Question & AnswerQ&A (FDA CIRCULAR NO. 2010-009)
The main subject of FDA Circular No. 2010-009 is the amendment to the reporting procedures on adverse drug reactions, specifically amending the last paragraph of Memorandum Circular No. 5, s. 1994 regarding reports on adverse drug reactions.
Serious adverse drug reaction reports must be submitted to the Bureau of Food and Drugs (BFAD).
Serious adverse drug reaction reports must be submitted within 72 hours (3 working days) and no later than 7 working days after receipt of the report.
Reports on other adverse drug reactions must be submitted every 30th day of the first month of each quarter of the year.
In cases of low efficacy or low potency, a corresponding report must be submitted using the prescribed Pharmaceutical Product Problem Report form.
The amendment clarifies the deadlines for the submission of serious and other adverse drug reaction reports, ensuring timely reporting and action by regulatory authorities.
Memorandum Circular No. 5, s. 1994 is being amended by FDA Circular No. 2010-009.
Adverse drug reactions are any unintended, harmful reactions experienced following the administration of a pharmaceutical product.
The purpose is to monitor drug safety, protect public health, and take necessary regulatory actions to prevent harm from medications.