ISO in revision of IDMP standards – what should you know?
November 16, 2017

As popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of data elements, formats and terminologies that enable unique identification and exchange of medicinal information. The standards (ISO 11616, ISO 11615, ISO/DIS 11238, ISO/TS 20451, ISO/TS 20443 and ISO/TS 19844) help simplify the exchange of medicinal product information and aid promotion of safer patient care, by helping regulators to interoperate with each other. The ISO (International Organizations for Standardization) which took over reins from the International Council for Harmonization (ICH), Japan, is currently revising a series of IDMP standards.

Why is this revision?

While the five IDMP standards were finalised in 2012, the ISO eventually went one step further and also developed implementation guides to help in the safety monitoring of medicines, and to simplify the exchange of information. Therefore, the proposed revision is said to be necessary to improve medicinal products’ description across the globe. The revision is important to exchange the product information in a consistent manner which is the primary objective of medicines regulations and pharmacovigilance. 

The aspects that the IDMP standards cover to improve the description of a medicinal product include:

  • Medicinal product name
  • Ingredient substances
  • Pharmaceutical product (route of administration, strength)
  • Marketing authorization
  • Clinical particulars
  • Packaging
  • Manufacturing

Meanwhile, the central question to be considered is to how the IDMP submissions should be made. Experts say, for the benefit of all concerned to comply with IDMP standards, the submissions should be made with consistent documentation. They should allow:

  • Precise and comprehensive analysis of drug safety events by identifying relevant products in the market
  • Linking information with specialized databases (national or international)
  • Collaboration with global Health Authorities on registration processes

What can we expect further?

The implementation of the IDMP standards is currently being done by the European Medicines Agency (EMA) in a phased manner. Apart from the current revision of ISO IDMP standards, it is expected that many significant changes would come up, such as:

  • Creation of educational material and uniform implementation for manufacturer as well as Regulatory
  • EU IDMP Implementation guideline is postponed to release; shifted from 2017 to mid-2018

As the IDMP implementation still needs to get into full force, it is imperative for medicinal product manufacturers and marketers to be prepared for the compliance. How compliant is your preparation can only be measured with how strong is your knowledge on the standards being developed? Get ahead with professional consultation. Decode Freyr’s support in collating and transforming XEVMPD data to IDMP data for large number of Market Authorization submissions.