Starting in 2018, the European Medicines Agency (EMA) will require biopharmaceutical companies to submit data in accordance with the IDMP's International Organization for Standardization (ISO) standards.
Per the EMA, this includes a “set common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines.”
The standards are the latest effort to increase transparency and improve patient safety – and other regulatory agencies are expected to implement similar requirements.
According to Parexel, the new solution, LIQUENT InSight® for IDMP™, is fully compliant with the five ISO IDMP standards defining product and registration data and details for investigational and registered medicinal products.
The EMA explained that these five ISO IDMP standards “should simplify the exchange of information between all stakeholders, enhancing interoperability of systems at European Union (EU) level and internationally.”
Paul Bidez, Ph.D., Vice President, Regulatory Solutions, Parexel, commented that the company’s new solution “combines deep subject matter expertise, specialized master data management, integration services, and purpose-built technology.”
“With this new offering, PAREXEL clients gain a well-structured IDMP program with the potential to ensure compliance, provide greater efficiency, reduce costs, and simplify processes,” he said.
The solution is available globally, directly from Parexel or through the Parexel Partner Program. It can be deployed on-premises or in the company’s regulatory cloud.