The impact of regulatory compliance on development of pharmaceutical and life sciences products is getting convergent and complex. It takes thorough analysis and ample amount of time and resources to understand a particular guidance and its implementation to be able to get compliant as per health authorities guidelines. With an aim to bring significant improvements, the year of 2012 witnessed approval of ISO IDMP that was intended to substitute the XEVMPD in Europe and the Electronic Drug Registration and Listing System (eDRLS) in the United States. This was a turning point both for the pharmaceutical companies and the health authorities as IDMP framework was designed to enhance pharmacovigilance across companies, products and authorities. Starting from 2016, all the pharma companies under EU are expected to comply with IDMP framework and other countries like US and Japan will follow the suit.
Recognizing the Reasons for Deploying IDMP
EMA is in the process of executing the standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP). These are a set of common global standards for data elements, formats and vocabularies for the distinct identification of and the exchange of information on medicines. The key objective behind proposing IDMP standard is to have a single product description that can be recognized by different divisions within an organization.
In other words, EMA aims to create international dictionaries for medicinal products classified on the basis of dose forms, substance identifiers, manufacturing process, and organization identifiers, etc. This will allow companies to be able to emerge in a new markets with the same product identification number. However a major challenge associated with using this vocabulary is that these terms may differ from country to country as per their respective language.
Pulling Off Groundwork Beforehand
Although companies are still waiting for detailed guidance by EMA Implementation, companies need to be ready with their own respective product data in accordance with proposed guidelines. Once implementation has been concluded, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these standards.
It is high time for companies to outline their strategies for collecting relevant medical product data, operating procedures, and most importantly an approach to manage and store this data. IDMP entails effective management of huge volumes of data as companies are required to harmonize their internal and external resources across various business areas.
Therefore it becomes a tedious task for companies especially the ones having a massive product line.
Smart Solution to Get Ready
Since companies are dealing with huge volumes of data here, the best suited solution at this point of time is deploying a robust and scalable data management software solution that efficiently monitors, tracks, updates and creates XML files that are compliant with EMA requirements.
Such software solutions are user-friendly and support authoring, reviewing, approving, publishing, and archival processes with state-of-the-art navigation and user interface components. Although XEVMPD set some advantages for the companies in terms of centralizing the distributed information about their products, they need to have a thorough IDMP Readiness, Gap analysis and Future State Recommendations to meet the IDMP proposed guidelines.
