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Danish Medicines Agency Talks Real-World Data With Japanese Regulators, Signs Confidentiality Agreement With US FDA

Posted 08 May 2018 | By Zachary Brennan 

Danish Medicines Agency Talks Real-World Data With Japanese Regulators, Signs Confidentiality Agreement With US FDA

The Danish Medicines Agency said it recently met with officials from the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen to discuss the use of real-world data. In March, the Danish agency also signed a confidentiality commitment with the US Food and Drug Administration (FDA) to discuss non-public information.

The Danish agency said its primary focus with the MHLW and PMDA officials was a discussion on their planned collaboration to use new technologies for collecting and analyzing health data, and how that data can be used – “both to enhance the development and design of new innovative medicines, and to strengthen monitoring of their safety and efficacy.”

The Japanese authorities have “extensive knowledge of and experience in collecting and using patient data that can document how medicines work when used to treat patients in clinical practice,” the Danish agency said in a statement.

"As new pharmaceutical treatments become more and more advanced, new requirements are imposed on the authorities' procedures for authorising, monitoring and handling any risks of these medicines,” Thomas Senderovitz, director general of the Danish agency, said. “The use of real world data is becoming increasingly important in this matter, which is something we have paid attention to at the Danish Medicines Agency in recent years. Real world data can give us greater knowledge about how well medicines work after marketing, and how they are used in large patient populations.”

The Danish agency in March signed an agreement saying it will protect FDA-provided non-public information from public disclosure.
 

Categories: Regulatory News

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