EMA loses more than 100 staffers in move to Amsterdam
Following its Brexit-related departure from London, the European Medicines Agency’s (EMA) staff has been reduced from 897 staffers to 775, EMA said Friday in an update from a board meeting in its new home in Amsterdam.
Although an October EMA management board update said the agency’s staff numbers were down to 730, the uptick comes as a 2017 report said that UK experts made up 15% of the EMA’s expert base and conducted about 20% of its scientific work.
“The Agency is still in the process of rebuilding its workforce after its relocation. It will continue to monitor staff levels and review whether it can relaunch additional activities in June 2020,” EMA said in an update to its webpage on Brexit.
The EMA board also agreed to the mandatory use of the ISO standard for individual case safety reports for the reporting of suspected side effects of medicines.
“The use of the new international standard will become mandatory as of 30 June 2022 for all reporting to EudraVigilance, the European database of suspected side effects reported with medicines authorized in the European Economic Area (EEA),” EMA said. Further information is expected next month.
The board also signed off on EMA’s budget for 2020, which is €358 million, a 3.3% increase from 2019.
And for the new clinical trial regulation, EMA is moving forward with a proposal to begin an audit of its Clinical Trial Information System in December 2020.
“In the first few months of 2020, product owners will work with EMA and the IT supplier to perform the analysis and design of the items that have been prioritised as still needing to be fixed/developed before the audit can begin,” the update says.
EMA also published on Thursday a decision by the executive director on the rules governing the secondment of national experts to the EMA.
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products.