Draft Food and Drug Administration (FDA) Circular "Guidelines on the Importation and Exportation Notification for Pharmaceutical Products and Raw Materials"

Protection of human health or safety (TBT)

Pharmaceutics (ICS code(s): 11.120)

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11.120 - Pharmaceutics

Human health

FDA Memorandum Circular (FMC) No. 2013-032, entitled “Requirements for the Immediate Release of Products Covered by the FDA at the Bureau of Customs”, was issued, wherein only valid FDA License to Operate (LTO) and Certificate of Product Registration (CPR) were required to be presented to the Bureau of Customs (BOC) for the release of pharmaceutical products. However, there is a need to strengthen market control within the distribution chain through measures to ensure that the public only receives quality-assured pharmaceutical products. The infiltration of substandard and counterfeit pharmaceutical products into the supply system shall be prevented through risk-based surveillance schemes and rigorous control.  Therefore, as part of the FDA’s powers and functions under RA No. 9711, requiring the concerned pharmaceutical establishments to notify each importation/exportation of pharmaceutical products and raw materials is necessary to strengthen the FDA’s overall market surveillance and control regulatory function. In the interest of public health, importation and exportation activities relative to pharmaceutical products and raw materials shall be regulated and monitored by the FDA. Hence, issuance of this Circular is imperative in ensuring consistency and effectiveness of these regulatory activities.

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