Parexel has developed software aiming to help biopharma companies better adjust to the new Identification of Medicinal Products (IDMP) standards championed by the European Medicines Agency.
The launch comes as companies have started preparing for compliance with that new regulation which is going to be implemented starting in early 2018, and preparation for pre-submission starts as early as next year.
In February 2015, the EMA announced its plan to replace its current eXtended EudraVigilance Medicinal Product Dictionary with ISO-compliant IDMP standards for the pharma industry to obey in the EU. The idea is to follow the globally accepted standards for data elements, formats and terminologies regarding medicines, and thus simplify the exchange of medicinal information.
These standards cover four domains in pharmaceutical regulatory processes: substance data, describing the medicine’s ingredients; product data about marketing information; organization data that involve contact details of organizations and individuals responsible for the medicine; and referential data, which provide preset vocabularies for information such as package codes, dosage, etc.
After that, the European regulator put together a task force to prepare for and monitor the progress. The first pre-submission phase is expected to begin in the first quarter of 2017 after the ISO technical specifications are finalized, falling slightly behind the original plan. And the agency intends to enforce submission starting from no earlier than the beginning of 2018 and wrap up that critical phase in one year when the new format becomes mandatory.
Once the EMA launches ISO documents and implementation guidance, biopharmas are supposed to start changing their current data submission format to the new HL7 SPL format based on the new standards. The module developed by the Massachusetts-based CRO, dubbed Liquent InSight for IDMP, is intended to help companies navigate that new system.
The software, which the company boasts is fully compliant with the five ISO standards, has been added to Parexel’s regulatory information management (RIM) platform and is available either directly from the CRO or through its partner program. With this new product, Parexel could help its clients “gain a well-structured IDMP program with the potential to ensure compliance, provide greater efficiency, reduce costs, and simplify processes,” said Paul Bidez, VP of regulatory solutions at Parexel.