일반의약품 허가제도의 국가간 비교 및 발전 방향
OTC Drug Regulatory System of Korea Comparing to Other Countries
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Abstract
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 for 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.
참고문헌 (22)
- 전문-일반의약품 분류결과 발표, "보건복지부 보도자료", pp.31~
- "의약품분류기준에관한규정"
- "유효성심사에관한규정"
- Pharmaceutical Administration, "Japan Pharmaceutical Manufacturers Association" (2005)
- "일반용의약품의 승인신청 관련", (0827003) (2003)
- "일반용의약품의 승인신청구분과 첨부자료에 관한 질의응답집" (2003)
- eu, "PHARMACEUTICALS IN THE EUROPEAN UNION"
- MHRA Guidance Note 11, "Changing the legal classificationin the United Kingdom of a medicine for humanuse" (2005)
- How we regulate, "Licensing of Medicines" (2005)
- eu, "Directive 2001", 83, pp.2005[DOI]
- "Notice to Applicants", me 2 - pharmaceutical legislation (2005)
- 21 CFR Section 330, "1 OTC-General conditions for generalrecognition as safe", effective and(t misbranded)
- Working Within the OTC Drug Monographs, "FDA-CHPASeminar", pp.~2
- 21 CFR Section 330, "12 OTC-Status of OTC drugs previouslyreviewed under the Drug Efficacy Study"
- "US FDA CDER Division of OTC Office of Drug EvaluationV Division of OTC" (2005)
- 21 CFR Section 330, "13 OTC-Conditions for marketingingredients recommended for over-the-counter"
- 21 CFR Section 330, "10 OTC-Procedures for classifyingOTC drugs as generally recognized as safe and effective andnot misbranded and for establishing monographs" (2005)
- "21 CFR Part 314 Applications for FDA approval to marketa new drug"
- 21 CFR Section 330, "14 Additional criteria and proceduresfor classifying OTC drugs as generally recognized as safeand effective and not misbranded"
- "A draft guidance for industry for TEA applications"
- 21 CFR Section 330, "11 OTC-NDA deviations from applicablemonograph"
- 21 CFR Section 314, "50 Content and format of an application"