The European Medicines Agency (EMA) has proposed a new template to facilitate the sharing of documents by pharmaceutical companies to support regulatory reliance, a process where one regulatory authority relies on assessments conducted by another trusted authority. The proposal, published on April 9, 2026, aims to streamline the submission of evidence for marketing authorisation applications, impacting pharmaceutical companies, regulatory authorities in EU member states, contract research organisations, and patient advocacy groups.
The document, released by EMA's Regulatory Science and Innovation Task Force, is a draft template for industry to use when providing documents that demonstrate reliance on a reference regulatory authority's assessment. It is not yet a binding requirement but is open for public consultation, with the agency seeking feedback from stakeholders before finalisation. The template is intended to standardise the format and content of such submissions, reducing duplication of effort and accelerating access to medicines.
Building on prior regulatory reliance initiatives
This proposal follows the EMA's ongoing efforts to promote regulatory reliance, as outlined in its 2025-2030 strategy. It also builds on the April 8, 2026 CHMP committee minutes, which discussed standardising patient-reported outcome measures (PROMs) to improve data comparability, though that document focused on clinical trial endpoints rather than regulatory submissions. The new template is part of a broader push to implement the Clinical Trials Regulation (EU) No 536/2014, which became applicable on January 31, 2022, and introduced a centralised EU portal (CTIS) for clinical trial applications. On April 7, 2026, EMA published a training module for CTIS, assisting sponsors with submitting substantial modifications to ongoing trials.
Policy orientations and trade-offs
The template represents a move towards greater harmonisation and efficiency in regulatory processes, potentially reducing the time and cost for companies to bring medicines to market. However, it also raises concerns about the balance between reliance and national sovereignty, as member state authorities may have different standards or capacities to assess reliance documents. The proposal is a recommendation rather than a mandatory requirement, leaving room for national regulators to adapt their procedures.
Impact on stakeholders
- Pharmaceutical companies: The template could simplify the submission process, reducing administrative burden and costs, especially for companies seeking approvals in multiple jurisdictions. However, they may need to invest in training to comply with the new format.
- National regulatory authorities: The template may facilitate faster assessments by providing standardised information, but could also limit their flexibility to request additional data specific to local contexts.
- Contract research organisations (CROs): CROs involved in preparing regulatory dossiers may need to update their procedures to align with the template, incurring initial adaptation costs.
- Patient advocacy groups: Faster access to medicines could benefit patients, but reliance on foreign assessments may raise concerns about transparency and accountability in the approval process.
Expected institutional follow-up
The EMA will collect feedback during the public consultation period, after which the template may be revised and adopted as a formal guideline. The agency is expected to work with the European Commission and national competent authorities to ensure consistent implementation across the EU.