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The 2004 mutual recognition agreement was updated to extend to sterile products, active pharmaceutical ingredients and biological products, including vaccines.
The European Union (EU) and Japan have agreed to expand the range of mutually approved medicines to check production sites.
mutual recognition agreement between the European Union, the European Union and Japan entered into force on 29 May 2004. It allows regulators to rely on Good Manufacturing Practices (GMP) inspections on each other's territories, exempts bulk inspections of medicines entering Japan from EU countries, and vice versa, and shares information on inspections and quality defects. As a result of this agreement, regulatory authorities in the European Union and Japan can make better use of their inspection resources and reduce duplication of inspections on each other's territories.
scope of the agreement has now been extended to include aseptic drugs, certain biological drugs, including vaccines and immunologicals, and active pharmaceutical ingredients for any drug covered by the agreement. This means that both eu and Japanese authorities have agreed that they have the same regulatory and procedural framework for the inspection of manufacturers of these products and can therefore be interdependent.
The full scope of the mutual recognition agreement now includes chemicals, homeopathic medical products (as long as they are treated as pharmaceutical products and meet Japan's GMP requirements), vitamins, minerals and herbs (if both parties consider them pharmaceutical products);
in the EU, inspections of pharmaceutical sites are carried out by the competent national authorities of EU member states. In Japan, GMP inspections are carried out by the Medicines and Medical Devices Administration (PMDA) and the inspection departments of 47 prefectures.
this is the first update of the original mutual recognition agreement. As part of the project to expand the product range, Japan has also assessed and identified all human drug testing authorities in the European Union. (This net special draft)
