Regulatory procedures for emergency approval of medical products by regulatory agencies

  • G HariCharan
  • Kishore Kumar Ramoju Institute of Technology, Carlow, Ireland
  • Suhana S
  • Yamini Lindait


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.

Keywords: Compassionate use, MRA, EMA, FDA, COVID-19, Remidesivir, Emergency use authorization (EUA)


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How to Cite
HariCharan, G., K. K. Ramoju, S. S, and Y. Lindait. “Regulatory Procedures for Emergency Approval of Medical Products by Regulatory Agencies”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 1-5, doi:10.22270/ijdra.v9i2.459.