P39: Impact of ISO IDMP on the Pharmaceutical Industry and Preparation to Comply
Director, Head of Reg Operations
Syneos Health United Kingdom
We will cover how the EMA and FDA are planning to implement IDMP standards followed by focus on EMA’s concept of Substance, Product, Organisation and Referential (SPOR) in the execution of IDMP and EU IDMP Implementation Guide published in early 2020 and how the industry will be impacted.
The intention of introducing ISO IDMP standards is to ensure all medicinal products for human use are described by a common set of definitions. This resultant improvement in product information will mean unambiguous communication about a product across jurisdictions.
ISO IDMP came from a need to standardise, and facilitate the reliable exchange of, medicinal product information in a robust and consistent manner. This further ensures wide interoperability across global regulatory and healthcare communities, which is critical for accurate analysis and unambiguous communication across jurisdictions.
The IDMP standards aim to meet the primary objectives of the regulation of medicines and pharmacovigilance and therefore support, at a minimum, the following interactions: regulator to regulator; pharmaceutical company to regulator; sponsor of clinical trial to regulator; regulator to other stakeholder; regulator to worldwide-maintained data sources
The ISO IDMP standards are being implemented by the EMA in phases, through a set of projects known as SPOR data management services (Substances, Products, Organisations, Referentials). The EMA will establish ISO IDMP compliant business services for the central management of data in each of the four SPOR areas. The phased implementation of the ISO IDMP standards has been endorsed by the European Union Network Data Board (EUNDB) and the EU ISO IDMP Task Force (SPOR Task Force).
The industry needs to focus on cross-functional collaborative regulatory initiatives to create harmonized, integrated platforms to plan for adherence to compliance. Based on xEVMPD implementation experience, it is safe to conclude that IDMP implementation will require thorough analysis and an ample amount of time and resources by the industry.
By the time IDMP is mandatory, MAHs will need to have remediated more than 160 extra fields of data. This includes data on: old products, acquired products, spread across departments and geographies where there might be more than one source of truth, and which does not match the requirements. Other considerations are being able to connect to the portal, how to maintain the data once it is cleaned, tracing the data lineage and defining the governance of the data.
IDMP is expected to bring benefits in a number of regulatory settings, for example:
Pharmacovigilance: Adverse event reports will be based on a harmonized set of product definitions, improving the quality of data used for signal management & speeding up communication, decision-making & regulatory actions;
Regulatory submissions: Use of a consistent standard to capture & manage data, allowing information on medicinal products to be shared & re-used across different procedures & among various regulators (subject to confidentiality restrictions);
Clinical: Stakeholders will access clinical trial data using agreed & well-supported standards, improving the assessment & scientific evaluation of medicines as well as communication & transparency;
GMP: 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.
Currently, product information is being submitted to the EMA in the form of xEVMPD data fields (approximately 40 data fields per product record). The first two projects that the EMA delivered were RMS & OMS, which laid down the foundations for the subsequent delivery of SMS & PMS.
Proposed implementation for SPOR:
Preparatory phase: Began after launch of the RMS & OMS in 2017.
Transition phase: Begin no sooner than 12 months after EMA publishes EU IGv2.
Submission phase: No less than 12 months after the start of transition phase. The EMA will decommission the xEVMPRM format & the new format will become mandatory.
Challenges of Marketing Authorisation Holders are for their products are:
- Identification - find all the data needed & get it in one place
- Detox – Cleanse the data in order to fit with the requirements
- Map – align the data with the IDMP data fields
- Portal connection – Connect with regulatory agency portals to ensure data can be uploaded