일반의약품 허가제도의 국가간 비교 및 발전 방향

다국어 초록 (Multilingual 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 far 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.

목차 (Table of Contents)

• 영문초록
• 연구방법
• 연구결과
• 고찰 및 결론
• 참고문헌

참고문헌 (Reference)

1 "일반용의약품의 승인신청구분과 첨부자료에 관한 질의응답집" 2003

2 "일반용의약품의 승인신청 관련" (0827003) : 2003

3 "의약품분류기준에관한규정" 보건복지부고시제2000-23호2000

4 "유효성심사에관한규정" 식품의약품안전청고시제2003-17호2003

5 전문-일반의약품 분류결과 발표, "보건복지부 보도자료" 31-,

6 "US FDA CDER Division of OTC Office of Drug EvaluationV Division of OTC" 2005

7 eu, "PHARMACEUTICALS IN THE EUROPEAN UNION" europeancommission20002005

8 "Notice to Applicants" me 2 - pharmaceutical legislation : 2005

9 How we regulate, "Licensing of Medicines" 2005

10 Pharmaceutical Administration, "Japan Pharmaceutical Manufacturers Association" 2005

11 Working Within the OTC Drug Monographs, "FDA-CHPASeminar" -2, 20032005

12 eu, "Directive 2001/83/EC of the European Parliament and ofthe Council of 6 November 2001 on the Communitycode relating to medicinal products for human use" 2005

13 MHRA Guidance Note 11, "Changing the legal classificationin the United Kingdom of a medicine for humanuse" 2005

14 "A draft guidance for industry for TEA applications"

15 21 CFR Section 314, "50 Content and format of an application"

16 "21 CFR Part 314 Applications for FDA approval to marketa new drug"

17 21 CFR Section 330, "14 Additional criteria and proceduresfor classifying OTC drugs as generally recognized as safeand effective and not misbranded"

18 21 CFR Section 330, "13 OTC-Conditions for marketingingredients recommended for over-the-counter"

19 21 CFR Section 330, "12 OTC-Status of OTC drugs previouslyreviewed under the Drug Efficacy Study"

20 21 CFR Section 330, "11 OTC-NDA deviations from applicablemonograph"

21 21 CFR Section 330, "10 OTC-Procedures for classifyingOTC drugs as generally recognized as safe and effective andnot misbranded and for establishing monographs" 2005

22 21 CFR Section 330, "1 OTC-General conditions for generalrecognition as safe" effective and (effective and):