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EMA, HMA and EC launch advice programs for trial applications and MAAs

Posted by on 19 June 2024
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Sponsors looking to test drugs in the EU can access a new advice service designed to improve the quality of clinical trial applications.

The advice program – which was unveiled by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission (EC) last week - consists of two schemes focused on marketing authorization applications and clinical trial applications, respectively.

In an official statement the EMA said “Developers of medicinal products who wish to receive advice on the requirements for a MAA or a CTA may apply to these pilots. The duration of both pilots will be evaluated over time based on data and feedback collected from applicants. All this information will inform a possible change of scope and a final decision from the ACT EU steering group on how to optimize clinical trial support in the future."

It added: “By strengthening the coordination of the European medicines regulatory network, these advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorization.”

The idea is that sponsors can access a broader range of information sources – specifically the Scientific Advice Working Party (SAWP) and the Clinical Trials Coordination Group (CTCG) - than they can through current support systems.

According to the EMA “Assessors of clinical trials are not consistently involved in scientific advice procedures for MAAs, and vice versa… This pilot consolidates the views of these two groups to minimize avoidable divergences. It is the first time that both entities are providing joint scientific advice on clinical trials.

The advice programs were developed as part of the 2022 ACT EU initiative, which aims to make the EU into a focal point for clinical research and promote the development of high-quality, safe and effective medicines.


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