Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 May;13(3):451-461.
doi: 10.1111/cts.12745. Epub 2020 Feb 6.

Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways

Erica M Cox  1 , Anita V Edmund  2 , Erica Kratz  1 , Sarah H Lockwood  1 , Aishwarya Shankar  1
Affiliations

Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways

Erica M Cox et al. Clin Transl Sci. 2020 May.

Abstract

Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many years. Once an applicant has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorization application. Review by regulatory authorities to evaluate whether the data support a positive benefit/risk profile takes many months, adding additional time before patients may access therapy. In this paper, we discuss the various opportunities the US Food and Drug Administration and the European Medicines Agency offer to expedite the drug development and regulatory approval timelines for drugs intended to treat serious diseases and unmet medical needs.

PubMed Disclaimer

Conflict of interest statement

The authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
US Food and Drug Administration (FDA) and European Medicines Agency (EMA) expedited programs. Note: Drugs may qualify for more than one expedited program. For US programs, drugs may be eligible for all of these programs, provided they meet the criteria. For EU programs, medicines may be eligible for most of these programs, if criteria are met. The only exception is that drugs pursuing approval under exceptional circumstances are not eligible for conditional approval.1, 2, 3 HA, Health Authority; PRIME, PRIority MEdicines.
See this image and copyright information in PMC

References

    1. US Food and Drug Administration (FDA) . Code of Federal Regulations Title 21 (21 CFR). Part 601, Subpart A–General Provisions and Subpart E–Accelerated approval of biological products for serious or life‐threatening illnesses and Part 314, Subpart B–Applications and Subpart H–Accelerated approval of new drugs for serious or life‐threatening illnesses. <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm> (2018). Accessed June 25, 2019.
    1. US Food and Drug Administration (FDA) . Guidance for industry. Expedited programs for serious conditions – drugs and biologics. <https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious...> (2014). Accessed June 25, 2019.
    1. European Medicines Agency (EMA) . 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. <https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-sc...> (2016). Accessed June 25, 2019.
    1. US Food and Drug Administration (FDA) . Fast track. <https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated...> (2018). Accessed September 30, 2019.
    1. US Food and Drug Administration (FDA) . Frequently asked questions: breakthrough therapies. <https://www.fda.gov/regulatory-information/food-and-drug-administration-...> (2019). Accessed September 30, 2019.

MeSH terms

LinkOut - more resources