The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).

EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.

The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use.

Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

They help to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across jurisdictions.

Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges European Union (EU) Member States, marketing authorisation holders and EMA to make use of the ISO IDMP standards. This will impact on many areas of the pharmaceutical regulatory environment, both in the EU and other regions.

For more information, see Introduction to ISO Identification of Medicinal Products, SPOR programme.

Data on medicines (ISO IDMP standards) in the product lifecycle

 

Research and developmentMarketing authorisationPost-authorisation
Substance, product, organisation and referential (SPOR) master data
 Data submission on authorised medicines (Article 57)

Scope of the ISO IDMP standards

The five standards provide data elements and structures to uniquely identify and exchange information on:

  • substances (ISO 11238);
  • pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239):
  • units of measurement (ISO 11240);
  • regulated pharmaceutical product information (ISO 11616);
  • regulated medicinal product information (ISO 11615).

These standards cover the following aspects to describe a medicinal product for human use:

  • medicinal product name;
  • ingredient substances;
  • pharmaceutical product (route of administration, strength);
  • marketing authorisation;
  • clinical particulars;
  • packaging;
  • manufacturing.

ISO IDMP covers the entire medicinal product lifecycle, including products in development, investigational products, products under evaluation and authorised products.

Although ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains.

Benefits in a regulatory context

Implementing the ISO IDMP standards should simplify the exchange of information between stakeholders and enhance the interoperability of systems in the European medicines regulatory network and internationally.

This is expected to bring benefits in a number of regulatory settings, for example:

  • pharmacovigilance: adverse event reports will be based on a harmonised set of product definitions, improving the quality of data used for signal management and speeding up communication, decision-making and regulatory actions;
  • regulatory submissions will use a consistent standard to capture and manage data, allowing information on medicinal products to be shared and re-used across different procedures and among various regulators (subject to confidentiality restrictions);
  • clinical trials: stakeholders will access clinical trial data using agreed and well-supported standards, improving the assessment and scientific evaluation of medicines as well as communication and transparency;
  • good manufacturing practice: inspections of manufacturing sites will be based on accessible information, which streamlines inspections particularly for urgent situations involving defects. Faster detection of falsified medicines can also be supported as a result of consistent data standards.

For more details, see Introduction to ISO Identification of Medicinal Products, SPOR programme.

Phased implementation

Pharmaceutical companies will be required to submit data to EMA in accordance with the ISO IDMP standards, following a phased implementation of the SPOR programme.

This is to ensure the consistent implementation of the regulation in the EU.

The submission and maintenance of data on authorised human medicines is already mandatory since July 2012. This is based on a format called Extended EudraVigilance Product Report Message (xEVPRM), which will be replaced by the ISO IDMP compatible format.

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