Regulatory Roundup: EMA Outlines Activities for 2011, and More. - Pharmaceutical Technology

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Regulatory Roundup: EMA Outlines Activities for 2011, and More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency (EMA) plans to focus on the implementation of its new pharmacovigilance legislation and the pending falsified drug legislation throughout 2011, according to its work program announcement on Feb. 11, 2011. Other planned activities for EMA in 2011 include: communicating and engaging with its stakeholders, including patients; continuing to increase the agency's level of transparency and openness; contributing to international activities and responding to the globalization of pharmaceutical research, development, and manufacturing; responding to public-health needs, including the availability of medicines for the elderly and improving animal health; and fostering the European medicines regulatory network. The work program for 2011 is the first step of the agency’s Road Map to 2015 (see back story).

FDA Acting Principal Deputy Commissioner John Taylor said the agency plans to use more contractors for foreign plant inspections, according to a Bloomberg report. Taylor said FDA will outsource inspections in an effort to leverage its resources, saying, “We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves.” Taylor made the remarks at a conference in Washington sponsored by consulting firms Venn Strategies and Greenleaf Health, says Bloomberg


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