- What is an Emergency Use Authorization?
- Risk-based procedure for assessing unlicensed (under development) vaccines, therapeutics
- During public health emergencies of international concern
- Aim of expediting availability to people affected by a public health emergency
- Based on essential set of available quality, safety, and efficacy performance data
- What are the eligibility criteria of a product to apply for an EUA?
- The disease may cause an outbreak, epidemic or pandemic
- No products available capable of eradicating or preventing the disease
- Products are manufactured in compliance with Good Manufacturing Practices
- Applicant undertakes to complete the development of the product and apply for prequalification once it is licensed
- What are WHO recommendations on regulatory preparedness and response in a pandemic?
- Regulatory frameworks with laws and/or policies that permit EUA for medicines
- Pandemic preparedness plan that acknowledges EUA
- Reliance and Recognition on trusted/reference authorities for the EUA
- Reliance: NRA may consider evaluations performed by another NRA
- Recognition: Acceptance of a regulatory decision of another NRA
- System to monitor EUA products in the market
- Post Marketing Surveillance/ Risk Marketing plan
- What other countries have a mechanism similar to an EUA?
- US Food and Drug Administration-
Emergency Use Authorization
- China National Medicinal Products Administration-
Emergency Use Authorization
- European Medicines Agency –
Conditional Marketing Authorization
- Australia Therapeutic Goods Administration
- Japan Pharmaceuticals and Medical Devices Agency-
Conditional Early Approval System
- What are the conditions for Issuance of the EUA based on EO 121?
The EUA shall only be issued and remain valid under all of the following conditions:
- Based on the totality of evidence available at the time of registration, including data from adequate and well- known controlled trials, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat COVID-19;
- The known and potential benefits of the product, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of the COVID-19 drug or vaccine; and
- No adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19. Said condition is deemed present when there exists no registered drug or vaccine in the country for diagnosing, preventing or treating COVID 19
- What is the validity of an EUA?
The EUA shall be valid until expressly withdrawn by the FDA Director General or upon issuance of full market authorization/Certificate of Product Registration.
- What surveillance will be done after the issuance of an EUA?
FDA together with other concerned offices of the DOH shall conduct post authorization monitoring to track adverse event following immunization (AEFI), product deployment and status from the manufacturer concerning full- product life cycle.
Read the FAQs on Emergency Use Authorization at https://bit.ly/EAU_FAQ_FDA