FDAnews Drug Daily Bulletin

The European Medicines Agency (EMA) is stressing the need for timely, coordinated communications between EU member states when one state learns of a drugmaker’s noncompliance with good manufacturing practices (GMPs) from a non-EU country’s regulator or from an international organization, such as the World Health Organization. The country that gets the notification of noncompliance should first determine the degree to which the issue affects drugs supplied to the EU so that the response can be based on the level of risk, according to a new EMA guideline, “Compilation of Community Procedures on Inspections and Exchange of Information.”
International Pharmaceutical Regulatory Monitor