• The Korean Society of Law and Medicine
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• v.24 no.3
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• pp.3-26
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• 2023

This paper reviewed the Pharmaceutical Affairs Act issues in case of self-administration of medicines by medical personnel without going through the general process (prescription, dispensing, distribution, administration). If a medical personnel self-medicates, the medicine supplier or medical personnel may be subject to criminal punishment under the Pharmaceutical Affairs Act. The core reprehensibility of the punishment lies in undermining the order in distribution of medicines stipulated in the Pharmaceutical Affairs Act. First, the sale of medicines by a medicine supplier to medical personnel may be the violation of Article 47 of the Pharmaceutical Affairs Act. However, if it was distributed for the case where medical personnels can dispense it directly under the Pharmaceutical Affairs Act, it can be justified under the general provision of the Criminal Act (justifiable act, the exclusion of illegality). If medicine suppliers distribute medicines knowing that the medical personnel acquires medicines for selfadministration, they can be punished as the violation of Article 47 of Pharmaceutical Act. Second, when a medical personnel acquires a medicine for the purpose of self-administration, the medicine supplier distributes the medicine under the false pretense that the medical personnel acquires the medicine for the case in which the medical personnel can directly dispense the medicine according to the Pharmaceutical Affairs Act. At this time, even if the medicine supplier has received all the payment for the medicines, the distribution of the medicines by deceit can constitute the fraud under the Criminal Act. Third, self-administration by medical personnel is a the violation of Article 23 of the Pharmaceutical Affairs Act. It is not a justifiable act under the general provision of the Criminal Act. This is because it is the abuse of the special status granted to medical personnel in the Pharmaceutical Affairs Act, which undermines the order in distribution of medicines.

• The Journal of Korean Medicine
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• v.35 no.3
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• pp.135-154
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• 2014

Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

• The Journal of Korean Medical History
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• v.26 no.2
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• pp.175-185
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• 2013

Purpose : The current Medical Law and the Pharmaceutical Affairs Act, which are incapable of utilizing the research results and the advanced academic, clinical, and pharmaceutical system of the present-day Korean (Oriental) medicine, have limitations and create a paradox by provoking social conflict among the professionals in the field. The aim of this study was to find out the legal and systematic problems that contributed to a complicated conflict amongst Korean (Oriental) medicine doctors, doctors, pharmacists, and Korean (Oriental) pharmacists regarding the classification of their functions. Methods : We reviewed the history and characteristics of the legislation regarding the duties of Korean (Oriental) medicine doctors and Korean (Oriental) pharmacists as well as the relevant and important public health policies since the enactment of the National Medical Services Law in 1951. We focused on the laws and regulations that are made in the process of the separating functions of physicians and pharmacists and the dispute between the Korean (Oriental) medicine doctors and the Korean (Oriental) pharmacists in the 1990s and 2000s. Results : The legislations and amendments of the medical and pharmaceutical laws and regulations that reflect the modern academic, clinical, and pharmaceutical system of the Korean (Oriental) medicine and the research results could be summarized as follows: 1) A partial amendment of the Medical Law in 1987, which added the provision of "Oriental health guidance" as one of the duties of Korean (Oriental) medicine doctors, assured a place for Korean (Oriental) medicine doctors in the field of public health. 2) A partial revision of Pharmaceutical Affairs Act in 1994 established a new system for Korean (Oriental) pharmacists, bringing about the creation of dualistic pharmaceutical system that complements the dualistic medical system. 3) The Promotion of the Research and Development of Wonder Drugs by Using Natural Substances Act was legislated in 2000 in order to stimulate research and development of Korean (Oriental) medicine and its industrialization. 4) Oriental Medicine Promotion Act in 2003 was enacted to lay foundation to specify and promote technology and industry that are related to Korean (Oriental) medicine. Discussions and conclusions : Although the dualistic medical and pharmaceutical system is set up by the Medical Law and Pharmaceutical Affairs Act, it is shown that the relevant regulations have been developed from a perspective of the western medicine.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.125-144
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• 2016

All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

• Herbal Formula Science
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• v.23 no.1
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• pp.1-14
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• 2015

Objectives : In Pharmaceutical Affairs Act, herbal medicinal preparations are defined as medicines made by Korean medicine principles. But in Act, Korean medicine principles are vague. Thus, there is a request to explain what the Korean medicine principles are. The aim of this study is to suggest implications of Korean medicine principles in definition of herbal medicinal preparations. Methods : With regard for definition of Korean medicine principles, we referred to the domestic and foreign regulations and literature about the history of herbal medicinal preparations. As a result, the meaning of Korean medicine principles was historically examined from various angles. Results : Through this study, we studied the Korean medicine principles from the past medical history. Due to the broad definition of Korean medicinal principles, we tried to extract general ideas of medicine principles first. We also found that we had scientific formulations based on korean medicine principles which could be used in modern society. In the end, we found that numerous medicine principles which include ‘Four qi and five flavors theory’, ‘Processing of medicinals’, ‘Yin and yang theory’, ‘Five phases theory’, ‘Meridian entry of viscera and bowels theory’, ‘Herb Couplet Interaction theory’, ‘Sovereign, minister, assistant and courier theory’, etc. Conclusions : Innumerable principles used from the past existed. These principles were broad and could be used as modern scientific principles. Based on these facts, we illustrated details of Korean medicine principles, hope this principles be widely shared and Korean herbal medicinal preparations be further developed.

• Journal of the Korean Society of Radiology
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• v.7 no.6
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• pp.397-402
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• 2013

This study suggests considerations for legislation of radiopharmaceutical manufacturing practice according as the Korea Pharmaceutical Affairs Act and guidelines on foreign radiopharmaceutical manufacturing practice. Pharmaceuticals should be verified safety, effectiveness, and uniformity. Therefore, it is expected that the efficiency of the administration of radiopharmaceuticals increase and nation's health promote if rational manufacturing management to consider of radiopharmaceutical properties is legislated.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.119-145
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• 2023

The Pharmaceutical Affairs Act stipulates medication counseling as an obligatory requirement in the case of preparation of medicine. In fact, there are many cases where pharmacists only tell patients the dose and time and do not properly guide them on taking medications. However, in light of the current situation where non-face-to-face treatment is being attempted, there is a high possibility of drug-taking accidents due to insufficient medication guidance. In addition, as an aging society progresses, the need for explanations on pharmaceuticals is increasing. If a pharmacist causes damage to a patient by failing to give appropriate medication guidance, the patient can claim compensation for damages. In addition, if a drug accident occurs due to a conflict between the pharmacist's duty to guide medication and the doctor's duty to explain, a joint tort is established between the pharmacist and the doctor. Nevertheless, there are cases in which only doctors are judged to bear the tort liability. However, the Pharmaceutical Affairs Act includes providing information for the selection of over-the-counter drugs in the medication guidance as part of the medication guidance obligation. Therefore, in order to reconsider the importance of the medication-taking guidance duty, it is necessary to define the medicationaking information provision method and the medication-taking guidance duty as separate concepts. In addition, it is necessary to amend related regulations centered on patients so that medication guidance, such as side effects of medicines and interactions with concomitant medications, can be made in detail.

• The Journal of Korean Medical History
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• v.28 no.1
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• pp.81-92
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• 2015

Objectives : The purpose of this study is to analyze and identify the problems of current laws and regulations regarding preparation and processing of herbal medicines at hospitals of Korean Medicine. Possible solutions are proposed in the end Methods : Based on the status of hospitals of Korean Medicine and characteristics of Korean Medicine and Korean Medicine industry, I analyze the laws and regulations in regards to preparation and processing of herbal medicines and propose possible solutions. Results : Regulations for the agents, places, and cautions in respect of preparation and processing of herbal medicines are inadequate. Meanwhile, the definition of drug preparation in the Pharmaceutical Affairs Act does not apply to processing and preparation of herbal Medicines at hospitals of Korean Medicine, since herbal medicines accompanies chemical and physical change. Discussions & Conclusions : New regulations for on-site preparation at hospitals of Korean Medicine are necessary. Also, the definition for herbal medicines preparation, which states possible chemical and physical changes of herbal medicines, should be specified in Pharmaceutical Affairs Act.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.61-74
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• 2015

Objectives: The main purpose of this study is to find a solution for modernized classification of herbal medicinal preparations in dual medical systems. Through this study, we expect to provide a reasonable foundation of herbal medicine for public health. Methods: We studied legal or technical terms of herbal medicinal preparations from the past regulations, and through this procedure, we could suggest clear definitions of terms for herbal medicinal preparations. We also investigated documents for approval of herbal medicinal preparation from US, EU(European union), The People's Republic of China, Japan, so that we can refer to them to revise regulation for appropriate use of herbal preparations. Results: In Korea pharmaceutical affairs act, any basis of 'Crude drugs' does not exist. But in some subordinary notifications, the way that they use the 'Natural product medicine' is used as a means of limiting basic rights of doctor or pharmacist of Korean medicine compared to doctor or pharmacist. At the same time, in subordinary notifications, provisions are vague and not enough for scientific evidence of Korean medicine. Thus, we re-categorized herbal medicinal preparations into new drugs, drugs made from herbal medicinal preparations and suggested requirements for drug approval. Conclusions: Instead of using the term 'Crude drug preparations', and we should use term 'Herbal medicinal preparations' in related act and notification. And also we suggest to amend subordinary regulations and documents for approval of herbal medicinal preparations. Through this, we can make herbal medicinal preparations be more industrialized.

• The Journal of Korean Medical History
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• v.26 no.2
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• pp.9-21
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• 2013

Purpose : The purpose of this study was to analyze the history and characteristics of laws and regulations of the medical and pharmaceutical system in Korea-focusing on the Korean (Oriental) medical and pharmaceutical system-from the modern period to the early days of the Republic. We reviewed how traditional notions and categories of Oriental medicine, which were regarded as experiential and conventional, became part of the current dualistic medical and pharmaceutical system, and examined problems and effects during the course of positioning. Methods : We classified the development of the medical and pharmaceutical laws and regulations chronologically, from the Korean Empire to the beginning of the Republic. The abolishment of the traditional medical system that was based on laws and regulations of the Joseon Dynasty, the implementation of dualistic medical system in the Korean Empire, the attempt to demolish Korean (Oriental) medicine under the Japanese colonial rule, and the process of developing a statute-based continental law system were thoroughly reviewed. Results : Although the dualistic medical system was specified in legislation via the enactment of the National Medical Services Law in 1951, we found that it was actually enacted in 1963, when the laws and systems regarding the educational institution of Korean (Oriental) medicine were stably established. Moreover, the dualistic pharmaceutical system was specified in legislation through the partial amendment of the Pharmaceutical Affairs Act in 1994, but we concluded that the actual enactment was rather in 2000, when the first Korean (Oriental) pharmacist was produced. Discussions and conclusions : An effort to establish a dualistic medical system of Korean (Oriental) medicine and Western medicine during the Korean Empire bore fruit a few decades later, after the Republic of Korea was founded. It means the basis for the legal system finally took shape in spite of the numerous attempts during the Japanese colonial era and the beginning of the Republic to abolish Korean (Oriental) medical and pharmaceutical system.