ISO: Identification of Medicinal Products Standards Revised
The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information.
"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," Christian Hay, senior consultant healthcare for GS1 and convenor of working group 6, Pharmacy and medicines business, of ISO technical committee ISO/TC 215, said.
Background
ISO IDMP standards cover various aspects of medicinal product descriptions, including the product name, ingredient substances, route of administration, strength, marketing authorization, clinical particulars, packaging and manufacture.
Initially, IDMP was driven by the International Council for Harmonization (ICH), but when Japan stopped its active participation in the development of the standards, ISO took over.
The standards cover a variety of regulatory activities related to the development, registration and life-cycle management of medicinal products, in addition to pharmacovigilance and risk management, according to ISO.
Revisions
So why is ISO revising the IDMP standards?
"The revision has become necessary as a consequence of the development of IDMP implementation guides (which take the form of four CEN [European Committee for Standardization] 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," Hay said.
For health authorities, according to the consultant Dieter Schlaps, who explained IDMP standards in a four part series of feature articles (for RAPS members only) beginning last year, central questions concern whether, when and how they should accept IDMP submissions from industry.
"It should be beneficial for all concerned to comply with IDMP for consistent product documentation," Schlaps wrote, "since it will allow:
- more precise and comprehensive analysis of drug safety events with identification of the relevant products in the market
- efficient information linkage with specialized national or international databases
- collaboration with other health authorities on product registration processes."
The European Medicines Agency (EMA) has said it is in the process of implementing the IDMP standards in a phased program based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) master data.
However, Shlaps noted that the EU IDMP Implementation Guideline, which was expected in Q1/Q2 of 2017, appears to be postponed until mid-2018.
Hay added that IDMP project leaders have initiated an ambitious standards development program, which consists of working on implementation guides for 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," Hay said.