EMA Scientific Advice Hits Record Volumes as Agency Plans Agile Pilot

EMA scientific advice volumes hit a record in the first half of 2026, pushing the European Medicines Agency to rethink how it supports medicine developers. The changes, which include a pre-payment model for advice applications and an agile advice pilot targeted for early 2027, were set out at the 16th Industry Stakeholder Platform on Research and Development Support on 2 July 2026. The agency published its report on 31 August 2026 under reference EMA/153098/2026.

Co-chairs Michael Berntgen and Iordanis Gravanis led the meeting, which brought regulators together with seven industry associations: AESGP, ARM, EFPIA, EUCOPE, EuropaBio, Medicines for Europe and Vaccines for Europe. Representatives of the CAT, COMP, CHMP, PDCO, SAWP-H and 3Rs Working Party joined from the scientific committees and the wider European regulatory network.

EMA scientific advice reaches record volumes

Scientific advice applications reached their highest level to date in the first half of 2026, and the agency acknowledged that some procedures started late or were postponed as a result. The number of discussion meetings, including explanatory teleconferences, held broadly steady with earlier years. Industry asked the agency to publish further guidance on the procedural option of explanatory teleconferences.

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On payments, a pre-payment model is under consideration so that applicants pay at submission rather than at validation, as has been the case since the start of 2025. Implementation is planned by the end of 2026. Direct debit will also be enabled for regulatory invoices. On broad scientific advice, the agency reported early internal thinking on involving other EU agencies, in line with the New Pharmaceutical Legislation, and will revisit the scope, process and public guidance as part of that legislation’s implementation.

Under the SAWP and Clinical Trials Coordination Group (CTCG) pilot, 19 applications had been received by mid-2026, and the pilot continues until further notice. Industry suggested making CTCG involvement part of regular operations in relevant cases and extending the scope in a new pilot to cover ethics committees and combination products.

Agile scientific advice pilot planned for 2027

A focus group with industry, the Scientific Advice Working Party (SAWP) and the agency has been set up to explore an agile scientific advice process for time-critical development while keeping the EU system robust and predictable. The group has agreed in principle on the need for a more agile tool and on testing the concept through a pilot. The proposed model would handle focused, well-defined scientific questions that need rapid feedback, often where accelerated timelines could meaningfully shape development decisions. It could be limited to a small number of questions within a single discipline where medical need and agility are justified. Complex or multidisciplinary topics would stay in the standard EMA scientific advice framework. The next phase will refine the scope, operating model, pilot design and success measures, with a pilot launch targeted for the first quarter of 2027.

Model-informed drug development pilot launched

The agency launched a pilot in May 2026 for scientific advice tailored to programmes where model-informed drug development (MIDD) evidence is expected to be central to regulatory decisions. The pilot sits within the implementation of the ICH M15 guideline and follows the HMA and EMA multi-stakeholder workshop on reporting and qualification of mechanistic models. A discussion meeting will be offered in all relevant cases unless both the applicant and the SAWP agree to cancel it.

Combination products and parallel EMA-FDA advice

On combination developments, the agency reported progress on Project 5 of the COMBINE programme, which looks at advice needs for sponsors of combination products that pair medicinal products with medical devices or in vitro diagnostics. The project has moved through needs clarification and gap analysis, using project group meetings, a stakeholder workshop and surveys of sponsors, authorities, ethics committees and notified bodies. A draft report is in preparation, a second stakeholder workshop is planned for late September 2026, and the final phase of proposal development runs from October 2026 into the first quarter of 2027.

Separately, the agency and industry presented interim results of a survey on parallel EMA and FDA support for global development plans. The survey found strong industry support for the two agencies working together, while flagging room to improve efficiency, transparency, communication and coordination across existing mechanisms.

PRIME scheme evolves toward a ten-year review

The agency reported a year-on-year rise in PRIME applications since 2022 and described the expansion of the Product Development Coordinator (PDC) pilot, launched in July 2025 to strengthen product-specific support. The pilot will be expanded in its second year, with lessons from the first 12 months used to refine the role and its performance indicators. Work continues on the product development tracker, feedback mechanisms, expedited scientific advice and submission readiness. The agency also set out the scope of a planned ten-year analysis of the PRIME scheme, covering eligibility patterns, development outcomes, regulatory interactions and the impact on marketing authorisation applications. Industry welcomed the progress and called for outcome- and impact-focused measures alongside operational indicators.

Qualification of novel methodologies modernised

The agency published updated procedural guidance for the Qualification of Novel Methodologies (QoNM), following broad stakeholder input. New elements include a chapter defining the scope of QoNM, early-interaction support with scoping meetings before formal submission, optional stakeholder consultation where external expertise is needed, publication of high-level information on qualification advice, periodic informal dialogue between the qualification opinion holder, the methodology developer and the agency, and lifecycle management considerations. The QoNM webpage will be upgraded by September 2026, and briefing document templates are being drafted, with a general template and a registry and real-world evidence template targeted for the third quarter of 2026. Questions and answers on the use of real-world data were published in May 2026, and a communication and engagement plan is being prepared for a webinar later in 2026.

NPL implementation and the platform’s role

The meeting also covered how the R&D stakeholder platform will feed into implementation of the New Pharmaceutical Legislation (NPL). The Industry Stakeholder Group will act as the strategic forum, while the stakeholder platforms provide topic-specific discussions. For the R&D platform, discussions are expected to focus on the Development Support and the ERA & 3Rs delivery streams. Industry asked for more detailed implementation plans as they become available.

Paediatric development and the regulatory sandbox

On paediatrics, the stepwise paediatric investigation plan (PIP) pilot has now been embedded into standard practice, so applicants can use the approach where scientifically justified as long as the initial PIP contains a paediatric strategy and future steps are well defined. The agency also flagged that the NPL will introduce the mechanism of action (MoA) concept, and noted that public consultation on proof-of-concept data to support paediatric oncology development had just closed, with a workshop to follow on 21 September. Two short communications are due shortly, one on translating non-clinical proof of concept using HER2-targeting antibody-drug conjugates and another on PARP inhibitors.

On the regulatory sandbox, the agency presented the concept as provided for in the NPL and flagged a joint European Commission and EMA multi-stakeholder workshop on 21 September. Industry associations were invited to submit proposals for questions and topics by 4 September, and highlighted the IHI BRIDGE consortium and the need to bring in small and medium enterprises and academia.

Real-world data, indirect comparisons and 3Rs pilots

A focus group on real-world data and evidence reported that a question-and-answer document on DARWIN EU is under final review and should publish after the summer. With no further deliverable planned, the group will likely convert to a sounding board, with a closing report due at the platform meeting at the end of 2026.

The agency is also developing question-and-answer guidance on indirect treatment comparisons (ITCs), focused on how ITCs should be reported in submissions rather than on evidentiary standards. The work spans the Methodologies Working Party, COMP and CHMP, and is backed by a research project reviewing ITC use and reporting in all orphan maintenance procedures initiated between 2023 and 2025.

Finally, the agency provided an update on the Voluntary Data Submission (VDS) pilot for new approach methodologies (NAMs), which spans four regulatory areas: biologics risk assessment, developmental and reproductive toxicity, safety pharmacology, and hepatotoxicity and drug-induced liver injury. The pilot will launch in the third quarter of 2026. On bioequivalence, the list of expected product-specific bioequivalence guidelines for 2026 has been published under ICH M13A, section 4 questions and answers have been reviewed, and the agency proposed an annual survey for future topic selection.

Source: European Medicines Agency, Highlight report from the 16th Industry Stakeholder Platform on Research and Development Support (EMA/153098/2026).