Pharma 4.0: Data-Driven Regulation January 18, 2022

Pharma 4.0: Data-Driven Regulation

Konstantin Koshechkin, Head of Electronic Solutions at Inpharmatis, spoke about how the digital transformation of the pharmaceutical industry is changing the regulatory environment in the European Union.

Konstantin Koshechkin noted that eCTD 4.0 being implemented in the global markets to have become one of the key trends affecting the legislation regulating pharma industry. Moreover, some countries immediately implement this format, even if they have not previously used earlier versions.

“Speaking about the drug registration process as a whole, we should emphasize that electronic solutions are becoming an integral part of the regulatory lifecycle. One of the requirements for such software is end-to-end automation. Digital transformation has grown especially important in the recent two years due to the pandemic. The life and health of people depends on the speed of approval of new, really effective drugs,” added Konstantin Koshechkin.

According to the expert, new solutions introduced into regulatory practice should be suitable both for working with the dossier and submissions, and for automating the internal work of the regulatory agency, ensuring effective planning and management of registration procedures.

“One of the comprehensive solutions that Inpharmatis implements in the Russian, CIS and EAEU markets is EXTEDOPulse. This comprehensive solution supports regulatory agency with means of a portal that is used for keeping all the necessary data and downloading the submitted dossiers. The next step is validation, which is performed automatically. During the validation process, dossiers are compared with structured data from references describing the medicinal product,” said Konstantin Koshechkin.

Information on medicinal products is generated on the basis of data packages prepared according with IDMP standards. These data should be built on the basis of directories of international non-proprietary names, dosage forms, dosages, names of organizations, and so on. To maintain such directories, the Sporify system has been developed in Europe, where the applicant must enter information before he can use it to describe the medicinal product.

Konstantin Koshechkin noted that before an automated system is introduced, we should carefully assess if both the industry and the regulatory agency are ready for such transition. To do so, at the stage of implementation, a pilot group is selected, where the approbation is carried out. Only upon successful completion of testing, the system is put into commercial operation.

“Naturally, it is impossible to move from paper submissions to making decisions digitally at once. Currently creation of documents still remains an important task. In this case, the role of validation increases significantly since it will be necessary to ensure the identity of documents and structured information. Automation of registration procedures allows, after the end of the assessment process, to reuse the data if required. For example, for electronic prescriptions, monitoring the availability and tracking the movement of medicines, etc.,” commented Konstantin Koshechkin.