The drug regulatory authorities in the European Union and Japan have entered into an agreement which means that the two will exchange confidential information about the authorisation and safety of medicines.

The decision to set up confidentiality arrangements between the European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare, in tandem with the Japanese Pharmaceuticals and Medical Devices Agency, was announced at a bilateral meeting in Tokyo.

Commenting on the pact, European Commission vice president Günter Verheugen, responsible for enterprise and industry policy, said that this closer cooperation with the Japanese authorities “will provide earlier access to information and thus make it easier and quicker to take action to protect public health,” adding that our close relationship will also allow us to tackle technical barriers to trade in medicines and help prevent new barriers occurring.”

The EMEA’s executive director, Thomas Lönngren, noted that the agency “has been working closely with our Japanese counterparts for many years and I see these new confidentiality arrangements as an important step forward.” This relationship has included a mutual recognition agreement on manufacturing of medicines, through the International Conference on Harmonisation as well as in bilateral meetings.

Both the EU and Japan said that the new confidentiality arrangements build on that relationship and will allow exchange of information between the parties as part of their regulatory and scientific processes, “both before and after a medicine has been approved.” The types of information covered include advance drafts of legislation and/or regulatory guidance documents, scientific advice on product development given to companies to promote innovation, assessments of applications for marketing authorisations and information about the safety of marketed medicines to better protect public health.

The two bodies are hoping that the potential benefits of this exercise will include accelerated access of patients to new and innovative medicines, resource savings due to reduced duplication of assessment and “improved performance and safety as a result of the involvement of the best available regulatory expertise from both the EU and Japan,” they concluded.

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