Credit: NCATS

As drug development and production has become an increasingly globalized process, regulators and industry stakeholders have struggled to efficiently and accurately exchange information about what substances are in any given medicine. The NIH's National Center for Advancing Translational Sciences (NCATS) is now launching the Global Ingredient Archival System (GINAS) to facilitate this process. “Instead of relying on drug or chemical names, which vary across countries and regions, GINAS will enable substances to be defined by standardized, scientific descriptions,” says the NCATS. GINAS classifies substances according to broad categories (chemical, protein, plant substance, etc.) and captures details for each substance category consistent with international standards (chemical structure, DNA sequence, etc).

NCATS scientists developed the software for this system with input from the FDA, the European Medicines Agency and other regulatory authorities. Regulators will use this software to store the detailed, proprietary information they need to fulfil their regulatory function. NCATS has published a public subset of these data on its website. NCATS will release a new public version — with information on medicinal products, uses and metabolism of substances, mechanisms of action and more — towards the end of the year.