Amendment on Adverse Drug Reaction Reports

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FDA CIRCULAR NO. 2010-009: Amendment on Adverse Drug Reaction Reports

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Title Supreme Court: Amendment on Adverse Drug Reaction Reports

Law: Fda Circular No. 2010-009

Decision Date: Apr 16, 2010

The FDA mandates that serious adverse drug reaction reports must be submitted within 72 hours and no later than 7 working days, while other adverse reactions are to be reported quarterly, ensuring timely monitoring of pharmaceutical safety.

administrative law

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Reporting Schedule for Other Adverse Drug Reactions

Reports of adverse drug reactions that are not serious must be submitted every 30th day of the first month of each quarter.
This means such reports are due quarterly, aligning with a regular schedule.

Procedure for Reporting Low Efficacy or Low Potency of Pharmaceutical Products

Any instance of low efficacy or low potency must be reported separately.
The report must be made using the prescribed Pharmaceutical Product Problem Report form specifically designed for such cases.

Legal and Regulatory Compliance

The amendment emphasizes strict compliance with the prescribed reporting timelines and forms.
The amendment updates the previous memorandum circular provision, reflecting a stricter timeline for serious ADR reports.

Authority and Enforcement

The circular is issued by the Director IV of the Bureau of Food and Drugs.
It mandates immediate implementation and observance by all concerned parties in the pharmaceutical sector.

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