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EU, Japan Expand Mutual Recognition Agreement

Posted 18 July 2018 | By Michael Mezher 

EU, Japan Expand Mutual Recognition Agreement

The European Medicines Agency (EMA) announced on Wednesday that the EU and Japan have expanded their 14-year-old mutual recognition agreement for the first time since its inception to include new types of products and active pharmaceutical ingredients (APIs). 

Since 2004, the EU and Japan have mutually recognized good manufacturing practice inspections conducted by each other's medicines regulators, EMA and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). 

Now, EMA says the agreement has been extended to include sterile products, certain biological products including vaccines and immunological products, and the APIs for any finished drug that falls under the scope of the agreement. 

"Authorities from the EU and Japan have agreed that they have equivalent regulatory and procedural frameworks for inspections of manufacturers for these products and can therefore rely on each other's inspections," EMA says. 

With the update, EMA also says that Japan now recognizes all EU competent authorities for medicines inspections as equivalent. 

Previously, the agreement covered pharmaceuticals, homeopathic products subject to GMP requirements in Japan, vitamins, minerals and regulated herbal medicines. 

The agreement also allows Japan and EU countries to waive batch testing requirements for imported drugs and allows for information sharing between EMA and PMDA on inspections and quality issues. 

EMA says the mutual recognition agreement has allowed the two regulators to make better use of their resources by reducing duplicative work. 

The EU also has mutual recognition agreements with Switzerland, Australia, New Zealand, Canada and Israel, and just last year signed an agreement with the US to mutually recognize GMP inspections conducted by the Food and Drug Administration (FDA). 



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