The five IDMP standards and upcoming changes to data submission
As the submission process for the Identification of Medicinal Products (IDMP) in Europe is set to change, here is an explainer of what these standards are and what the new process involves
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In October 2022, pharmaceutical companies operating in the European Union will need to change the way they submit data relating to the Identification of Medicinal Products (IDMP).
The European Medicines Agency (EMA) is in the process of implementing IDMP standards that specify standardized definitions to identify and describe medicinal products for human use only, excluding veterinary products. The purpose of these standards is to facilitate the exchange of information related to medicines between different regulatory bodies around the world.
The five IDMP standards
There are five IDMP standards that apply to the entire product lifecycle including drug development.
• Dose forms and routes of administration
• Units of measurement
• Medicinal product identification such as product name, contraindications and marketing authorization
• Pharmaceutical product identifier relating to pharmaceutical composition based on substance, strength and dosage form
• Substance identification
Currently information is submitted via a PDF electronic Application Form (eAF), however this is being replaced with the Digital Application Dataset Integration (DADI) user interface from October 2022.
Companies will have until April 2023 to transition to the new interface and can continue using the web-based PDF form in the meantime.
How to prepare for DADI
The introduction of DADI aims to improve the interoperability of data between different regulatory frameworks and its adoption may require businesses to improve their data capture methods.I It is advisable that they have robust data governance practices in place that will ensure full visibility over their data, where it resides and who has access to it.
Issues with poor quality data that can impact submissions will slow down approvals and therefore time-to-market, so adequate data management needs to be a strategic priority.
Selecting a vendor which provides tools to manage data such as cloud-based solutions can support the IDMP submission process, especially as the requirement to provide data sets alongside documents is increasing.
Quick links
- The latest regulatory changes for pharma supply chains
- How to navigate UK and EU quality regulations in a post-Brexit world
- Group class action: An emerging legal risk for pharma businesses
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