EU drug safety reporting system delayed

Launch of a new European drug safety reporting system has been delayed for four months – taking the date to November next year, the regulator has announced.

The European Medicines Agency (EMA) said the enhanced EudraVigilance system has been delayed as its current performance will not match demand.

In a management board update, the EMA said that the system will process very large numbers of reports and interactions every day.

Use will increase significantly as new functions are made available, the EMA added.

The EMA said in a statement: “The four-month delay is mainly due to the need to optimise the performance of the new system prior to its launch.”

The announcement means that the new system will be in place more than five years after the 2012 pharmacovigilance directive that mandated it.

EudraVigilance will allow electronic exchange of individual case safety reports between the EMA, national regulators, marketing authorisation holders and clinical trial sponsors.

It will also provide early detection and evaluation of possible safety signals and product information for authorised medicines.

Electronic reporting will be obligatory for marketing authorisation holders and sponsors for clinical trials.

Aside from the fully automated message processing system, the system provides a large pharmacovigilance database with query and tracking functions.

The EMA has also added new civil society representatives to its board. Ilaria Passarani, head of the food and health department at the European Consumer Organisation and Yann Le Cam, CEO and co-founder of the European Organisation for Rare Diseases will represent patients’ organisations.

Wolf-Dieter Ludwig, head of the Department, Oncology, Tumor Immunology and Palliative Care at the German hospital Helios Klinikum Berlin-Buch, will represent healthcare professionals.

Former health commissioner Tonio Borg has been appointed to represent the European Parliament, and will serve alongside Bjorn Lemmer, who has been reappointed. Nancy De Briyne will represent the Federation of Veterinarians of Europe.

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