Comparison of the Expedited Programs for Innovative Drug Development and Approval among United States, European Union, and Republic of Korea-Reference-Cited by-同舟云学术

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

Published:2024-03-31 Issue:1 Volume:34 Page:39-61
ISSN:1226-6051
Container-title:Korean Journal of Clinical Pharmacy
language:en
Short-container-title:Korean J Clin Pharm

Author:

Park Jiyeon¹,Shin Hyewon¹,Lee Jangik. I.¹

Affiliation:

1. College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul 08826, Republic of Korea

Publisher

The Korean College of Clinical Pharmacy

Link

https://pdf.medrang.co.kr/KJCP/2024/034/KJCP034-01-04.pdf

Reference72 articles.

1. USA. 21 United States Code § 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions. Available from https://www.law.cornell.edu/uscode/text/21/356. Accessed March 22, 2024.

2. APEC Harmonization Center and Drug Approval System of the United States of America. 2016. Available from https://www.mfds.go.kr/brd/m_617/view.do?seq=32337&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=4. Accessed March 22, 2024.

3. EuroGCT. Expediting marketing authorisation pathways. Available from https://www.eurogct.org/research-pathways/commercialisation/market-access-atmps/expediting-marketing-authorisation-pathways. Accessed March 21, 2024.

4. European Medicines Agency. European Medicines Agency Guidance for applicants seeking access to PRIME scheme. Available from https://www.ema.europa.eu/system/files/documents/other/european_medicines_agency_guidance_for_applicants_seeking_access_to_prime_scheme_en_0.pdf. Accessed March 22, 2024.

5. Ministry of Food and Drug Safety. Uiyakpum sinsoksimsa bogoseo. 2022.9. Available from https://www.mfds.go.kr/brd/m_218/view.do?seq=33486&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1. Accessed March 22, 2024.