Early stakeholder interaction and advice on RWD and RWE: a scoping review

Study identification

• EU PAS number:
  EUPAS1000000669
• Study ID:
  1000000669
• Official title and acronym:
  Early stakeholder interaction and advice on RWD and RWE: a scoping review
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Real-World Data (RWD) and Real-World Evidence (RWE) are increasingly being considered in the scientific evaluation of human medicines both globally and within the European regulatory framework.; The European Medicines Agency (EMA) plays a key role in providing scientific advice and support to pharmaceutical companies throughout the drug development process. This support can begin even before marketing authorisation, during the early stages of scientific dialogue related to drug research and regulatory approval.; The Agency engages with a wide range of stakeholders - including small and medium-sized enterprises (SMEs), large pharmaceutical companies, and academic institutions - through various mechanisms. These include specialised working groups and divisions that actively incorporate RWE into their advice. The outcomes of these engagements vary: some documents remain internal and confidential within the Agency, while others are incorporated into official EMA documents, such as assessment reports, and made publicly available.; This study aims to analyse the content and focus of stakeholder requests, along with the corresponding advice or outcomes provided by EMA during early interactions related to RWD and RWE, by reviewing EMA documents over the past five years (2020–2025).; Through this analysis, the study also aims to identify gaps in how RWD/RWE-related requests are currently addressed during early stakeholder engagement to enhance the quality and consistency of scientific advice. It will also assess how aligned the support provided is across different EMA mechanisms, with the goal of informing strategies for more effective and coherent regulatory collaboration in the future.
• Study status:
  Ongoing

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Networks

EU Pharmacoepidemiology and Pharmacovigilance (PE&PV) Research Network

Netherlands

Study timelines

Date when funding contract was signed

Planned:18/11/2024

Actual:09/07/2025

Study start date

Planned:18/11/2024

Actual:09/07/2025

Date of final study report

Planned:11/01/2026

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable