• 약학회지
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• 제59권1호
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• pp.40-46
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• 2015

The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

• 의료법학
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• 제22권4호
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• pp.159-184
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• 2021

첨단재생바이오법의 제정 의의는 본질적으로 '이식'이라는 의료행위인 재생의료를 약사법 규제에서 벗어나 의료기술적 접근으로 환자치료기회를 확대하는 데 있다. 그러나, 법이 시행된 지 1년여가 지난 상황에서 식약처가 승인하는 고위험연구는 1건도 승인되지 않고 있는 등 임상연구가 활성화되지 않고 있다. 그 이유는 환자치료기회 확대를 위한 법률 취지에도 불구하고 법률적 근거가 미흡함에도 임상연구 승인을 위한 자료요건을 의약품 개발과 연결하여 정하고 있어 많은 연구자들이 자료요건을 맞추기가 어려운 실정이다. 법 제정 이전 약사법 체계 내의 세포치료제 임상연구를 위한 제출자료는 품질 및 비임상시험 자료가 상당히 면제되었지만, 첨단재생바이오법이 시행되면서 임상연구 계획 승인신청 시 품질 및 비임상시험자료를 의약품에 준해 요구하고 있다. 이를 바로잡으려면 치료기회 확대를 위한 첨단재생의료 임상연구의 정체성을 고려할 때 의약품 개발과 연결하는 데는 제한점이 있음을 인식하고 첨단재생의료 임상연구의 정체성을 지키고, 한편으로 품목허가 시 임상연구 결과를 활용할 수 있도록 하면서 활용요건을 구체화하여 시장의 힘으로, 임상연구자의 자발적인 동기로 임상연구 승인을 위한 기본요건보다 필요한 자료를 스스로 준비할 수 있도록 해야 한다.

• 의료법학
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• 제23권4호
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• pp.75-102
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• 2022

본 글에서는 보건의료관련 법령 중 「연명의료결정법」, 「정신건강복지법」, 「장기이식법」, 「인체조직법」, 「약사법」, 「에이즈예방법」, 「결핵예방법」, 「감염병예방법」을 검토하였다. 이들 법률에 민법적 사고가 필요한 부분은 환자의 자기결정권과 동의에 관한 부분이다. 그리고 환자가족을 통한 의사결정이 환자의 의사결정을 대행하는 것인지 환자가족이 환자를 위하여 고유의 권한으로 의사를 결정하는 것인지와 관련하여 성년후견제도에서 후견인의 동의대행과 비교하여 이해할 필요가 있다. 보건의료관련 법령은 환자의 자기결정권과 그 실현을 위한 동의대행의 문제에서 민법과 깊게 연관되어 있음에도 불구하고 개개 법률의 관련 규정은 민법의 동의에 관한 원칙이나 성년후견제도와 별개로 규정되어 있음을 확인할 수 있다. 보건의료관련법령의 일차적 목적이 환자의 자기결정권 실현에 있지 않다고 하더라도 의료관련 행정이 통일적으로 운영되기 위해서는 민법의 의사결정 및 그 대행에 관한 원칙을 이해할 필요가 있다.

• 한국임상수의학회지
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• 제35권4호
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• 대한예방한의학회지
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• 제18권1호
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• pp.23-41
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• 2014

Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.

• 대한기관윤리심의기구협의회지
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• 제1권2호
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 한국토양비료학회지
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• 제48권4호
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• pp.278-284
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• 2015

In general, plant roots accumulate more heavy metals than the above ground organs such as leaf, stem, and fruit. This implies that root medicinal plants would be an issue with excessive heavy metal accumulation. Therefore, the current study was carried out to investigate the distribution of heavy metal (focused on Cd and Pb) concentrations in soils and medicinal plant roots grown in different region of Korea. Total 293 samples for each soil and plant were collected along the national wide. Soil pH, total and phytoavailable metal concentrations (1 M $NH_4NO_3$ extracted) in soils were determined and heavy metal concentrations in root of the medicinal plants were analyzed. Heavy metal concentrations of the soil samples studied were not exceeded standard limits legislated in 'Soil Environmental Conservation Act', except 2 samples for Cu. However, substantial amount of Cd was accumulated in medicinal plant roots with 29% samples exceeding the standard limit legislated in 'Pharmaceutical Affairs Act' while all plant samples were lower than the standard limit value for Pb. Also the current study demonstrated that cadmium concentrations in the roots were governed by the phytoavailable Cd in soils, which decreased as soil pH increased. From this result, application of heavy metal immobilization technique using a pH change-induced immobilizing agents can be suggested for safer root medicinal plant production.

• 한국환경농학회지
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• 제34권4호
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• pp.282-287
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• 2015

BACKGROUND: The current study was carried out to investigate Cd, Hg, Pb and As contaminations in 222 commercial medicinal plants and to estimate the potential health risk through dietary intake of commercial medicinal plants in Korea.METHODS AND RESULTS: The Cd, Hg, Pb, and As in medicinal plants were analyzed by ICP/MS and mercury analyzer.The potential health risk was estimated using risk assessment tools. Total amount of Cd in medicinal plants with 29% samples exceeded the standard limit legislated in 'Pharmaceutical Affairs Act' while all plant samples were lower than the standard limit value for As, Hg, and Pb. However, when applying the standard limit for root vegetable (fresh weight) in the Food Sanitation Act, four samples exceeded the standard limit of Pb. For health risk assessment, the values of cancer risk probability were 0.3~5.9×10^-7which were less than the acceptable cancer risk of 10^-6~10^-4for regulatory purpose. Also, Hazard quotientvalues were lower than 1.0.CONCLUSION: Therefore, these results demonstrated that human exposure to Cd, Hg, Pb, and As through dietary intake of commercial medicinal plants might notcause adverse health effects although some medicinal plants were higher than the standard limit values for Cd and Pb.

• 대한임상독성학회지
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• 제16권1호
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• pp.42-48
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• 2018

Purpose: On November 15, 2012, sales of OTC (Over-The-Counter) drugs began at convenience stores, which changed the accessibility of some drugs. As a result, the exposure and access patterns of these drugs could have changed. In this study, we reviewed the changes in the characteristics of drug poisoning patients because of the reposition of nonprescription drugs according to the revised Pharmaceutical Affairs Act. Methods: A retrospective study was conducted to evaluate changes in characteristics of drug poisoning patients between 2008 and 2016. A registry was developed by an emergency medical center in a local tertiary teaching hospital, and patients who visited the center were enrolled in this registry. We compared two periods, from 2008 to 2012 (Pre OTC) and from 2013 to 2016 (Post OTC), for type of intoxicant, time from poisoning to visiting the emergency center, intention, psychiatric history, previous suicidal attempt, alcohol status, and emergency room outcomes. The primary outcome was the number of patients who took acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Secondary outcomes were ICU admission rate, mortality rate, and number of patients who visited the ER when the pharmacy was closed after taking acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Results: Among 1,564 patients, 945 and 619 patients visited the emergency room during pre and post OTC periods. The number of patients with acetaminophen and NSAIDs poisoning decreased from 9.2% to 6.1% (p=0.016). The ICU admission rate and mortality rate in the emergency room did not show significant results in the relevant patient groups, and so was the number of patients visiting ER when the pharmacy was closed taking acetaminophen and NSAIDs. Conclusion: Despite the sales of nonprescription drugs at convenience stores, the number of acetaminophen and NSAIDs poisoning patients decreased.