Question & AnswerQ&A (BFAD MEMORANDUM CIRCULAR NO. 5, s, 1994)
The main purpose of BFAD Memorandum Circular No. 5, s. 1994 is to adopt and implement a system of reporting adverse drug reactions to ensure the purity, safety, efficacy, and quality of drugs in accordance with R.A. 3720.
BFAD is mandated under Republic Act No. 3720, also known as the Food, Drugs, Devices and Cosmetics Act, to ensure the safety, efficacy, and quality of drugs.
All drug establishments and parties concerned are required to submit reports of adverse drug reactions to the Office of the Director, BFAD.
Serious adverse drug reaction reports, including reactions to new drugs, drugs of current interest, suspected drug interactions, and reactions that could cause death, danger to life, hospital admission, prolongation of hospitalization, absence from productive activity, birth defects, or significantly affect patient management must be reported within two weeks.
Other adverse drug reaction reports must be submitted on or before January 15 of each year.
Serious adverse drug reactions include reactions that cause death, danger to life, admission to hospital, prolongation of hospitalization, absence from productive activity, birth defects, or significantly affect the management of a patient.
Yes, the memo specifically requires that all suspected reactions to new drugs, especially drugs of current interest, be reported.
Reports are to be submitted to the Office of the Director of BFAD.
This Circular took effect immediately upon adoption on April 20, 1994.
The BFAD implements this system by virtue of the powers vested by R.A. 3720, the Food, Drugs, Devices and Cosmetics Act.