Regulatory cooperation in generic and biosimilar medicines: An opportunity for Japan and the EU

May 30, 2014 8:03 AM

The EGA participated in several meetings with Japanese government officials and regulators, the Japanese Generic Medicines Association (JGA), the Nippon Keidanren (Japanese Industry Association) and the EU Delegation to Japan to promote regulatory cooperation on generic and biosimilar medicines as part of the EU-Japan free trade negotiations.

Japan and the EU share similar objectives to promote generic and biosimilar medicines as key components of sustainable health care models. The EGA is supporting efforts to improve regulatory cooperation in this field, notably on the single development for the approval of biosimilar and complex specialty generic medicines to avoid the unethical duplication of clinical studies and on the mutual recognition of Good Manufacturing Practice (GMP) inspections to reduce duplicative inspections.

“Japan is facing an increasing demand for healthcare 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.” Said Adrian van den Hoven Director General of the EGA.

Source: EGA press release

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