The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make best use of big data to support innovation and public health, in a report published today .
EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.
EMA’s safety committee (PRAC) has confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of estradiol to a single treatment period of up to 4‑weeks. This follows a re-examination of its recommendation of October 2019 which was requested by one of the companies that market high-strength estradiol cream.
EMA is pleased to announce the appointment of Dr Hilmar Hamann as Head of the Information Management Division as of 16 January 2020.
At its December 2019 meeting, EMA’s Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting individual cases of suspected side effects in patients across the world. This follows a recommendation from EMA’s safety committee (PRAC) in October 2019. 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 with medicines authorised in the European Economic Area (EEA).
EMA has published an overview of its key recommendations of 2019 regarding the authorisation and safety monitoring of veterinary medicines.
EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.