BFAD adverse drug reaction reporting

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BFAD MEMORANDUM CIRCULAR NO. 5, s, 1994: BFAD adverse drug reaction reporting

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Title Supreme Court: BFAD adverse drug reaction reporting

Law: Bfad Memorandum Circular No. 5, S, 1994

Decision Date: Apr 20, 1994

The Bureau of Food and Drugs (BFAD) mandates the reporting of adverse drug reactions, including those related to new drugs and significant drug interactions, to ensure the safety and efficacy of pharmaceuticals.

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Scope of the Adverse Drug Reaction Reporting System

Applicable to all drug establishments and concerned parties.
Requires reporting of adverse reactions to drugs with focus on:
- New drugs, especially those of current interest.
- Suspected drug interactions.
- Other drugs causing significant management issues.

Key Definitions and Criteria for Reporting

Adverse reactions include those leading to death, danger to life, hospitalization, extended hospital stay, absence from productive work, birth defects, or any serious adverse drug reaction.

Reporting Procedures

Serious adverse drug reaction reports must be submitted within two weeks of receiving the information.
Other ADR reports must be submitted annually, on or before January 15.

Legal Effectivity and Compliance

The circular was adopted and took effect immediately on April 20, 1994.
Compliance with the reporting system is mandatory to uphold drug safety standards.

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