According to the Mutual Recognition Agreement – which was first signed between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in March 2017 – the EU and US will recognise active pharmaceutical ingredient (API) and drug plant inspections conducted in their respective territories.
Ireland and Lithuania’s inclusion takes the total number of EU Member States recognised in the cross-Atlantic agreement to 14.
In November 2017, the US agreed to accept good manufacturing practice (GMP) inspections conducted by regulators in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK. In March this year, the Czech Republic, Greece, Hungary, and Romania were included in the alliance.
According to the EMA, mutual benefits for regulators include being able to rely on each other’s inspection resources to focus on higher-risk sites, and helping reduce the administrative burden and costs from duplicate inspections for API and finished drug product manufacturers.
Plans for the agreement to be operational in all EU Member States by July 15 2019 are on track, the Agency added.
Ireland’s Industrial Development Authority (IDA) said the recognition and inclusion of its Health Products Regulatory Authority (HPRA) in the Mutual Recognition Agreement is a “significant endorsement of Ireland’s entire ecosystem for lifesciences.”
“The importance of regulatory expertise and skills is paramount to the ongoing success of the lifescience cluster in Ireland,” IDA Ireland’s Michael Lohan told us.
“The capability and competencies which HPRA possess and continue to develop in line with the sectors product evolution is an advantage on which Ireland can rely for quality, safety and efficacy of medicines,” he added.