Pharmaceutical Regulations and Registration in South Korea (MFDS)

The pharmaceutical market in South Korea was estimated to be worth 25.4 trillion South Korean won in 2021. The market size has been growing since 2008, and this reflects an increase from roughly 23.2 trillion won the year prior.

High-quality pharmaceutical items are produced by Korean enterprises, with output value estimated to be over 1.3 trillion won in 2021. Drugs for the cardiovascular system were the most popular therapeutic category in Korea, accounting for almost 3.7 trillion won in manufacturing. medications for the digestive and other metabolic processes came in second, then medications for the central nervous system.

Pharmaceutical Regulations and Registration in South Korea (MFDS)

Pharmaceutical regulations in South Korea are overseen by the Ministry of Food and Drug Safety (MFDS), earlier known as the Korea Food and Drug Administration (KFDA). Under the MFDS, the Pharmaceutical Safety Bureau, hold primary responsibility for the review, approval, and regulation of pharmaceutical products.Pharmaceutical drugs are regulated under South Korea’s Pharmaceutical Affairs Act.

Classification of Pharmaceuticals in South Korea (MFDS)

and are classified into drug products and pharmaceutical ingredients. Drug products are categorized into three classifications:

New drugs - Any new pharmaceutical material that is different in chemical structure or original composition from pharmaceutical products previously approved in Korea, or a multiple preparation containing a new material as an active drug substance.

Pharmaceuticals that require data submission - Pharmaceuticals required for the evaluation of safety and efficacy that is not referred to a new drug e.g., pharmaceuticals with enhanced effectiveness, new composition of active drug substance, and pharmaceuticals administered via new route of administration.

Generic drugs – Pharmaceuticals that are regarded as a new drug for which there is a reference drug that is similar to the new drug with respect to the active ingredient, dosage form, and strength.

Good Manufacturing Practices (GMP) Regulation for medicinal products –

The Good Manufacturing Practices (GMP) for Medicinal Products (No.2021-87, Nov 4 2021) specifies detailed requirements for enforcement, expiration dates of GMP compliance certificates, and submission of documents for certain medicinal products. The document covers various articles and annexes under different acts and regulations, detailing procedures for GMP compliance, validation methods, and contract manufacturing and analysis. 

Annex	Products Covered in the Annex
Annex 1	Manufacture Of Sterile Medicinal Products
Annex 2	Manufacture Of Biological Medicinal Substances And Products For Human Use
Annex 3	Manufacture Of Radiopharmaceuticals
Annex 4	Manufacture Of Medicinal Gases
Annex 5	Manufacture Of Herbal Medicinal Products
Annex 7	Manufacture Of Liquids, Creams And Ointments
Annex 8	Manufacture Of Pressurised Metered Dose Aerosol Preparations For Inhalation
Annex 10	Use of Ionising Radiation in the manufacture of Medicinal Products
Annex 11	Manufacture of Investigational Medicinal Products
Annex 12	Manufacture Of Medicinal Products Derived From Human Blood Or Plasma
Annex 15	GMP Guide for active Pharmaceutical Ingredients
Annex 17	Good Manufacturing Practice for Medicinal Products

 Key Labeling Requirements for Pharmaceuticals in South Korea (MFDS)

• Drug Name and Strength; Dosage Form and Route of Administration

• Indications and Usage: The label must specify the approved medical conditions or diseases for which the drug is intended to be used.

• Contraindications: The label should list any medical conditions, patient populations, or concomitant medications for which the drug should not be used due to potential risks or adverse interactions.

• Warnings and Precautions: Important safety information, including potential risks and precautions, should be prominently displayed on the label.

• Adverse Reactions: The label must include a list of known adverse reactions or side effects associated with the drug.

• Storage Instructions: Proper storage conditions, such as temperature and humidity requirements, should be provided.

• Expiration Date: The label should indicate the expiration date beyond which the drug should not be used.

• Batch or Lot Number, Barcode and Serialization for traceability

• Manufacturing Information

• Patient Information Leaflet (PIL): In some cases, a patient information leaflet with detailed instructions for patients may be required.

All labeling information should be provided in Korean, the official language of South Korea.

Clinical Trial Requirements for Pharmaceuticals in South Korea (MFDS)

• As a first step, an application to conduct a clinical trial must be submitted to the Ministry of Food and Drug Safety (MFDS). The application should include details of the trial protocol, including the study design, objectives, inclusion/exclusion criteria, and endpoints.

• The Application is forwarded to the Institutional Review Board (IRB) for ethical review and IRB shall review the study protocol to ensure that it meets ethical standards and protects the rights and welfare of study participants.

• After receiving ethical approval, the MFDS conducts a regulatory review of the clinical trial application. The regulatory review includes an assessment of the scientific validity of the study, as well as a review of the safety and efficacy data.

• Upon successful completion of the regulatory review, MFDS approves the application, the sponsor may proceed with the trial.

• Sponsors shall submit regular reports on the progress of the trial to the MFDS. This includes safety reports, interim analysis reports, and final study reports.

• The process for approval of a clinical trial may take about 30 days to 50 days.

Documents required for clinical trial approval

Clinical trial Plan; Information on the evidence of chemical structure and the physicochemical and biological properties; non-clinical tests; Clinical trial protocol; Investigator’s Brochure

Registration Process for Pharmaceuticals in South Korea (MFDS)

1. Pre-Submission Meeting: It is often beneficial for companies to have a pre-submission meeting with the MFDS to discuss the registration process, requirements, and any specific concerns related to the product.

2. Compilation of Registration Dossier: The company must compile all the necessary data and documentation into a comprehensive registration dossier, including information on the drug's quality, safety, and efficacy.

3. Submission of Application: The company submits the registration dossier to the MFDS as part of the application for market approval. The application should include detailed information on the product, its intended use, manufacturing details, preclinical and clinical data, and other relevant documents.

4. Review Process: The MFDS reviews the registration application and evaluates the data provided. The review process aims to ensure that the product meets the required standards for safety, efficacy, and quality.

5. Approval Decision: MFDS will make a decision on whether to approve the product for marketing in South Korea. If approved, the company will receive an approval number.

6. Validity of License for the sale of medicinal products is generally granted for five years. The license holder must file a renewal application with the MFDS six months before expiration. A renewal application must include necessary information on drug safety and quality control and sales during the authorization period.

7. The fee for obtaining a marketing license for medicinal products is between 279,000 (220 USD) and 9,763,000 (7650 USD) South Korean won.

Import & Distribution Requirements and Documentation

• Commercial Invoice

• Certificate of Origin

• Self-certification of origin by the producer or exporter

• Import Declaration to clear customs

• Certificate of Pharmaceutical Product (CPP)

• Product Registration

• Good Manufacturing Practice (GMP) Compliance

• Distribution License

Prior approval from the USFDA or the EMA

The recognition of approvals from trusted international regulatory agencies, such as the EU or the US, can streamline the registration process in South Korea. This is often referred to as "regulatory reliance" or "regulatory harmonization." The MFDS in South Korea may take the approval from the EU or the US into consideration during its own evaluation process, which can lead to a faster and smoother registration process.

Post Marketing Surveillance

• The MFDS operates a pharmacovigilance system to receive, process, and evaluate adverse event reports. The system aims to identify patterns, trends, and potential safety signals associated with specific drugs or drug classes

• Pharmaceutical companies and healthcare professionals are required to report any suspected adverse events or safety concerns related to pharmaceutical products to the MFDS. This includes both serious and non-serious adverse events observed in patients using the medications.

• The MFDS may require pharmaceutical companies to submit Risk Management Plans. These plans outline strategies to identify, minimize, and manage potential risks associated with the product. They are part of the overall risk assessment and management in the post-marketing phase.

• The MFDS collaborates with other regulatory agencies and international organizations to share safety information and benefit from global pharmacovigilance efforts.

• If safety concerns or new information arise during post-marketing surveillance, the MFDS may require updates to the product labeling to reflect any changes in safety information.

References:

• https://www.khidi.or.kr/board?menuId=MENU02291&siteId=SITE00032

• https://www.lexology.com/library/detail.aspx?g=97c1f1c6-1a0a-4914-834d-4230b47bc632

• https://www.statista.com/statistics/830348/south-korea-pharmaceutical-industry-market-size/