Executive Order No. 121 (2020) — —to strengthen their own interventions and responses against COVID-19, other countries such as Australia, China and the United States of America adopted, and the WHO recognized, the regulatory practice of issuing an Emergency Use Authorization to hasten the availability and use of COVID-19 drugs and vaccines, particularly those supported by strong evidence that patients have benefited therefrom, in the absence of available approved and adequate alternatives;

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Executive Order No. 121 (2020)

—to strengthen their own interventions and responses against COVID-19, other countries such as Australia, China and the United States of America adopted, and the WHO recognized, the regulatory practice of issuing an Emergency Use Authorization to hasten the availability and use of COVID-19 drugs and vaccines, particularly those supported by strong evidence that patients have benefited therefrom, in the absence of available approved and adequate alternatives;

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Section 1 · Emergency Use Authorization for COVID-19 Drugs and Vaccines Section 2 · Conditions for the Issuance of EUA Section 3 · Applications for EUA Section 4 · Reliance and Recognition Section 5 · Expert Panel Section 6 · Validity of the EUA Section 7 · Post-Authorization Monitoring Section 8 · Implementing Guidelines Section 9 · Reports Section 10 · Separability Section 11 · Effectivity

Section 1

Emergency Use Authorization for COVID-19 Drugs and Vaccines

Section 1.

Emergency Use Authorization for COVID-19 Drugs and Vaccines. —The Director General of the FDA is hereby authorized to issue an Emergency Use Authorization (EUA), subject to conditions provided in this Order. Outside clinical trials and except in cases where a Compassionate Special Permit is issued, no unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without an EUA.

Section 2

Conditions for the Issuance of EUA

Section 2.

Conditions for the Issuance of EUA. An EUA on a COVID-19 drug or vaccine shall be issued and remain valid only when all of the following circumstances are present:

i. Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;

ii. The known and potential benefits—of—the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any; and

iii. There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19. ℒαwρhi৷

Section 3

Applications for EUA

Section 3.

Applications for EUA. —An application for the issuance of an EUA shall be submitted by the industry or government agency concerned, such as the national procurer or the public health program implemented

The application should demonstrate compliance with current Good Manufacturing Practices, and accompanied by an undertaking by the manufacturer to complete the development of the drug and vaccine, among others.

Section 4

Reliance and Recognition

Section 4.

Reliance and Recognition. —In evaluating applications for EUA, the FDA Director Genera! shall have the power to implement reliance and recognition processes for emergency use of drugs and vaccines. For this purpose, the FDA Director General may accept the regulatory decision of the WHO, US-CDC, or other internationally recognized and established regulatory authorities.

Section 5

Expert Panel

Section 5.

Expert Panel. —The FDA shall convene a pane! composed of experts on drug and vaccine development, which shall conduct a review of available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA. After review, the panel shall submit to the FDA Director General its report and recommendations on the application for EUA.

Section 6

Validity of the EUA

Section 6.

Validity of the EUA. —An EUA issued pursuant to this Order shall be valid only within the duration of the declared public health emergency due to COVID-19, without prejudice to the discretion of the FDA Director General to revisit or revoke the same, as may be appropriate, to protect the general public health and safety.

Section 7

Post-Authorization Monitoring

Section 7.

Post-Authorization Monitoring. —The FDA, together with other concerned offices of the DOH, shall conduct post-authorization monitoring to track product deployment, additional relevant information, and the status from the manufacturer concerning full-product life-cycle. The holder of an EUA shall be required to complete specific pharmacovigilance obligations, with a view to providing comprehensive data confirming a positive benefit-risk balance.

Section 8

Implementing Guidelines

Section 8.

Implementing Guidelines. —The FDA shall formulate and issue guidelines, as may be necessary, for the effective implementation of this Order. ℒαwρhi৷

Section 9

Reports

Section 9.

Reports. —The FDA shall submit to the President, through the DOH, a monthly report on the implementation of this Order.

Section 10

Separability

Section 10.

Separability. —If any part or provision of this Order shall be held unconstitutional or invalid, the other parts or provisions not affected thereby shall continue to be in full force and effect.

Section 11

Effectivity

Section 11.

Effectivity. —This Order shall take effect immediately upon publication in the Official Gazette or in a newspaper of general circulation.

DONE, —in the City of Manila, this 1st day of December in the Year of our Lord, Two Thousand and Twenty.

(SGD.)— RODRIGO ROA DUTERTE

By the President:

(SGD.)— SALVADOR C. MEDIALDEA Executive Secretary