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Confidentiality ‘Lite’ May Help Drugmakers With Foreign Regs

April 23, 2010

A new type of confidentiality agreement under development by the European Medicines Agency (EMA) may reduce the regulatory burden on drugmakers seeking to market products internationally.

EMA is working on “lite” confidentiality agreements, which would be faster to institute among the agency and international regulatory bodies than traditional confidentiality agreements but still enable EMA to share important drug information with other countries. This could reduce the time and effort sponsors must take to ensure compliance.

“Often, drugmakers would like a country to use work that is being done by another authority,” Emer Cooke, international liaison officer with EMA, said. “It can help reduce the time that might be needed to do an assessment.”
Drug GMP Report