Two additional countries to benefit from EU-US mutual recognition agreement for inspections

Luxembourg and the Netherlands have been included in the GMP mutual recognition agreement between the EU and the US.

Both Member States were deemed capable to carry out good manufacturing practice (GMP) inspections at an equivalent level to the United States Food and Drug Administration (FDA). This follows the acceptance of Portugal into the agreement in September 2018.

The European Commission confirmed that the FDA is competent in carrying out GMP inspections at an equivalent level to the EU in June 2017. On 1 November of the same year the mutual recognition agreement came into effect.

Mutual benefits for EU authorities and the FDA include:

  • the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured
  • prioritising inspections of medicines manufacturing sites for higher risk cases
  • reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured
  • improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk
  • reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers

More information on mutual recognition agreements can be found here.

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Published 20. June 2019 in News, News EU