식약처 승인 아토피 피부염 의약품 국내 임상 시험의 특성 - ClinicalTrials.gov 등록 임상시험을 중심으로-

황미리,안재현,제하경,김수영,정현아 대한한방안이비인후피부과학회 2019 한방안이비인후피부과학회지 Vol.32 No.2

Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

Korean Government’s response to COVID-19: role of Ministry of Food and Drug Safety (MFDS)

신인수,주선태 한국행정학회 2020 International Review of Public Administration Vol.25 No.4

The purpose of this article is to introduce MFDS risk management system and to summarize a series of administrative actions taken during COVID-19. The action covers facilitation of production of personal protective equipment(PPE) including masks and hand sanitizer and their rapid transparent supply, emergency use approval of diagnostic testing kit. MFDS is also in charge of clinical trial approval of therapeutics and vaccine candidates to accelerate the development of vaccines to protect people against COVID-19. At the end, we attempt to assess our COVID-19 management strategies and to suggest future directions in terms of risk management and public communication.

1개 기관 보건직 공무원의 조직문화인식이 직무만족도에 미치는 영향

최우창,강성욱,정성화 한국보건정보통계학회 2013 보건정보통계학회지 Vol.38 No.1

Objectives: The aims of this study were to examine the perceived organizational culture and job satisfaction and to determine the factors associated with job satisfaction among a public health officials. Methods: A total of 321 subjects (160 men and 161 women) conveniently selected from 1,460 public officials working at the Ministry of Food and Drug Safety (MFDS). The survey was conducted by selfadministered questionnaire which consisted of perceived organizational culture, job satisfaction, and socio- demographic and job-related characteristics. Univariate and multivariate analyses were performed to determine an association between perceived organizational culture and job satisfaction using SPSS 18.0. Results: The 40.8% of respondents perceived that the organizational culture of MFDS was a clan type, whereas only 6.2% perceived it was an adhocracy type. The mean of job satisfaction was 3.46. Moreover, those who felt the culture was adhocracy recorded the highest levels of job satisfaction. The workers who perceived their organizational culture was market or hierarchy were more discontent than those who perceived theirs was clan after adjusting for socio-demographic and job-related characteristics. Conclusions: It is desirable to transform the organizational culture at MFDS into one of clan or adhocracy type.

농산물 중 잔류 플루피리민과 그 대사체 분석법 개발

김대원 ( Dae Won Kim ),김지영 ( Ji Young Kim ),김효진 ( Hyochin Kim ),송지영 ( Ji Young Song ),한아름 ( A Reum Han ),김종수 ( Jong Soo Kim ),윤상순 ( Sang Soon Yun ),정용현 ( Yong Hyun Jung ),윤혜정 ( Hae Jung Yoon ),윤은경 ( Eun 한국환경농학회 2020 한국환경농학회 학술대회집 Vol.2020 No.-

Flupyrimin is used for rice plants. Not only it exhibits outstanding pesticidal property, but also it ensures excellent safety for organisms with pollinator by interacting with insectile neurons(nAChR, nicotinic Acetylcholine receptor). In this study, an analytical method for the determination of Flupyrimin and its metabolites residues in foods was developed as Ministry of Food and Drug Safely (MFDS) method. We used five agricultural products (mandarine, potato, soybean, hulled rice, and chilli pepper) as group representative to verify. The sample preparation process was conducted in two steps with QuEChERs method. First, in order to extract the samples, 2% formic acid in acetonitrile was added and shaken for 10 minutes. After that magnesium sulfate and sodium chloride were added, followed by centrifugation (4,700 G) for 10 minutes. Thereafter, to remove the interferences in samples, dispersive-SPE using C18 and magnesium sulfate was performed for 10 minutes before LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) analysis with C18 column. The linear standard calibration curve were confirmed (coefficient of determination with calibration range). Mean average accuracies of Flupyrimin and its metabolites (Flupyrimin-M1) were shown 85.18~110.66% and 72.36~100.06%, respectively. The precision were also shown less than 10.58% for all five samples. These results are suitable for CODEX guideline for residue analysis (CAC/GL 40). In short, the proposed method for determination of Flupyrimin residue in foods could be utilized as governmental method.

Main Structure of Agro-food Safety Control System in Korea

( B. O. Lee ) 강원대학교 농업생명과학연구원(구 농업과학연구소) 2014 강원 농업생명환경연구 Vol.26 No.3

Ministry of Food and Drugs Safety (MFDS) encompasses all food safety policies and promotions. There are also several food safety related institutions, such as, NAQS (agricultural products safety inspection), KOFHAS and KOLPHAS (HACCP Certification), NFSI and KAPE (traceability system), QIA (quarantine and livestock epidemics prevention). Food Safety Basic Act and Food Sanitation Act are two major laws on food safety. Agricultural Products Quality Control Act, Livestock Products Sanitation Act, Environmentally-friendly Agriculture Fostering Act, Act on the Traceability of Cattle and Beef, etc. play an important role as well. Agro-food certification system includes Environmentally-friendly Agro-Livestock Products Certification, GAP, HACCP, and Traceability System. Environmentally-friendly Agricultural Products Certification is classified into organic, non-pesticide, and low-pesticide for agricultural products and organic and non-antibiotics for livestock products. To develop environmentally-friendly livestock industry, direct payment subsidies have paid since 2009. HACCP certification initiated from 1995 for food and from 1997 for livestock products. Mandatory HACCP in the slaughterhouses has been implemented since 2003. Beef traceability system initiated in 2008 by mandatory system. However, many issues are at hand to solve to improve food safety in Korea, such as, rational division of food safety costs among producers, consumers and the government, harmonization of closed HACCP and opened traceability system, enhancing precautionary food safety system, developing low cost safety control models for the smaller food operations.

농산물 중 잔류 페톡사미드 시험법 개발

이유선 ( Yu Seon Lee ),박인주 ( Inju Park ),신서영 ( Seoyoung Shin ),최근화 ( Keunhwa Choi ),유지현 ( Ji Hyun Yoo ),이정미 ( Jung Mi Lee ),장귀현 ( Gui-hyun Jang ),문귀임 ( Gui Im Moon ),허수정 ( Soojung Hu ),전대훈 ( Daehoon Jeon 한국환경농학회 2022 한국환경농학회 학술대회집 Vol.2022 No.-

As a herbicide that controls cell division by interfering with the synthesis step of very long-chain fatty acids constituting the cell wall, Pethoxamid is used before or just after germination of crops such as rice and corn. It has a short half-life and low resistance, so it is very effective in removing a wide range of weeds. In this study, an analytical method for the determination of Pethoxamid in foods and agricultural products was developed as Ministry of Food and Drug Safety(MFDS) method. We used five agricultural products(mandarine, potato, soybean, hulled rice, and chilli pepper) as group representative to verify for this study. The sample preparation process was conducted in two steps with QuEChERs(quick, easy, cheap, effective, rugged, and safe) method for making the extraction and purification process efficient. First, in order to extract the samples, 0.1% formic acid in acetonitrile was added and shaken for 10 minutes. Next, magnesium sulfate anhydrous and sodium acetate were added, followed by centrifugation(4,700 G, 10 minutes). Thereafter, to remove the interferences in samples, dispersive solid-phase extraction(d-SPE) using C18, magnesium sulfate anhydrous, PSA and GCB was performed for 10 minutes before LC-MS/MS(Liquid Chromatography-Tandem Mass Spectrometry) analysis with C18 column. The linear standard calibration curves were confirmed showing r-square values higher than 0.99(coefficient of determination with calibration range). Mean average accuracies of Pethoxamid were shown 78.8∼95.2%. The precision were also shown less than 7.5% for all five samples. These results are suitable for CODEX guideline for residue analysis(CAC/GL 40). In summary, the proposed method for determination of Pethoxamid residue in foods could be included in the Korean Food Code for enabling the safety management of pesticides.

농산물 중 잔류 아이소사이클로세람과 그 대사체 식품공전 분석법 개발

이유선 ( Yu Seon Lee ),김지영 ( Ji Young Kim ),김효진 ( Hyochin Kim ),이정은 ( Jeong Eun Lee ),송영빈 ( Young Bin Song ),이정미 ( Jung Mi Lee ),정용현 ( Yong-hyun Jung ),문귀임 ( Gui Im Moon ),허수정 ( Soo Jung Hu ),강길진 ( Gil J 한국환경농학회 2021 한국환경농학회 학술대회집 Vol.2021 No.-

As a insecticide belonged isoxazoline class, Isocycloseram is an active chemical against lepidoptera, true bugs and beetles. Also, this chemical acts as a noncompetitive inhibitor for γ-aminobutyric acid(GABA) receptor of invertebrates. In this study, an Korea governmental official analytical method, Ministry of Food and Drug Safety (MFDS) method, for the determination of Isocycloseram and its metabolites residues (SYN549431, SYN548569) in foods and agricultural products was developed. Five agricultural products (mandarine, potato, soybean, hulled rice, and chilli pepper) as group representative to verify was used in this study. The sample preparation process was conducted in two steps with "quick, easy, cheap, effective, rugged, and safe (QuEChERs) method". First, in order to extract the samples, 0.1% formic acid in acetonitrile was added and shaken for 10 minutes. Next, magnesium sulfate anhydrous and sodium chloride were added, followed by centrifugation (4,700 G, 10 minutes). Thereafter, to remove the interferences in samples, dispersive-SPE using C18 and magnesium sulfate anhydrous was performed for 10 minutes before LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) analysis with C18 column. The linear standard calibration curve were confirmed (coefficient of determination with calibration range). Mean average accuracies of Isocycloseram and its metabolites were shown 72.0∼109.8%, 71.5∼ 109.6% and 81.9∼106.9% respectively. The precision were also shown less than 10.80% for all five samples. These results are suitable for CODEX guideline for residue analysis (CAC/GL 40). In sum, the proposed method for determination of Isocycloseram and its metabolites residues residue in foods could be utilized as a governmental official method.

식품안전법제의 문제점과 개선방향

문상덕(MUN, Sang-Deok) 행정법이론실무학회 2013 행정법연구 Vol.- No.37

인간의 생존 유지와 건강 보호를 위하여 일상적으로 섭취하는 식품은 최소한 생명이나 신체에 대한 위험으로부터 자유로워야 한다는 조건을 충족해야 한다. 그런 까닭에 식품이 생산되어 소비되기까지의 전 과정에서 식품의 안전성을 확보하는 것은 국민 전체의 건강 및 안전과 직결되는 문제로서 최상위의 공익 중의 하나이고, 국가와 지방자치단체는 국민의 건강과 안전을 지키는 막중한 책임을 감당하면서 이를 담보하기 위한 고도의 식품안전법제와 시스템의 보완ㆍ개선에 진력하여야 한다. 본 논문에서는, 먼저 우리나라의 식품안전 관련 법제의 전개와 그 현황을 개관해 보았는데, 식품안전법제는 헌법을 정점으로 하여 국민의 생명과 건강의 보호라는 식품안전의 공익을 확보하기 위하여 기본법으로서의 식품안전기본법과 중심법인 식품위생법을 필두로 하여, 여러 분야의 식품관련 법제가 계속하여 제정ㆍ정비되는 등 상당히 체계적인 법제 발전을 이루어 왔다. 한편 식품안전법제에 기초하여 식품안전관리조직의 정비ㆍ일원화도 추진되었는바, 국무총리를 위원장으로 하는 식품안전정책위원회의 구성과 국무총리 소속의 식품의약품안전처의 확대ㆍ승격이 그 주요 내용이라 하겠다. 이어서 최근 새로 제정된 식품안전기본법에 관한 법적 검토를 시도하였는데, 이것은 향후 식품안전기본법의 발전적인 보완ㆍ개선을 통하여 한층 체계적이고 완비된 기본법으로서의 지위와 역할이 필요하다고 보았기 때문이다. 이 부분에서는 식품안전기본법의 기본법으로서의 위상과 역할에 부합하는 기본이념과 지도원칙 등을 보다 더 선명하게 제시할 필요가 있고, 식품안전정책위원회 구성상 한계를 극복하기 위하여 식품관련 위험평가의 객관성ㆍ공정성을 제고하는 방향으로 운영될 필요가 있으며, 산하 위원회 조직 등을 통하여 그에 관한 미비점들을 실질적으로 보완하여야 한다고 보았다. 마지막으로 식품안전기본법의 규정내용들이 식품위생법을 비롯한 식품안전관련 여타 법률(실시법)들과 체계조화적 관점에서 일부 중복 내지 혼선의 가능성이 있는 것으로 보이므로 이를 해소하는 차원에서 추가적인 법제정비가 필요하다고 보았다. 다음으로 식품안전법제에 있어서 필자 나름으로 선정한 주요 문제점과 개선사항을 제언하였는데 그 기본방향으로서, 식품안전관리의 체계성과 통일성ㆍ합리성을 도모하기 위하여 사전예방의 강화, 위해분석을 통한 과학적ㆍ객관적 접근, 현장 중심의 관점 중시, 정보공개와 공유를 통한 식품행정의 투명성ㆍ공정성ㆍ신뢰성 제고, 시민참여 유도와 민ㆍ관ㆍ사업자의 소통ㆍ협력을 증진하는 거버넌스(Governance)체제 확대 등을 설정하였다. 이어서 신고제 중심의 식품업체 진입규제를 식품안전 확보의 관점에서 재검토할 필요성을 지적하였고, 글로벌화에 따른 수입식품 안전조치의 강화책을 강구하도록 하며, 건강기능식품에 관한 법제 미비점 개선의 촉구, 첨단 식품안전시스템의 도입ㆍ활용과 법제 정비의 필요성, 식품관련 분쟁조정절차의 도입 등 식품분쟁해결절차의 보완 등을 제언하였다. 이러한 다양한 문제의식과 방책들을 통하여, 향후 우리나라의 식품안전법제가 종전의 단순한 위생ㆍ안전 중심에서 질병예방, 건강까지 아우르는 생애주기별 영양ㆍ식생활 관리로 식품안전의 패러다임이 전환되어야 함을 강조하였다. It is very important to secure the food safety to protect human life and health. Central and local governments which have policy-making and legal control power of food are responsible for it and they should make efforts to improve the legal systems of food safety. In this research, I tried to analyze the present situation and problems of the food safety laws and policies in KOREA. And I also tried to suggest several legal or legislative improvements for better food safety law system. First of all, I gave an overview of the food safety laws and policies in Korea. Mainly, Framework Act on food safety, The committee of Food Safety Policy, The Ministry of Food and Drug Safety(MFDS) etc. Second, I reviewed the legal or legislative problems in Framework Act on food safety such as the obscurity of basic ideas and leading principles, the overlap or confusion between Framework Act on food safety and Food Sanitation Act. Third, I suggested several improvement measures in food safety law systems. They are the tightening (up) of the entry regulation for food company and the safety measures of imported food. And I also suggested the legal improvements of health functional food and the introduction of dispute conciliation system of food.

A commercialization strategy for advanced medical products supported by short-cut approval process in KBio

Donwoong Choi 한국실험동물학회 2016 한국실험동물학회 학술발표대회 논문집 Vol.2016 No.08

Vaildation of Analytical Method for Fluoxapiprolin Residue in Agricultural Products

Seoyoung Shin,Young Bin Song,Yu Seon Lee,Jung Mi Lee,Gui-hyun Jang,Mi Ok Eom,Soojung Hu,Bonghyeon Nam 한국농약과학회 2024 한국농약과학회 학술발표대회 논문집 Vol.2024 No.4