Austrian Medicines Agency is a member of ICMRA
The International Coalition of Medicines Regulatory Agencies (ICMRA) admitted the Federal Office for Healthcare Safety/AGES Medical Market Surveillance as an associate member on March 20, 2017. ICMRA is a forum composed globally of the heads of a number of regulatory agencies committed to providing strategic leadership worldwide to address current and future regulatory and safety issues of human medicines. Key areas that Austria can bring to the forum are excellent IT expertise with a vision to develop a common IT platform for mutual information exchange of relevant assessments and data. In the foreseeable future, this could, for example, allow assessment reports to be efficiently distributed and made accessible between authorities via the so-called Active Substance Master File (ASMF). The Austrian authority also has special expertise in areas such as the "EU-Network Training Center", which serves the joint development of a Europe-wide platform for scientific and regulatory training and qualification. Also of high importance is Austria's contribution to the European Compliance Group's Joint Audit Programme (HMA's Joint Audit Programme) in the context of GMP inspections. Upon receipt of the Expression of Interest dated November 21, 2016, ICMRA quickly but carefully evaluated the profile and scope of operations of the Austrian Agency and, in light of its own strategic objectives, recognized and endorsed the compatibility and benefits of Austrian membership. ICMRA concluded that Austrian membership would be a noticeable enrichment to ICMRA's fundamental direction and would provide a valuable contribution to the strong and thriving base of global regulatory coordination and cooperation. Existing global coalition members can also benefit from future participation of their Austrian partner. In turn, Austria will derive benefits from the deepened global networking for the effcient design of future projects. The Austrian Medicines Agency is pleased to be included in this high-level, strategic forum and looks forward to a fruitful collaboration with ICMRA in the future.
