본문 바로가기
KERD
논문KCI 등재

한국, 미국, 유럽의 혁신적 의약품 개발 및 허가제도 비교 연구

Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea

이장익|신혜원|박지연
한국임상약학회 (Korean College Of Clinical Pharmacy)|2024.03|한국임상약학회지 (Korean Journal of Clinical Pharmacy)|제34권 제1호|pp. 39-61|DOI 10.24304/kjcp.2024.34.1.39

2

조회

0

다운로드

0

인용

0

참고문헌

키워드

fast track: Accelerated approvalbreakthrough therapypriority review
주제분류약학

초록

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

Abstract

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA’s programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA’s regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

참고문헌 (72)

  1. "USA, 21 United States Code § 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions"[URL]
  2. "Drug Approval System of the United States of America" (2016)[URL]
  3. "Expediting marketing authorisation pathways"[URL]
  4. "European Medicines Agency Guidance for applicants seeking access to PRIME scheme" (2023)[URL]
  5. "Uiyakpum sinsoksimsa bogoseo" (2022)[URL]
  6. "Pharmaceutical Affairs Act (Act No. 19357) Article 35 (ConditionalPermission)" (2022)[URL]
  7. "Uiyakpum deungui anjeone gwanhan gyuching (chongniryeong No.1835) Article 40(2) (Pummong jogeonbu heoga sincheong deung)" (2023)[URL]
  8. "Sigyakcheo, jogeonbu heogawa useonsimsa sebu gyujeong deung maryeon" (2021)[URL]
  9. "Introduction to GIFT"[URL]
  10. Yangmee Shin, "Current Paradigm for Expedited Development of Drugs and Biologics: Breakthrough Therapy Designation", The Korean Society of Food, Drug and Cosmetic Regulatory Sciences, 10(2), pp.101~109 (2015)
  11. Sylvia Park, "Expedited Drug Development and Approval Programs of the US and EU: Trends and Key Issues", Yakhak Hoeji, 61(3), pp.147~157 (2017)
  12. "Fast Track"[URL]
  13. "Breakthrough Therapy"[URL]
  14. "USA, Title 21 Chapter 1 Subchapter D Part 312 Subpart I - Expanded Access to Investigational Drugs for Treatment Use § 312.300 General" (2009)[URL]
  15. "Priority Review"[URL]
  16. "Accelerated Approval"[URL]
  17. "Guidance for Industry, Expedited Programs for Serious Conditions-Drugs and Biologics"[URL]
  18. "Biopharmaceutical Approval ProceduresGuide" (2022)[URL]
  19. "Sinsoksimsagwa, haeoe juyogung sinsoksimsa saryejim (minwonin annaeseo)" (2021)[URL]
  20. "Uiyakpumui sinsoksimsa jeogyonggijune daehan gaideurain" (2021)[URL]
  21. "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry" (2019)[URL]
  22. "correspondence documents (for Sotorasib)"[URL]
  23. "Integrated Review (for Zokinvy) (Contract No.: 213969Orig1s000)" (2020)[URL]
  24. "Title 21 Chapter I Subchapter D Part 314 Subpart H - Accelerated Approval of New Drugs for Serious or Life - Threatening Illnesses" (2004)[URL]
  25. "Biogen, Ejai leqembi (lecanemab) FDA Gasokseungin" (2023)[URL]
  26. "Administrative and correspondence documents (for Lecanemab)" (2023)[URL]
  27. "PRIME: priority medicines"[URL]
  28. "Drug Approval System of European Medicines Agency (EMA)" (2020)[URL]
  29. "Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need - Scientific guideline"[URL]
  30. "Assessment report: Polivy" (2019)[URL]
  31. "List of medicines currently in PRIME scheme" (2023)[URL]
  32. "Acclerated assessment"[URL]
  33. "Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004"[URL]
  34. "Pre-authorisation guidance"[URL]
  35. "EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer" (2020)[URL]
  36. Fabiany da Costa Gonçalves, "A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU", Clinical and translational science, 15(8), pp.1959~1967 (2022)
  37. "Exceptional circumstances" (2023)[URL]
  38. "Marketing Authorisation under exceptional circumstances"[URL]
  39. "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use"[URL]
  40. "Strensiq"[URL]
  41. "Guideline on Procedures for the Granting of a Marketing Authorisation Under Exceptional Circumstances, Pursuant to Article 14 (8) of Regulation (EC) NO 726/2004" (2005)[URL]
  42. "Volume 2B Module 1.2: Administrative information Application form" (2021)[URL]
  43. "Module 1: Administrative information Application form User guide for the electronic application form for a Marketing Authorisation" (2023)[URL]
  44. "Regulation (EC) No 726/2004 of the European Parliament and of the Coundcil" (2004)[URL]
  45. "Conditional marketing authorisation" (2023)[URL]
  46. "Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004" (2016)[URL]
  47. "Decision No 1082/2013/EU of the European Parliament and of the Council" (2013)[URL]
  48. "Regulation (EC) No 141/2000 of the European Parliament and of the Council" (2000)[URL]
  49. "Commission Regulation (EC) No 507/2006" (2006)[URL]
  50. "Paxlovid" (2023)[URL]
  51. "COVID 19 Public Health Emergency of International Concern (PHEIC) Global research and innovation forum: towards a research roadmap" (2020)[URL]
  52. "Health technology assessment body" (2023)[URL]
  53. "Post-authorisation measures: questions and answers" (2023)[URL]
  54. "Act On The Safety of And Support For Advanced Regenerative Medicine And Advanced Biological Products (Act No. 17472)" (2023)[URL]
  55. "Cheomdanbaiouiyakpum anjeon min jiwone gwanhan gyuchik" (2020)[URL]
  56. "Drug Approval System of Korea" (2016)[URL]
  57. "Uiyakpumui pummokeogasingosimsa gyujeong, 2021-90" (2021)[URL]
  58. "Uiyakpum pummong jogeonbu heoga gwallijichim (minwonin annaeseo)" (2022)[URL]
  59. "Rare Disease Managemente Act (Act No. 16410)" (2020)[URL]
  60. "Uiryojepumui sinsoksimsa jijeongsincheong si goryeosahang (minwonin annaeseo)" (2021)[URL]
  61. "Uiryojepumui sinsoksimsa unyeong bangan" (2020)[URL]
  62. "Saengmulhakjeokjeje deungui pummokeogatpsimsa gyujeong, 2021-29" (2003)[URL]
  63. "Hanyak(saengyak)jeje deungui pummokeogatpsingoe gwanhan gyujeong, 2016-40" (2011)[URL]
  64. "FAST TRACK Designation Requestes Received" (2023)[URL]
  65. "CDER Breakthrough Therapy Designation Requests Received by Fiscal Year" (2023)[URL]
  66. "PRIME: Analysis of the first 5 years’ experience" (2022)[URL]
  67. "Avastin (bevacizumab) Information" (2018)[URL]
  68. "Withdrawn | Cancer Accelerated Approvals" (2023)[URL]
  69. "CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint As of September 30, 2023"[URL]
  70. "CBER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint As of December 31, 2022" (2022)[URL]
  71. "Table of all EPARs for human and veterinary medicines" (2023)[URL]
  72. "Human Medicines Highlights 2022"[URL]

관련 논문AI추천

Studies on the Comparison of the Expedited Programs for Regenerative Medicine Therapies among the United States, the European Union and the Republic of Korea고채은, 이장익한국임상약학회 · 한국임상약학회지2025 · 제35권 제1호환자의 신약 접근성 강화 정책 제안최유나, Lee Hyeong Ki한국임상약학회 · 한국임상약학회지2021 · 제31권 제1호항암면역세포치료제의 국제 규제 체계 비교 연구김종윤, 오경선, 이향미한국병원약사회 · 병원약사회지2024 · 제41권 제4호첨단치료 의약제품(ATMP)에 대한 규제체계 연구 : 유럽연합 및 미국의 규제체계 비교를 중심으로김수동, 김주희, 이창규한국의료법학회 · 한국의료법학회지2022 · 제30권 제1호다지역 임상시험의 계획 및 설계에 대한 국제 제도적 동향 분석김인화, 김재현, 손민지, 송윤경, 오정미, 전아영, 지은희한국임상약학회 · 한국임상약학회지2018 · 제28권 제2호비처방의약품 허가 제도의 국가별 비교 연구 및 고찰이정, 곽혜선, 이경은, 이관영, 김주희(Joo Hee Kim)한국임상약학회 · 한국임상약학회지2018 · 제28권 제4호

이 간행물의 다른 논문 (5건)

비만 치료에서 semaglutide의 효능 및 안전성에 대한 고찰박태은, 한승훈pp. 1-20대한민국 청소년의 주간 졸음증에 관련된 요인 분석한지민, 김기태, 곽혜선, 장은정, 김정선pp. 21-29장기처방약의 조제방식에 대한 일반인의 선호도 조사: 분할조제 관점에서이영미, 이은주, 김대진, 손현순pp. 30-38지역약국 약사의 처방중재 활동 평가정경혜, 구현지, 성종미, 정선영pp. 62-70The Impact of Drug Interactions with Tyrosine Kinase Inhibitors on Adverse Event Development based on the changes of drug concentration level: Meta-analysis이희영, 황진아pp. 71-78
원문 보기