지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
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After the massive manipulation scandal(2006-2007) of bioequivalence data, a variety of opinions were presented. Some drug companies denunciated bioequivalence test very strong, and other physicians insisted on strengthening bioequivalence test before the introduction of alternative dispensing by pharmacists.
At first, Korean government responded to the manipulation scandal passively, until Seoul Administrative Court(Seoul Administrative Court decision 2007 Guhab 15131 Delivered on October. 5, 2007) decided to make the bioequivalence data within the government open. The Korean Supreme Court((Supreme Court Decision 2008 Du 8628 Delivered on November 13, 2008) decided, the manipulation of bioequivalence data and its false report is the cause of revocation of pharmaceutical approval, even though the pharmaceutical meets the bioequivalence criterion consequently. This decision has deep significance in Korean pharmaceutical and public health law, because bioequivalence criterion will be firmly established as an important criterion of drug approval by it.
Notwithstanding the importance of the Supreme Court's Decision, it is doubtful whether the cause of this decision is right. In my opinion, the Supreme Court should have applied special regulations about revocation of pharmaceutical approval, instead of applying general principle about the revocation of administrative act directly. The Supreme Court ignored special regulations of Korean pharmaceutical Act and its implementing ordinances, even though they regulated the revocation of pharmaceutical approval directly. By this way, The Supreme Court could have urged the government to reform seriously wrong special regulations about the sanction including revocation, and, our government, instead of revoking drug approval uniformly, will be able to differentiate the instruments of sanction following the classes of the violation of bioequivalence criteria.
At first, Korean government responded to the manipulation scandal passively, until Seoul Administrative Court(Seoul Administrative Court decision 2007 Guhab 15131 Delivered on October. 5, 2007) decided to make the bioequivalence data within the government open. The Korean Supreme Court((Supreme Court Decision 2008 Du 8628 Delivered on November 13, 2008) decided, the manipulation of bioequivalence data and its false report is the cause of revocation of pharmaceutical approval, even though the pharmaceutical meets the bioequivalence criterion consequently. This decision has deep significance in Korean pharmaceutical and public health law, because bioequivalence criterion will be firmly established as an important criterion of drug approval by it.
Notwithstanding the importance of the Supreme Court's Decision, it is doubtful whether the cause of this decision is right. In my opinion, the Supreme Court should have applied special regulations about revocation of pharmaceutical approval, instead of applying general principle about the revocation of administrative act directly. The Supreme Court ignored special regulations of Korean pharmaceutical Act and its implementing ordinances, even though they regulated the revocation of pharmaceutical approval directly. By this way, The Supreme Court could have urged the government to reform seriously wrong special regulations about the sanction including revocation, and, our government, instead of revoking drug approval uniformly, will be able to differentiate the instruments of sanction following the classes of the violation of bioequivalence criteria.
목차
Ⅰ. 의약품의 생물학적 동등성의 개념과 연혁
Ⅱ. 우리 의약법상 생동성기준의 등장과 시험절차
Ⅲ. 생동성자료의 조작과 제재조치의 선택
Ⅳ. 결어
참고문헌
〈Abstract〉
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UCI(KEPA) : I410-ECN-0101-2010-363-001995263