Globalization sets the stage for immense challenges and opportunities for regulatory organizations, the pharma industry, and the world health market. Emergent diseases and the growing volume of inferior, contaminated, and counterfeit products can overburden regulators. Ingredients for pharmaceutical products are routinely sourced on an international basis and it is uncommon that all ingredients for a single product are produced within a single dominion. In order to regulate the global supply chain adeptly, it is essential to have a global information system for pharmaceutical ingredients. GInAS’s main objective 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 will be a solution to the costly, duplicative, and fragmented approaches presently being used.
The ISO IDMP set of standards includes detailed information about substances. ISO 11238 expressly addresses the identification and exchange of regulated information on substances. This will ensure a robust substance registration system that supports the additional needs of national and regional authorities that are consistent with the ISO 11238 standard. The system will support all substance types described in the standard and provide multiple language capability for the naming of substances and controlled terminology used within the system.
GInAS is working to become a freely distributable software system that will facilitate the implementation of the 11238 Standard and provide a Global Identifier.
The system will be:
- Capable of registering diverse substances and specified substances
- A central repository of substance definitions and identifiers
- A central repository of information related to substances
- Capable of maintaining public data and confidential data at the element and record level
Canadian, Dutch, German, Swiss, and U.S. regulators, EDQM and USP are all involved in the development of the system. The system will have the ability to be deployed locally by each regulatory agency. This movement toward an open implementation of Substance Registration and ISO 11238 can only stimulate an enhanced and healthier global supply chain.