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.”
Each EU competent authority should have procedures for reviewing noncompliance information and determining whether it will impact products in the EU, the guideline states. If a potential health risk is identified, the competent authority in the member state that received the noncompliance notice should provide that information to all other authorities in the EU via teleconference in a timely manner.
International compliance is no longer simply a matter of playing by the same old rules. There’s been a dramatic increase in foreign inspections, and many countries are collaborating via joint inspections and confidentiality agreements that permit sharing of inspection results.
And in many countries, drug safety concerns are prompting new requirements. You either learn the new rules of the game, or cede the playing field to competitors.
That’s where the FDAnews Guide to International Pharma Regulation: 2012 Edition comes in. With this compilation of more than 150 reports highlighting changes from the past year, you could supercharge your international sales ... or stop them in their tracks.
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