Food and Drug Administration (FDA) Recognizes Quality of INFARMED Inspections

Food and Drug Administration (FDA) Recognizes Quality of INFARMED Inspections - 

 

The Food and Drug Administration (FDA), the drug regulatory body of the United States, acknowledged the capability and quality of the inspections carried out by INFARMED. This means that the FDA will stop conducting inspections in Portugal and will recognize the results associated with the INFARMED Good Manufacturing Practices inspections.

In addition to avoiding duplication of inspections, this recognition will contribute to increasing the volume of domestic exports to the United States. According to preliminary data for 2017, the value of exports of Portuguese companies to the United States was 55 million euros, which is the country that leads the national exports.

In a communication sent to the Board of Directors of INFARMED, the FDA noted that "Infarmed has the capability, means and procedures required to conduct good manufacturing practice (GMP) inspections that meet FDA requirements." The products to which this agreement applies are, inter alia, medicinal products for human use, biological medicines and medical gases.

 

Source: INFARMED website and author on September 18, 2018