The countdown to IDMP compliance – are you ready?
After delays and uncertainty, the countdown to IDMP (Identification of Medicinal Products) is getting closer. The IDMP framework provides pharma companies with the opportunity to improve data processes across the regulatory lifecycle, and will significantly impact regulatory affairs and operations, pharmacovigilance, marketing, master data management and more.
IDMP is a set of 5 ISO standards designed to standardize the description of marketed medicinal products. Better patient safety is the main goal, by improving the reporting of adverse events and safety signals globally. IDMP will be mandatory worldwide for all Marketing Authorization Holders in ISO countries.
IDMP timelines are approaching rapidly – get your ducks in a row
The EMA will be the first health agency to mandate compliance with ISO IDMP, with the FDA not far behind. Pharma organizations face a rapidly shortening timeframe to prepare for full transition of regulatory data and systems to comply with this complex mandate.
Publication of the EU Implementation Guidelines v2 in February 2021 started the 2-year implementation window. EU IG V2.1 is due out in June 2021. And, in Q1 2022, the EMA expects pharma companies to be able to submit product data in IDMP format, and by Q1 2023, this will be mandatory.
How can Natural Language Processing help with IDMP compliance?
Capturing the hundreds of data entities required per product, 70% of which lie in unconnected silos of unstructured text, demands time, resources and investment.
However, manual curation is not the only option for extraction of the necessary data attributes. Linguamatics NLP text mining regulatory solution can save your organization time and reduce mistakes on its IDMP-compliance journey. Linguamatics NLP can extract, standardize and structure the required data elements from IDMP-relevant unstructured text documents, including Summary of Product Characteristics (SmPC); Manufacturing licenses; Chemistry, Manufacturing and Control (CMC) documents, and other regulatory and compliance documents, such as eCTDs (electronic common technical documents).
Case studies where NLP brings value to Pharma organizations
Linguamatics NLP has been used by top pharma, such as Johnson & Johnson. Linguamatics worked with J&J Consumer to extract IDMP data elements from regulatory documents including Summary of Product Characteristics and regulatory dossiers. The challenges included a varied set of documents, some up to 50 years old, in mixed formats, across 5 different languages (English, French, Spanish, German, Italian). The output was mapped to the J&J schema for their IDMP submission and internal business use. Over 1300 documents were processed, with an overall accuracy above 94%, saving J&J Consumer significant time and resources.
For Mundipharma, we developed an enterprise workflow to automate the identification, extraction, and coding of data elements from regulatory documents in preparation for IDMP implementation. NLP queries were developed to extract the individual data elements using standard and customized ontologies, as well as linguistic features of SmPCs. Linguamatics NLP provides an agile environment for rapid query development: an ideal tool to help deliver IDMP compliance. Business rules can be rapidly translated into search queries, and this flexibility is key while the IDMP framework is still evolving.
So, whether you need bulk extraction of IDMP data attributes from historic and current regulatory documents, or you are planning to set up automated workflows to handle IDMP compliance within your master data management strategy, NLP can help your IDMP journey, with rapid effective extraction from unstructured regulatory documents.