EMA Opens Applications for 2026 Portfolio and Technology Meetings for Large Pharmaceutical Companies

Details of the Update

The Portfolio and Technology Meetings (PTMs) provide an opportunity for large pharmaceutical companies to discuss portfolio-wide regulatory and scientific considerations directly with the EMA. The meetings are conducted virtually and without cost to applicants, lowering barriers to participation while enabling strategic engagement. 

The program is specifically designed to help identify issues affecting product portfolio progress and facilitate dialogue on innovative and disruptive technologies that may influence future regulatory assessments. Through these discussions, the EMA aims to align its scientific and regulatory competencies with the evolving needs of industry pipelines. 

If a meeting request is granted, applicants must submit a completed briefing document using the EMA-provided template (Reference Number: EMA/571070/2023). This document must be delivered four to six weeks before the scheduled meeting via Eudralink. 

In addition, applicants must submit a pre-meeting presentation and a list of meeting participants one week prior to the meeting date. 

Feedback Deadline

The deadline to submit the Portfolio and Technology Meeting application form is April 30, 2026. 

The European Medicines Agency will communicate application outcomes and next steps by the end of May 2026, with approved meetings scheduled to take place during the second half of 2026. 

Why It Matters

The PTM program offers a structured opportunity for companies with large medicinal product pipelines to address cross-portfolio development challenges and emerging technologies with regulators at an early stage. 

By enabling early dialogue, the initiative supports proactive regulatory strategy, improves alignment on scientific expectations, and helps reduce future regulatory uncertainty across complex portfolios, including novel modalities, biologics, and advanced therapies. The virtual and no-fee format further improves accessibility for qualifying organizations. 

Who This Is Relevant For

This announcement is particularly relevant for Regulatory Affairs, Medical Affairs, Research and Development, and Commercial teams within pharmaceutical companies managing large medicinal product portfolios. These functions play key roles in preparing PTM applications, identifying cross-portfolio issues, and coordinating briefing materials that address scientific, regulatory, and strategic pipeline considerations.

Next Steps

Organizations planning to participate should initiate internal coordination early to ensure timely preparation and submission of the Portfolio and Technology Meeting (PTM) application form by April 30, 2026. 

• Regulatory Affairs teams should first assess portfolio eligibility, complete and submit the PTM application, and if the meeting request is approved, coordinate preparation of the EMA briefing document (EMA/571070/2023) and manage the Eudralink submission four to six weeks before the scheduled meeting. 

• Medical Affairs teams should identify cross-portfolio scientific and development issues that may require regulatory discussion and work closely with Regulatory Affairs to shape the meeting agenda and briefing inputs. 

• Research and Development teams should contribute to pipeline data and technology-related topics, including novel or disruptive modalities, for inclusion in the briefing document and pre-meeting presentation. 

• Commercial and Marketing teams should provide input on portfolio strategy and lifecycle management priorities that may benefit from early scientific alignment with the European Medicines Agency. 

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FAQs

What is the new CDE guidance on influenza vaccine clinical trials? 

Portfolio and Technology Meetings (PTMs) are structured virtual meetings organized by the European Medicines Agency to allow large pharmaceutical companies to discuss product portfolio development challenges and emerging technologies with the regulator.

Who can apply for EMA Portfolio and Technology Meetings? 

The PTM program is open to large pharmaceutical companies with extensive medicinal product portfolios. Eligible companies must submit an application form to the EMA for review.

When is the deadline to apply for a PTM in 2026? 

The application deadline is April 30, 2026. The EMA will communicate application outcomes by the end of May 2026, and approved meetings will take place in the second half of 2026.

How can RegASK help organizations manage updates like this? 

RegASK’s agentic AI regulatory intelligence platformhelps pharmaceutical companies monitorglobal regulatory announcements, engagement opportunities, and consultation programs in real time. This enables regulatory teams to identify initiatives such as EMA Portfolio and Technology Meetings, coordinate internal preparation, and maintain compliance readiness across complex global pipelines.