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EU regulators seeks new partners for real-world data network

Written by | 10 Apr 2024

Real-world data looks set to play an increasingly important role in how medicines are assessed for safety and effectiveness in Europe. The Data Analysis and Real-World Interrogation Network… read more.

Green light for 12 new medicines from EU watchdog

Written by | 8 Apr 2024

The European Medicines Agency (EMA) has recommended the approval of twelve new products, following reviews by its key human medicines committee (CHMP). This brings to twenty-five the number… read more.

EU recommendations for seasonal flu vaccine composition

Written by | 7 Apr 2024

The winter flu season may be over in the northern hemisphere, but EU regulators are already looking ahead to the next outbreak in autumn 2024. Influenza viruses continuously… read more.

Regulators in Europe set out vision for AI in medicines data

Written by | 11 Jan 2024

Artificial intelligence (AI) will play a role in drug development, including the way in which medicines are regulated, according to European experts. The European Medicines Agency (EMA) and… read more.

Green light for 77 new medicines in the EU in 2023

Written by | 11 Jan 2024

A total of seventy-seven new medicinal products were approved in Europe last year, seven of which were given the green light in December. At European level, the EMA’s… read more.

EU gives green light for 7 new medicines

Written by | 23 Oct 2023

The European Medicines Agency (EMA) has recommended seven medicines for approval at its October 2023 meeting. The brings the total number of newly approved medicines this year to… read more.

New transparency rules for EU Clinical Trials System

Written by | 22 Oct 2023

The European Medicines Agency (EMA) has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The changes give access… read more.

EMA gives green light for 14 new medicines

Written by | 6 Sep 2023

The EU medicines watchdog, the European Medicines Agency (EMA), has approved 14 new products at its summer meeting in Amsterdam. This brings to 46 the total number of… read more.

EMA to revamp Emergency Task Force

Written by | 22 Jun 2023

The European Medicines Agency (EMA) was praised for its contribution to the EU’s pandemic response, as the agency took steps to review the role of its Emergency Task… read more.

Green light for two new medicines in the EU

Written by | 22 Jun 2023

The European Medicines Agency (EMA) has approved two new medicines at its May meeting. This brings to 30, the number of products given the green light by the… read more.

Green light for new medicines in the EU

Written by | 13 Apr 2023

The European Medicines Agency (EMA) approved a total of 89 new medicines in 2022. Of these, 41 had a new active substance which had never been authorised in… read more.

EMA trials scientific advice for high-risk medical devices

Written by | 11 Apr 2023

The European Medicines Agency (EMA) has launched a pilot to give scientific advice on the intended clinical development of certain high-risk medical devices. The new initiative applies to all… read more.

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