Evidence map›Paper›PMID 41147890›Full record

ReviewClinical pharmacology and therapeutics2025

A Fast Path from Innovation to Safe and Effective Medicines.

Peter Arlett, Falk Ehmann, Ralf Herold, Evdokia Korakianiti, Pierpaolo Moscariello, Liese Barbier, Iordanis Gravanis, Frank Pétavy, Emmanuel Cormier, Andrew Thomson and 2 more

Abstract readReview
In one paragraph

Review in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Peter ArlettEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0000-0002-6640-0117
Falk EhmannEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0000-0001-9226-027X
Ralf HeroldEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0000-0002-8148-6748
Evdokia KorakianitiEuropean Medicines Agency, Amsterdam, The Netherlands.
Pierpaolo MoscarielloEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0009-0007-1981-0731
Liese BarbierEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0000-0003-1786-2080
Iordanis GravanisEuropean Medicines Agency, Amsterdam, The Netherlands.
Frank PétavyEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0000-0003-3668-9922
Emmanuel CormierEuropean Medicines Agency, Amsterdam, The Netherlands.
Andrew ThomsonEuropean Medicines Agency, Amsterdam, The Netherlands.
Spiros VamvakasEuropean Medicines Agency, Amsterdam, The Netherlands.
Steffen ThirstrupEuropean Medicines Agency, Amsterdam, The Netherlands.ORCID 0000-0003-0903-682X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Consistent progress in medicines development has allowed both for de novo treatment options and for the refinement of existing products that improve effectiveness or reduce harm. Nonetheless, unmet medical needs persist, particularly in rare diseases, pediatrics and underserved populations. The many promises of pharmacological, technological, and regulatory innovation spark new hope for patients and doctors searching for treatments, and it is therefore essential that progress made translates into the availability of new and improved medicines. We here present our vision for accelerating the path from innovation to safe and effective medicines. Our vision is driven by the continued and transparent collaboration between regulators, academia, industry, patients, and healthcare professionals. Through concrete examples and strategic initiatives, we illustrate how the EMA works with stakeholders to support continuous evolution of regulatory science, contribute to patient-focused refinements in evidence generation and medicines assessments, and engage in forward-looking initiatives that monitor and examine innovative developments. The ultimate goal is to future-proof the regulatory ecosystem and ensure that scientific progress translates into meaningful health outcomes.

Indexed as

Drug DevelopmentDrug ApprovalDrug IndustryHumans

Identifiers

PMID41147890
PMCPMC12641078

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.