Emergency Use Authorization Flashcards
Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19
FDA Circular No. 2020-036
General Guidelines
- Center for Drug Regulation and Research (CDRR) and Expert Panel - review the application and recommends on the COVID-19 drug or vaccine being applied for an EUA.
- Director General - issuing the EUA or a Letter of Disapproval (LOD).
- COVID-19 drug or vaccine with issued EUA shall be subject to post authorization surveillance.
a. Pharmacovigilance obligations
b. Post-authorization commitments implementors
Conditions for Issuance of EUA
Totality of evidence available
Potential benefits outweight risk
There is no adequate, approved and available alternative to the product
Filling of Application
All applications shall be filed with the FDA Action Center (FDAC).
Requirements
Applications for EUA for drugs and vaccines shall comply with the following documentary requirements which shall be in the English language
- Cover letter requesting to issue an EUA with comprehensive discussions on the public health need for the product,
- Valid License to Operate (LTO) as Drug Importer, with copy of the exclusive distributorship agreement with the manufacturer of the drug or vaccine,
- Good Manufacturing Practice (GMP) Certificate or equivalent document issued by the national regulatory authority or other competent regulatory authority. For drugs or vaccines coming from non-PIC/S countries or non-WHO-Prequalified, the application must be supported by a Foreign current Good Manufacturing Practice (FcGMP) Certificate following **Administrative Order No. 2013-0022 **
- List of Countries where the EUA is approved, with proof of approval for emergency use from the corresponding approving counterpart NRAs,
- Reports on actual use from the issuance of EUA of approving counterpart NRA to the application for EUA in the Philippine FDA;
- Complete assessment report including question and answer documents from the approving counterpart NRA,
- Clinical trial data and results with the inclusion of racial distribution showing Filipino/Asians/ Pacific Islanders,
- Currently available stability studies and list of ongoing studies,
- Risk Management Plan
- Summary of Product Characteristics
- Summary Lot Protocol
- Product labeling with minimum information including name of vaccine, type of vaccine, method of administration, dose per vial, storage, batch or lot number, manufacturing and expiration dates (compliance with Administrative Order No. 2016-0008 or the Revised Rules and Regulations Governing the Generic Labelling Requirements of Drug Products for Human Use shall not be required), and instruction for usage— smart labelling is encouraged; and
- Proof of Payment
Pre-assessment
The Office of the Director General (ODG) shall determine the completeness of the** submission for application**.
Thereafter, the application shall be referred to the Expert Panel and CDRR for a simultaneous review of the application.
Review and Recommendation
- CDRR - Review the quality of the drug or vaccine applied for an EUA based from the requirements submitted.
- Expert Panel which shall review the safety and efficacy of the product applied for EUA.
- The Expert Panel - Composed of at least three (3) experts on drug and vaccine development or related fields such as immunology, infectious disease, pharmacology, public health, toxicology and others.
- The review of the expert panel shall identify
(a) based on the totality of evidence available, including data from adequate and well- known controlled trials
(b) Potential benefits outweigh risks of the drug or vaccine
Approval of the application for EUA
Director General shall approve the application for EUA.
- The approval may include one or more special conditions for use. ost-authorization safety and effectiveness reporting requirements, limitations, restrictions on advertising and promotion, and other special conditions.
Disapproval
a. Failure to satisfy all of the conditions for the issuance of the EUA;
b. Failure to demonstrate the safety, effectiveness, and quality profile to prevent, diagnose, and treat COVID-19;
c. Failure to settle unresolved problems regarding quality, safety, and effectiveness;
d. Failure to disclose other relevant quality, safety, and effectiveness issues; and
e. The label of the product (including package insert) is false and misleading.
TF: The decision to disapprove an application is final and irrevocable. An applicant may re-apply in case of a disapproval of its application for EUA provided that the deficiencies initially noted have been complied.
True
Revocation / Suspension or Cancellation of EUA
a. Violation of pharmacovigilance obligations and post authorization commitments; and
b. Violation of any provision of the Circular and applicable laws, rules and regulations as identified by FDA.
In case of revocation, cancellation or suspension of EUA, the Uniform Rules of Procedure under R.A. No. 9711 shall apply.
Validity
The EUA shall be valid only within the duration of the declared public health emergency due to COVID-19, or upon issuance of full market authorization/Certificate of Product Registration.
In the event that the declared public health emergency is lifted, or when a COVID-19 drug or vaccine is registered with the FDA, any issued EUA shall have a provisional validity for a period of one (1) year from date of lifting of the declaration or registration of the drug or vaccine for the sole purpose of exhausting remaining products.
Post Authorization
1. Lot Release
The holder of the EUA of COVID-19 Vaccines shall ensure that a complete Summary Lot Protocol which contains the manufacturer’s production data and quality control test results, and recognition/acceptance of Lot Release Certificate from the country of origin (responsible NRA/NCL) or its equivalent is submitted to FDA.
2. Monitoring
The holder of the EUA has the ultimate responsibility for monitoring the safety including inventory control and maintenance of appropriate storage until delivery, among others.
The FDA and DOH shall conduct post-authorization monitoring to track product deployment, additional relevant information, and the status from the manufacturer concerning full-product life-cycle, including adverse events following immunization (AEFI) or adverse drug reactions (ADR).
3. Commitments of the Holder of the EUA
a. Complete specific pharmacovigilance obligations (ongoing or new studies, or additional activities) with a view to providing comprehensive data confirming a positive benefit-risk balance. Pharmacovigilance obligations shall adhere to the guidelines and subsequent circulars as issued by the FDA;
b. Complete pending studies and trials. The holder of the EUA shall subsequently proceed to a marketing authorization following FDA guidelines on the condition that it has proven to be safe and effective for the proposed indication;
c. Complete unavailable documents or submit additional necessary documents as may be required by FDA, including provision of further data and response to inquiries; and
d. Secure Lot/Batch Release Certification for all biologicals from the FDA prior to distribution.
4. Pharmacovigilance
The holder of the EUA shall have a comprehensive pharmacovigilance system for their product following the system or protocol for of a registered drug and biological product.
The holder of the EUA shall ensure compliance with the Risk Management Plan (RMP) including additional pharmacovigilance activities. A summary of RMP shall be provided containing information on product safety profile and explain the measures to characterize the risk including ongoing, new studies or additional activities. The summary of RMP shall be published in the FDA website.
5. Post Authorization Changes
Any deviation from or changes to the manufacture and changes in label of the product must be notified with the FDA.
Responsibility of the national procurer and health program implementors
The pharmacovigilance obligations and post-authorization commitments of the holder of the EUA shall be shared by the national procurer and health program implementors to the fullest extent possible and applicable.
I. Fees
The fee for application for EUA is P50,000.00 + LRF*
*LRF is equivalent to one percent (1%) of the filing fee imposed, but in no case lower than ten pesos.
