FDA Gives Two More EU Countries Seal of Approval
Following a positive assessment by the US Food and Drug Administration (FDA), Lithuania and Ireland have today joined the list of EU countries recognized as capable to carry out good manufacturing practice (GMP) with regard to inspections of sites that manufacture human medicines. The FDA recognized eight EU countries on 1 November 2017 and four additional countries on 1 March 2018, bringing the total number of EU countries accepted by the FDA to 14. Remaining member states will be evaluated by the FDA on a rolling basis, with completion by 15 July 2019. The EU authorities and the FDA benefit from each other by focusing their inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured, prioritizing inspections of medicines manufacturing sites for higher risk cases.
