System for receiving, validation and reviewing marketing authorisation applications and other regulatory submissions for medicinal products

The Finnish Medicines Agency Fimea (later Fimea) is preparing the procurement of a system for receiving, validation and reviewing marketing authorisation applications for medicinal products and other regulatory submissions. Fimea is primarily looking for a software as a service (SaaS) off-the shelf solution that is provided from a public cloud. The system shall enable the necessary integrations with Fimea's other systems, which will be defined later. The procurement will also include the deployment, support and maintenance services for the system to be procured. Life cycles of the medicinal product dossiers (sequences and attributes) must be migrated to the system. Migration will be part of the procurement. The purpose of this request for information is to identify potential tenderers and to gather information on the solutions available on the market. Following the market dialogue, a call for tenders for the procurement will be prepared. DESCRIPTION The system to be procured shall support the receipt and validation of regulatory submissions, as well as the view and review of application materials. The system shall ensure a smooth and consistent user experience for the marketing authorisation specialists and to minimise manual steps through automated workflow functionalities. Preliminary requirements for the procurement are: - Data import functionalities: The solution shall support automated and manual import of regulatory submissions related to medicinal products. • Different types of submissions: o eCTD (electronic Common Technical Document, all formats), (v)NeeS (Non-eCTD electronic Submission), non-standard based submissions, ASMF (active substance master file), PSUR (Periodic Safety Update Report) • The sources of data: o Common European Submission Portal (CESP) o Other possible sources, e.g. EMA Common Repository (CR), Union Product Database (UPD), PSUR repository o Manual import of material (e.g. from email) to the system also enabled - The system sends a notification about a new submission and forms a job queue - Technical validation of regulatory submissions, including all versions of eCTD - Flexible dossier and sequence management for agency administrators - API capabilities: The system shall include flexible API capabilities to enable integrations with other relevant systems and repositories, such as case management systems and archiving solutions - User management: The system shall include advanced user management features, enabling the administration of access rights and roles for different user groups - View and review of the dossier in the system • Different view modes (single sequence vs. cumulative view of the application) • Advanced search functionalities • Possibility to use AI-assisted review: The system shall include or support the integration of AI#assisted tools - The location of the data needs to be in the EU region, and the cloud service provided by the service supplier