Regulatory News - March 2019

EMA relocation in Amsterdam - EMA London offices will close on 1 March 2019 and re-open on 4 March in Amsterdam, The Netherlands. From 4 to 8 March, the Agency will operate on the basis of extended teleworking. Reduced staff will be present in the new building to deal with any emergencies. From 11 to 15 March, EMA staff will gradually move into the new building.

Updated “Questions & answers on signal management” available on EMA webpage - This revision includes:

  • Information on the implementation of the legal requirement for MAHs to monitor EudraVigilance data and inform EMA and national competent authorities of validated signals, with reference to the ongoing pilot (questions 5 and 6);
  • Update of the requirements for the submission of additional data (question 11);
  • Clarification of the variation category (question 15);
  • Minor alignments with revision 1 of GVP Module IX and editorial improvements throughout

Big data - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support of the evaluation and supervision of medicines by regulators were published on 15 February as part of a summary report of the Heads of Medicines Agencies (HMA) - EMA Joint Big Data task force. The recommendations and associated actions set out what needs to be addressed, but the mechanisms by which this may be achieved requires further focused work over the coming year. Stakeholders are invited to submit feedback and observations on the recommendations to inform the upcoming work of the group. Massive amounts of data are generated on a daily basis through wearable devices, electronic health records, social media, clinical trials or spontaneous adverse reaction reports. There is no doubt that insights derived from this data will increasingly be used by regulators to assess the benefit-risk of medicines across their whole lifecycle. However, in order to benefit from and make prudent use of the data collected, regulators need a deeper understanding of the data landscape.


Stakeholders and members of the public are invited to submit their comments on the core recommendations in the summary report (not to exceed 1,000 words) to bigdatasec@dkma.dk until 15 April 2019. In particular, views on the prioritisation of future actions would be welcomed.

Suspension of fenspiride medicines in the EU - EMA’s PRAC recommended EU-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases. The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes. Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past. To explore the potential link between fenspiride and these heart rhythm problems, animal studies were carried out which now show that fenspiride has the potential to prolong QT in humans. The PRAC will now examine all the available evidence and make recommendations on the action to be taken on marketing authorisations for fenspiride medicines across the EU. Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.

Review of cancer medicine Lartruvo - EMA has started a review of the cancer medicine Lartruvo (olaratumab) after preliminary results from the ANNOUNCE study, which was requested at the time of authorisation in 2016, became available. These show that adding Lartruvo to doxorubicin does not prolong the lives of patients with soft tissue sarcoma more than doxorubicin alone. Based on the preliminary results of the study, EMA has already recommended that no new patients should start treatment with the medicine, and healthcare professionals have been informed in writing of the updated treatment recommendations. EMA will now assess the impact of the full study results on the medicine’s authorised use and recommend whether Lartruvo’s marketing authorisation in the EU should be maintained, varied or suspended.

Review of study on bleeding risk with direct oral anticoagulants - EMA is reviewing the results of a study with the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban). This observational study, commissioned by EMA, assessed the risk of major bleedings with these medicines when used to prevent blood clotting in patients with non-valvular atrial fibrillation (irregular rapid contractions of the heart), in comparison with other oral anticoagulants.
Results from this study show differences in the risk of major bleedings between these medicines. They also raise concerns about the level of adherence in clinical practice to restrictions, special warnings and precautions in the medicines’ product information.
The review aims to assess whether the results of this study have implications on the use of the medicines in clinical practice and whether any changes to the conditions of use and current measures to minimise the risk of bleeding would be needed.

Signal safety reporting in Switzerland - Swissmedic published an information sheet, “Drug Safety Signals”, on the reporting of drug safety signals in Switzerland.