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

Article

EMA Outlines Activities for 2011, and more.

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 Bloombergreport. 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

Recent Videos
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.
Mike Baird from Schlafender Haser discusses industry trends from 2024 and those expected to have an impact in 2025 from the perspective of a software developer.
Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes