Summary of part 1 and 2:
In our last blog posts of the series you were informed about eCTD v3.2.2 and eCTD v4.0. The articles resolved around the advantages of eCTD v3.2.2 over paper or non-eCTD electronic submissions and the improvements from eCTD v4.0 over eCTD v3.2.2. If you have not read it, you will find the first article here and the second article here.
ISO IDMP Introduction
Our International Trends in Drug Registration and Evaluation series also resolves around safety, and the efforts of the pharmaceutical industry and regulators to increase drug and patient safety on a global scale. The ISO IDMP standards, after full implementation, should enable global pharmacovigilance and lead to increased drug and patient safety.
ISO IDMP and the MPID
The ISO IDMP standards were developed to enable the unique identification of medicinal products and ingredients around the globe. ISO 11615 – MPID – describes the “data elements and structures for unique identification and exchange of regulated medicinal product information”.
Numerous regulatory authorities have indicated they will begin using the IDMP standards with EMA leading the efforts. While there have been delays in the development of the standards and eventual implementation, the development efforts have created valuable conversation about how regulatory authorities and regulated industry currently manage their data related to substances, products, and other master data – the EMA SPOR project – and how those processes can be improved.
For USFDA, the HL7 SPL message has been identified as the current standard that will be used for the transmission of IDMP data, and as a result, it has been modified throughout the last few years to meet the requirements. However, USFDA has also begun collaborating with EMA to “develop and test HL7 FHIR exchange mechanism”.
Master Data Management
Prior to the implementation of IDMP, both regulatory authorities and regulated industry recognized the need to examine how their master data was organized and managed. The EMA is undertaking a project to make the public portions of this data available to industry through the SPOR portal. This should increase the quality of data as it will be reviewed, corrected, and assigned a unique ID before being made available and then managed through a governance process. The curation of this data also enables the use of this master data by other systems within the EMA and possibly throughout the world. In the future, this data could also be referenced by its unique ID within regulatory submissions, like the eCTD, instead of being resubmitted in each evaluation application.
Other regulatory authorities have completed these activities internally, or like Health Canada, are currently in the process of analyzing their master data, but do not plan to make their master data available to the public in the same manner as EMA.
As more regulatory authorities adopt available data standards the opportunities for the reuse of information will expand. Until now, regulatory authorities and regulated industry have been focused on the interoperability of systems, meaning allowing systems to speak to each other to provide links to information in different silos. In the future, the focus will shift to systems that truly share data, meaning the data is stored and managed in a single system and all others have access and use that master data. Once adopted by a single regulatory authority, the standards introduced earlier (eCTD v3.2.2, eCTD v4.0, ISO IDMP, HL7 SPL, and HL7 FHIR) will increase sharing and access to information between parties. For example, instead of submitting product information in PDF format in module 3 of the eCTD, it might be possible to simply reference an IDMP ID for that product and the systems will know where to find the full details and display them to the reviewer in a structured manner, more conducive to the review/evaluation. On the drug registration side, when a safety signal for a specific ingredient is detected, a regulatory authority should be able to instantly identify the ingredient and all products that contain it. This interoperability of standards will lead to both more efficient evaluations and enhanced patient safety.