At the end of April, the European Commission and Japan's Ministry of Foreign Affairs exchanged so-called 'diplomatic notes' on the issue, clearing on of the final hurdles to mutual recognition of GMP standards that is due to start on 29 May.
The two regions have been working for years on a document entitled the Sectoral Annex on GMP for Medicinal Products, designed to facilitate trade of drugs and medical devices between them. The recognition will reduce registration costs, as medicinal products imported into one region will be able to circulate in the other without the need for additional testing.
To start with, the Sectoral Annex only covers a limited number of products. For example, finished chemical and biological pharmaceuticals are covered, as are those dietary supplements and homeopathic remedies that are regulated as medicines in both the EU and Japan. Medicinal gases, in vitro diagnostics and blood and plasma products are not covered as they are not treated as medicinal products under the legislation.
The European Medicines Agency (EMEA) noted that medicinal products for clinical trials and active pharmaceutical ingredients (APIs) are also not included in the mutual recognition agreement, but may be added in the future.
