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

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 da

SUBMITTER: Peryea T 

PROVIDER: S-EPMC7779023 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature