Following a number of counterfeit drug cases in recent years, the Taiwan Food and Drug Administration (TFDA) has begun monitoring and requiring monthly inventory reports on a list of 50 big-ticket drugs to prevent a repeat of such incidents.
The TFDA on July 31 announced [regulatory revisions] to require submission of monthly inventory reports for 50 National Health Insurance (NHI)-reimbursed drugs with high prescription volume and high prices.
The TFDA’s Division of Medicinal Products said that the list is selected from the latest NHI drug reimbursement data and targets drugs that have a high risk of being counterfeited, such as those with high usage and high prices. The list excludes oncology drugs and drugs classified as controlled substances as well injectables as well as those used to treat rare diseases. Under these criteria, drugs that reduce blood pressure, lipid and sugar levels topped the list.
In addition, the list also includes flu drugs that contain pseudoephedrine and ephedrine to prevent bad actors from refining them for ingredients to produce recreational drugs.
The Division of Medicinal Products said that effective Oct. 1, drug manufacturers and distributors licensed to handle such drugs must upload drug inventory records from the previous month before the 10th of each month to the TFDA’s tracking system, including data on quantity and batch numbers.
【2019-07-31 / CNA】
