Expediting Patients’ Access to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval Process
Abstract
Ideally, well-designed global pharmaceutical development programs that include simultaneous submissions to multiple regulatory agencies can result in predictable regulatory approvals and expedited access to medicines for all patients. The workshops described herein investigated current trends in development and submission strategies along with regulatory review performance data in order to consider whether barriers to predictable expedited approval outcomes can be overcome through innovative clinical development approaches and a better understanding of review processes and procedures, particularly as these relate to the assessment of a product's risk-benefit profile.
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Access and affordability to medicines for all patients can be facilitated by global pharmaceutical development programs.
“Ideally, access and affordability to medicines for all patients can be facilitated by global pharmaceutical development programs (1).”
From BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements (2016) · cites this paper as [1]
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References 3 · Cited by 20
- Authors
- Liberti, L., Breckenridge, A., Eichler, H. G., Peterson, R., McAuslane, N., & Walker, S.
- Affiliations
- Centre for Innovation in Regulatory Science (GB)
- Medicines and Healthcare products Regulatory Agency (GB)
- European Medicines Agency (NL)
- University of British Columbia (CA)
- Corresponding author
- Liberti, L
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2010-01
- Volume
- 87
- Issue
- 1
- Pages
- 27-31
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W2089453005
- Cited by
- 20
- References
- 3
- Citations by year
- 2024: 1 · 2023: 1 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 1 · 2017: 2 · 2016: 2 · 2015: 2 · 2014: 1 · 2013: 2 · 2012: 3
- FWCI
- 2.98
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- regulatory approval process, risk-benefit assessment, clinical development strategy
- MeSH terms
- District of Columbia, Drug Industry, Pharmaceutical Preparations, United Kingdom, Health Services Accessibility, Humans, Predictive Value of Tests, Technology, Pharmaceutical, Drug Approval
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