. Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice

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Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice

Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).

After it was confirmed by European Commission in June 2017 that FDA has the capability, capacity and procedures to carry out GMP inspections at a level equivalent to the EU, eight member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom) were included by FDA on 1st Nov 2017 to carry out GMP inspections equivalent to EU whereas on 1st Mar 2018 additional four states were also recognized. After inclusion of Lithuania and Ireland, now there are 14 EU member states which are included in an agreement allowing FDA to rely on European Commission inspection results to replace their own inspections.

The mutual recognition agreement between EU and US regulators has the following benefits:

1) Duplication avoided as information is being continuously exchanged regarding GMP inspections of manufacturing sites
2) Lead to better use of resources for inspection of higher risk manufacturing sites
3) Irrespective of manufacturing sites, patients can rely on the quality, safety and efficacy of all medicines
4) Improvement in identification of potential risks and addressing the problems at manufacturing sites before making it a possible public health risk
5) Reduction in the burden and cost of duplicative inspections

According to EMA,” Around 40% of finished medicines marketed in the EU come from overseas and for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union. This is the reason why every year national authorities across the EU, alongside FDA, inspect many manufacturing sites of medicines in the EU, US and elsewhere to ensure compliance with GMP.