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EuropaBio recommendations to support EU ATMP Innovation


Outlines and elaborating EuropaBio’s position and policy recommendations to the European Commission (EC)

EuropaBio has released a white paper with recommedations to the European Commission to ensure the EU remains a leader in ATMP innovation. These recommendations are broken up into short term, mid term and long term measures focussing on Clinical Trials, Genetically Modified Organism and Optimised Evidence requirements. You can find the full document here.

EuropaBio ATMP Whitepaper_09032020

As a quick summary recommendations for;

  1. Clinical Trial Requirements – Rapid Advice, Enhanced Paediatric Advice, Optimisation of PRIME scheme, EMA-FDA Collaboration, Expert Group Formation, EMA-FDA Collaboration
  2. Genetically Modified Organism (GMO) – Assess whether GMO requirements are appropriate for medicines given the current state of knowledge, The potential for centralised decision-making on GMOs
  3. Optimised Evidence Requirements Including Real World Evidence (RWE) – Parallel Consultation Optimisation, ATMP HTA Framework, Demonstration Projects, RWE Best Practice, Strategic Initiative

Who is EuropaBio?

The European Association for Bioindustries (EuropaBio) represents 81 corporate and associate members and bio regions, and 15 national biotechnology associations in turn representing over 1800 biotech SMEs at a Member State level. They are the recognised voice of the European biotech community championing world-class solutions for society’s challenges.

Find out more here.