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Nutraceutical Regulation and Registration in South Korea (MFDS)

Nutraceuticals, a fusion of "nutrition" and "pharmaceuticals," represent a burgeoning sector at the intersection of food and medicine. Growing health awareness and an aging population have fueled the high demand for Nutraceutical in South Korea. According to South Korea's Ministry of Food and Drug Safety, there were 12,495 different types of health supplements available in the country in 2012, but that number increased to 26,342 by 2019. The market volume of Korean dietary supplements reached 4.58 trillion KRW (about 4.104 billion USD) in 2019 and the South Korea’s health supplement market has grown during the pandemic. It was worth KRW 4.04 trillion in 2021 and is estimated to grow by 14.6% in 2022. The South Korean nutrition and supplements market is projected to surge to $11.52 billion by 2030, marking substantial growth from its 2022 value of $5.57 billion.


By 2030, it is anticipated that the South Korean nutrition and supplements market will reach a value of $11.52 Billion from $5.57 Billion in 2022, growing at a CAGR of 9.5% during 2022-2030.

Nutraceutical Regulation and Registration in South Korea (MFDS)

This articles outlines the Nutraceutical regulations and registration in South Korea (MFDS):


South Korea Regulatory framework

In South Korea, dietary supplements are called Health Functional Food(HFF) and they are regulated by the Ministry of Food and Drug Safety (MFDS). The MFDS formulates policies for functional health foods and assesses their ingredient usage. It also sets labeling guidelines for health supplements and nutraceutical products. Collaborating with the National Institute of Food and Drug Safety Evaluation (NIFDS), MFDS oversees the application and evaluation of functional ingredient use in dietary supplements. The Korea Health Supplement Association (KHSA), a public organization, supports both industry and regulatory entities in their endeavors.


Nutraceutical Product classification South Korea

  • Health Functional Foods (HFFs): they contain bioactive compounds with proven health benefits. Rigorous scientific evaluation and MFDS assessment ensure compliant products with accurate, transparent labeling.

  • Dietary Supplements: dietary supplements are not subject to the same stringent scientific evaluation. However, they still must adhere to quality and safety standards set by the MFDS.

  • Health supplements registration in South Korea.

Nutraceutical and dietary supplement registration in South Korea ensure product safety and quality. The MFDS oversees the Nutraceutical and dietary supplement regulation and registration process in South Korea focusing on efficacy and safety. HFF Registration pathway involves,

  1. HFF with ingredients registered with MFDS.

  2. Safety and Efficacy Assessment.

  3. Submit an application for HFF Registration.

  4. Registration of manufacturing site.

  5. Receive HFF approval.

  6. Post-Market Surveillance.

Documents required for nutraceutical product registration

  1. Application Form.

  2. Nutraceutical Product Information.

  3. Ingredients in Nutraceutical Information.

  4. Nutraceutical Formulation Details.

  5. Manufacturing and Quality Control.

  6. HFF Safety Data.

  7. HFF Efficacy Data.

  8. Nutraceutical product Labelling and Packaging.

  9. Product Samples

  10. Authorization Letter and Power of Attorney.

Timeline and Fees associated in registration of nutraceutical in South Korea


The timeline for nutraceutical product registration in South Korea can vary widely based on factors such as the type of product, its complexity, the completeness of the submitted documents, the workload of regulatory authorities, and any potential follow-up requirements

Nutraceutical regulations registration South Korea mfds

Post-marketing Activities Nutraceuticals in South Korea

  1. Adverse Event Reporting: Manufacturers and distributors are required to promptly report any adverse events or side effects associated with their nutraceutical products.

  2. Quality Control and Testing: Routine testing of nutraceutical products.

  3. Labeling Compliance: Regulatory bodies ensure that nutraceutical products' labeling remains accurate

  4. Market Surveillance: Regular market surveillance activities are conducted to ensure safety.

  5. GMP Inspections: Good Manufacturing Practice (GMP) inspections of manufacturing facilities.

  6. Consumer Education: This empowers consumers to make informed decisions and promotes responsible usage.

  7. Regulatory Updates: Regulatory bodies may introduce new guidelines and standards.

  8. Import and Export Monitoring: regulatory agencies may monitor these activities to ensure compliance with international trade regulations.

  9. Enforcement Actions: In cases of non-compliance, regulatory authorities may take enforcement actions, such as recalls, product withdrawals, fines, or other penalties to safeguard public health.

  10. Collaboration with Industry: Regulatory bodies do collaborate with nutraceutical manufacturers, distributors, and associations to ensure mutual understanding of regulations and facilitate compliance.

References



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