FDAnews Drug Daily Bulletin

EC, EMEA TO INTENSIFY CROSS-ATLANTIC COOPERATION ON PHARMACEUTICAL REGULATION

March 23, 2006
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The FDA, European Commission (EC) and European Medicines Agency (EMEA) have agreed to increase cooperation in the area of pharmaceutical regulation.

During a meeting in Brussels, the three regulatory bodies agreed to increase transatlantic cooperation in the area of medicinal products, with a particular focus on vaccines (including preparedness for influenza pandemic), medicines for children, orphan drugs, oncology and pharmacogenomics, the FDA said recently.

An existing confidentiality arrangement allows the EC, EMEA and FDA to exchange information on legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures and postmarketing surveillance.

Additional public health priority areas such as counterfeit medicines will be explored in the coming months, the FDA said. Other organizations are working to curb the proliferation of counterfeit drugs. The World Health Organization is working with the international pharmaceutical industry to create a global task force that will seek tougher measures to combat counterfeit prescription drugs.