|
원문 |
• 국내 의약외품의 시장규모는 점진적으로 확대되고 있으며 생활용품에 대한 안전관리 패러다임의 변화로 의약외품 범위가 확대되는 추세임.// 하지만, 성격이 다른 다양한 제품 군에 Ø 말하고자 하는 바: 시스템을 구축해야 함 Ø 이유와 배경: 시장규모와 범위의 확대로 인한 현재 대응 체제의 허점 |
김동우 |
Quasi-drugs categorizations should be redefined, and preemptive response system should be established because of:
l gradual expansions of the quasi-drugs market l expanding categories of quasi-drugs caused by changes in regulations on safety management l insufficient safety
management system for various product l |
김혜원 |
Re-establishment of quasi-drugs and building up proactive response systems caused by social and institutional shifts are essential because: l the l the range of quasi-drugs is l the safety management system suitable for diverse product groups is insufficient l the quasi-drugs are vulnerable to constant safety issues |
최유나 |
The size of the domestic market for non-medical products is gradually Ø 관사: system, shift. (system의 경우 mass noun으로 쓰이는 경우가 있습니다. 다만 한정적인 상황에서 쓰이므로 관사를 붙이는 게 좋을 듯합니다) |
김동혁 |
The
Over-The-Counter(OTC) medicine market in-country
형용사?is gradually expanding, and the shift However, the safety control system for each product has not been sat? properly, which
can bring safety issues due to the nature of OTC medicines. Therefore, Ø 일반의약품(OTC medicine)과 의약외품(quasi-drug)의 차이: 일반의약품은 그 성능이 매우 안정적인 이유로 의사의 처방 없이 약국에서 구매가 가능한 비처방약이며, 그에 해당하지 않는 약품을 (처방전?) 의약외품이라고 부른다고 합니다.. |
신원주 |
The market and the scope of the quasi-drugs in Korea are gradually
extending, driven by the paradigm shift in good!safety
control over household items. However, the inadequacy of safety control systems and the risk of safety issues |
최리하 |
Redefining classification of quasi-drugs and establishing a l A market for quasi-drugs is becoming bigger in Korea l The l The safety management system suitable for distinct products is inadequate l Quasi-drugs’ potential risks may contribute to good! |
조현지 |
The necessity to redefine good! l Gradual expansion of domestic quasi-drugs markets l Diversification the range of quasi-drugs due to the shifting paradigm of safety management of consumer goods l Insufficient standards of safety management system l The possible occurrence of chronic safety issues because of the characteristics of quasi-drugs |
이주연 |
Domestic
Quasi-Drug markets are gradually widening in size. A paradigm change in
safety management of personal care goods leads to the expansion of the scope
of quasi-drugs. The current management system for various products is so insufficient that To
prevent the above described, the Ministry of Food and Drug Safety
is responsible for redefining Ø 식약처가 관련한 일을 도맡아서 해야함이 자명해보이나, 직접적으로 지목하는 방향이 올바른지 잘 모르겠습니다. 따라서 이에 대해 논의를 해봄이 바람직해 보입니다. Ø Classification: [mass noun] The action or process of classifying something. / [count noun] A category/group into which something is put. - ‘classification’에 앞서 redefining이라는 동사를 사용하였기에, 해당 단어가 [count noun]의 의미로 활용되는 것 같습니다. 따라서 관사가 붙거나, ‘re-classification’ 따위로 수정할 수 있을 것 같습니다. |
하우림 |
Domestic quasi-drugs markets are is
gradually expanding as well as its scope is being diversified as the paradigm
of safety supervision on household items is shifted. However, because the
appropriate safety supervision system |
이연주 |
With the gradually growing market size, the spectrum of domestic
quasi-medical products is also expanding |
교수님 레퍼런스:
▶The Growing markets of quasi-medical products
▶The greater scope of the markets in Korea as a result of renewed insight into the safety management of household goods
▶The potential risk of safety problems caused by properties and the inappropriate provision of safety management systems for disparate products
▶The necessity of redefinition of what constitutes this category and establishment of proactive countermeasures in response to shifts in social and systematic contexts.
원문 |
• 국내 의약외품이 미국, 영국, 일본에서는 의료기기, 화장품, 공산품, 살충제 등으로 분류되며// 각각의 규제기관, 법령, 사전ㆍ사후관리 등의 규제현황을 Ø 문제점: 국내와 다른 주요국의 의약외품이 다름 Ø 이유: 서로 다른 분류체계와 규제현황 때문임 |
김동우 |
Differences
l The other countries define Korean quasi-drugs as l Each country categorizes quasi-drugs differently. l Current regulations on quasi-drugs are non-identical / not aligned/harmonized. Ø “current regulations”에 대한 자세한 설명이 누락되어 있음. |
김혜원 |
l Korean quasi-drugs are categorized into medical appliances, cosmetics, industrial products, and pesticide in the United States, the United Kingdom, and Japan. l Each country assorts them into dissimilar groups and the regulatory situations are distinct from each other, according to the analysis of regulatory authorities, legislation, and pre and post management. |
최유나 |
Domestic non-medical products are categorized as medical devices,
cosmetics, industrial products and insecticide Ø the United States of America: 조사하다 알게 된 재미있는 사실은, 1776년 7월 4일의 “독립선언문”에서 제1항의 내용이 … of the thirteen ‘u’nited States of America 라는 것이었습니다. 따라서 그 당시에는 “States of America”가 국가명이었나 봅니다. 이후 1781년에 다시 “… The United States of America”로 바뀌었다고 합니다. Ø Great Britain과 United Kingdom: 브리태니커 백과사전에 따르면, Great Britain은 잉글랜드, 웨일즈, 스코틀랜드를 가리키는 지리적 용어라고 합니다. 즉, 영국에서 북아일랜드 지역이 빠진 것입니다. 이에 반해 U.K는 정치적인 용어로 국가를 가리키는 말로 쓰인다고 합니다. 따라서 현재와 같이 국명이 나열되는 경우에는, 물론 북아일랜드는 다른 법을 쓸 수 있겠지만, the United Kingdom (of Great Britain and Northern Ireland)을 활용함이 적당해 보입니다. |
김동혁 |
Domestic OTC medicines are categorized as medical appliances, cosmetics, industrial products, and pesticides in the United States, the UK, and Japan. According to the research about regulatory authorities, legislations, pre- and post-management, OTC medicines sometimes are categorized as different products. The current condition of regulation seems different as well. Ø 형태적으로 통일하면 좋을 것 같습니다. |
신원주 |
Unlike Korea good!, the quasi-drugs fall into
categories of medical devices, cosmetics, manufactured products and
pesticides in the US, the UK, and Japan and
even often same drugs are differently classified by countries. Also, their
current regulations are distinctive, |
최리하 |
l Domestic quasi-drugs are classified as medical devices, cosmetics, industrial products, insecticides, and others in the U.S., the UK, and Japan l Investigation |
조현지 |
l Korean quasi-drugs classified into different categories l Categorization of domestic quasi-drugs |
이주연 |
The present conditions are as below: 1. In the U.S., Britain, and
Japan, the ROK’s quasi-drugs are classified as medical devices, cosmetics,
industrial products or insecticide. > Britain: Britain을 U.K.라고 보는 시각과, Great Britain의 줄임말로 보는 관점이 있다고 합니다. 나라가 나열되어 있으므로 오해의 소지는 적을 것이라고 생각합니다만, 확실한 단어가 있다면 그 단어를 쓰는 것도 괜찮아 보입니다. |
하우림 |
Compared to the standards that the U.S., UK,
and Japan have been made, Korean quasi-drugs can be categorized as medical
devices, cosmetics, industrial products and pesticides and the analysis |
이연주 |
The quasi-medical products are classified as medical devices, cosmetics, industrial products, pesticides and others in the U.S., the U.K., and Japan. According to the analysis of regulatory status in each country, there are discrepancies good! in classifications and regulations. |
교수님 레퍼런스:
▶The discovery of the process of unique classification and regulation from country to country according to an analysis of its regulators, relevant laws, regulatory status such as pre and post management systems
ex. Domestic quasi-drugs falling into medical devices, cosmetics, industrial products or pesticides in the U.S., the U.K. and Japan
원문 |
• (1)국내 및 해외 의료기기의 등급분류기준을 참고하고, / (2)사용목적, 사용기간, 위해도에 따른 점수화 Ø 재분류의 필요성/(어떤 것을?) 3등급 분류/현재와 유사하고/사용상 주의사항을 참고한/ (왜?) 품목의 다양한 특성 고려를 위해 Ø 의문점: ‘국내 및 해외’가 수식하는 것은? 의료기기? 등급분류기준? truancy |
김동우
등급분류기준 |
A grade list is prepared from:
l referring classification of domestic and foreign medical appliances l grading by intends intent/intention –intended use and period of usage l usage 용법/use 사용 At first, three-class classification was
considered, which is similar to (that of) current
medical appliances, in accordance with the precautions for use. It is
necessary to reclassify the items |
김혜원
등급분류기준 |
This study contains: l national and international score indexes of medical
appliances l scoring charts consist of intended use, duration and the safety level
Referring to the precautions for use, a three-grade |
최유나
의료기기 |
Referring to Rating Classification Criteria(대문자로 해야 할까?) of domestic and overseas medical devices, |
김동혁 등급분류기준 |
Based on both domestic and foreign gradi |
신원주 등급분류기준 |
|
최리하
의료기기 |
This paper involves: l Scoring(소문자) criteria based on the grouping of the medical devices in Korea and overseas, intended use, duration, and risks Adopting three regulatory classes similar to Korea’s classification was taken into consideration with reference to instructions, however--. But , reclassifying the devices is required due to varying specifications |
조현지
의료기기 |
As a result, a score sheet is prepared with the following references for the reclassification. (:) l Referring to l Scoring the criteria l Considering precautions of the various equipment 내용 누락: (현재 의료기기 등급 분류와 비슷한 3등급 분류의 도입/품목의 다양성 고려) |
이주연 등급분류기준 |
2. With reference to national
and international criteria for medical devices, the bureau |
하우림 등급분류기준 |
According to classification on medical devices at home and abroad, a grading
system has been established |
이연주 등급분류기준 |
|
교수님 레퍼런스:
▶The compilation of a score index underpinned by the rating standard for domestic and foreign medical devices
▶The conversion of the purpose and duration for their use and harmful effects into numerical value
▶The need of the reclassification of the discussed three-tier standard similar to that of current medical products built on directions for usage to consider diverse features of items
원문 |
• 의약외품과 & 의약외품 유사한-like 품목의 / a system of 품목허가 및 신고, 품목보고제, 재평가제, 품목갱신제, 제조 및 품질관리 기준 시행방안 등을 제시하였으나, / 특성 properties-specific 별 품목 분류와 그에 따른 등급 (중요) 분류가 선행되어야 하며, 그 구체적인 시행 방안은 추후 연구가 더 필요함. Precede=take precedence over |
김동우 |
Thus, the following suggestions have been made:
l approval and notification of quasi-drugs and quasi-drug-like items l new systems of reporting items, re-evaluation, and item renewal l initiatives(new ideas강조) 구상/measures for manufacturing and quality control standards
However, the categorization of items by characteristics and its classification should be preceded; consequently, detailed initiatives require further research. 왼쪽 것이 아니라 생략된 오른쪽이 선행되어야 한다고 읽힘
precede: 타동사로, 목적어를 필요로 함. (ex: She preceded him.) 수동태로 쓰일 때는 be preceded by (ex: This evening's talk will be preceded by a brief introduction from Mr Appleby. -Cambridge Dictionary) |
김혜원 |
This study suggests implication methods of quasi-drugs and similar items’: l (_) permission and report l reporting system l revaluation system l renewal system l manufacture and quality assurance criteria
However, item classification and scoring considering each product’s features should be preceded, and their specific execution plan needs further research. |
최유나 |
Although we proposed Permission(소문자) and reporting of items similar to those of non-medical and non-medical
items, 의약외품(Quasi-drugs) Non-medical 가능할까? "의약외품(醫藥外品)"이란 식약처장이 지정하는 것으로, 사람이나 동물의 질병을 치료·경감(輕減)·처치 또는 예방할 목적으로 사용되는 섬유·고무제품 또는 이와 유사한 것으로서 인체에 대한 작용이 약하거나 인체에 직접 작용하지 아니하며, 기구 또는 기계가 아닌 것과 이와 유사한 것 (식약처) 의약품: 의약품이란 질병의 진단과 치료, 경감, 예방을 목적으로 사용되거나 인체의 구조와 기능에 약리적인 영향을 주는 물질로서 기구, 기기 또는 장치가 아닌 것, 의약외품이 아닌 것을 말한다. (식약처) |
김동혁 |
|
신원주 |
The filing(신고? 제기, 제출?--> reporting or
registering ) and approval, the report system, the
reevaluation and the action plans for manufacturing and quality control of
the quasi-drugs and similar items are suggested. However, each item needs
precise categories |
최리하 |
This paper presents future directions quasi-drugs and their analogous items for: l Approval l Notification l Report l Reevaluation l Renewal l Manufacture guidance l Quality control criteria Classification based on specification and grouping in accordance with the classification should precede (sth), and concrete implementation plans need further research. |
조현지 |
Current suggestions for quasi-drugs and similar items are as below: l Item permission and reporting system l Re-evaluation system l Item renewal system l Implementation of manufacturing and quality control standard
|
이주연 |
3. Approval, notification, manufacturing and quality control for
quasi-drugs and their similar products are presented. Classification of the items by each feature and its |
하우림 |
General plans on quasi-drugs and the similar products have been
proposed including the process of approval, report, revaluation, renewal,
production and quality management(품질관리?), but classification and grading regarding
the features of the products should take precedence |
이연주 |
In regards to quasi-medical products terminology they/ the drugs and the relevant
items, permission and declaration system, item reporting, re-evaluation
system, item renewal system, manufacturing and quality control standards are
proposed. However, the classification by features and grading system shall be preceded, and |
교수님 레퍼런스:
▶The suggestion of aligned systems involving approval, report, reevaluation, renewal, production, and quality control of these goods and similar goods
▶The primary need of the feature-centered product
classification and a system of subsequent rating, prior to the implementation of the suggested
systems which entail
further research
|