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Regulatory News | 19 December 2016 | By Zachary Brennan
The European Medicines Agency (EMA) on Monday announced that its management board signed off on a slightly increased 2017 budget as preparations for the UK’s departure from the EU continue.
“The extent of the impact of Brexit on the Agency’s operations and location is uncertain and will depend on the future relationship between the EU and the UK,” EMA said. “Depending on the outcome of the negotiations, this could cause significant disruption to the Agency’s operations and business continuity plans will need to be in place. As part of its preparedness, the Agency will continue carrying out impact assessments to identify the main risks and propose possible mitigating measures to maintain the Agency’s ability to protect public health.”
Back in July, EMA said the decision to move its headquarters and more than 800 employees would be decided by EU member states. Ireland, Spain, Sweden, Denmark, Italy and Germany are all seeking to host the headquarters of the drug regulator.
Despite the uncertainties due to Brexit, EMA’s management board signed off on a budget of 322 million Euros for 2017, a 4.4% increase over 2016.
The additional funds are expected to cover the 5.4% increase in EMA’s fee-financed workload and will also allow the agency to focus on priority areas, which it says includes antimicrobial resistance, supporting innovation and access to both human and veterinary medicines, increasing and improving regulatory capacity and capability, as well as its continued commitment to increased transparency.
A full work program will be published by the end of January 2017.
In addition to the budget, the board endorsed an extension of the concept of forming multinational assessment teams to perform post-authorization assessments.
Since 2013, EMA has been encouraging the formation of assessment teams by expertise, initially for the assessment of new medicines. And following the board’s endorsement, assessment teams made up of experts from several member states will evaluate applications for extensions of marketing authorizations of existing medicines beginning April 2017.
In addition, the board gave the green light for the launch of a public consultation in January 2017 to revise the agency’s existing policy on access to documents. The revision seeks to take account of the experience gained since the current policy entered into force in 2010, and to extend its scope to include both access to documents that relate to human or veterinary medicines, and to corporate information.
The board also endorsed an update to the existing framework for interactions with healthcare professionals, which places new focus on the involvement of general practitioners and family physicians.
Tags: EMA and Brexit, EMA budget, EMA transparency