Evidence map›Paper›PMID 33800934›Full record

ReviewPharmaceutics2021

Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework.

Marina López-Paniagua, Ana de la Mata, Sara Galindo, Francisco Blázquez, Margarita Calonge, Teresa Nieto-Miguel

Open access · goldAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.5field-weighted citation impact, top 11% of its field
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

17 citing papers in PubMed, 27 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Marina López-PaniaguaOcular Surface Group, Instituto de Oftalmobiología Aplicada (IOBA), University of Valladolid, Campus Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.
Ana de la MataOcular Surface Group, Instituto de Oftalmobiología Aplicada (IOBA), University of Valladolid, Campus Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.ORCID 0000-0001-5273-5285
Sara GalindoOcular Surface Group, Instituto de Oftalmobiología Aplicada (IOBA), University of Valladolid, Campus Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.ORCID 0000-0002-3184-2425
Francisco BlázquezClinical Trials Unit, Instituto de Oftalmobiología Aplicada (IOBA), University of Valladolid, Campus Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.
Margarita CalongeOcular Surface Group, Instituto de Oftalmobiología Aplicada (IOBA), University of Valladolid, Campus Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.
Teresa Nieto-MiguelOcular Surface Group, Instituto de Oftalmobiología Aplicada (IOBA), University of Valladolid, Campus Miguel Delibes, Paseo de Belén 17, 47011 Valladolid, Spain.ORCID 0000-0002-8374-5379
Universidad de Valladolid · ES

Funding

Institute of Health Carlos III, CIBER-BBN, Spain CB06/01/003 MICINN/FEDER, EUMinistry of Science and Innovation, Spain PID2019-105525RB-100, MICIN/FEDERRegional Center for Regenerative Medicine and Cell Therapy of Castilla y León. Department of Education, Castilla y León Regional Government. Sapin VA168P18 FEDER, EU
6 · The paper itself

Abstract

Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called combined ATMPs that consist of one of the previous three categories combined with one or more medical devices. During the last few years, the development of ATMPs for the treatment of eye diseases has become a fast-growing field as it offers the potential to find novel therapeutic approaches for treating pathologies that today have no cure or are just subjected to symptomatic treatments. Therefore, it is important for all professionals working in this field to be familiar with the regulatory principles associated with these types of innovative products. In this review, we outline the legal framework that regulates the development of ATMPs in the European Union and other international jurisdictions, and the criteria that each type of ATMP must meet to be classified as such. To illustrate each legal definition, ATMPs that have already completed the research and development stages and that are currently used for the treatment of eye diseases are presented as examples.

Indexed as

advanced therapy medicinal productATMPcell therapyeyegene therapymarketing authorizationocularophthalmologyregulatorytissue engineering

Identifiers

PMID33800934
PMCPMC8000705
OpenAlexW3135247441

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.