Cooperation in Global Regulation Sees Benefits

August 2, 2012
Susan Haigney

Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, susan.haigney@ubm.com.

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the collaboration.

Specifically, EMA reported on an increase in the exchange of information and interaction between the two regions, including a new Japanese liaison officer and increased conference attendance. EMA stated in a release that the presence of the Japanese liaison “has provided a strong basis for mutual education, awareness of opportunities for interaction and communication between the European and Japanese authorities, helping to address public-health issues and avoid duplication of work.”

FDA, the Australian Therapeutic Agency, and the United States Pharmacopeia have done similar exchange programs. With the increasing global nature of the pharmaceutical industry, the positive results reported by EMA would seem to prove that this trend in global collaboration is a good one.

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