Spring Intro 2023

22/03/2023

EMA Regulatory Science to 2025 GOALS*

Goal 1

Goal 2

Goal 3

Goal 4

Goal 5

Support precision medicines omics

Contribute to down stream decision making

Partner with academia on fundamental research

Foster innovation in Clinical Trials

Health threats preparedness

Collaborate on emerging scientific questions

Invest in special populations

Translation of ATMPs to patients

Bridge collaboration with payers

New anti microbials

Optimize modeling

Use of RWE in decision making, Big Data

Identify best expertise in EU and Internationally

Novel manufacturing technologies

Address supply issues

simulation & extrapolation

Exploit digital tech and AI in decision making

Integrated evaluation for Med Dev and IVDs

Product information in electronic format (ePI)

Support re purposing of known actives

Disseminate and exchange knowledge

The Organisation for Professionals in Regulatory Affairs

* Selected goals, for full EMA RSS to 2025 objectives refer to EMA: https://www.ema.europa.eu/en/documents/leaflet/ema-regulatory-science 2025-five-goals_en.pdf

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EUROPEAN COMMISSION ROADMAP FOR EVALUATION & REVISION OF EU PHARMACEUTICAL LEGISLATION

Overview: As part of the European Commission’s ‘Pharmaceutical Strategy for Europe’, a roadmap for the evaluation and revision of the pharmaceutical legislation was published in April 2021 DRAFT legislative text publication awaited 29 March 2023

The objective of the initiative is to: 1

Ensure access to affordable medicines in the EU Foster innovation, particularly in areas of unmet medical need (such as orphans, pediatric, antimicrobials) Enhance security of supply, while adapting to new scientific and technological developments and reducing regulatory burden Future-proof and crisis-resistant pharmaceutical system by drawing on lessons learnt from COVID-19 pandemic

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The Organisation for Professionals in Regulatory Affairs

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