looking to succeed in the Korean pharmaceutical market.

The Journey of Drug Approval

To successfully navigate drug registration in Korea, international pharmaceutical companies need to comprehend the critical stages of the drug approval process in the country.

Pre-clinical Testing: The First Step

Pre-clinical testing serves as the crucial first step in the drug approval process. This stage, conducted in a controlled laboratory environment, involves a meticulous examination of the drug’s safety profile and pharmacological effects. Various tests are conducted to understand the drug’s potential toxicity, pharmacokinetics, and overall behavior in the body. Pre-clinical testing aims to gather crucial data that informs researchers and regulators about the drug’s potential risks and benefits before proceeding to human trials.

The Phases of Clinical Trials

Upon successful completion of pre-clinical tests, the drug progresses to the next phase: human clinical trials. Clinical trials are conducted in three main phases, each serving a distinct purpose.


  • Phase I involves administering the drug to a small group of healthy volunteers to evaluate its safety, dosage range, and potential side effects.
  • Moving on to Phase II, the drug is tested on a larger cohort of individuals who have the condition that the drug aims to treat. This phase focuses on assessing the drug’s efficacy, optimal dosage, and further evaluation of side effects.
  • In Phase III, the drug is administered to a substantial number of patients to monitor its effectiveness, safety, and potential side effects.

The New Drug Application Process

After successfully completing the clinical trials, the next critical stage is the submission of a New Drug Application (NDA). Businesses seeking drug approval must compile comprehensive data from pre-clinical and clinical studies and submit it to the Korean Ministry of Food and Drug Safety (MFDS) for a thorough review. The NDA serves as a comprehensive dossier, providing detailed information about the drug’s development, efficacy, safety, and quality. It is essential to showcase that the benefits of the drug outweigh the potential risks, providing robust evidence and documentation to support its approval.

Post-Marketing Surveillance: A Continuing Obligation

Once the drug receives market authorization, post-marketing surveillance becomes a continuing obligation. This phase involves closely monitoring the drug’s safety and efficacy as it is widely used by the public. The local Korean Market Authorization Holder needs to report adverse events or other drug problems that may emerge over time. It plays a crucial role in ensuring the ongoing safety and effectiveness of the drug, as additional information may be gathered from real-world usage and larger patient populations.

Impact of Regulatory Compliance

Compliance with the Korean MFDS regulations are integral to achieving success in the Korean pharmaceutical industry. It holds direct implications for both the product approval process and the company’s market reputation in Korea. Infringing the MFDS’s regulations carries grave repercussions, from costly fines and delays in product approval to potential bans on business operations. Conversely, businesses that align their operations with the drug safety policies of Korea’s MFDS reap numerous benefits. Compliance ensures a smooth product approval process, fosters market trust, and grants a competitive edge over non-compliant competitors.

Practical Insights for Successful Navigation

To successfully maneuver the Korean MFDS’s regulatory landscape, international companies need to adopt effective strategies.

Tips for Global Businesses

For international drug companies seeking drug approval in Korea, having comprehensive knowledge of the regulatory landscape is essential. Understanding the specific Korean requirements and processes set by the MFDS is crucial for a successful approval journey. This includes staying updated on the latest Korean drug regulations, guidelines, and expectations of the agency. Engaging with local Korean regulatory experts and consultants who have an in-depth understanding of the MFDS’s policies can significantly streamline the approval process. These Korean drug regulatory experts can provide valuable insights, guidance, and support in navigating the intricacies of the regulatory framework.

The Role of Local Partners and Consultants

Collaborating with local Korean drug regulatory partners who have experience in drug approval in Korea can also prove invaluable. These Korean drug regulatory partners can offer localized expertise, assist with the preparation and submission of regulatory documentation, and help ensure compliance with the MFDS’s requirements. Additionally, meticulous documentation is a vital aspect of the approval process.

Accurate and thorough documentation of pre-clinical and clinical studies, safety data, manufacturing processes, and quality control measures is crucial for the successful submission of the New Drug Application. Maintaining clear and well-organized records that align with the MFDS’s expectations will facilitate the review and evaluation process, improving the chances of a positive outcome.

Stay Updated With Evolving Policies

Keeping abreast of the dynamic policies and trends in drug registration in Korea and drug approval is crucial. Continuous, vigilant monitoring of policy changes is key to maintaining regulatory compliance.

Understanding and complying with the drug policies of the Korean MFDS is not only critical but also beneficial for businesses intending to operate in the Korean drug market. As a roadmap to success in the Korean pharmaceutical industry, compliance with the MFDS regulations promises a competitive advantage. Knowledge about Korean drug registration, along with a commitment to follow the changing regulatory landscape, can ensure a successful venture in this burgeoning market.

Tran Doan – Director, Pacific Bridge Medical (PBM)
Ms. Doan leads Asian market research, regulatory, and consulting projects at PBM. She graduated with a B.A., Phi Beta Kappa, in Mathematics and Economics from Franklin and Marshall College.

Source used in the article: https://www.mfds.go.kr/eng/wpge/m_17/denofile.do