On 25 September 2024, the EMA and the HMA held a joint workshop on submission predictability, bringing together representatives from the national competent authorities, industry, and EMA, to focus on submission predictability and how it...
The European Medicines Agency (EMA) organised a hybrid SME (small and medium-sized enterprises) info day on 18 October 2024. The SME info day is a training event dedicated to small and medium-sized enterprises in the...
On 22 April 2024, EMA organised a workshop to present and discuss to Notified Bodies (NBs) the current activities being developed by the Expert Panels. The secretariat presented an overview of the consultation procedures – Clinical Evaluation Consultation Procedure (CECP) and Performance...
As set out in the interim report of the pilot: In 2020, the joint Big Data Task Force of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published ten priority recommendations...
New pages dedicated to Medical devices and In Vitro medical devices have been created on the EMA Website: Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert...
On 22 October 2024, the ACT EU multi-stakeholder platform held its annual meeting as already mentioned in a previous news. The EMA published the presentation materials as well as the video recording of the meeting,...
The EMA released its revised version of the Guidance for applicants seeking access to PRIME scheme. This document provides guidance to prospective applicants to the PRIME (PRIority MEdicines) scheme, including relevant templates. More information on...
The EMA released a new factsheet summarizing the key elements of the PRIME scheme. More information on the PRIME scheme on the EMA Website.
EMA is revising its policy on handling of competing interests of scientific committee members and experts (‘Policy 0044’). Stakeholders are invited to comment on the draft revised policy until 10 November 2024 using an online...
EMA and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 for an eight-week public consultation. This is a review and update to the original five-year strategy, which...
