• Proceedings of the PSK Conference
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• 2003.10a
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• pp.35-37
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• 2003

Efficacy and safety of drugs are evaluated in the process of drug registration along with the basis of setting test method and acceptance criteria for assuring quality of the drugs. Quality of drugs plays a key role to guarantee the efficacy and safety of drugs approved in the evaluation process at the marketing stage after approval. Most important role of pharmacopoeia is to give the basis of assuring the quality of drugs. (omitted)

• Food Science and Industry
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• v.47 no.1
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• pp.46-49
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• 2014

• Journal of Biomedical Engineering Research
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• v.31 no.4
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• pp.280-284
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• 2010

Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

• Journal of Food Hygiene and Safety
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• v.29 no.1
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• pp.21-25
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• 2014

Formaldehyde and phenol used in the production of melamine-wares may be intended to come into foodstuffs. So this study investigated the migration of formaldehyde and phenol from 222 articles Articles were cups(14), bowls(75), plates(85), spoons(10), chopsticks(4), food trays(8), rice paddles(4), spatulas(9) and scoops(12). The food stimulants were 4% acetic acid, 20% ethanol, distilled water and n-heptane. Korea regulation (Standards and specifications for food utensils, containers and package) specifies migration limits for formaldehyde and phenol in food stimulants. Formaldehyde and phenol are restricted by 4 mg/L, 5 mg/L respectively. In all cases the migration of formaldehyde and phenol were below the limit set in Korea regulation. The level of formaldehyde and phenol migrated to food simulants were in the range of N.D~2.949 mg/L, N.D~0.078 mg/L respectively. These migration results of formaldehyde and phenol will provide a scientific basis for the safety management of melamine-wares.

• YAKHAK HOEJI
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• v.58 no.1
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• pp.53-57
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• 2014

In recent, the abuse of newly-emerging psychoactive drugs, ('designer drugs') is a rapidly increasing problem in Korean society. Quantitative-structure activity relationship (QSAR) is an alternative method to predict bioactivities of new abused compounds. In this study, cathinone-related new designer drugs, 4-methylbuphedrone and 4-methoxy-N,N-dimethylcathinone were tested for prediction of the bioactivity with QSAR model. The bioactivity of 4-methylbuphedrone and 4-methoxy-N,N-dimethylcathinone was similar to those of methylone. These results suggest that the prediction with QSAR model may provide scientific evidences for regulatory decision.

• KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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• v.13 no.2
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• pp.75-78
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• 2007

Regulation of food packaging in Korea, Eurpoe and USA are surveyed. Food packaging manufacturer or converter has a responsibility to evaluate the safety of migration of harmful materials from typical finished packaging items. The 'overall migration limit' of all components from the packaging and 'specific migration limits(SML)' of monomers or additives are evaluated with food simulants, water, acetic acid, ethanol and n-heptane, based on the regulations of the countries. A substance not regulated has to be authorized with the technical data required, information on chemical identity, physical chemical and other properties, the intended use, migration studies and toxicological studies.

• Toxicological Research
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• v.17
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• pp.185-188
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• 2001

Genetically modified foods and food additives are derived from organisms that have been inserted foreign genetic materials by recombinant DNA techniques to improve the quality or any other pur-poses. The problems such as toxicity, allergenicity and antibiotics resistance in the safety of genetically modified foods are usually concerned. In Korea, the safety of foods is ensured by the Food Sanitation Act. Although there is no specific provision regarding the genetically modified foods in it, any foods that might cause negative effect(s) on public health or human life are prohibited to sell in the market. In order to systematically evaluate safety of genetically modified foods, the Korea Food and Drug Administration (KFDA) promulgated "Guidelines regarding review of safety assessment data for genetically modified foods and food additives (KFDA Notification 1999-46)". The objectives of these guidelines are to ensure safety of genetically modified foods and food additives. In order to evaluate the safety of genetically modified foods. KFDA operates a special expert committee composed by experts from government, universities, research institutes. and consumer's unions. Recently. manufacturers and consumers are interested in the issues on safety and labeling of genetically modified foods, because of increment of imported genetically modified crops and processed foods. Since government and consumers unions have different viewpoints, their positions regarding the issue are different each other. Therefore, the regulation of labeling on genetically modified foods is prepared and should be enforced at July 2000 in Korea. in Korea.

• Korean Journal of Food Science and Technology
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• v.43 no.1
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• pp.6-11
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• 2011

Vinyl chloride (VC) and vinylidene chloride (VDC), which may be present in poly(vinyl chloride) (PVC) and poly(vinylidene chloride) (PVDC) food packaging, were analyzed by using a headspace-gas chromatograph (GC)/mass spectrometer (MS) equipped with a PLOT Q column. 1-Chloropropane (1-CP) was used as an internal standard. The determinations of VC and VDC were carried out by monitoring the characteristic ions for each compound: m/z=61, 62, 64 and m/z=61, 96, 98, respectively. The method validated in this study can be suitable for the compliance test of EU regulation. Among 103 food packaging samples, VC and VDC were not detected, except in one PVDC food package. However, the detected level of VDC in the sample was below the EU regulatory specific limitation.

• The Korean Journal of Pesticide Science
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• v.9 no.1
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• pp.51-59
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• 2005

Korean maximum residue limits (MRLs) for pesticides have been established based on scientific data of good agricultural practice, acceptable daily intake (ADI), food intake, average body weight and others. MRLs for pesticides are generally set under the principle that theoretical maximum daily intake (TMDI) are always below ADI. As results, 104 MRLs are going to be newly established for 24 pesticides and 102 MRLs are going to be added for 63 pesticides that have regulation already, Among new pesticides, ethaboxam and flupyrazofos are effective components that are first developed in Korea. In case of dithiocarbamates, MRLs are classified by 3 groups such as dimethyldithiocarbamates, ethylenebis (dithiocarbamate)s and propineb.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.