A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia-Reference-Cited by-同舟云学术

A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia

Published:2023-06-27 Issue:5 Volume:37 Page:385-394
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Yoffe Alina,Liu Johnson,Smith Greg,Chisholm Orin^ORCID

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s40290-023-00483-x.pdf

Reference21 articles.

1. Han FV, Weiss K. Regulatory trends in drug development in Asia Pacific. Ther Innov Regul Sci. 2019;53(4):497–501. https://doi.org/10.1177/2168479018791539.

2. Lezotre J-P. International cooperation, convergence and harmonization of pharmaceutical regulations. Amsterdam: Academic Press; 2014.

3. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Global Health; Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines. In: Cuff P, Wood AJ. editors. Regulating medicines in a globalized world: the need for increased reliance among regulators. Washington (DC): National Academies Press; 2019.

4. Australian Government Department of Health. Expert review of medicines and medical devices regulation; 2017. https://web.archive.org/web/20180316090008/https://www1.health.gov.au/internet/main/publishing.nsf/content/expert-review-of-medicines-and-medical-devices-regulation. Accessed 9 Mar 2023.

5. Yoffe A, Liu J, Smith G, Chisholm O. Regulatory reform outcomes and accelerated regulatory pathways for new prescription medicines in Australia Ther. Innov Regul Sci. 2022. https://doi.org/10.1007/s43441-022-00465-2.