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IDMP – Identification of Medicinal Products
In February 2020, the European Medicines Agency has released the version 1 of the EU ISO IDMP Implementation Guideline (EU IG v1). With this release, EMA is providing the information about the implementation requirements of the ISO IDMP standards and terminologies in the EU.
The EU IG v1 contains the following chapters:
- Introduction: Introduction, legal basis and scope of the EU IG for implementation of ISO IDMP standards
- Chapter 1 – Pre-registration requirements: Guidance on how to get access to SPOR and what to do prior to submission
- Chapter 2 – Initial submission: Guidance on which medicinal product information (data fields and business rules) shall be submitted
- Chapter 6 – Technical specifications on structure and format: Technical specifications for the API, contains description of principles, security, resources, calls, end-points
- Chapter 7 – Migration guide: migration rules between xEVMPD and PMS including backwards compatibility rules
Therefore this version provides the basis of the mandatory data elements for Iteration 1 of ISO IDMP and how the migration from xEVMPD to ISO IDMP will be managed.
Next steps for the full implementation of Iteration 1 of ISO IDMP will be the release of EU Implementation Guidance v2, including the rest of the chapters and defining the business processes. This version won’t be released before February 2021.
Once this version 2 is released, Industry will have two years to see IDMP standards mandatory: one year implementation period for optional use of ISO IDMP, followed by a 1 year implementation period before ISO IDMP becomes mandatory.
Tasks that companies need to perform for ISO IDMP and Asphalion can support with:
- Pharma data management: data collection or extraction, verification, mapping and cleaning;
- Tool review and selection (RFP, RFI);
- Tool and process adaptation and implementation;
- Data mapping with SPOR master data;
- GAP analysis of IDMP readiness.
Given the above tasks that lie ahead for any pharmaceutical company, it is important to start as soon as possible with the regulatory strategy to make an estimation of the effort in order to comply.
Asphalion has a dedicated team for ISO IDMP and data governance and is in direct contact with EMA and involved in the review of the EU Implementation Guide.
RIM Data Solutions: Regulatory Information Management
In order to comply with ISO IDMP standards, but even more importantly, in order to optimize processes within a pharmaceutical company, a Regulatory Information Management (RIM) system is a vital element of any regulatory strategy.
There are many different RIM data solutions on the market and for a pharmaceutical company it is important to select a RIM solution that fits it’s needs. Not a single pharma software company is the same, with regards to the number of Marketing Authorizations, type of products, region of activities, manufacturer of finished product and/or active substance, etc.
As the implementation of a RIM solution is time consuming and involves a significant investment, it is important to make a proper selection of the final technical solution based on the requirements and needs.
As an independent Pharma software company, Asphalion can support with an objective evaluation of the different RIM data systems, pharma data management and any other pharma solution needs of companies.
Asphalion’s Support with RIM Data Solutions:
Selection of RIM:
• Set-up of User Requirements, Functional Specifications
• Report on the available RIM solutions in the market
• Preparation of Request for Information/Proposal for RIM implementation
• RIM system evaluation and final recommendation
• Consulting for business process translation into RIM
• Regulatory Strategy Training
• Data Cleaning
• Data-migration and validation
• SOP and WI updates
• Project and pharma data Management
Do you need support or more information about the services? Contact us!