MFDS NAMs Report - Regulatory Acceptance and Research Outcomes

Sep 4, 2026

Uploaded by Jiven

MFDS NAMs Report outlines regulatory acceptance and research outcomes for New Approach Methodologies (NAMs) in safety assessment, emphasizing non-animal testing. It describes the Korean Center for the Validation of Alternative Methods (KoCVAM) since 2009, including international cooperation with OECD and ICATM, and contributions to mutually accepted data under MAD. The report summarizes key R&D areas and validation of internationally harmonized alternative test methods, plus advanced-technology platforms for toxicity and safety evaluation.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages161

Reading Time6 h 46 min

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KoCVAM and R&D in NAMs

KoCVAM: past, present and future

Regulatory acceptance of NAMs

MFDS R&D budget relating to NAMs

Development and validation of internationally harmonized alternative test methods recognized by the OECD

The first domestically-developed skin sensitisation test method adopted in OECD TG 18

Development of an alternative eye irritation test method adopted in OECD Test Guideline 492

Development and OECD adoption of androgen receptor screening assay

Development and OECD adoption of an alternative skin irritation test method

Development and validation of NAMs based on advanced technologies

Organod platform for toxicity assessment

Next-generation toxicity prediction and evaluation method

Basis for next-generation toxicologic pathology diagnosis

Latest technology trends of stem cells and organoid

Next-generation safety pharmacology evaluation of cardiovascular effects

Next-generation neurotoxicity evaluation method

Evaluation of (new) narcotics pharmacology and toxicity in central nervous system

Latest studies on NAMs and their regulatory acceptance

OECD skin sensitization test method using nanomaterial

Mitochondria-targeted toxicity evaluation method

Alternative developmental neurotoxicity evaluation using stem cells

Drug interaction evaluation using big data and machine learning

Big data-based model for predicting drug cardiovascular safety

Government Publications Registation Number (GPRN) 11-1471057-000647-01 MFDS NAMs Report: Regulatory Acceptance andResearch Outcomes MINSTRY OF FOOD AND DRUG SAFETY National Instituteof Food and Drug Safety Evalution Korean Center for theValidation of Alternative Methods. MFDS NAMs Report: Regulatory Acceptance and Contents Research Outcomes |I| KoCVAM and R&D in NAMs………………………………………………………………………5 1.KoCVAM: past, present and future…………………………………………………………………………………………………7 2. Regulatory acceptance of NAMs…8 3. MFDS R&D budget relating to NAMs……………………………………………………………………………………10 Ⅱ| Development and validation of internationally harmonized alternative test methods recognized by the OECD……………………15 1. The first domestically-developed skin sensitisation test method adopted in OECD TG 18 2. Development of an alternative eye iritation test method adopted fourth in the OECD Test Guideline 492………………………………………………………………………………………………24 3. Development and OECD adoption of androgen receptor screening assay………………34 4. Development and OECD adoption of an alternative skin iritation test method……40 Ⅲ| Development and validation of NAMs based on advanced technologies……………………………………………………………………………………………………………47 1. Development and standardization of organoid platform for toxicity assessment…50 2. Development of next-generation toxicity prediction and evaluation method …………59 3. Study on creation of basis for next-generation toxicologic pathology diagnosis……72 4. Survey on the latest technology trends of stem cells and organoid …………………………82 5. Study on next-generation safety pharmacology evaluation of cardiovascular effects·84 6. Study on next-generation neurotoxicity evaluation method………………………………………90 7. Study on development of a method for evaluation of (new) narcotics pharmacology and toxicity in central nervous system………………………………………………………………………95 |IV| Latest studies on NAMs and their regulatory acceptance…111 1. Study on development of OECD skin sensitization test method using nanomaterial·114 2. Development of mitochondria-targeted toxicity evaluation method……………………………130 3. Development of alternative developmental neurotoxicity evaluation technology using stem cells……………………………………………………………………………………………………………………………………………………140 4. Study on evaluation of drug interaction using big data and machine learning………148 5. Study on establishment of big data-based model for prediction of drug cardiovascular safety………………………………………………………………………………………………………………………155 8 工 # KoCVAM and R&D in NAMs ①KoCVAM:past,present and future ②Regulatory acceptance of NAMs ③MFDS R&D budget relating to NAMs KoCVAM:past,present and future ● Korean Center for the Validation of Alternative Methods(KoCVAM)has been operatedwithin the Ministry of Food and Drug Safety(MFDS)since 2009 in order to introducealternative test methods or new approach methodologies(NAMs)in safety assessment,which conventionally relies on animal testing,and to support the promotion andutilization of NAMs. ● MFDS has provided support for the promotion of NAMs since when they were notmuch popular and nor studied by,for example,conducting research and providingeducation on the methods.MFDS is the only government agency in Korea that hasdeveloped NAMs adopted in OECD Test Guidelines.As a member of the OECD,Koreahas adhered to the Mutual Acceptance of Data(MAD),a multilateral agreement onrecognition of the safety assessment data of chemicals including cosmetics,and mutuallyaccepts the safety assessment data with other participating countries.According thethe OECD,the MAD saves around 300 million euros(300M€)of testing cost and sacrificesof over 10,000 laboratory animals each year.MFDS has helped the national industryand GLP facilities to increase their competitiveness in the world by helping domestictechnologies to be adopted by the OECD,which the MAD system is based on. ● This is attributed to over 14 years of KoCVAM's commit

FAQs

What is KoCVAM and what role does it play in NAMs?

KoCVAM is operated within the Ministry of Food and Drug Safety to introduce alternative testing approaches (NAMs) for safety assessment and to support their promotion and utilization.

How does OECD Mutual Acceptance of Data (MAD) relate to NAMs in the report?

The report explains that MAD helps recognize safety assessment data among participating countries, saving testing costs and reducing the use of laboratory animals each year.

Which areas does the report cover under regulatory acceptance and NAMs research outcomes?

It covers KoCVAM’s past, present and future, regulatory acceptance of NAMs, MFDS R&D budgets, OECD-recognized harmonized alternative test method development and validation, advanced-technology NAMs, and the latest regulatory-acceptance studies.

Sep 4, 2026

Uploaded by Jiven

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