표제지
목차
1. 파푸아뉴기니 의약품허가제도 2
약어 3
목차 4
I. 의약품 규제기관 5
1. 국립보건부 5
1.1. 홈페이지 5
II. 관련 법령 6
III. 의약품의 분류 7
1) 의약품(Pharmaceutical product) 7
2) 생물의약품(Biologicals) 7
3) 방사성의약품(Radiopharmaceuticals) 7
4) 멀티소스의약품(Multi-source products) 7
5) 입증된 의약품(Well-established medicines) 8
IV. 의약품 허가제도 9
1. 임상시험계획 승인신청 9
1.1. 임상시험 증명서 요건 9
1.2. 임상시험 증명서 발행 10
2. 신약 허가신청 11
2.2. 의약품 등록대상 12
2.3. 신청유형 14
2.4. 제출 15
2.5. 규제자문시스템 17
2.6. 제출서류 17
3. 제네릭의약품 허가신청 17
4. 희귀의약품 17
5. 우선심사 18
6. 약물감시 18
6.1. 시판 후 안전성 자료 18
6.2. 정기심사 19
V. 기타 허가사항 20
1. 의약품 제조 및 품질관리기준 20
1.1. 안정성 자료 20
2. 원료의약품등록 20
3. 표시기재사항 및 첨부문서 21
4. 의약품제조판매증명서 21
5. 수입허가 21
5.1. 의약품 수입허가신청 21
5.2. 허가권자 조건 21
6. 수수료 22
VI. 참고문헌 23
부록 24
부록 1. 의약품 신청요건 체크리스트(임시단계 1) 24
부록 2. 의약품 신청요건 체크리스트(임시단계 2) 27
부록 3. 의약품 신청요건 체크리스트(전체 품목허가) 30
부록 4. 의약품 신청요건 체크리스트(허가 후 변경/변경 등록) 33
부록 5. 의약품 용기 표시기재사항에 대한 정보 최소요건 36
2. Drug Approval System of Papua New Guinea 38
Abbreviation 40
Contents 42
I. Drug Regulatory Agency 43
1. National Department of Health 43
1.1. Website 43
II. Related Laws and Regulations 44
III. Classification of Pharmaceutical Product 45
1) Pharmaceutical product 45
2) Biologicals 45
3) Radiopharmaceuticals 45
4) Multi-source products 45
5) Well-established medicines 46
IV. Drug Approval System 47
1. Investigational new drug application 47
1.1. Requirements for clinical trial certificate 47
1.2. Issuance of clinical trial certificate 49
2. New drug application approval 50
2.2. Subjects for drug registration 51
2.3. Types of application 53
2.4. Submission 55
2.5. Regulatory consultation system 57
2.6. Required dossiers 57
3. Generic drug approval application 58
4. Orphan drugs 58
5. Priority review 58
6. Pharmacovigilance 59
6.1. Post marketing safety data 59
6.2. Periodic review 59
V. Others 60
1. Good Manufacturing Practice 60
1.1. Stability data 60
2. Drug Master File 61
3. Labelling and package inserts 61
4. Certificate of Pharmaceutical Product 61
5. Import license 61
5.1. Application for license to import medicinal products 61
5.2. Condition for license holder 62
6. Fees 63
VI. References 64
Appendix 65
Appendix 1. Checklist of Requirements for Provisional Medicine Registration Application - Phase I 65
Appendix 2. Checklist of Requirements for Provisional Medicine Registration Application - Phase II 68
Appendix 3. Checklist of Requirements for Full Marketing Authorization Application 71
Appendix 4. Checklist of Requirements Post-Approval Change/Variation Registration Application 74
Appendix 5. Minimal Requirements for Information on the Medicine Container Labelling 77
판권기 78