Poland and Slovenia Added to EU–US Mutual Recognition Agreement
The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.
On Feb. 11, 2019, the European Medicines Agency (EMA) announced that Poland and Slovenia have been included into the mutual recognition agreement between the European Union and the United States to carry out US-level GMP inspections at European facilities. The agreement recognizes pharmaceutical manufacturing facility inspections conducted in different territories. FDA and EMA can then rely on those inspections results and avoid duplicate efforts.
The agreement allows the EU and the US to focus its resources on other parts of the world and prioritize on higher-risk sites. It also reduces administrative burdens and costs that would be incurred by duplicate inspections.
With the addition of Poland and Slovenia, the total number of EU countries involved in the agreement is now at 22 Member States. It is anticipated that all EU Member States will be involved by July 15, 2019.
Source: EMA
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
International Women’s Day 2025: A Promising Future for Gender Diversity in Pharma
March 8th 2025In an interview with BioPharm International®, Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
