Regulatory procedures for emergency approval of medical products by regulatory agencies
Abstract
Emergency use authorization of medical products by the regulatory agencies is not a usual procedure; it happens to cope with unanticipated health emergencies affecting a large group of population, these can be because of outbreak agents like virus, bacteria, etc., which can cause contagious diseases. Contagious diseases are classified into an outbreak, epidemic and pandemic disease, based on size and intensity of spread of the disease. Epidemic and Pandemic disease conditions such as CoVID-19 will trigger the emergency use authorization of products that help in the control, prevention and/or cure for the disease. EMA and FDA are well known advanced regulatory bodies, with eminent procedures for approval of the medication, harmonization of the standards as per the global regulatory acceptance. However, there are some differences between the two, in case of initiating the procedure, timelines, data required for approval of products under the emergency use. This article focuses on emergency approval of medications, regulations involved in the approval of medications and vaccines by EMA and FDA, some of the important data companies or sponsors need to submit to the regulatory bodies for approval, verification procedure and timelines for evaluation of manufacturer submitted data. Mutual recognition agreement and timeline of Remdesivir for approval by EC and FDA.
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References
2. SC, Supriya Kumar, Freimuth V S, Kidwell K., and Musa D. "Public willingness to take a vaccine or drug under Emergency Use Authorization during the 2009 H1N1 pandemic." Biosecurity and bioterrorism: biodefense strategy, practice, and science [Internet] ncbi; 2009 [cited on 2021 Mar 06]; 7(3):275-290. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998968/
3. U.S. Food and Drug Administration. 2021. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine [Internet]. FDA; 2021Feb 27 [cited on 2021 Mar 05] Available at: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine#:~:text=Today%2C%20the%20U.S.%20Food%20and,SARS%2DCoV%2D2) .
4. Tsuyuki K, Yano K, Watanabe N, Aruga A, Yamato M. Compassionate use of drugs and medical devices in the United States, the European Union and Japan. Regenerative Therapy [Internet]. Ncbi; 2016 Jun 01 [cited on 2021 Feb 21]; 4:18-26. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6581800/
5. U.S. Food and Drug Administration. Guidance—Emergency Use Authorization of Medical Products [Internet]. FDA; July 2007. [Cited on 2021 Mar 20] Available at: www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm. .
6. Emergency Use Authorization Declaration [Internet]. Federal Register; 2020 [cited Mar 15 2021]. Available from: https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use-authorization-declaration.
7. Nightingale SL, Prasher JM, Simonson S. Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States. Emerg Infect Dis. 2007;13(7):1046. https://doi.org/10.3201/eid1307.061188
8. European Medicines Agency. Conditional marketing authorisation [Internet]. European Medicines Agency [cited 2021 Mar 20]. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation
9. Avorn J, Kesselheim A. Regulatory decision-making on COVID-19 vaccines during a public health emergency. Jama [Internet]. Pubmed; 2020 Oct 06 [cited on: 2021 Jan 25];324(13):1284-5. Available on: https://pubmed.ncbi.nlm.nih.gov/32870268/
10. European Medicines Agency. Guideline on the Scientific Application and the Practical Arrangements Necessary to Implement Commission Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use Falling Within the Scope of Regulation (EC) No 726/2004 [Internet]. European Medicines Agency; 2016 Feb 25 [cited on 2021 Mar 15] Available on: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-application-practical-arrangements-necessary-implement-commission-regulation-ec/2006-conditional-marketing-authorisation-medicinal-products-human-use-falling_en.pdf
11. Cavaleri M, Enzmann H, Straus S, Cooke E. The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines. The Lancet [Internet]. Ncbi; 2021 Jan 30 [cited on 2021 Mar 26];397(10272):355-7. Available on: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7833511/
12. COVID-19 guidance: evaluation and marketing authorisation - European Medicines Agency [Internet]. European Medicines Agency; 2021 [cited 21 March 2021]. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/guidance-developers-companies/covid-19-guidance-evaluation-marketing-authorisation.
13. Mutual recognition agreements (MRA) - European Medicines Agency [Internet]. European Medicines Agency; 2021 [cited 22 March 2021]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra\
14. Lamb Y N. Remdesivir: first approval. Drugs [Internet]. Pubmed; 2020 Sep 01 [cited on 2021 Mar 19]:1-9. Available on: https://pubmed.ncbi.nlm.nih.gov/32870481/
15. Saint-Raymond A, Sato J, Kishioka Y, Teixeira T, Hasslboeck C, Kweder SL. Remdesivir emergency approvals: a comparison of the US, Japanese, and EU systems. Expert Review of Clinical Pharmacology [Internet] 2020 Oct 2 [Cited on 2021 Mar 05];13(10):1095-101. Available on: https://www.tandfonline.com/doi/full/10.1080/17512433.2020.1821650
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