Danish-Japanese collaboration – FDA Confidentiality Commitment
The Danish Medicines Agency recently met with representatives from the Japanese Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in Copenhagen.
The purpose of the meeting was to exchange knowledge and experience regarding regulatory work in the pharmaceutical area, and to begin a broader collaboration between the agencies. The primary focus of the planned collaboration will be on how to use new technologies for the collection and analysis of health-related 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.
Furthermore, the Danish agency in March signed an agreement saying it will protect FDA-provided non-public information from public disclosure.