Europe – EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials
The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application...
Europe – EMA Management Board: highlights of March 2024 meeting
EMA annual report 2023
The Board adopted EMA’s annual report for 2023. In 2023, EMA recommended 77 medicines for marketing authorisation for human use, 39 of which...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
12 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
The CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec)...
Europe – Regulatory requirements for conditional marketing authorization ‘evolving’
Regulatory requirements for conditional marketing authorizations (CMAs) are “evolving” and more complicated than in the past in terms of demonstrating a product’s major therapeutic...
Europe – Environmental risk assessment of medicinal products for human use
It is mandatory for a marketing authorisation application (MAA) for a medicinal product for human use (HMP) to include an environmental risk assessment (ERA)....
Europe – Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT...
UK – New treatment option available today for womb cancer
540 adults will have access to Dostarlimab (also called Jemperli and made by GSK). Dostarlimab is a monoclonal antibody and helps the immune system...
Europe – EU pharmaceutical policy: MEPs support comprehensive reform
On Tuesday, the Environment, Public Health and Food Safety Committee adopted its position on the new directive (66 votes in favour, two against and...
Europe – European Parliament committee proposes changes to pharma legislation
The European Parliament’s health committee is set to debate and vote on changes to the proposed pharmaceutical legislation on 19 March, including provisions that...
Europe – EU regulators and industry clash on pharmaceutical reform package
European Union officials said a proposal to reform the EU pharmaceutical legislation will go a long way towards providing equal access to new medicines,...
