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EMA to Reinstate Some Activities Halted by Brexit

Posted 17 June 2019 | By Zachary Brennan 

EMA to Reinstate Some Activities Halted by Brexit

While noting some progress in its Brexit preparations on transferring medicine marketing authorizations from the UK to the EU, the European Medicines Agency (EMA) on Monday announced a series of activities that will ramp up, in addition to the highest priority activities, for the remainder of 2019.

But EMA also reiterated that between 20% and 25% of the agency’s staffers are expected to leave. And in the most recent EMA update, of the agency’s 776 staff members, 464 have relocated to the EMA’s new headquarters in the Netherlands, but 312 are working remotely, mostly from London.

“Due to resource constraints, most activities temporarily suspended at the end of 2018 remain on hold. These include guideline development, most working party meetings, engagement in international activities and the proactive publication of clinical data. A further review by EMA's Management Board will take place in October 2019,” EMA said.

As far as the new activities to be reinstated, EMA said the focus will be on projects aiming to increase the efficiency of EMA’s operations, such as with IT systems supporting medicine evaluations and the digitalization of administrative processes. Key public health priorities, including the availability of medicines and antimicrobial resistance (AMR) will also see renewed work, in addition to the restarting of some of the EU network working groups.

In addition to those activities, EMA also said it faces a substantial workload from new legislation for which no additional resources have been made available. These include the regulations on medical devices and in vitro diagnostic medical devices, for which EMA has published guidance, the EU Data Protection Regulation and the veterinary legislation, which foresees the development of major IT infrastructure and re-engineering of processes.

“Preparatory work on these pieces of legislation has been tentatively planned to start as of June 2019, but any work undertaken will be subject to availability of the required human and financial resources,” EMA said. 

Brexit Progress

The regulator also offered some positive news on Brexit preparations, noting that as of this month, just three marketing authorizations for human medicines still needed to be transferred from the UK to an EU member state. 

For qualified persons for pharmacovigilance (QPPVs), the necessary changes have been made for 243 out of 335 medicines, for pharmacovigilance system master files (PSMFs), changes have been made for 313 out of 376 medicines, and for batch release sites, changes have been made for 95 out of 119 medicines.

“Good progress” has been made for products with QPPVs and PSMFs based in the UK, EMA said. “Although companies have reassured EMA that their plans are in place, the Agency reminds them of their responsibility to make the necessary changes required by EU law as soon as possible.”

EMA

Categories: Regulatory News

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