EMA Forming Four New Human Medicines Units within Agency

If the European Medicines Agency (EMA) has seemed to be uncharacteristically silent in recent months, it's not just your imagination: It has been, toiling on a massive overhaul of the agency's operations and processes to make it future-ready, in the words of Executive Director Guido Rasi. Now the agency is giving the public a glimpse into its progress thus far, illustrating some major changes about to affect the agency.

Background

The EMA overhaul was first announced by Rasi on 19 December 2012. At the time, the agency said it was planning to make changes "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations."

EMA added that the end goal was to allow its scientific committees-the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee for Advanced Therapies (CAT) and others-to be able to reach "high-quality, consistent opinions."

In a statement to Regulatory Focus at the time of that announcement, EMA spokesman Martin Harvey said that the changes were geared toward making the committees more efficient. "We have a lot of new legislation and changes coming through in the next year," Harvey said. "The new changes are about doing more with less while maintaining the Committee's workload. [The Committees] were designed a long time ago, and these changes are meant to improve their efficiency."

But for an agency that already regulates a huge number of products on a fairly tight budget, that means something had to give, and EMA said it would need to cut back on the number of meetings and forums it could attend in 2013. In addition, it said that its scientific and support staff would be heavily vested in the effort, potentially delaying some of their other work as well.

Four New Units

Since that announcement, however, EMA has been mostly silent about how the effort is progressing. Silent, that is, until now.

In a 3 May 2013 statement, EMA explained that the entire reorganization is expected to launch in August 2013, with full deployment occurring in the subsequent 18 months.

The final details are still in the works, the statement explained, but industry and the public can expect at least one major change: The dissolution of its existing medicines evaluation units.

"The main high-level changes are the replacement of the current two Units dealing with medicines for human use with four Divisions focused on: support to the R&D phase; medicines evaluation and lifecycle management; procedure management and business data; and lastly inspections and pharmacovigilance."

"The current entities responsible for veterinary medicines, ICT and administration will remain unchanged, except perhaps for their names," EMA added.

EMA said other changes will include more support to industry during the R&D phase, new "contact functions" for industry, and more efficient interactions between EMA and its stakeholders.

EMA: European Medicines Agency reorganisation