EMA IRIS Guide: How to Create, Submit and Manage IRIS applications, for Industry and Individual applicants

In the ever-evolving regulatory landscape of EU pharmaceuticals, digital solutions are a linchpin for timely and transparent scientific interactions. The European Medicines Agency (EMA) has championed this digital transformation with IRIS "Integrated Review of Information System", its one-stop online portal for managing regulatory and scientific applications.

Pharmaceutical development involves complex procedures, from orphan drug designations to scientific advice requests and marketing status updates. To simplify and harmonize these processes, the European Medicines Agency (EMA) developed IRIS, an integrated online portal.

IRIS is designed as the central platform for submitting, tracking, and managing regulatory and scientific procedures with the EMA. It serves both industry stakeholders and individual applicants, delivering a harmonized digital interface for:

• Application creation and submission

• Communication management

• Regulatory entitlement tracking

• Collaborative multi-user input and oversight

Supported submission types in IRIS

• IRIS manages applications for a range of regulatory and scientific processes, including:

• Orphan designation applications and post-designation updates

• Scientific advice and protocol assistance

• PRIME eligibility requests

• Parallel distribution notifications

• Marketing status updates (including bulk uploads)

• ITF briefing meeting requests

• Paediatric investigation plans (PIP) and related activities

• GMP, GCP, and GVP inspections

• Veterinary signal management

• Product Lifecycle Management (PLM) procedures like variations, renewals, and safety updates.

📄 How to create and submit an application

• IRIS applications follow a consistent process:

  1. Log in and select “Create new submission” under “My Draft submissions.”

  2. Choose whether applying as an individual or on behalf of an organization.

  3. Select submission type (e.g., orphan designation, scientific advice).

  4. Add required details and upload documents.

  5. Assign managers and contributors (recommended: at least two managers).

  6. Generate the application form for your records.

  7. Complete the declaration and submit.

Each submission is given a unique reference number (e.g., EMA/OD/0000001234 for orphan designations or EMA/SA/0000001234 for scientific advice).

Managing applications after submission

• Track progress via “Ongoing Submissions.”

• Respond to EMA notifications by updating data or uploading new documents.

• Withdraw or delete drafts as needed.

• View regulatory entitlements linked to your organization.

• Manage contact persons to ensure timely communication.

Special features

• Research Product Identifiers (RPI): Identify specific research products.

• Parallel distribution procedures: Dedicated steps for product distribution within the EU.

• Marketing status updates: Notify the EMA about market launches, cessations, or withdrawals for centrally authorized products (CAPs).

• Scientific advice clarifications: Request clarifications on closed scientific advice cases.

For comprehensive instructions, detailed procedural walkthroughs, and the latest functionalities, applicants are encouraged to consult the full EMA IRIS Guide for Applicants.

Also check out this guidance about the New fee regulation working arrangements and New fee regulation: General questions and answers for all applicants