IDMP standards and technical specifications, comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844, support the activities of medicines agencies worldwide. These cover a variety of regulatory activities related to the development, registration and life-cycle management of medicinal products, as well as pharmacovigilance and risk management.
Christian Hay, Senior Consultant Healthcare for GS1 Global Office and Convenor of working group 6, Pharmacy and medicines business, of ISO technical committee ISO/TC 215, Health informatics, explains: “IDMP standards are essential for the world’s increasingly integrated healthcare. They provide the precise architecture for the computerization of information on medicinal products all around the world. When regulators adopt IDMP, their capacity to interoperate with each other makes for safer patient care; this is, for example, a huge benefit for adverse-event reporting and for documenting medication in patient records.”
To meet the primary objectives of the regulation of medicines and pharmacovigilance, the reliable exchange of medicinal product information in a robust and consistent manner is essential. IDMP standards fully support this and that is why a revision of the standards was deemed opportune.
ISO IDMP standards cover the following aspects to describe a medicinal product:
- Medicinal product name
- Ingredient substances
- Pharmaceutical product (route of administration, strength)
- Marketing authorization
- Clinical particulars
- Packaging
- Manufacturing
“The revision has become necessary as a consequence of the development of IDMP implementation guides (which take the form of four CEN1) ISO technical specifications). The overall standard has not really changed but has gained in usability for implementers. By developing implementation guides, it has been possible to shift some detailed information from the standard itself to its corresponding implementation guide,” says Christian Hay.
“By publishing the ISO IDMP standards in 2012, the community has been able to understand a potential fundamental change in each respective data model – which are currently very diverse. Having learned from users’ reactions, the IDMP project leaders have initiated an ambitious standards development programme, which consists of working on implementation guides (namely, the four CEN ISO technical specifications). Now, one can expect the creation of educational material and a uniform implementation both on the part of the manufacturer and the regulator. In parallel, IDMP provides a basis for existing or new IT solutions, such as prescriptions, medication reports, medicinal product dictionaries for clinical use, and more,” he adds.
Using ISO IDMP within regulatory activities brings benefits to regulators, industry and, ultimately, patients. “The trend towards global standards continues to increase. I cannot imagine the world without IDMP, whose implementation programme is going to last several years. Without IDMP, the existing information fragmentation by country or region would cause increasing risks to patients globally – not only those who travel, but those who are faced with mobile health or because of the globalization of supply chains,” explains Christian Hay.
ISO IDMP standards were developed by ISO technical committee ISO/TC 215, Health informatics, whose secretariat is held by ANSI, ISO’s member for the USA. It is now available from your national ISO member or through the ISO Store.
1) CEN: European Committee for Standardization
