Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Link
https://link.springer.com/content/pdf/10.1007/s43441-023-00600-7.pdf
Reference15 articles.
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2. IFPMA. Policy briefing: Regulatory agilities applied to regulatory processes-Processes for submission, review and approval of applications for marketing authorization and post-approval changes 2022 https://ifpma.org/publications/regulatory-agilities-and-regulatory-processes/
3. Andersson F. The drug lag issue: the debate seen from an international perspective. Int J Health Serv. 1992;22(1):53–72.
4. Cho I, Han E. Drug lag and associated factors for approved drugs in Korea compared with the United States. Int J Environ Res Public Health. 2022;19(5):2857. https://doi.org/10.3390/ijerph19052857.
5. Wileman H, Mishra A. Drug lag and key regulatory barriers in the emerging markets. Perspect Clin Res. 2010;1(2):51–6.
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