European Medicines Agency (EMA) is in the process of implementing 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 terminologies for the unique identification of and the exchange of information on medicines. Once implementation has been fully completed, pharmaceutical companies will be required to submit data on medicines to the EMA in accordance with the new IDMP standards.
The five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616) simplify the exchange of information between Regulatory authorities internationally and improve the safety monitoring of medicines by facilitating the assessment of data across various classes of medicines and therapeutic areas. ISO finalized the IDMP standards in 2012 and is currently developing implementation guides at international level. Following the implementation of the ISO IDMP standards, the agency will replace its data-submission format in line with the ISO IDMP standards, terminology and formats.
It is tentatively accepted by the European Parliament house to implement IDMP in Europe in multiple iterations starting with product information, which includes eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) information and additional fields. However, the official confirmation from the EMA is still awaited.
Being a specialist provider of Regulatory consulting, operations & technology services, Freyr provides efficient and seamless IDMP consulting services for its clients. As part of the IDMP solutions, following data management software solutions and accelerators are being deployed.
- Data level status reports and analytics in terms of availability, accuracy and integrity
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