Identification of Medicinal Products (IDMP) refers to a suite of International Organization of Standardization (ISO) standards whose objective is to define, characterize, and uniquely describe regulated medicinal products. This definition will support all regulatory documentation and processes concerned with medicinal products throughout their life-cycle, from development through to authorization, post-marketing management, and final withdrawal from the market. The suite is led by ISO 11615, the Medicinal Product and Packaged Product standard, which provides the pattern to uniquely describe each product and each package as it is authorized. The other standards support by contributing concepts: Substance Information (ISO 11238), Dose Form or Packaging Concepts (ISO 11239), Units of Measurement (ISO 11240), and Pharmaceutical Product information (ISO 11616).
Although now delivered through ISO, IDMP originated in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use initially for pharmacovigilance. Much of the stimulus for implementation has occurred in Europe, led by the European Medicines Agency (EMA), motivated by the regulations for Eudravigilance, which include implementing regulation 520/2012 for medicinal product terminology that specifically states the use of the ISO IDMP standards, and prior to their implementation, the xEVMPD (Article 57) legislation.
However, having been through the ISO process, the IDMP standards are international standards, and to truly fulfill their aim of supporting all regulatory documentation and processes concerned with medicinal products throughout their life-cycle, their implementation must be global. So what do we see if we look more widely?
In many respects, the US Food and Drug Administration (FDA) has already commenced implementation of IDMP, through its Structured Product Label (SPL) specification as part of its Guidance for Industry on Electronic Submissions (in PDUFA – the Prescription Drug User Fee Act). Looking at the content of an SPL submission, a significant proportion (more than 80%) of the data items required by the 11615 standard are already present within the SPL specification, with the main difference being in how those data items are described. For example, indications may be given in text in SPL, whereas they must be coded in IDMP; and for the items that are coded, the controlled terminology that is currently in use differs. However, with a commitment to move towards using the Global Ingredient Archival System (GINAS) and its G-SRS software, which maintains and makes available global coded concepts for ingredient substances (thereby implementing ISO 11238), and the EDQM controlled terminology for dose forms (units of presentation, e.g., the implementation of ISO 11239 within the SPL, etc.) that mismatch diminishes significantly.
Bearing in mind that the first submission-based implementation of IDMP in Europe will use the SPL specification, as described in the in-development ISO DTS 20443 Technical Specification, the correspondence between what is already done in the US and what is being implemented in Europe becomes even greater — which, of course, is how it should be for a global standard to facilitate information-sharing.