EU and Japan broaden Mutual Recognition Agreement on GMP inspections

The European Medicines Agency (EMA) has announced that the European Union (EU) and Japan have agreed to broaden their 14 year-old mutual agreement which recognises each other’s inspections of manufacturing sites.

Since 29th May 2004, the EU and Japan have mutually recognised good manufacturing practice (GMP) inspections conducted by each other’s medicines regulators; EMA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The EMA stated that the agreement has now been extended to include sterile products, certain biological products including vaccines and immunological products and the active pharmaceutical ingredients (APIs) for any finished drug that falls under the scope of the agreement. Previously, the agreement covered pharmaceuticals, homeopathic products subject to GMP requirements in Japan, vitamins, minerals and regulated herbal medicines. “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.”

Japan now recognises all EU competent authorities for medicine inspections as equivalent. 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.

The EMA states that the mutual recognition agreement had allowed the two regulators to make more efficient use of their resources by reducing duplicative work. The EU also has mutual recognition agreements with Switzerland, Australia, New Zealand, Canada and Israel. Last year the EU signed an agreement with the United States (US) to mutually recognise GMP inspections conducted by the Food and Drug Administration (FDA).

To read more about the EU and Japan reinforcing their collaboration on inspections of medicine manufacturers, please click here.