Emergency Use Authorization for COVID-19 and Purchase Limit / Cap

FDA Circular No. 2020-036

Emergency Use Authorization for Drugs and Vaccines for COVID-19 is amended by FDA Circular No. ____________

Emergency Use Authorization (EUA)

[DEFINITION OF TERMS]

Authorization issued for unregistered drugs or vaccines during a public health emergency.

TRUE

[DEFINITION OF TERMS]

TRUE OR FALSE:

Emergency Use Authorization (EUA) is NOT a Certificate of Product Registration (CPR) and NOT a marketing authorization.

Recognition

[DEFINITION OF TERMS]

Acceptance of the regulatory decision of another trusted institution.

Recognition

[DEFINITION OF TERMS]

Based on evidence of conformity that regulatory requirements are sufficient.

Example: World Health Organization (WHO)

World Health Organization (WHO)

[DEFINITION OF TERMS]

Recognition is when a regulatory authority (like the Philippine FDA) accepts the regulatory decisions of another trusted institution instead of doing its own full assessment.

Example of this trusted institution is the _________

Reliance

[DEFINITION OF TERMS]

Act whereby the National Regulatory Authority (NRA) gives significant weight to assessments of another NRA or trusted institution.

Examples:

● US Food and Drug Administration (US FDA)

● European Medicines Agency (EMA)

● US Food and Drug Administration (US FDA)

● European Medicines Agency (EMA)

[DEFINITION OF TERMS]

Reliance occurs when a National Regulatory Authority (NRA), such as the Philippine FDA, uses the assessments or decisions of another trusted regulatory authority as a significant basis for its own decision.

This means the NRA still conducts its own evaluation but gives heavy weight to the trusted authority's assessment.

Examples of these trusted authorities are ___________

● Center for Drug Regulation and Research (CDRR)

● Expert Panel

[SALIENT POINTS]

These shall review EUA applications and give recommendations.

FDA Director General

[SALIENT POINTS]

The _______ shall approve on the application by issuing:

● Emergency Use Authorization (EUA)

● Letter of Disapproval (LOD)

● Emergency Use Authorization (EUA)

● Letter of Disapproval (LOD)

[SALIENT POINTS]

The FDA Director General shall act on the application by issuing:

post-authorization monitoring

[SALIENT POINTS]

COVID-19 drug or vaccine with EUA shall be subjected to _________

● Totality of evidence shows the product may be effective

● Benefits outweigh risks

● No adequate, approved, and available alternative product

[SALIENT POINTS]

EUA shall be issued and remain valid only if ALL are present:

● Only during the declared public health emergency

● Until issuance of full market authorization / CPR

[SALIENT POINTS]

EUA validity:

1. Approval

2. Disapproval

3. Revocation / Suspension / Cancellation of EUA

[FDA DECISION ON EUA APPLICATION]

FDA Decision on EUA Application includes:

January 10, 2022

[SETTING OF PURCHASE LIMIT / CAP FOR CERTAIN MEDICINES]

Setting of Purchase Limit / Cap for Certain Medicines was issued on ______________

● Paracetamol - analgesic/antipyretic

● Phenylephrine Hydrochloride - decongestant

● Carbocisteine - mucolytic

● Chlorphenamine Maleate - antihistamine

[SETTING OF PURCHASE LIMIT / CAP FOR CERTAIN MEDICINES]

Covered drugs under Purchase Limit/Cap include:

● To impose a reasonable limit on the sale and purchase of covered goods

● Prevent hoarding and ensure public access

[SETTING OF PURCHASE LIMIT / CAP FOR CERTAIN MEDICINES]

Purpose of Setting Purchase Limit / Cap for Certain Medicines