Global Ingredients Archiving System (GINAS)
What is GINAS in relation to ISO 11238
GINAS and ISO 11238 specifically addresses the identification and exchange of regulated information on substances. GINAS supports all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the IDMP.
Background of GINAS
GINAS Project Description
The Global Ingredient Archival System (GINAS) represents a major opportunity for regulators worldwide to tackle the challenges of sharing ingredient information. This tool makes it possible to create a global standard for defining substances and a common identifier to identify ingredients in medicinal products. This will enable the global health community to share and use information to significantly improve health care delivery, the proper use of medications, and the management of risks involved in their use.
The project’s main goal is to provide a consistent definition of substances globally, and a common identifier for all the substances used in marketed medicinal products as well as active substances under clinical investigation. It is envisioned that a consortium of regulators from different national and international agencies would operate and maintain the platform in a secure and trusted manner. This centralized database will result in higher quality data while still respecting confidentiality requirements.
The software tools used in this project are developed, maintained, and distributed to project members and other interested parties by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). As well as containing definitional information and identifiers, the system is able to store a wide variety of structured information on the identification, analysis, use, manufacture, pharmacology, and toxicology of medical product substances.