Korea’s Ministry of Food and Drug Safety (MFDS)
Medical Devices
Medical Devices in South Korea are regulated by the Ministry of Food and drug safety (MFDS) formerly known are the Korean Food and Drug Administration (KFDA). Registering medical devices and IVD in S. Korea is a complex and challenging process. Most of MFDS regulations are not written clearly and some are only available in the Korean language. Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in S. Korea.
Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in the South Korea’s market.
Pharmaceuticals
South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate. The South Korean regulatory agency, the Ministry of Food and Drug Safety (MFDS), has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product(s) without sufficient knowledge and experience with the S. Korean regulatory authorities can become exhaustive and costly.
Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your drug in the South Korea’s market.
Authorized local agent
In South Korea, the holder of a medical product registration must be a S. Korea-based entity. This entity is called the In-Country Caretaker (ICC). Foreign medical companies without their own local Korean office and who do not want to use their distributor as their local agent can have an independent ICC in Korea maintain their product registrations in the name of the foreign manufacturer.
- An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, documenting and reporting adverse events or product failures, etc.
- An ICC can also act as a liaison between the foreign manufacturer and its Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests.
- Communication with the MFDS
- Assistance with MFDS inspections
- Adverse Effect Reporting
- Importation of products
- Organize and support MFDS consultation meetings
- Product registration
- Product storage in an establishment with ICC licensing
- Support importation process
- Post-market vigilance
- Manage Distributors
Regulatory & Market Access Services
Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.
Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.
South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task. Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign pharmaceutical companies to register their products quickly and efficiently.
GRP’s Pharmaceutical Regulatory Strategy Services in South Korea:
- Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
- Proactively identify challenges or issues that may delay the approval of your pharmaceutical in South Korea.
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your pharmaceutical product registered in South Korea.
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.
At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in South Korea.
Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in South Korea. GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.
GRP’s Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management. GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements. GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise MFDS authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Product registration
The Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), is the main regulatory body for drug registration and approval. The Korean Pharmacopoeia (KP) is a pharmaceutical order implemented by the Korean government with regard to the improvement of public health. The KP defines the standard for quality and safety, hence drugs stated by the KP are acknowledged to be safe and efficacious in the treatment and prevention of diseases. The classifications for pharmaceuticals are as follows:
- Drug products that do not require a safety and efficacy review– Drugs that have already been deemed safe and efficacious or are listed in the Korean and U.S. Pharmacopeia. These drugs only require a MFDS notification submission.
- Drug products that require a safety and efficacy review, and intensive management– Drugs that require a review and approval to prevent risk factors
Consultation meetings with the MFDS can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. GRP regulatory affairs team has organized and supported numerous consultation meeting with the MFDS health authorities.
- Submit investigational new drug (IND) application to the MFDS.
- The MFDS conducts the IND application review.
- Submit new drug application (NDA) to the MFDS.
- If the MFDS does not require supplementary data, the NDA is approved.
- Prepare the application dossier for drug approval.
- Submit the application to MFDS Management Division for Drug Approval & Review.
- The MFDS conducts an initial assessment of the application, generates a report outlining the application dossier, and submits it to the MFDS Drug & Evaluation Department.
- The Drug & Evaluation department conducts a review of the following, including: results of the initial assessment, technology, safety & efficacy data, product standards, clinical trial data, good manufacturing practice (GMP) data, Drug Master File (DMF) data, impacts on intrinsic (genetic) factors, and extrinsic (factors) etc.
- If no further documentation or supplementary data is required, The MFDS issues the applicant a Certificate of Approval.
The application dossier generally includes:
- Origin or backgrounds leading up to discovery and development.
- Product structure (physical, chemical, biological) nature
- Stability test data
- Toxicity data
- Pharmacologic effects
- Clinical data – New products must fulfill the requirements of the MFDS New Drug Application (NDA)
- Uses in other countries (if applicable)
- Comparison with similar domestic products (if applicable)
Drug Master File (DMF) preparation: The MFDS requires registration of certain substances, which are subject to DMF registration. A DMF will often contain confidential information on facilities, materials, processes, and packaging. By submitting a DMF to the MFDS, the registered manufacturer can then refer importers or distributors to the registration number without disclosing confidential information to Korean business counterparts.
- Application submission: Applicants who wish to register their API may submit their application via the Korea Drug Master File (KDMF). Foreign manufacturers of these drug substances or products containing these substances can submit a DMF through a Korean importer or third-party representative with a Korean address. Domestic manufacturers can submit a DMF to the MFDS directly.
- Once a DMF is submitted, the MFDS will review the documents and conduct a facility inspection. Most applications will need to undergo a facility inspection prior to receiving approval.
- Once the application is approved, the MFDS will send a letter of acceptance and publicize the names of the DMF sponsors and registered substances. The timeframe is approximately 5-6 months, however, can extend to 8-9 months depending on the current capacity of the MFDS.
Whitepaper: Consultation Meetings with Health Authority (MFDS)
In South Korea, the Ministry of Food and Drug Safety (MFDS) offers pharmaceutical, biotech and food companies, different types of consultation meetings, to allow them seek guidance and advice on their clinical development programs and products’ registration in South Korea.
whitepaper: registration of Drug master File ( dmf ) in south korea
The Ministry of Health and Food Safety (MFDS) requires manufacturers and importers of certain Active Pharmaceutical Ingredients (API), to register their DMFs before introducing them to the South Korean market.
whitepaper: Registration of Quasi-Drugs in south korea
In South Korea, “Quasi-Drugs” are defined as products that belong to one of the following three groups: 1) Fibers, rubber products or other similar products intended to be used for treating, reducing, or preventing diseases in human and animals, or 2) Non-equipment or non-machinery products that have minimal effect or do not have a direct effect on human, or other similar products, or 3) Products intended to be used for disinfection, insecticide or other similar purposes to prevent infectious diseases.
Clinical
Conducting clinical trials in South Korea is cost effective, and the data generated is well regarded internationally. GRP can help pharmaceutical manufacturers assess the suitability of South Korea as a site for conducting clinical trials for their drug. We also provide assistance in researching and analyzing the appropriate clinicians and institutions and in screening CROs as prospective clinical trial managers in South Korea.
There are a total of 166 clinical trial centers designated by MFDS
To obtain approval for clinical trials in S. Korea, companies must go through the clinical trial authorization (CTA) process. Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI). Korean PIs must be well educated, trained, and have foreign language abilities. The sponsor and head of the clinical trial site will sign a written contract before the trial begins. If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.
In order to conduct the clinical trial itself, companies must execute further steps, including receiving approval from an Institutional Review Board (IRB), recruiting subjects and trial personnel, and ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs in order to determine which documents will be needed. All documents submitted by the sponsor for the clinical trial authorization (CTA) should be in Korean.
(1) Documents or notarial writings which confirm that submitted clinical study data were already submitted to or approved by competent regulatory authorities (of approval or registration) in other economies
(2) Data that are published in a specialized academic journal listed in the Science Citation Index (SCI)
(3) Data that verify the reliability of clinical trial institution and compliance with Good Clinical Practice (GCP)
Whitepaper: Clinical Trial Application (CTA) in South korea
The Korean Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA), is the main regulatory body for drugs, medical devices, food, and cosmetic products, that oversees the clinical trial in South Korea.
Cosmetics
In South Korea, Cosmetics are regulated by the Ministry of Food and Drug Safety (MFDS) and the Ministry of Health (MOH). Cosmetics sold in the South Korean market must comply with the Cosmetic Enforcement Ordinance, Cosmetic Enforcement Regulations and MFDS Notifications.
Global Regulatory Partners Inc., (GRP) can help your company find the right regulatory pathway for your cosmetics in South Korea. GRP’s team of professionals can act as your ICC and are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics and can help you register your Cosmetic product in South Korea.
Health Foods
In South Korea, Nutraceuticals are known as “Health Functional Food”. They are regulated by the Minister of Food and Drug Safety (MFDS). Health functional foods are products manufactured (and processed) with functional ingredients or elements useful for human health. “Functional” implies adjustment of nutrients in the human body structure or function, or those that bring useful health effects such as in physiological reaction.
GRP has a team of experts in South Korea who can help Nutraceutical and food supplements companies in South Korea during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.