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Enhancing border inspection of active pharmaceutical ingredients 【Date:2019-01-24】 unit:藥品組

The Taiwan Food and Drug Administration (TFDA) announced the amendment of ”Regulations for the Inspection and Examination of Imported Medicaments” on August 22th 2018, clearly defined the inspection procedures at the border for all active pharmaceutical ingredients (APIs) which were listed in the Chapters 28 and 29 of the Import and Export Commodity Classification.

APIs are the key components of medicines. To ensure the drug quality, all imported APIs need to comply with GMP standards. The reinforcement of border controls can strengthen the management of APIs at the border, so as to prohibit counterfeits. Furthermore, Executive Yuan launched the “New Generation Anti-drug Strategy” to block the sources of illicit drugs. Border inspection of APIs can be one of the effective actions.

Randomly-selected batch will be examined by rapid test instruments “Raman Spectrometer” at customs. Once the imported items are determined to be illicit drugs, they will be forwarded to the judicial/police authority for further investigation. If the characteristics of the imported items cannot be identified, they shall be sealed and stored at the GMP compliant sites immediately. After the applicants have prepared the assurance statements and the supporting documents, the TFDA will assign staffs to the storage sites and unseal the items for further examinations.

Manufacturers should proactively prepare all the relevant documents and apply for inspections from the TFDA in order to enhance drugs supply chain integrity and also fight against illicit drugs.