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Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
Pharmacoepidemiol Drug Saf. 2015 Jul; 24(7):709-15.PD

Abstract

INTRODUCTION

The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA.

METHODS

This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed.

RESULTS

Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies.

CONCLUSION

Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products.

Authors+Show Affiliations

International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences (MCPHS University), Boston, MA, USA.International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences (MCPHS University), Boston, MA, USA. Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.School of Public Health and Health Sciences, University of Massachusetts, Amherst, MA, USA. The Institute for Global Health, University of Massachusetts, Amherst, MA, USA.International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences (MCPHS University), Boston, MA, USA. Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA. Department of Medicine, McGill University, Montreal, Quebec, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26013294

Citation

Alqahtani, Saad, et al. "Priority Review Drugs Approved By the FDA and the EMA: Time for International Regulatory Harmonization of Pharmaceuticals?" Pharmacoepidemiology and Drug Safety, vol. 24, no. 7, 2015, pp. 709-15.
Alqahtani S, Seoane-Vazquez E, Rodriguez-Monguio R, et al. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? Pharmacoepidemiol Drug Saf. 2015;24(7):709-15.
Alqahtani, S., Seoane-Vazquez, E., Rodriguez-Monguio, R., & Eguale, T. (2015). Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? Pharmacoepidemiology and Drug Safety, 24(7), 709-15. https://doi.org/10.1002/pds.3793
Alqahtani S, et al. Priority Review Drugs Approved By the FDA and the EMA: Time for International Regulatory Harmonization of Pharmaceuticals. Pharmacoepidemiol Drug Saf. 2015;24(7):709-15. PubMed PMID: 26013294.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals? AU - Alqahtani,Saad, AU - Seoane-Vazquez,Enrique, AU - Rodriguez-Monguio,Rosa, AU - Eguale,Tewodros, Y1 - 2015/05/27/ PY - 2015/01/27/received PY - 2015/03/31/revised PY - 2015/04/02/accepted PY - 2015/5/28/entrez PY - 2015/5/28/pubmed PY - 2016/4/1/medline KW - European Medicines Authority (EMA) KW - Food and Drug Administration (FDA) KW - drug indication KW - drug regulation KW - marketing approval KW - pharmacoepidemiology KW - priority review SP - 709 EP - 15 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 24 IS - 7 N2 - INTRODUCTION: The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. METHODS: This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed. RESULTS: Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies. CONCLUSION: Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products. SN - 1099-1557 UR - https://neuro.unboundmedicine.com/medline/citation/26013294/Priority_review_drugs_approved_by_the_FDA_and_the_EMA:_time_for_international_regulatory_harmonization_of_pharmaceuticals DB - PRIME DP - Unbound Medicine ER -