The EU’s regulation Identification of Medicinal Products (IDMP) Iteration 1, has been delayed and some pharmaceutical companies are putting their initiatives around IDMP on hold. However, this will be enforced, eventually and the delay is an opportunity for businesses to address the impact on internal business processes supporting IDMP and Substances, Products, Organizations and Referential (SPOR) compliance. Companies should continue their assessment on affected areas to make sure they are ready when the time comes. There is a lot involved in gaining a better understanding of where IDMP data resides, knowledge of authoritative source/systems for key IDMP data attributes, potential data gaps, and data governance guidance and procedural development.
The European Medicines Agency (EMA) has shifted their focus from IDMP Iteration 1 to the release of the Digital Application Dataset Integration (DADI) user interface, which replaces the electronic Application Form (eAF). Initially their vision for structured data submission through EMA Product Management Service (PMS) was the FHIR message. However, the vehicle has changed and will leverage the DADI user interface as a method for structured data submissions through the EMA PMS, at least for the near future.
Companies that do not abandon the IDMP implementation and adapt to the new DADI requirements will be setting the stage for success. Companies have to make strategic decisions regarding the implementation of these activities and the challenges they can present. Here are some key areas pharmaceutical companies should be focusing on right now.
1. Data Sources
Identify your company’s various IDMP data sources, no matter its form. Adoption of IDMP is not just about compliance, but a great opportunity for cross functional integration of data to server broader organization goals. Gathering the data for IDMP lead to better decision making and improving efficiencies across an organization. Here are some examples:
- Medicinal Product – The product administered to a patient for treating or preventing disease.
- Example data: Combined Pharmaceutical Dose Form
- Possible sources: Dossier, Regulatory Information Management system (RIMS)
- Manufacturer – Information on the manufacturer of the product.
- Example data: Manufacturing License Number.
- Possible sources: RIMS, ERP, Manufacturing information systems, Dossier
- Marketing Authorization – The registration and marketing of the product.
- Example data: Marketing Date.
- Possible sources: Dossier, RIMS
- Packaged Medicinal Product – The packaging of the product.
- Example data: Image of the packaged product.
- Possible sources: Advertising & Promotion system, ERP, Artwork systems, Manufacturing information systems
- Pharmaceutical Product – Data regarding the manufactured item. Often equal to the Medicinal Product, but product can undergo transformation before being administered.
- Example data: Strength of all ingredients.
- Possible sources: Dossier, RIMS, ERP
- Clinical Particulars –Information about indications, contra-indications, undesirable effects, and interactions.
- Example data: Intended Effect.
- Possible sources: Dossier, RIMS, Product Information (Systems), SmPC, SPL, Drug safety systems
- Substances –Supporting details of substances used.
- Example data: Molecular weight.
- Possible sources: Dossier, RIMS, ERP, SRS
2. Project Scoping
Assessing the scope of an IDMP project can be an arduous task. There are various areas a company must evaluate to ensure the project is appropriately scoped:
- Regulatory Scope
- Number of dossiers (determine how many are eCTD)
- Legacy of national products
- Global or regional company
- Number of license partners
- Supply Chain Scope
- Number of plants
- In-house vs contract manufacturing
- Process Maturity
- All processes described
- Process orientation vs functional (silo) orientation
- Procedural arrangements with third parties (e.g., CROs)
3. Business Process
With DADI web form as the mechanism for eAF, an organization can initially focus on this business process, gaining an understanding of its use for an ongoing IDMP initiative. You need to further develop your regulatory procedures through process mapping to align with EMA Target Operating Model (TOM) for both centralized and non-centralized procedures. This will include the approach to DADI-related requirements for submitting structured data. In addition, technical writing support can be provided to develop Policies, SOPs, and Work Instructions to ensure regulatory compliance across multiple functional areas. Here are some examples of categories of mappings:
- Initial IDMP Submission
- MedDRA Process
- IDMP Maintenance with eCTD Closing Sequence
- IDMP Maintenance with No eCTD Closing Sequence
4. IT Architecture and Systems
Companies face additional challenges managing data across xEVMPD, PMS, and IDMP Iteration 1, each with its own attributes. IT architecture and strategic use of systems will be vital for:
- Infrastructure for master data management
- Integration level for applications
- ERP policy (single instance vs multiple)
- RIM system requirement gathering & implementation
- Systems validation per 21 CFR Part 11
- Data Center(s) qualification
5. Data Governance
As you look toward data governance, there currently exists the SPOR to provide specifications for data standards; however, it is recommended that your governance sustainment plan include the DADI attributes. Due to the regulated nature of IDMP data governance activities, it is necessary to ensure a comprehensive set of regulatory compliant procedures. Some of examples could include:
- Data Governance Policy and SOP
- Work Instructions for:
- Data Standards Review & Maintenance
- Role Maintenance
- Processing New Data Attributes
How Orion Can Help
You are not alone in getting yourself ready for IDMP implementation. Orion can provide expertise in the areas you require the most assistance. We can help you with:
- Identifying the IDMP data sources
- Assessments for project scoping around regulatory scope, supply chain, and process maturity
- Business process and developing your regulatory procedures to align with EMA TOM
- IT architecture and systems
- Formalize procedures for data governance
Regardless of the delay of IDMP Iteration 1 implementation, pharmaceutical companies should continue to implement best practice that will eventually help them adhere to the new regulation. Some of the aspects of implementing IDMP data sources, business process realignment, IT architecture, and data governance procedures can be daunting for executives to address on top of business as usual. The most successful companies will take this hiatus on the IDMP implementation as a time to seek assistance from third party vendors that can assist with data, business process, and technology preparation. Orion has been serving the Healthcare and Life Sciences industry for almost two decades. We can partner with you to accelerate your data and digital initiatives. Contact us for an appointment to discuss your current needs.