• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.59-88
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• 2021

The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• 동물약계
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• no.111
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• pp.3-4
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• 2007

동물야사감시 행정처분 결과 홍보/협회 창립기념 축령산 등반/소독제 사용방법 개선시험 협의회 개최/수입백신 특별소위원회 개최/소독제 품목허가 변경 협의회 개최/동물약품 마케팅 교육 실시/2008년도 방역지정업체 선정 신청/동물의약품 부가가치세 영세율 추진/2008 세계양식학회 및 국제양식박람회 안내/2006 세계 동물약품 시장 규모

• The Korean Chronic Disease News
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• no.310
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• pp.1-18
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• 2006

강원도 인제군 보건소 권장원 소장/‘만성질환관리사업지원단’설치.운영/경기도립노인전문병원 2008년 건립/전통 한의약 세계적 브랜드로 육성/인터넷 이용 결핵환자 원격판독/“간호조무사 대체 법적 근거 마련”/건보-자보 일원화 추진 논란/“아시아 당뇨 대란 심각하다”/2010년 세계뇌졸중학회 서울 유치/“성분명처방, 시간 필요하다”/생동성 관련 품목허가취소 가처분 수용/KGMP“ 의약품 품목별로 평가한다”/식약청, 11번째 국산 신약 시판 허가/내년부터 의약품 설명서 알기 쉽게 교체/군부대장병 금연환경조성을 위한 이동금연클리닉 사업/외래환자 1위는‘서울아산병원’/‘대한네트워크병의원협회’발족/뇌혈관질환 50대 이후 사망원인 1위 차지/건강한 생활습관이 심혈관질환 예방의 첩경/

• 동물약계
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• no.5
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• pp.3-3
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• 1993

1. 제조업 허가사항 변경 2. 국가검정 동물용의약품 국가검정 면제 3. KGMP 추진현황조사(93. 9. 2.) 4. 설명회 개최안내(93. 9. 8) 5. 의정활동 자료협조(93. 9. 16.) 6. 국가검정 동물의약품 관리 철저 요청(93. 9. 17.) 7. $\ulcorner$산업 및 품목분류표$\lrcorner$ 개선의견 제출(93. 9. 16.) 8. 생물학적제제 특별 관리 방안 중간 추진현황

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.3
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• pp.137-146
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• 2020

Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

• The Korean Journal of Applied Statistics
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• v.15 no.2
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• pp.281-296
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• 2002

On the new medical system separating the prescription and dispensing of the drug, the qualification of pharmacist in substitution of prescribed medicine was restricted, except bioequivalence-certified drugs. Also, Korean Food and Drug Association(KFDA) revised the bioequivalence regulation on August, 2001 Among many changes from old guideline, impressive one is the statistical consideration. Specially, to estimate and analyze bioequivalence measures, AUC and $C_{max}$, the log-transformed model is recommended and the equivalence interval is modified from $\pm$20 rule to [In(0.8),In(1.25)] one. This meaningful act is very hope-for because it is statistically reasonable and is agreed with worldwide bioequivalence guideline, including USA, EU, Japan and Canada. In this paper, we introduce the new regulation of assessing bioequivalence, announced at August, 2001, mainly on statistical view points. Key points for the new regulation are discussed and the minimum sample size based on simulation studies are proposed.

• Journal of the Korean Society of Food Science and Nutrition
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• v.33 no.8
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• pp.1407-1413
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• 2004

This study was performed to investigate the usage and management of flavorings inside or outside (Europe, Japan, JECFA and USA) for that establish a legislation about the flavoring management in Korea. Also, this study contributed to prevent confusion when manufacturers produce flavorings used in food industry. 6,434 among 8,386 flavorings authorized by Korea Food and Drug administration are compound flavorings, and 618 among 6,434 compound flavorings are synthetic flavorings. Many other substances except for flavorings are using as solvent in flavoring manufacture. Flavorings used in food industries of Korea are listed at least one among FEMA, JECFA, CoE and JFFMA except for isooctyl acetate and tricyclene. 493 items out of total 618 synthetic flavorings have completed safety evaluation by JECFA. 106 synthetic flavorings out of the rest listed FEMA as GRAS and 20 synthetic flavorings used in Japan. The replier answered that the most frequently used flavorings are strawberry, grape, orange, plum, lemon and vanilla flavor and that the usage of flavoring added to foodstuffs is less than 0.5%.

• Journal of the Korea Institute of Military Science and Technology
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• v.19 no.1
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• pp.119-126
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• 2016

The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.

• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.