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EU aims to make medicines review more efficient

Written by | 3 Nov 2024

The European Medicines Agency (EMA) and the European medicines regulatory network plan to improve the efficiency of how new medicines are assessed and approved. A new initiative aims… read more.

Green light for 10 new medicines in the EU

Written by | 2 Nov 2024

Ten new medicines have been recommended for approval by the European Medicines Agency (EMA), with another six products recommended for extension of their therapeutic indications. This brings to… read more.

European watchdog to support African drug regulator

Written by | 7 Sep 2024

The EU medicines regulator, the European Medicines Agency (EMA), has announced plans to support its counterparts in African countries – paving the way for the creation of a… read more.

New EU plan to boost orphan medical devices

Written by | 6 Sep 2024

The European Medicines Agency (EMA) has launched a pilot programme to support the development and assessment of orphan medical devices in the European Union (EU). The initiative offers… read more.

EU gives green light for 14 new medicines

Written by | 5 Sep 2024

The European Medicines Agency (EMA) has approved fourteen new medicines at a summer meeting, with a further eleven products recommended for extension of therapeutic indications. The Agency’s human… read more.

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.

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