ISO to Revise IDMP Technical Standard, Implementation Guides
The International Organization for Standardization has begun revising its Identification of Medicinal Products standards and technical specifications, also known as IDMP, which cover regulatory activities, product development and pharmacovigilance.
IDMP standards and technical specifications — comprising ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844 — cover the aspects used to describe a product: such as the product name, ingredients, route of administration, strength, marketing authorization, manufacturing, packaging and clinical particulars.
While the overall standard has not really changed, the revision was necessary following the development of IDMP implementation guides — allowing the shift of certain details from the standard itself to its corresponding guide, according to Christian Hay, senior consultant at QS1, who works on ISO/TC 215, the technical committee to standardize health informatics and develop the IDMP standard.
IDMP provides a basis for new or existing IT solutions, such as for prescriptions, medication reports and product dictionaries, he said.