What’s in a pill? The identification of everything that goes into medication, known as IDMP, is a highly regulated area, and ISO has a range of standards and guidance documents for the IDMP that support the activities of medicines agencies worldwide. They provide the basis for data collection and the exchange of information related to the characteristics of medicinal products. This enables the identification of the ingredients of medicinal products globally, which is necessary for commercial and regulatory purposes.
ISO/TR 14872, Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms, provides a framework for ongoing maintenance and support of identifiers and terms that meet the criteria of IDMP standards. It describes a service delivery model and core principles which can be used as evaluation criteria for choosing IDMP terminology service providers. It also helps with the development of more robust service level agreements and governance processes used by IDMP data owners and terminology maintenance providers.
The new technical report will be of use to many organizations in the biopharmaceutical and pharmaceutical industry, including global regulators involved in the development, authorization, marketing and distribution of medicinal products.
Convenor of the ISO working group responsible for the IDMP standards and ISO/TR 14872, Christian Hay, said that the terminology maintenance service delivery model proposed in this document will help to provide a framework for greater collaboration and shared data governance amongst IDMP stakeholders.
“Collaboration amongst regulators, pharmaceutical companies and other parties in the industry helps to improve patient care through improving the reporting and documentation of things like adverse-events and patient records.”
ISO/TR 14872 was developed by ISO/TC 215, Health informatics/WG6, Pharmacy and medicines business, the secretariat of which is held by NEN, ISO’s member for the Netherlands.