• The Korean Journal of Nuclear Medicine
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• v.38 no.2
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• pp.140-142
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• 2004

As a molecular imaging is the most up-to-date technology in Nuclear Medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. for clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology.

• Journal of radiological science and technology
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• v.39 no.4
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• pp.651-660
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• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• The Korean Society of Law and Medicine
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• v.12 no.2
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• pp.317-338
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• 2011

The World Health Organization (WHO) tries to accomplish the goal of 'smoke free society', and developed countries regard the nicotine as an addictive drug. In order to better protect human health, all parties are required to adopt and implement effective legislative, executive, administrative or other measures for tobacco control in accordance with Article 4 the Framework Convention on Tobacco Control (FCTC). In order to achieve the objective of the FCTC and its protocols and to implement its provisions, Korea need to take an attention on the U.S. Family Smoking Prevention And Tobacco Control Act of 2009 and Final Rule. It is need to integrate and centralize of tobacco safety administration and smoking prevention for the national health promotion.

• Journal of Food Hygiene and Safety
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• v.25 no.3
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• pp.226-231
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• 2010

We aimed at the monitoring medroxyprogesterone acetate (MPA) residue amount in meats and confirmed the safety of its residue in meats. Optimized condition for analytical and instrumental methods was obtained by method validation. The limit of detection (LOD) and limit of quantification (LOQ) were validated at 1.5 and 5.0 ug/kg, respectively. The calibration curve showed good linearity ($r^2$ = 0.9968) within the concentration range of 5.0~50.0 ug/kg. We selected progesterone-d9 for internal standard, The recoveries in fortified meat ranged from 67.5 to 109.56% at the 3 spiking levels. As the regulation of MPA analysis method used by LC-MS/MS on other products have established. We selected 3 species of farm stock products (cattle, pig, chicken) and purchased at the markets of seven major cities. The total 196 of meat including 46 of domestic beef, 43 of import beef, 60 of domestic pork, 12 of import pork and 35 of domestic chicken. No residue of synthetic growth hormones were detected in cattle, pig and chicken samples tested.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.31 no.3 s.52
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• pp.245-251
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• 2005

Safety is one of the key issue in the regulation of cosmetics. Cosmetic Act deals with it in Korea. The guidance for the testing cosmetic ingredients and their safety evaluation are prepared by Korea Food and Drug Administration. Ultraviolet radiation could Induce skin damage, edema, erythema, photoaging, immune dysfunction and skin cancer. Ultraviolet radiation is classified as Group 2A(probably carcinogenic to humans) by International Agenry for Reaserch on Cancer(IARC). The in vitro methodologies for evaluating the toxic potential of ingredients reported in the literature have not yet been sufficiently validated for use in areas other than the study for mutagenicity/genotoxicity, for pre-screening for severe irritancy, for screening of phototoxicity and for evaluating the percutaneous absorption. The 3T3 neutral red uptake photoxicity test (3T3 NRU PT) was accepted as OECD toxicity guideline in 2002. The 3T3 NRU PT is an in vitro method based on a comparison of the cytotoxicitv of a chemical when tested in the presence and in the absence of exposure to a non-cytotoxic dose of UVA/visible light.

• Journal of Food Hygiene and Safety
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• v.34 no.3
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• pp.219-226
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• 2019

This study was conducted to understand the overall status of the monitoring program for pesticide residues in foods of South Korea. Further propositions for its improvement were made, and from this study, the status on this program can be summarized as follows. In South Korea, the Ministry of Food and Drug Safety (MFDS) is responsible for overall control of pesticide residue monitoring. Depending on the time of monitoring (sampling at distribution or production step), the government agency responsible for monitoring is different: MFDS, Regional Offices of Food and Drug Safety and local governments are responsible for monitoring of foods at the distribution step, while the National Agricultural Products Quality Management Service (NAQS) and local governments are responsible for monitoring of foods in the production step (partially at sale and distribution steps). According to purpose of monitoring, domestic monitoring programs could be divided into two types: MFDS's "Residue Survey" and NAQS's "National Residue Survey" are conducted mainly for risk assessment purposes and various monitoring programs by the Regional Offices of Food and Drug Safety and local governments are conducted mainly for regulation purposes. For imported foods, monitoring should be conducted at both steps of customs clearance and distribution: the MFDS and the Regional Offices of Food and Drug Safety are responsible for the former, and for the latter, local governments are also responsible. However, it appeared that systematic and consistent monitoring programs are not being conducted for imported foods at the distribution step. Based on the information described above and more detailed information included in this paper, the following proposals for improving the monitoring program were forwarded: i) further clarification of monitoring program purpose, ii) strengthening of the monitoring program for imported foods, iii) providing the public with monitoring results by publication of an annual report and database. It is thought that exhaustive review on the pesticide residue monitoring program and efforts for its improvement are needed in order to assure both food safety and the success of the recently begun positive list system (PLS).

• Food Science and Industry
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• v.52 no.2
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• pp.130-139
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• 2019

Safety of genetically modified foods (GM foods) in Korea is evaluated according to "Food Sanitation Act" and "Regulation on safety evaluation for GM foods" based on the concept of substantial equivalence. In which cases a person who imports, develops or manufactures GM foods for the purpose of eating imports GM foods for the first time, he/she shall undergo a safety evaluation of the relevant foods, etc. by Ministry of Food and Drug Safety (MFDS). And in which cases ten years have elapsed since GM foods underwent safety evaluation, they shall be re-evaluated for their safety. As of April 2019, a total of 199 events have been approved by MFDS and they are 169 events of GM crops including soybean (29), maize (87), cotton (29), canola (14), sugar beet (1), potato (4), alfalfa (5), 6 events of GM microorganisms (GMM) and 24 events of GM food additives originated from GMM.

• Korean Journal of Pharmacognosy
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• v.38 no.3 s.150
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• pp.205-216
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• 2007

South Korea is the representative consumption country of herbal medicines and most of herbal medicines circulating in Korea have been importing from the developing countries of Southeast Asia such as China, Vietnam, Indonesia and so forth. Domestic hygiene and safety are continuously proposed because herbal medicines which are circulating have the possibility could remain contaminants or residues. Physicochemical contaminants such as heavy metals, persistent organic pollutants, radionucleosides, microbial toxins, biological contaminants such as microorganisms and animals, agrochemical residues such as pesticides, substances used for fumigation, antiviral agents, and solvent residues are classified as major contaminants and residues in herbal medicines from 2005 September WHO.$^{1)}$ Currently our administration have established a permission standard and the inspection criteria against the heavy metal, the residual pesticides and a residual sulfur dioxide. Furthermore our administration is continuously monitoring and conducting researches for the policies and their scientific ground against herbal medicines. But the appearances or discoveries of the harmful new species due to environmental and industrial developments are becoming social problems. Therefore it may be necessary to continuously consider and investigate regarding hereupon. Recently, the contamination of the mycotoxins against foods such as cereals, nuts and the powdered red pepper have developed and started became problematic issue, and possibility of contamination against the herbal medicine is proposed. And since populations who are using the herbal medicines very limited to several nations, recognition and researches about contamination of mycotoxins in herbal medicines are very insufficient. Therefore it will be need to more focus on the international regulation of quality control and safety for herbal medicines. Now on, we are going to introduce the importance, occurrence, characteristic properties, World-wide research trends and detoxification of aflatoxins, which is known as the most potent mutagen, carcinogen and teratogen mycotoxins.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.28 no.1
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• pp.31-38
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• 2022

Due to the increasing consumer demands for the safety, shelf life, and quality of food, the application and development of active packaging in the food and packaging industry have been improved. According to the standards and specifications of the Republic of Korea for utensils, containers, and packages, the function of active packaging is to remove or alleviate factors that degrade food quality. Although extensive reviews regarding the development and commercialization of active packaging have been conducted, the legal regulations and safety assessments concerning active packaging have rarely been examined. This review provides information regarding the definition, structure, components, operational mechanisms, and applications for active packaging that actively removes oxygen, moisture, carbon dioxide, and ethylene. Furthermore, the legal regulations and research results related to the development of test methods for safety assessments of active packaging are investigated.