• 한국임상약학회지
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• 제21권4호
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• pp.339-346
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• 2011

Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.

• 한국임상약학회지
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• 제16권2호
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

• 무역학회지
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• 제41권1호
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• pp.187-213
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• 2016

미국이 주도하는 TPP와 TTIP협정에서 「규제일관성(regulatory coherence)」의 개념이 도입되었다. 규제일관성이란 국내 정부기관들간, 그리고 여러 국가들의 정부간 규제관련 협력의 강화를 통해서 국내적 제도를 개선하고 국내 정책목표의 실현을 원활화하며, 국제무역과 투자 및 경제성장과 취업을 장려하도록 규제조치의 계획, 디자인, 발효, 집행 및 검토 절차에 좋은 규제 모범관행을 사용하는 것을 의미한다. 본 글은 규제일관성 개념의 발전과정과 TPP 협정문의 내용을 살펴보고 한국의 관점에서 TPP 등 국제협정에 포함되어 있는 규제일관성의 내용을 수용할 수 있을지를 검토해보고자 한다. 또한 정부는 보도자료에서 규제일관성을 규제수렴으로 번역하고 있는데, 이는 전혀 다른 개념이므로 정부는 이러한 번역관행을 수정해야 할 것이다.

• 한국임상약학회지
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• 제15권2호
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• pp.127-138
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• 2005

This is to examine the OTC regulatory system of Korea in comparison with those of Japan, UK and US, and suggest the possible regulatory actions to harmonize it to international standards. Individual countries have their own regulatory requirements and processes far OTC application based on established drug monographs and safety profiles from clinical experiences. Categories of OTC drug monographs are being expanded with transparent establishment procedure according to detailed guidelines, and public opinions as well as professional experts for assessing appropriateness of wide usage without physician's prescription. In line with trend of self-medication worldwide, the number of OTC drugs is increasing and more efficient and professional drug review is underway in the separate OTC division in regulatory agency. For improving OTC regulatory system in Korea, settlement of optimal drug classification policy and management for encouraging OTC drug use, development of more detailed and specific guidelines for OTC drug application, expansion of OTC drug monographs, transparent process for OTC monographs establishment, and establishment of OTC division in health authority, are suggested.

• East Asian Economic Review
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• 제17권1호
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• pp.27-53
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• 2013

In this paper, we look at the relationship between international trade and the rule of law, using the World Justice Project Rule of Law Index, which include index figures on human rights, limits on government powers, transparency and regulatory efficiency. Based on regression analyses using the rule of law index figures and international trade figures (merchandise trade, service trade, exports and imports as percentage of GDP,) international trade and basic human rights seem to have little relationship; but trade has a close positive relationship with strong order and security. Somewhat surprisingly, regulatory transparency and effective implementation seems to have little or no effect on international trade and vice versa. International trade shows a clear positive relationship with the country's criminal justice system, but the relationship with the civil justice system is not as clear as such. For regulatory implementation and civil justice, services trade positively affect these institutions, but these institutions in turn affect exports more strongly than services trade. Finally, the effect of trade on rule of law is stronger on a medium to long term (10-20 year) time horizon.

• Nuclear Engineering and Technology
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• 제50권7호
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• pp.997-1005
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• 2018

The regulatory periodic safety inspection system is one of the most important methods for confirming the safety of nuclear power plants and the defense in depth in nuclear safety is the most important basic means for accident prevention and mitigation. Recently, a new regulatory technology based on risk-informed and safety performance has been developed and used in advanced countries. However, since the domestic periodic inspection system is being used in the same way over 30 years, it is necessary to know how the inspection contributes to the safety confirmation of the nuclear power plants. In this study, the domestic periodic inspection system currently in use was analyzed from the perspective of defense in depth in nuclear safety. In addition, the analysis results were compared to the U.S. NRC's safety inspection system to obtain consistency and lessons in this study. As a result of analysis, the NRC's safety inspections were distributed almost evenly at the all levels of defense in depth, while in the case of domestic inspection, they were heavily focused on the level 1 of defense in depth. Therefore, it appeared urgent to improve the inspection system to strengthen the other levels of defense in depth in nuclear safety.

• 대한예방한의학회지
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• 제28권1호
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Toxicological Research
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• 제20권1호
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• pp.1-11
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• 2004

Evaluation of toxicological pathology is to some extend subjective judgments by pathologist and the accuracy of pathologist's works is based on the individual training and experiences. It has been required to establish a peer review system for toxicologic pathology and these review system has been employed by various practice of toxicological pathology. It would be pointed out that the possible causes of drifts in pathology are due to 1) lack of knowledge or experience of individual pathologists, 2) poorly maintained consistence of grading among animals in study, 3) different interpretation of findings between pathologists, or 4) pathology data processing. Example cases of diagnostic errors and current practice of peer review including tissue selection criteria, documentation and problem resolution for short-term and carcinogenicity studies were introduced. For sound regulatory system and high integrity of practice in toxicological pathology, current approaches of peer review system were reviewed.

• Environmental Analysis Health and Toxicology
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• 제31권
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• pp.15.1-15.6
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• 2016

A number of absurdities surrounding the humidifier disinfectant (HD) incident may have occurred because 1) a judicial system operates on the underlying false assumption that the involved parties are equals in knowledge, information and resource mobilization capabilities, regardless of respective real status as company or individual; 2) there is a lack of a system that mandates a company to prevent and actively manage possible catastrophes; 3) the regulatory scheme makes companies believe that as long as they are complying with the existing regulations, they have satisfied all of their responsibilities. I believe that this issue is an opportunity to bring about changes in the judicial redress system, the system of internal management of manufacturers, and the regulatory system of the government. The following regulation amendments are needed to move towards the changes stated above. First, legislation relating to victim relief that is applicable to the HD incident must be established. Second, a risk management system must be formed within the manufacturing company and to this end an institutional environment for the system must be established within regulatory framework. Furthermore, legislation must be passed that could punish companies themselves that have caused severe damage to individuals because they had failed to take necessary actions to avoid foreseeable harm. Finally, the framework of regulation must be changed so that the company, who has the necessary information regarding the product and the component chemicals used in the product, must self-directed experiment and assessment of the safety of their own products.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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• pp.28-28
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• 2003

After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)