Timeliness, more guidance sought for EMA early interaction meetings

Manufacturers and other experts are generally satisfied with the European Medicines Agency (EMA) initiatives to bring medicines to market faster; however, early meetings could be improved by being more timely and providing more clarity on scope and processes.

EMA conducted two surveys in 2024 that asked drug manufacturers and European Medicines Regulatory Network (EMRN) experts how they rated EMA's early engagement efforts to help bring new drugs to market faster. More specifically, the surveys asked for feedback on the level of support the agency offered in relation to the meeting request process, the content of the discussions, the meeting output, and the overall experience.

Results from EMA's survey of industry stakeholders published on 16 April found that drugmakers are generally satisfied with the timing and clarity of the early meeting request process, the information they've received from the support teams, the overall meeting experience, and the outcomes. However, manufacturers also provided feedback on ways the agency could improve its processes.

For Innovation Task Force Briefing Meetings (ITF BM) and Portfolio and Technology Meetings (PTM), drugmakers asked for more clarity in the published information, and a more streamlined process and templates. They also asked for improved dialogue with the expert team in the case of ITF BMs and more flexibility of templates in the case of PTMs.

Quality Innovation Group (QIG) meetings received positive reviews from manufacturers, but respondents also recommended ways to improve the meetings.

“Responders mainly suggested to improve timelines, promote engagement during the meetings with more focused discussions and to have more clarity on topic selections,” said EMA. “The need to have more clarity on how the QIG interlinks with other groups was also flagged.

“Responders suggested to establish regular QIG contact points and provide additional guidance [in QIG targeted interactions],” the agency added.

When asked about small and medium-sized enterprises briefing meetings (SME BM), manufacturers said they want more clarity on guidance regarding pre-meeting preparation.

In the survey of EU network experts, respondents recommended improving the expert selection process during ITF BMs and clarifying the scope of the meeting to manufacturers. For QIG meetings, they asked EMA to improve the overall timelines and team composition, raise awareness amongst SMEs and academia, and issue more guidance to companies about the scope of the meetings.

EMA report

Timeliness, more guidance sought for EMA early interaction meetings

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