EU medicines regulator mandate reinforced

Photo: EP

Parliament adopted on Thursday its position for negotiations with Council on extending the mandate of the European Medicines Agency and strengthening its role, the EP press service reported. The report was adopted with 587 votes in favour, 28 against and 81 abstentions.

To enhance the agency’s powers in crisis preparedness, management for medicinal products and medical devices, MEPs call for the creation of an interoperable digital EU database aimed at detecting, predicting and preventing shortages of medicinal products. The new database would facilitate, on a permanent basis, access and exchange of information between the agency and corresponding national authorities.

“The pandemic has shown that the EU and its member states were not prepared to tackle a challenge of this magnitude. Agencies such as the EMA did not have an adequate mandate or sufficient resources. We are now strengthening the EMA's capacity to deal with future emergencies. Parliament wants to strengthen the transparency of both the Agency and all actors in the supply chain, and give a more active role to healthcare professionals, as well as encouraging synergies between EU agencies,” Nicolás González Casares (S&D, ES) said.

The experience of running clinical trials during the pandemic revealed a number of shortcomings, including duplication of efforts, the under-representation of important population subgroups in trials, based on gender, age, ethnicity or medical comorbidities, and a lack of collaboration between trials. To improve on this, MEPs call for more coordinated, well-designed and transparent clinical trials.

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