Last weeks round-up; 9 – 13 December 2019

EMA NEWS: PRAC SIGNAL ASSESSMENTS

In the six years since implementation of the pharmacovigilance legislation over 26,000 potential signals were reviewed, resulting in 453 signals assessed by EMA’s safety committee (PRAC). More than half of the PRAC recommendations resulted in changes to medicine product information supporting the safe and effective use of medicines. The system also proved responsive with recommendations for risk minimisation measures made in as little as five days of a signal being confirmed (median of five months). A recent article describes the process for signal management in place in the EU, and outlines the specific actions to rapidly communicate reliable information on the safety of medicines. The article can be found under this link – https://lnkd.in/d8evMMd

EMA UPDATE ON METFORMIN DIABETES MEDICINES

EMA update on metformin diabetes medicines On the 6th December the EMA issued a press release indicating that the levels of NDMA in the affected non-EU metformin medicines are very low and appear to be within or even below the range that people can be exposed to from other sources, including certain foods and water. Patients in the EU should continue taking their metformin medicines as normal. EMA will provide further updates as more information becomes available. https://lnkd.in/dKzYKru