As previously reported in our Asia Medical eNewsletter, the Taiwan Food and Drug Administration (TFDA) will combine the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs in order to better integrate the management of food and drug safety.
The TFDA will run a single-window operation to increase efficiency, decrease processing time, and improve transparency. In the future, instead of applying for medical equipment registration to different agencies depending on the type of device, medical device companies can send product information directly to the TFDA. Additionally, the TFDA will manage all import inspection, while routine inspections will be managed by the private sector.
The TFDA will also run a single-window operation for new drugs. Currently, new drugs are inspected by three institutions: the Bureau of Pharmaceutical Affairs, Center for Drug Evaluation (CDE), and the Bureau of Food and Drug Analysis. Once the TFDA is established, all data pertaining to new drugs can be submitted to the TFDA. The TFDA will then relay new drug technical data over to the CDE for further review. Companies will be permitted to request the status of the application at any point during the process. Deputy Minister Yan-Jen Sung states that this single-window approach will reduce the processing time from the current 230 days to less than 200 days.