IDMP compliance: The European Medicines Agency’s new data standards
Is your business ready for IDMP compliance? The EMA’s publication of its Identification of Medicinal Products (IDMP) data standards on February 22 presents a new regulatory challenge and opportunity for life science businesses.
Version 2 of the EMA IDMP Implementation Guide lays out the requirements for how data is collected, managed and submitted for medicinal products – specifically, how the 5 IDMP standards developed by ISO are to be applied within the EU. Here’s what you and your business should know.
The five standards
The five IDMP standards were first pitched by ISO back in 2017 as a way to simplify life science data exchange and facilitate deeper connection between supply chain, laboratory and pharmacovigilance.
The standards now migrating into the EU are as follows:
1) ISO 11615: medicinal product identification
2) ISO 11616: pharmaceutical product identification
3) ISO 11238: substance identification
4) ISO 11239: dosage form and route of administration
5) ISO 11240: units of measurement
Up until now, a product or active substance passing through the clinical, regulatory, pharmacovigilance and supply chain elements might be given a different name and terminology at each stage of the lifecycle.
The new EMA IDMP Implementation Guide is designed to standardise and simplify this medicinal data – with all the efficiency and speed-to-market benefits that follow.
Regulatory departments will benefit from simplified generation and sharing of documentation, which should ease compliance burden and reduce both operational costs and inconsistencies.
Standardised IDMP-structured data exchange should simplify how product registrations across countries and regions are compared, improving how batch release processes and shortages are managed.
And global pharmacovigilance should become easier, as adverse events become easier to trace back to single products. For instance, a universal ID for a particular drug can be referenced in Individual Case Safety Reports (ICSRs) to allow faster international pinpointing of potentially dangerous products.
The four domains
As was expected, the IDMP standards are based on the four domains of pharmaceutical regulatory master data developed by the EMA:
Preparing for the collection, recording and usage of this SPOR data is the first step businesses should take towards meeting the IDMP standards.
On top of this, the new Target Operating Model (TOM) laid out in the Guide will help businesses overhaul and structure their data management approach long-term.
What happens next
Your regulatory department should expect to be submitting product data for new medicines (or medicine variations) from the very beginning of the regulatory activity. So considering how to combine training, departmental coordination and the technology your organisation uses to facilitate cogent and standardised data collection will be key.
In particular, you should think about the quality and regulatory management systems your business uses for IDMP compliance. Manual and paper-based data management is made increasingly obsolete by the new standards. Leveraging electronic systems to centralise and standardise documentation and procedures is a crucial step toward embedding IDMP compliance, building stronger competitive advantage, and embracing and harnessing a more standardised and connected life sciences world. Find out more about our life sciences quality management software solutions.