EMA to restructure with drug reviews and plant inspections in mind

By Gareth Macdonald

- Last updated on GMT

Related tags: Pharmacology

EMA to restructure with reviews and inspections in mind
EMA to restructure with reviews and inspections in mind
The EMA has announced plans to change how it reviews drugs and inspects production facilities by 2014 as part of a wide ranging restructuring programme.

The European Medicines Agency (EMA) revealed it has set up four new divisions – R&D support, evaluation, business support and inspections - late yesterday, explaining that the move would better support its scientists, improve how it shares information and provide benefits for both patients and the drug industry.

Executive director Guido Rasi said the new structure will allow the agency to adapt to future challenges and seize opportunities, explaining that: “My aim is to give our scientific committees the best possible support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions.

“These changes will enable us to use our resources more efficiently and effectively and ensures that the Agency is better prepared for future legislative and policy challenges."

Early days

The announcement is just the start of a wider process due to extend into 2014 according to EMA spokeswoman Monika Benstetter who told in-Pharmatechnologist.com the plan is to allow “the agency do more with what we have​.”

We have a skeleton structure and senior management in place, but we not made any concrete changes​” she said adding that “we obviously want to keep stakeholders informed​.”

Benstetter explained: “No changes affecting [Drug industry] stakeholders have been made​,” going on to say that pharmaceutical firms will continue to work with the same EMA representatives until the new structure is in place.

The EMA first mooted the restructuring plan in December last year shortly before it released its budget for 2013.

At the time the agency predicted that it will spend some €231m ($302m) in the year to December 31, 2013, which is 4% more than its outlay in 2012, and said that it increase what it charges drugmakers to review products to fund the increase​.

Related topics: Markets & Regulations, Regulations

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