In order to closely monitor the sources and flows of drugs, to prevent counterfeit drugs from entering the legal supply chains and to avoid the misuse of legal drugs, the TFDA made an advance announcement on April 19, 2019, about the draft revision of the drug categories subject to the track-and-trace system pursuant to Article 6-1 of the Pharmaceutical Affairs Act.
This advance announcement is to revise the drug categories subject to the track-and-trace system as announced previously in October 30, 2017 and February 8, 2018. Based on the principles of risk assessment, the TFDA examined the drugs of high usage volume, excluding cancer drugs, controlled drugs, drugs for rare diseases and injections, and finally selected 50 items to be included in the scope of the track-and-trace system. 38 items from the original list are to be dropped.
According to the current regulations, the license holders of the preparations containing (pseudo-)ephedrine are required to submit a quarterly report of the product flows as a measure for preventing the misuse or abuse of such drugs. Now, the TFDA suggested including these drugs in the scope of the track-and-trace system with a view to strengthening the control.
The license holders or wholesalers of the drugs subject to the track-and-trace system should submit the data via the reporting system established by the TFDA. Submission should be made before the 10th of each month. The TFDA will organize training sessions to help drug companies to use the reporting system.
Details of the aforementioned announcement are available to download from the Executive Yuan Gazette Online, the MOHW’s website (Health and Welfare Regulation Search System à Draft Regulations), the TFDA’s website (Announcements à TFDA Announcements) and the National Development Council’s “Public Policy Participation Platform”. Any suggestions about this announcement should be made to the TFDA within 60 days.
【2019-04-19/ TFDA】
