europabio-logoeuropabio-logoeuropabio-logoeuropabio-logo
  • About us
    • Who we are
      • Governance
      • Staff
      • Vacancies
    • What we do
  • Members
    • EuropaBio Members
    • About Membership
  • How we work
    • Healthcare Biotechnology Council
      • Cell & Gene Therapies
      • Medicines For Rare Diseases And Children
      • Regulatory Efficiency
      • Biosimilars & Public Procurement
      • Data & Digital
      • Patient Bio-Forum
    • Industrial Biotechnology Council
      • Food, Feed & Nutrition
      • Circular Bioeconomy
    • National Associations Council
    • SME Platform
    • Biomanufacturing Platform
  • Activities
    • 25 Years of Innovation
    • EFIB 2022
    • European Biotech Week
  • Events
  • Newsroom
    • News & Publications
    • Library
Become a member
✕

EuropaBio on Use of Real-World Data (RWD) and Real-World Evidence (RWE) for regulatory decision-making

20/10/2020
PRESS RELEASE
EuropaBio on Use of Real-World Data (RWD) and Real-World Evidence (RWE) for regulatory decision-making

Use of Real-World Data and Real-World Evidence for regulatory decision-making

October 2020

Objective: With the present paper, EuropaBio would like to support the generation of EMA/HMA guidance(s) on RWD/RWE aligned with international regulatory requirements already used by other Regulatory Authorities.

Health data which are generated in clinical practice and are increasingly in day-to-day life by novel technologies provide a large data pool that should be more broadly utilized to support regulatory decision-making.

Fit-for-purpose Real-World Data (RWD) and subsequent Real-World Evidence (RWE) should become more broadly acceptable for regulatory decision-making beyond the already established use of reactive post-approval safety changes based on real-world market surveillance data. EuropaBio members, who develop treatments for the recognised unmet needs relying on evolving science for biotherapeutics, call for the development of guidance on RWE to pave the way for its use in support of regulatory decisions for sponsor-desired post-approval changes, as well as of initial filings where Randomized Controlled Trials are not appropriate.

In particular, EuropaBio, asks the EU regulators to foster collaborations between relevant stakeholders including HTA bodies and develop a RWE framework and guidelines in alignment with international stakeholders, establish real-world data standard and a common data model, as well as for facilitation of RWE pilots. EuropaBio will advocate use of high-quality and fit-for-purpose RWD and RWE in the decision-making process in the context of new approvals, where clinical trials are not feasible, or post-marketing authorisation labelling changes. We will also proactively involve in guideline commenting and multi-stakeholder activities related to RWD/RWE for regulatory purpose.

Download the file below to read the full Position Paper.

Use of Real-World Data and Real-World Evidence for regulatory decision-making


Download
Share
Alexandra Simionca
Alexandra Simionca

Related posts

06/02/2023

Delivering Europe’s ambitions in rare disease


Read more
01/02/2023

Joint Statement: The Data Act is a leap into the unknown


Read more
31/01/2023

EuropaBio’s 2022 Patient BioForum sets out recommendations to address the challenges of patients with unmet medical needs and calls for multi-stakeholder approach


Read more
17/01/2023

EuropaBio launches SME BioForum in Rare Diseases


Read more

Important links

  • Delivering Europe’s ambitions in rare disease
  • Joint Statement: The Data Act is a leap into the unknown

Categories in our Newsroom

Subscribe for our newsletter

Subscribe to the EuropaBio newsletter to receive the latest news and developments in the Biotech sector!


Subscribe
EuropaBio-Logo-White

EuropaBio represents corporate and associate members across sectors, plus national and regional biotechnology associations which, in turn, represent over 2600 biotech companies, 2300 out of them are SMEs.

Contact us

Extra links

Members
Staff
Privacy policy
Legal & cookies
Events
Newsroom

Become a member

Media pack

© 2023 Europabio. All Rights Reserved. Designed by EYAS
Become a member
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.OkLegal & Cookies