Evidence map›Paper›PMID 33137173›Full record

ArticleNucleic acids research2021

Global Substance Registration System: consistent scientific descriptions for substances related to health.

Tyler Peryea, Noel Southall, Mitch Miller, Daniel Katzel, Niko Anderson, Jorge Neyra, Sarah Stemann, Ðắc-Trung Nguyễn, Dammika Amugoda, Archana Newatia and 5 more

Abstract read
In one paragraph

Article in Nucleic acids research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

14 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Drug and Clinical Candidate Drug Data in ChEMBL.Journal of medicinal chemistry · 2025
    Review
  5. DrIVeNN: Drug Interaction Vectors Neural Network.Journal of computational biology : a journal of computational molecular cell biology · 2025
    Article
  6. Predicting Natural Product-Drug Interactions with Knowledge Graph Embeddings.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2025
    Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Modernization of the National Institutes of Health Dietary Supplement Label Database.Journal of food composition and analysis : an official publication of the United Nations University, International Network of Food Data Systems · 2021
    Article
  14. 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

15 authors.

Tyler PeryeaOffice of the Commissioner, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Noel SouthallInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Mitch MillerInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Daniel KatzelInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Niko AndersonInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Jorge NeyraInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Sarah StemannInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Ðắc-Trung NguyễnInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Dammika AmugodaInformatics, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD 20892, USA.
Archana NewatiaOffice of the Commissioner, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Ramez GhazzaouiOffice of the Commissioner, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Elaine JohansonOffice of the Commissioner, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Herman DiederikCollege ter Beoordeling van Geneesmiddelen, 3531 AH Utrecht, Netherlands.
Larry CallahanOffice of the Commissioner, US Food and Drug Administration, Silver Spring, MD 20993, USA.
Frank SwitzerOffice of the Commissioner, US Food and Drug Administration, Silver Spring, MD 20993, USA.

Funding

Global Substance Registration SystemZIATR000055 · NCATS · NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES · PI MATHÉ, EWY · 2015 to 2025
$13.2M
6 · The paper itself

Abstract

The US Food and Drug Administration (FDA) and the National Center for Advancing Translational Sciences (NCATS) have collaborated to publish rigorous scientific descriptions of substances relevant to regulated products. The FDA has adopted the global ISO 11238 data standard for the identification of substances in medicinal products and has populated a database to organize the agency's regulatory submissions and marketed products data. NCATS has worked with FDA to develop the Global Substance Registration System (GSRS) and produce a non-proprietary version of the database for public benefit. In 2019, more than half of all new drugs in clinical development were proteins, nucleic acid therapeutics, polymer products, structurally diverse natural products or cellular therapies. While multiple databases of small molecule chemical structures are available, this resource is unique in its application of regulatory standards for the identification of medicinal substances and its robust support for other substances in addition to small molecules. This public, manually curated dataset provides unique ingredient identifiers (UNIIs) and detailed descriptions for over 100 000 substances that are particularly relevant to medicine and translational research. The dataset can be accessed and queried at https://gsrs.ncats.nih.gov/app/substances.

Indexed as

Databases, ChemicalDatabases, FactualDatabases, PharmaceuticalBiological ProductsDatasets as TopicDrugs, InvestigationalHumansInternetNucleic AcidsPolymersPrescription DrugsProteinsPublic HealthSmall Molecule LibrariesSoftwareUnited StatesBiological ProductsDrugs, InvestigationalNucleic AcidsPolymersPrescription DrugsProteinsSmall Molecule LibrariesXenobiotics

Identifiers

PMID33137173
PMCPMC7779023

What OpenQuestion holds

Textmetadata
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.