4. Supply of Ingredients

Ingredients Regulation Overview for Ingredient Manufacturers
South Korea

This section provides information on any notification, registration, or importation requirements for the ingredient categories in scope.

4.1 As Drug Substances for Drug Manufacture (B2B)

4.1.1 Registration

4.1.1.1 Registration requirements

According to the Regulation on the Registration of Active Pharmaceutical Ingredients, registration is only required for new drug substances that are used as active ingredients of a new drug product for which approval of manufacture/marketing/import has been applied for or are listed in Annex 1 of the regulation. Vitamins and carotenoids are not considered new drug substances since they are listed in the Korean Pharmacopeia and/or USP, and they are not included in Annex 1, therefore registration would not be required. 

However, according to the Regulation for Pharmaceutical Approvals, Notifications and Reviews (Notification No. 2021-90), drug substances are subject to notification if:

• a person intends to manufacture or sell a drug substance OR
• a person intends to engage in importation of a drug substance,

AND

• the substance is listed in the Korean Pharmacopeia or official compendia approved by the MFDS (see Section 3.1.1) or Korean pharmaceutical codex.

Therefore, vitamins and carotenoids would be subject to notification for import and sale in Korea.

4.1.1.2 Registration process

The notification process is described in the Regulation on the Safety of Pharmaceuticals. Notification of a foreign drug substance would be submitted by the Korean importer by completion of Form No. 6 and submission of the following data:

1. Data proving that the drug substance is listed in Korean Pharmacopeia or official compendia approved by the MFDS (see Section 3.1.1) or Korean pharmaceutical codex.
2. Certificate of free sales which verifies the product is for sale in compliance with the laws and regulations of the country where the product has been approved and registered, issued by the government or public agency of the country.
3. Data necessary for evaluation of compliance with GMP for drug substance.

When the notification is approved, a Certificate of Notification and permit number are issued.

4.1.1.3 Documents required from ingredient supplier

To satisfy the data requirements above, the ingredient supplier should provide:

1. Certificate of Suitability (CEP) with letter of access if available. Otherwise, evidence of compliance with the pharmacopeial monograph.
2. Certificate of Free Sale.
3. Certificate of GMP covering the manufacture of the drug substance being notified.

4.1.1.4 Cost and Timelines

The fee for notification of import is 385,700 KRW (approx. 275 EUR/USD).

4.1.2 Importation

4.1.2.1 Overview of Process

The importer must have a License to Import Pharmaceutical Products and the product to be imported must be notified as described in Section 4.1.1 above.

4.1.2.2 Documents Required from the Ingredient Supplier

See Section 4.1.1.3.

4.1.3 Change Notification

A change to the API trade name would have no regulatory impact.

4.2 In Pharmaceutical Products Produced by Korean Manufacturers (B2C)

4.2.1 Registration of Drug Product

4.2.1.1 Registration Requirements

Marketing authorization is required for drug products via registration or notification (in cases where the drug product has a pharmacopeial monograph). Registration must be performed by a Korean entity with an appropriate license. 

Vitamins would not qualify as a new drug substance therefore the drug categories in which vitamins may be used as a drug substance are either:

1. Drugs requiring data submission:
   1. Drugs containing new salt (isomer, etc.) as active substance 
   2. Drugs with new indications
   3. Drugs with new composition of active substance or only with changes in strength
   4. Drugs with new route of administration
   5. Drugs with new administration/dosage
   6. Enzyme, yeast, or bacterial preparations with new origin that is almost pharmacologically equivalent to the previously approved drugs
   7. Drugs with new dosage form, but with the same route of administration
2.  Generic drugs

The classification would depend on whether the formulation is qualitatively and quantitatively the same as an existing product.

4.2.1.2 Registration Procedure

1. Required data is submitted electronically via the e-Drug Service. The dossier is submitted in the eCTD format. 
2. A separate submission portal is available for upload of a DMF restricted part (https://nedrug.mfds.go.kr/ext/CCABA01/dmfLoginPopup). 

4.2.1.3 Documents to be Provided by Ingredient Supplier

For APIs

Specific requirements may differ depending on the exact classification of the drug within the drug requiring data submission/generic drug categories but in most cases the following documentation is required: 

1. Current GMP certificate or evidence of GMP compliance
2. Data for drug substance
   1. Data for defined structures 
   2. Data for physicochemical characteristics 
   3. Data for manufacturing methods 
   4. Data to describe specification and test methods 
   5. Source data for specification and test methods 
   6. Data for test results 
   7. Data for reference standards and reagents and reagent solutions 
   8. Data for containers and packaging

This data may be submitted in the form of a DMF or CEP with an accompanying letter of access. In these cases, Certificates of Analysis will also be required and in the case of a CEP, stability data must be provided unless the CEP specifies a re-test period.

For Excipients

CoAs are required for excipients used.

4.2.1.4 Cost and Timelines

For drugs requiring data submission, the review period is 120 days. This is reduced to 90 days for generic drugs. Approval of drugs in both of these categories is 2,007,350 KRW (approx. 1400 EUR/USD but may be less if only notification or safety/efficacy review is not required.

4.2.1.5 Renewal Frequency and Cost

The validity of registration is five years. Renewal cost is 363,000 KRW.

4.2.2 Importation

Not applicable to locally manufactured products.

4.2.3 Change Notification Relating to API Trade Name Change

A change to the API trade name would have no regulatory impact. 

4.3 As Active Substances for Health Supplements (B2B)

4.3.1 Registration requirements

Vitamins are recognized as functional ingredients for use in health functional foods, therefore no registration is required. 

4.3.2 Importation

4.3.2.1 Overview of Process

The MFDS has introduced mandatory registration of overseas food manufacturing facilities for import clearance. Registration is via an online application (https://impfood.mfds.go.kr/?locale=en_EN). After creating an account, details of the facility are entered and the required documents attached. The approval process takes only three days but registration must be renewed every two years.

The importer in Korea requires an import license. They must submit an import declaration to the MFDS, through the electronic UNI-PASS system. 

4.3.2.2 Documents Required from the Ingredient Supplier (For registration of facility)

Government-issued certificate of registration according to the country’s applicable food laws. Acceptable certificates are:

1. ISO 22000
2. HACCP
3. GMP of food/drugs
4. FSSC
5. BRC Food
6. SQF
7. IFS Food

4.3.3 Change Notification

A change to the active substance trade name would have no regulatory impact as an import declaration is made for each import. 

4.4 In Health Supplements Produced by Korean Manufacturers (B2C)

4.4.1 Registration of Health Supplement

4.4.1.1 Registration Requirements

The Korean manufacturer of health supplements is required to submit a Health Functional Food Item Manufacture report.

4.4.1.2 Registration Procedure

The manufacturer submits a Health Functional Food Manufacture report electronically to the Commissioner of the Food and Drug Administration. 

4.4.1.3 Registration Documents to be Provided by Ingredient Supplier

Not applicable- the Health Functional Food Item Manufacture report requires only listing of the name and contents of ingredients.

4.4.1.4 Cost and Timelines

Submission of the report incurs a fee of 20,000 KRW (approx. 13.50 EUR/14.75 USD).

4.4.1.5 Renewal Frequency and Cost

Not applicable.

4.4.2 Importation

Not applicable to locally manufactured products.

4.4.3 Change Notification

A change to the active substance brand name would have no regulatory impact.

4.5 As Ingredients for Veterinary Products (B2B)

4.5.1 Registration

Ingredients for the manufacture of veterinary medicines are not required to be registered. 

4.5.2 Importation

Substances imported for the manufacture of veterinary drugs are exempt from import product approval from and reporting to the QIA.

4.6 In Veterinary Product Produced by Korean Manufacturers (B2C)

4.6.1 Registration

4.6.1.1 Overview of Process

Veterinary drugs require marketing approval before supply in Korea. The applicant for marketing approval must hold an appropriate license from the QIA.

The following documentation is submitted by the applicant for review by the QIA:

1. Documents regarding the product name, quantity of raw materials, properties/manufacturing method, usage, dose, storage, expiry, precautions, test standards and test methods.
2. Documents for safety and efficacy if required (e.g. for new drugs).
3. Documents regarding the manufacturing process.

4.6.1.2 Documents Required from Ingredient Supplier

Manufacture of the drug product must be in accordance with standards equivalent to the WHO GMP for medicinal products but limited documentation is required on the ingredients, particularly if the substances are already in use and a safety and efficacy review of the product is not required (i.e. if listed in the Korean Pharmacopeia or other pharmacopeias).

A certificate of analysis from the ingredient supplier demonstrating compliance with pharmacopeial standards would be submitted for approval.

4.6.1.3 Cost and Timeframes

The cost of the application is 10,000 KRW (approx. 7 EUR/USD). If no safety or efficacy review is required, the process should take 10 days.

4.6.2 Importation

Not applicable for local manufactured product.

4.6.3 Change Notification

A change to the API trade name would have no regulatory impact.

4.7 References

1. Pharmaceutical Affairs Act

https://elaw.klri.re.kr/eng_service/lawView.do?hseq=40196&lang=ENG

2. Guide to Drug Approval System in Korea

3. Regulation on the Registration of Active Pharmaceutical Ingredient

https://www.mfds.go.kr/eng/brd/m_18/view.do?seq=71515

4. Regulation on Safety of Pharmaceuticals

https://www.mfds.go.kr/eng/brd/m_18/down.do?brd_id=eng0003&seq=71527&data_tp=A&file_seq=1

5. Regulation for Pharmaceutical Approvals, Notifications and Reviews MFDS Notification No. 2021-90

https://www.mfds.go.kr/eng/brd/m_18/down.do?brd_id=eng0003&seq=71512&data_tp=A&file_seq=1

6. Enforcement Rule of the Health Functional Food Act

https://www.mfds.go.kr/eng/brd/m_15/down.do?brd_id=eng0001&seq=70009&data_tp=A&file_seq=1

7. Imported Food Safety

https://www.mfds.go.kr/eng/wpge/m_11/de011002l001.do

8. Rules for Handling Veterinary Medicines, etc. Enforcement 2024.1.5 [Ministry of Agriculture, Food and Rural Affairs Ordinance No. 628, 2024.1.5., partially revised]

https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EB%8F%99%EB%AC%BC%EC%9A%A9%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EC%B7%A8%EA%B8%89%EA%B7%9C%EC%B9%99 (In Korean)