Regulatory framework for fast track approval of Drugs in different countries
Abstract
This review aims to analyze and compare the regulatory frameworks for fast-track drug approval in various countries, focusing on the US, Europe, Japan, and Australia. The study highlights the significance of expedited drug approval pathways in addressing unmet medical needs while ensuring safety and efficacy. A detailed evaluation of the standard approval pathways is performed to provide context, followed by a comparative analysis of fast-track mechanisms. Challenges associated with these programs are also explored. The study identifies similarities & differences in expedited drug approval pathways across countries, highlighting unique features of the Fast Track Designation in the U.S., PRIME in Europe, Sakigake in Japan, and Priority Review in Australia. Despite their effectiveness in accelerating drug availability, challenges such as balancing speed with rigorous evaluation, regulatory inconsistencies, and resource allocation are evident. Expedited approval programs significantly impact public health by improving access to innovative therapies. However, harmonizing regulatory processes and addressing associated challenges are crucial for optimizing their implementation globally.
Keywords:
Regulatory Affairs, Fast track designation, Priority Medicines(PRIME) Designation, FDA, CDER, CBER, NDA, Priority review
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References
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https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm484294.htm
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http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM430299.pdf
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41. Tang Y, Zhang YC, Chen Y, Xiang Y. Efficacy and safety of cangrelor for patients with coronary artery disease: a meta-analysis of four randomized trials. Int J Clin Exp Med. 2015;8(1):800–8.
42. Serebruany VL, Aradi D, Kim MH, Sibbing D. Cangrelor infusion is associated with an increased risk for bleeding: Meta-analysis of randomized trials. Int J Cardiol. 2013;169:225-8.
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https://pmc.ncbi.nlm.nih.gov/articles/PMC3113981/10.1186/1745-6215-12-106.
45. Davis C. Drugs, cancer and end-of-life care: a case study of pharmaceuticalization? Soc Sci Med [Internet]. 2015 Apr [cited 2014 Dec 2];131:207–14. Available from: https://pubmed.ncbi.nlm.nih.gov/25533871/
doi: 10.1016/j.socscimed.2014.12.007.
46. Gainor JF, Chabner BA. Ponatinib: Accelerated disapproval. Oncologist [Internet]. 2015 Aug [cited on 2015 Jul 14];20(8):847–8. Available from:
https://pubmed.ncbi.nlm.nih.gov/26173838/
2. P GM, Maanvizhi S. Fast track USA regulatory approval for drugs to treat emerging infectious diseases. Asian J Pharm Clin Res. 2021;14(7):1–4.
3. U.S. Food and Drug Administration. The Drug Development Process [Internet]. Silver Spring (MD): USFDA; 2018 Jan 04 [cited 2024 Oct 17]. Available from:
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
4. Arjun S, Venkatesh M, Balamuralidhara V, Kumar TP. Expedited programs for drug development and approval in the USA. Res J Pharm Technol. 2020;13:1409-14.
5. Reichert J, Rochon S, Zhang B. A decade of the fast track programme. Nat Rev Drug Discov. 2008;7:885-6.
6. Pawar A, Patil H, Desale MS. Drug regulatory affairs: an insight on regulatory authorities of various countries. Int J Pharm Sci Res. 2023;12(13):121-61.
7. CDRH, FDA. Regulatory pathways for medical devices and drugs [Internet]. Silver Spring (MD): Center for Devices and Radiological Health, U.S. FDA; 2020[cited 2024 Oct 17] Available from: https://www.fda.gov
8. U.S. Food and Drug Administration. Guidance, compliance, and regulatory information [Internet]. USFDA;2023 Aug 21 [cited 2024 Oct 17]. Available from:https://www.fda.gov/drugs/guidance-compliance-regulatory-information
9. U.S. Food and Drug Administration. Accelerated approval [Internet]. USFDA; 2023 Feb 24[cited 2024 Oct 20]. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
10. Warreth S, Harris E. The regulatory landscape for ATMPs in the EU and US: a comparison. Level 3. 2020;15(2):5.
11. Shoemaker D, Barber K, Kingon GA. Accelerating regulatory product development and approval for drugs and biologics in the U.S. [Internet]. Durham (NC): Rho; 2020 [cited 2024 Oct 20]. Available from:
https://www.rhoworld.com/wp-content/uploads/Rho_AcceleratingRegulatoryApprovals_WEB.pdf.
12. Michaeli DT, Michaeli T, Albers S, Boch T, Michaeli JC. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. Eur J Health Econ. 2024 Aug;25(6):979–97
13. European Medicines Agency. Exceptional circumstances [Internet]. Amsterdam (NL): EMA [cited 2024 Oct 25]. Available from: https://www.ema.europa.eu/en/glossary-terms/exceptional-circumstances
14. European Medicines Agency. Accelerated assessment [Internet]. Amsterdam (NL): EMA; [cited 2024 Oct 25]. Available from:
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessmen
15. European Medicines Agency. Conditional marketing authorisation [Internet]. Amsterdam (NL): EMA [cited 2024 Oct 25]. Available from:
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation
16. European Medicines Agency. Priority Medicines (PRIME) [Internet]. Amsterdam (NL): EMA [cited 2024 Oct 25]. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
17. Pharmaceuticals and Medical Devices Agency. Regulatory measures to promote fast patient access in Japan. [Internet]. Tokyo (JP): PMDA;2023 Feb 1[cited 2024 Nov 2]. Available from:
https://www.pmda.go.jp/files/000250259.pdf
18. Pharmaceuticals and Medical Devices Agency. Reviews [Internet]. Tokyo (JP): PMDA; [date unknown] [cited 2024 Nov 2]. Available from:
https://www.pmda.go.jp/english/review-services/reviews/advanced-efforts/0001.html
19. Schneider ME. Convergence: understanding expedited approval pathways in Japan [Internet]. RAPS; 2022 Sep [cited 2024 Nov 2]. Available from:
https://www.raps.org/news-and-articles/news-articles/2022/9/convergence-understanding-expedited-approval-pathw
20. Therapeutic Goods Administration. Fast track approval pathways. Canberra (AU): Australian Government Department of Health and Aged Care [Internet]. 2022 Sep[cited 2024 Nov 2. Available from:
https://www.tga.gov.au/fast-track-approval-pathways
21. Therapeutic Goods Administration. Provisional approval pathway: prescription medicines [Internet]. Canberra (AU): TGA; 2023 Mar 16[cited 2024 Nov 2]. Available from:https://www.tga.gov.au/provisional-approval-pathway-prescription-medicines
22. Bootes A, Maundu J, Golding S, McDonald M, Lombard J. Fast-track pathways for drug approvals: the Australian experience so far. Aust Prescr. 2019 Aug;42(4):118.
23. Michaeli DT, Michaeli T, Albers S, Boch T, Michaeli JC. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy. Eur J Health Econ. 2024 Aug;25(6):979–97.
24. U.S. Food and Drug Administration. Fast track [Internet]. Silver Spring (MD): FDA; 2024 Aug 13[cited 2024 Nov 20]. Available from:
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
25. U.S. Department of Health and Human Services. Fast track drug development programs-designation, development, and application review [Internet]. Silver Spring (MD): U.S. FDA; 2006 [cited 2024 Nov 20]. Available from:
https://www.fda.gov/media/72208/download
26. Friends of Cancer Research. FDA expedited review programs [Internet]. Washington (DC): Friends of Cancer Research; 2020 [cited 2024 Nov 20]. Available from:
https://www.friendsofcancerresearch.org/fda-expedited-review-programs
27. Barham L. How fast are the FDA fast lanes? Pharm Exec. [Internet]. 2018 Oct 10[cited 2024 Dec 5]. Available from: https://www.pharmexec.com/view/how-fast-are-fda-fast-lanes
28. U.S. Food and Drug Administration. Expedited programs for serious conditions-drugs and biologics [Internet]. Silver Spring (MD): U.S. FDA; 2014 [cited 2024 Dec 5]. Available from:
https://www.fda.gov/files/drugs/published/expedited-programs-for-serious-conditions-drugs-and-biologics.pdf
29. U.S. Food and Drug Administration. SOPP 8414: Fast track drug development programs: designation and review programs [Internet]. Silver Spring (MD): U.S. FDA; 2001 [cited 2024 Dec 5]. Available from:
https://www.fda.gov/media/108986/download
30. Abbott Laboratories. Ritonavir (Norvir) approval for HIV treatment [Internet].Silver Spring (MD): U.S. FDA; 1999 Jun 29[cited 2024 Dec 5]. Available from:
https://www.fda.gov
31. Ghosh A, De Jesus E. Ritonavir and the history of HIV treatment. J Clin Pharmacol. 2005;45(2):185–92.
32. CDER fast track designation requests received [Internet]. Silver Spring (MD): U.S. FDA; 2020 [cited 2025 Jan 10]. Available from:
https://www.fda.gov/media/97830/download
33. CY 2024 CDER fast track calendar year approvals [Internet]. Silver Spring (MD): USFDA; 2024 Dec 31[cited 2025 Jan 10]. Available from:
https://www.fda.gov/media/159901/download?attachment
34. Chary KV. Expedited drug review process: Fast, but flawed. J Pharmacol Pharmacother. 2016 Apr-Jun;7(2):57-61. doi: 10.4103/0976-500X.184768.
35. Chary KV, Pandian K. Accelerated approval of drugs: ethics versus efficacy. Indian J Med Ethics. 2017 Oct-Dec;2(4):244-247. doi: 10.20529/IJME.2017.062.
36. U.S. Food and Drug Administration. Recalls, market withdrawals, and safety alerts [Internet]. Silver Spring (MD): U.S. FDA; [cited 2025 Jan 10]. Available from:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
37. U.S. Food and Drug Administration. Potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System (FAERS) between July – September 2015 [Internet]. Silver Spring (MD): USFDA; 2015 [cited 2025 Jan 10]. Available from:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm484294.htm
38. U.S. Food and Drug Administration. The novel new drugs of 2014 [Internet]. Silver Spring (MD): USFDA; 2014 Dec 17[cited 2025 Jan 10]. Available from:
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM430299.pdf
39. Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol. 2005 May;105(5 Pt 1):1114-8.
40. U.S. Food and Drug Administration. FDA drug safety communication: new risk factor for progressive multifocal leukoencephalopathy (PML) associated with Tysabri (natalizumab) [Internet] Silver Spring (MD): USFDA; 2012 Jan 20 [cited 2025 Jan 11]. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm
41. Tang Y, Zhang YC, Chen Y, Xiang Y. Efficacy and safety of cangrelor for patients with coronary artery disease: a meta-analysis of four randomized trials. Int J Clin Exp Med. 2015;8(1):800–8.
42. Serebruany VL, Aradi D, Kim MH, Sibbing D. Cangrelor infusion is associated with an increased risk for bleeding: Meta-analysis of randomized trials. Int J Cardiol. 2013;169:225-8.
43. Hahn S. Understanding non-inferiority trials. Korean J Pediatr. 2012 Nov;55(11):403
44. Schumi J, Wittes JT. Through the looking glass: understanding non-inferiority. Trials [Internet]. 2011 Dec [cited on 2011 May 3];12:106. Available from:
https://pmc.ncbi.nlm.nih.gov/articles/PMC3113981/10.1186/1745-6215-12-106.
45. Davis C. Drugs, cancer and end-of-life care: a case study of pharmaceuticalization? Soc Sci Med [Internet]. 2015 Apr [cited 2014 Dec 2];131:207–14. Available from: https://pubmed.ncbi.nlm.nih.gov/25533871/
doi: 10.1016/j.socscimed.2014.12.007.
46. Gainor JF, Chabner BA. Ponatinib: Accelerated disapproval. Oncologist [Internet]. 2015 Aug [cited on 2015 Jul 14];20(8):847–8. Available from:
https://pubmed.ncbi.nlm.nih.gov/26173838/
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Pachika V, Gilla MR, Gopu VS. Regulatory framework for fast track approval of Drugs in different countries. Int J Drug Reg Affairs [Internet]. 2025Jun.15 [cited 2026Jan.31];13(2):7-16. Available from: https://www.ijdra.com/index.php/journal/article/view/751
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