Europe–Japan cooperation on generics and biosimilars regulation

Home/Policies & Legislation | Posted 06/06/2014 post-comment0 Post your comment

Japanese and European generics groups have met to discuss increase regulatory cooperation between the two regions.

Regulation V13H16

The Japanese Generic Medicines Association (JGA), the Nippon Keidanren (Japanese Industry Association), the European Generics medicines Association (EGA) and the European Union (EU) Delegation to Japan met in March/April 2014 to promote regulatory cooperation on generics and biosimilars as part of the EU–Japan free trade negotiations.

According to EGA, Japan and the EU share similar objectives to promote generics and biosimilars as key components of sustainable healthcare models. The association is therefore supporting efforts to improve regulatory cooperation in this field. In particular, they are focused on the single development for the approval of biosimilars and complex specialty generics to avoid the unethical duplication of clinical studies. While another area of importance is the mutual recognition of good manufacturing practice (GMP) inspections to reduce duplicative inspections.

According to Mr Adrian van den Hoven, Director General of EGA, ‘Japan is facing an increasing demand for health care due to its ageing population. Regulatory cooperation with the EU will help Japan reach its generic medicines targets and will increase the use of biosimilar medicines making healthcare more sustainable for Japan and for patients.’

The EU–Japan negotiations for a Free Trade Agreement were officially launched on 25 March 2013. Until now five negotiating rounds have taken place (in April, June, and October 2013 and in January and March/April 2014). Japan is the EU’s second biggest trading partner in Asia, after China. Together the EU and Japan account for more than a third of the world’s gross domestic product (GDP).

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Source: EGA, Europa

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