New EU regulation sets high expectations for the exchange of product information
New EU regulation (IDMP - Identification of Medicinal Products) sets high expectations for the exchange of product information .
The EU regulation on the identification of medicinal products (IDMP) introduces new requirements for the exchange of product information between manufacturers, regulatory authorities, suppliers and distributors. In future, pharmaceutical and biotech companies are obliged to transmit and maintain detailed product information in electronic form at all times. This presents a major challenge for manufacturers and requires considerable changes to existing product-related processes and systems.
msg industry advisors will accompany you through this challenging transformation and support you in all phases of your IDMP implementation project.
IDMP implementation as an opportunity for more efficient processes
As part of IDMP implementation, pharma and biotech companies need to overcome traditional interdepartmental barriers and implement robust guidelines to ensure data governance. When implemented correctly, IDMP offers pharma and biotech companies the opportunity to sustainably optimize their business and regulatory processes by standardizing drug data and creating a “single source of truth” of information within the company.
However, this requires a holistic approach that not only considers technological aspects but also the organization and its processes. It is necessary to adapt the roles and responsibilities in the Regulatory Affairs unit as well as its cross-functional cooperation with other specialist departments. Another aspect is ensuring data quality and availability throughout the entire life cycle and implementing IT systems to enable the IDMP-compliant, automated transfer of product data to the EMA and, in future, to other agencies such as the FDA.
Our Capabilities
msg industry advisors offer you a comprehensive portfolio of services to improve your IDMP capability depending on your needs and your current progress. We take a holistic IDMP approach that covers the areas of processes, organization, data and technologies to ensure full compliance with the requirements.
We use training courses and workshops to raise awareness among decision-makers in your organization of the future requirements and possible effects of the IDMP introduction.
We analyze data quality and availability, processes and your existing IT landscape to obtain a comprehensive picture of your IDMP maturity level.
Based on a comprehensive fit/gap analysis, we work with you to develop a viable roadmap and set up the right setup for your IDMP transformation.
We guide you through the entire IDMP implementation process – from data consolidation and cleansing to the creation of an IDMP master data model and the selection of suitable IT systems and tools.
We ensure the IDMP-compliant operation of your product-related processes and systems through accompanying training measures and continuous support.
Our holistic approach for your IDMP transformation
Are you looking for ways to make your organization IDMP-ready? We have the right approach for each phase of the IDMP implementation.