Following a positive assessment by the US Food and Drug Administration (FDA), Lithuania and Ireland have today joined the list of EU countries recognised as capable to carry out good manufacturing practice (GMP) with regard to inspections of sites that manufacture human medicines. The FDA already recognised eight EU countries on 1 November 2017 and four additional countries on 1 March 2018. This brings the total number of countries accepted by the FDA to 14. The remaining Member States will be assessed by the FDA on a rolling basis, to be completed by 15 July 2019.
For its part, the European Commission confirmed already in 2017 that the US FDA has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU.
This important agreement, which updates the mutual recognition agreement from 1998, strengthens reliance upon each other’s inspection expertise and resources. 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 problems at manufacturing sites before they become a public health risk; and
- Reducing the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers.
To make this agreement operational, teams from the EU national competent authorities, European Commission, European Medicines Agency and the US FDA have been working intensively on auditing and assessing the respective supervisory system.
Mutual recognition covers medicinal products for human use with the exception of vaccines, plasma derived medicinal products and investigational medicinal products (clinical trial material).
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