On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide "IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants" for industry professionals and individual applicants on how to effectively use the IRIS platform for regulatory submissions. The IRIS (Integrated Regulatory Information System) platform is designed to streamline processes such as application submissions and management, enhancing transparency and efficiency in regulatory activities.
The IRIS platform is a centralized system for handling applications related to medicines regulation within the European Union (EU). It integrates various regulatory processes, including orphan designation requests, scientific advice, and more. This system allows applicants to submit, track, and manage their regulatory interactions in a streamlined manner.
IRIS has been developed to provide applicants with instructions on preparing, submitting, and managing applications and data for scientific procedures (orphan designation applications, scientific advice, requests for ITF briefing meetings, PRIME, marketing status reports, inspections, veterinary signal management) and related activities, including Parallel Distribution requests.
Key Steps for Applicants
Creating an Account: Applicants must first register on the IRIS platform. The registration process requires submitting certain details and verifying the applicant's credentials. Once registered, applicants can access the system to begin their submissions.
Creating an Application: The IRIS platform allows users to create new applications by selecting the appropriate regulatory procedure, such as orphan designation or scientific advice. The system provides a guided interface to ensure that applicants input all necessary data for the specific regulatory request.
Submitting an Application: Once the application form is completed and all necessary documentation is attached, the user can submit it for review. The IRIS platform ensures that submissions meet the required format and content standards, reducing the likelihood of errors that could delay the review process.
Managing Submissions: After submission, the IRIS platform allows applicants to track the status of their applications, respond to requests for additional information, and view decision outcomes. The system offers real-time updates on the progress of the regulatory review.
The EMA IRIS guide serves as a valuable tool for applicants navigating the regulatory submission process within the EU. By using the IRIS platform, applicants benefit from a more efficient, transparent, and organized system for submitting and managing regulatory applications.
For more detailed information, applicants can access the full IRIS Guide for Applicants here.
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